ObesityPhase 4STRIVENCT03036800
Saxenda in Obesity Services (STRIVE Study)
A Phase 4 study testing Saxenda and Specialist Obesity Management Services in people with Obesity and Weight Loss, run by University of Leicester at 5 sites in 2 countries.
Trial summary
A two year, parallel, two group, open-label, real-world randomised controlled trial (RCT) design for subjects with severe and complex obesity who are referred to a Tier 3 or equivalent specialist weight management/obesity service. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity, Weight Loss, Diabetes Mellitus
- What is being tested?
- Saxenda and Specialist Obesity Management Services
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 28 Nov 2017to 25 Feb 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be aged between 18-75 years old (inclusive)
- understand written and spoken English
- be able to give in informed consent
- a body mass index ≥35 kg/m2,
- have been referred to Tier 3 weight management or equivalent service in one of the five participating sites,
- have a stable body weight (less than 5kg self-reported change during the previous 12 weeks),
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- Participant must be able to meet at least one of the inclusion criteria listed below:
- prediabetes (defined as established diagnosis of impaired fasting glycaemia (IFG) from GP and/or established diagnosis of impaired glucose tolerance (IGT) from GP and/or HbA1C 42-47 mmol/mol (6-6.4%) without glucose lowering medications, at a blood test during the last 6 months) and/or
- type 2 diabetes [defined as established diagnosis of Type II diabetes from GP and/or HbA1C ≥48 mmol/mol (>6.5%) at a blood test during the last 6 months] being treated with any combination of lifestyle, metformin, sulphonylureas, thiazolidinediones (TZDs) or SGLT-2, and/or
- hypertension treated (defined as being on antihypertensive treatment with or without a diagnosis of hypertension from GP) or untreated (defined as Systolic Blood Pressure (SBP) ≥140 mmHg at two consecutive visits at the Tier 3 clinic), and/or
- obstructive sleep apnoea (on CPAP or established diagnosis of Apnoea Hypopnoea Index ≥15 at sleep studies during the last 12 months)
Who cannot join
- Diagnosis of Type 1 diabetes
- Type 2 diabetes with treatment on DPP-IV or insulin currently
- Treatment with GLP-1 receptor agonists within the last 6 months and/or have a history of GLP-1 receptor agonist intolerance.
- Treatment with anti-obesity drugs within the last 12 weeks prior to randomisation
- eGFR ≤30ml/min/1.73m2 on serum testing over the last 26 weeks
- Females referred to the clinic because of fertility problem
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- Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using or willing to use adequate contraceptive methods during the study period
- Have terminal illness
- Are not primarily responsible for their own care
- Not willing or able to give informed consent
- Any other significant disease or disorder which in the opinion of the investigator, may either put the participants at risk or may influence the result of the study or the participant's ability to participate
- Untreated or uncontrolled hypothyroidism/hyperthyroidism defined as thyroid- stimulating hormone >6 mIU/liter or <0.4 mIU/liter
- Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
- Personal history of non-familial medullary thyroid carcinoma
- History of chronic pancreatitis or idiopathic acute pancreatitis
- Amylase levels three times higher than the upper normal range
- Obesity induced by other endocrinologic disorders (e.g. Cushing's Syndrome)
- Current or history of treatment with medications that may cause significant weight gain, within 12 weeks prior to screening, including systemic corticosteroids (except for a short course of treatment, i.e. 7-10 days), atypical antipsychotic and mood stabilizers (e.g. clozapine, olanzapine, valproic acid and its derivatives, and lithium)
- History of major depressive episode during the last 2 years
- History of initiation of antidepressants during the last 12 weeks
- Simultaneous participation in other clinical trials of investigational drugs, lifestyle or physical activity interventions.
- Previous surgical treatment for obesity (excluding liposuction if performed >1 year before trial entry)
- History of other severe psychiatric disorders
- History of known or suspected abuse of alcohol and/or narcotics
- History of major depressive episode during the last 2 years
- Simultaneous participation in other clinical trials of investigational drugs, lifestyle or physical activity interventions. Patients will only be able to take part following participation in a previous clinical trial after a wash-out period of 16 weeks.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United Kingdom4 sites
NHS Greater Glasgow and Clyde West Glasgow Ambulatory Care Hospital
Glasgow
University Hospitals of Leicester NHS Trust, Leicester General Hospital
Leicester
University Hospital Aintree
Liverpool
Guy's and St Thomas' NHS Foundation Trust
London
About this study
Official title: EFFECTIVENESS AND COST OF INTEGRATING A PROTOCOL WITH USE OF LIRAGLUTIDE 3.0 MG INTO AN OBESITY SERVICE: (STRIVE Study)
A two year, parallel, two group, open-label, real-world randomised controlled trial (RCT) design for subjects with severe and complex obesity who are referred to a Tier 3 or equivalent specialist weight management/obesity service. Participants will be randomised to receive 1) standard care (obesity-specialist care), or 2) targeted prescribing pathway (obesity-specialist care plus targeted use of Liraglutide 3.0mg [LIRA 3mg] with pre-specified stopping rules for the medication). The aim of the study is to compare the effectiveness, budget impact, and cost-effectiveness between the two groups in a real-world setting among otherwise largely unselected patients.
Read the detailed description
Summary of Trial Design A two year, parallel, two group, open-label, real-world, RCT design for patients with severe and complex obesity who are referred to a Tier 3 obesity service (including patients who are referred to a Tier 3 service as part of the bariatric surgery pathway). The total duration of participation will be 104 weeks (+/-2 weeks).
The first 52 weeks of the study (after randomisation) will determine whether using the targeted prescribing pathway in a Tier 3 setting will result in more participants attaining ≥15% weight loss compared with standard care. The second 52 weeks of the study will assess whether patients who lose ≥15% of their baseline weight by the first 52 weeks are more likely to maintain ≥15% weight loss for another 52 weeks in the targeted prescribing pathway compared with standard care. Further, budget impact, cost-effectiveness, improvement in obesity-related co-morbidities, complementary aspects of safety, effectiveness, adherence, and treatment satisfaction of both treatment groups will be assessed and compared.
Participants will be randomised in a 2:1 fashion to either the intervention (targeted prescribing pathway + standard care) or control (standard care) group (2 intervention: 1 control). The control group will receive standard care in a specialist obesity service (Tier 3 or equivalent), according to the best practice in each site and can include total or partial meal replacement strategies. The intervention group will receive the same standard care as the control group (i.e. according to the best practice in each site) plus all participants will initially receive LIRA with pre-specified stopping rules. The targeted prescribing pathway: participants who do not meet the definition of a 'early and good responder' (defined as achieving ≥5% weight loss at 16 weeks, ≥10% weight loss at 32 weeks and ≥15% weight loss at 52 weeks) will have their LIRA 3mg treatment stopped. It is important to note that all participants will be analysed in the group to which they are randomised; in particular, participants in the intervention group who stop receiving LIRA 3mg will remain in the intervention group and will continue to receive standard care for the remainder of the study as per the targeted prescribing pathway (albeit, the part of the pathway where LIRA 3mg is not prescribed; see Figure 1).
The study is intentionally designed to reflect a pragmatic "real-world" scenario and each Tier 3 provider may require a different number of visits for their programme. However, study appointments for data collection, titration reviews, application of the stopping rules of LIRA 3mg, and dispensing will be standardised for all of the five sites.
Intervention (Targeted Prescribing Pathway)
The NHS Weight Management pathway is divided into four distinct tiers:
Tier 1: health promotion Tier 2: lifestyle interventions Tier 3: specialist multidisciplinary weight management services Tier 4: bariatric surgery
Across the UK, each region has a specialist Tier 3 obesity and/or weight management service or equivalent, usually referred to as Tier 3. This includes a clinician led multidisciplinary team approach, potentially including a specialist physician, nurse, dietician, psychologist, physiotherapist, etc. From this point forwards, Tier 3 specialist weight management and/or equivalent services will be referred to as 'Tier 3' throughout the remainder of this protocol.
Participants in the intervention group will receive the same standard care as those in the control group, i.e. the best medical practice delivered by the Tier 3 service at each site. Additionally, at baseline, LIRA 3mg will be prescribed to all of the participants in the intervention group at a starting dose of 0.6mg daily. Dose escalation of Liraglutide will occur according to a pre-specified titration protocol, from 0.6mg to a maximum of 3.0mg daily. Liraglutide dose will be initiated at 0.6mg and then increased to 1.2mg in Week 2, 1.8mg in Week 3, 2.4mg in Week 4, and 3.0mg in Week 5. Participants in the intervention group will be aware that the LIRA 3mg treatment may be stopped at various time points throughout the duration of the study and that continued use of LIRA 3mg is based upon their response to the treatment in terms of them achieving pre-defined weight loss targets at 16, 32 and 52 weeks.. Specifically, participants in the intervention group will continue to be prescribed LIRA 3mg for the 104 week duration of the study, unless one of the following stopping rules applies:
- st stopping rule: After 16 weeks (± 14 days) on the medication, only those participants who have lost ≥5% of their baseline weight will be offered further treatment with LIRA 3mg for another 16 weeks. Participants who have not met this weight loss target will have their LIRA 3mg treatment stopped but will still continue in the targeted prescribing pathway but will receive standard care only during the remainder of the study.
- nd stopping rule: After 32 weeks (± 14 days) on the medication, only those participants who have lost ≥10% of their baseline weight and are still on treatment with LIRA 3mg will be offered another 20 weeks on LIRA 3mg. Participants who have not met this weight loss target will have their LIRA 3mg treatment stopped but will still continue in the targeted prescribing pathway but will receive standard care only during the remainder of the study.
- rd stopping rule: After the first year of treatment (week 52; ± 14 days), only those participants who have lost ≥15% of their baseline weight and are still on treatment with LIRA 3mg will be offered another 52 weeks on LIRA 3mg. Participants who have not met this weight loss target will have their LIRA 3mg treatment stopped but will still continue in the targeted prescribing pathway but will receive standard care only during the remainder of the study.
Participants who fail to reach the pre-defined weight-loss targets to continue LIRA 3mg treatment, or who choose to stop receiving LIRA 3mg, will continue to be offered the standard care provided by the Tier 3 service. These participants will still attend the Clinical Review Visits but not the additional visits for participants who are still on LIRA 3mg (e.g. Weeks 65 \& 91) because these visits will not be relevant to them; visits at Weeks 65 and 91 are intended to provide a new prescription of LIRA 3mg and to discuss adherence and any side effects;; see Appendices 2 \& 3).
Participants will remain routinely in the Tier 3 service in-line with NICE guidance throughout the duration of the research study. Participants may be offered treatment options within the duration of the study, including bariatric surgery, as per NICE guidance and according to the decision of the local Tier 3 Multidisciplinary Team. Participants who have undergone bariatric surgery after randomisation will only be included in the intention to treat (ITT) analysis. This decision was made because the proportion of participants undergoing bariatric surgery is likely to be unbalanced between the treatment groups (i.e. more participants in the control group are expected to have bariatric surgery than in the targeted prescribing pathway treatment group), and thus weight loss in these individuals could unduly influence the study results. Participants who have been prescribed and start anti-obesity medication (such as Orlistat) will be ineligible for LIRA 3mg treatment.
Control (Standard Care) Participants in the control group will follow the best medical care provided by the Tier 3 service at the relevant site. This typically involves dietary advice to reduce energy intake (and may include a period of partial or total meal replacement), accompanied - if available - by a physical activity programme, both supported by behavioural change techniques with regular professional contacts. The nature of the standard care will vary between the different Tier 3 services at each site, as this is a pragmatic 'real-world' study. Clinician input will include the medical assessment of participants for severe and complicated obesity and the prescription of anti-obesity drugs (such as Orlistat) as per local Tier 3 service policy. As with the LIRA 3mg group those patients taking antihypertensive or antidepressant medication will be assessed and it will be at the clinician's discretion as to whether these medications are changed. Participants will remain routinely in the Tier 3 service in-line with NICE guidance throughout the duration of the research study. Participants may be offered treatment options within the duration of the study, including bariatric surgery, as per NICE guidance and according to the decision of the local Tier 3 Multidisciplinary Team.
- Conditions
- Obesity, Weight Loss, Diabetes Mellitus
- Being tested
- Saxenda, Specialist Obesity Management Services
- Medical subject headings
- Obesity, Weight Loss, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaxendaDrug
Also called Liraglutide 3mg
standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose)
Specialist Obesity Management ServicesOther
Specialist Obesity Management Services standard of care
| Study group | Role | What they receive |
|---|---|---|
| Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Experimental | Standard care plus targeted use of the intervention Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply Receives: Drug: Saxenda; Other: Specialist Obesity Management Services |
| Standard Care | Active comparator | standard Tier 3 obesity specialist service care Receives: Other: Specialist Obesity Management Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss of ≥15% From Baseline (Complete Cases)
Proportion of participants with severe and complicated obesity achieving weight loss of ≥15% at 52 weeks with the use of a targeted prescribing pathway (i.e. use of LIRA 3mg according to a pre-specified protocol in combination with standard care provided in Tier 3 services) versus standard care alone in a Tier 3 service.
Measured: 52 weeks
Weight Loss of ≥15% From Baseline (Intention to Treat)
Proportion of participants with severe and complicated obesity achieving weight loss of ≥15% at 52 weeks with the use of a targeted prescribing pathway (i.e. use of LIRA 3mg according to a pre-specified protocol in combination with standard care provided in Tier 3 services) versus standard care alone in a Tier 3 service.
Measured: 52 weeks
Weight Loss of ≥15% From Baseline (Per Protocol)
Proportion of participants with severe and complicated obesity achieving weight loss of ≥15% at 52 weeks with the use of a targeted prescribing pathway (i.e. use of LIRA 3mg according to a pre-specified protocol in combination with standard care provided in Tier 3 services) versus standard care alone in a Tier 3 service.
Measured: 52 weeks
Weight Loss of ≥15% From Baseline (Per Protocol Without Excluded Concomitant Medications)
Proportion of participants with severe and complicated obesity achieving weight loss of ≥15% at 52 weeks with the use of a targeted prescribing pathway (i.e. use of LIRA 3mg according to a pre-specified protocol in combination with standard care provided in Tier 3 services) versus standard care alone in a Tier 3 service.
Measured: 52 weeks
Secondary outcomes (77)
Participant Attendance at Appointments (Intention to Treat)
Attended at least 70% of scheduled Tier 3 appointments by 52 weeks
Measured: 52 weeks
Participant Attendance at Appointments (Intention to Treat)
Attended at least 70% of scheduled Tier 3 appointments by 104 weeks
Measured: 104 weeks
Cessation of Treatment Due to Adverse Effects (Intention to Treat)
Derived binary indicator showing whether participant stopped treatment with liraglutide 3mg by 52 weeks because of adverse effects (i.e., the main reason for stopping was listed as 'adverse event' or 'unable to tolerate drug'). This number does not include people who stopped treatment due to a stopping rule or reason other than an adverse effect. Only defined for participants who were currently eligible for liraglutide 3mg treatment. Participants may have stopped treatment due to adverse effects at an earlier timepoint and so the total number of 'yes' and 'no' responses is higher than the number eligible for liraglutide 3mg at the analysis time-point, i.e. if a participant stopped at week 16 due to adverse events then they would still be included in the 'yes' response.
Measured: 52 weeks
Cessation of Treatment Due to Adverse Effects (Intention to Treat)
Derived binary indicator showing whether participant stopped treatment with liraglutide 3mg by 104 weeks because of adverse effects (i.e., the main reason for stopping was listed as 'adverse event' or 'unable to tolerate drug'). This number does not include people who stopped treatment due to a stopping rule or reason other than an adverse effect. Only defined for participants who were currently eligible for liraglutide 3mg treatment. Participants may have stopped treatment due to adverse effects at an earlier timepoint and so the total number of 'yes' and 'no' responses is higher than the number eligible for liraglutide 3mg at the analysis time-point, i.e. if a participant stopped at week 16 due to adverse events then they would still be included in the 'yes' response.
Measured: 104 weeks
Participant Compliance With Treatment (Intention to Treat)
Derived binary indicator showing whether participant was compliant with liraglutide 3mg treatment up to 52 weeks. This was defined using the questionnaire answers as detailed in Appendix 7 of the SAP, and so includes all participants (i.e., not only those who attended the visit) up to the point when they stopped treatment or withdrew from the study.
Measured: 52 weeks
Participant Compliance With Treatment (Intention to Treat)
Derived binary indicator showing whether participant was compliant with liraglutide 3mg treatment up to 104 weeks. This was defined using the questionnaire answers as detailed in Appendix 7 of the SAP, and so includes all participants (i.e., not only those who attended the visit) up to the point when they stopped treatment or withdrew from the study.
Measured: 104 weeks
Patient Stopping of Treatment (Intention to Treat)
Derived binary indicator showing whether participant had stopped treatment with liraglutide 3mg at 16 weeks (due to stopping rules or other reason, such as an adverse event despite passing the stopping rule). Only defined for participants who were on liraglutide 3mg treatment at the previous time-point.
Measured: 16 weeks
Patient Stopping of Treatment (Intention to Treat)
Derived binary indicator showing whether participant had stopped treatment with liraglutide 3mg at 32 weeks (due to stopping rules or other reason, such as an adverse event despite passing the stopping rule). Only defined for participants who were on liraglutide 3mg treatment at the previous time-point.
Measured: 32 weeks
Patient Stopping of Treatment (Intention to Treat)
Derived binary indicator showing whether participant had stopped treatment with liraglutide 3mg at 52 weeks (due to stopping rules or other reason, such as an adverse event despite passing the stopping rule). Only defined for participants who were on liraglutide 3mg treatment at the previous time-point.
Measured: 52 weeks
Completion of Tier 3 Despite Liraglutide Cessation by 16 Weeks (Intention to Treat)
Derived binary indicator showing whether participant completed 52 weeks of the Tier 3 service programme despite stopping liraglutide 3mg at 16 weeks (due to stopping rules or other reason). Only defined for participants who stopped liraglutide 3mg treatment at 16 weeks.
Measured: 52 weeks
Completion of Tier 3 Despite Liraglutide Cessation by 32 Weeks (Intention to Treat)
Derived binary indicator showing whether participant completed 52 weeks of the Tier 3 service programme despite stopping liraglutide 3mg at 32 weeks (due to stopping rules or other reason). Only defined for participants who stopped liraglutide 3mg treatment at 32 weeks.
Measured: 52 weeks
Started on Anti-obesity Drugs at 52 Weeks (Intention to Treat)
Derived binary indicator showing whether participant started on anti-obesity drugs other than liraglutide (defined as a concomitant medication listing of Orlistat) at 52 weeks.
Measured: 52 weeks
Started on Anti-obesity Drugs at 104 Weeks (Intention to Treat)
Derived binary indicator showing whether participant started on anti-obesity drugs other than liraglutide (defined as a concomitant medication listing of Orlistat) at 104 weeks.
Measured: 104 weeks
Referral to Other Obesity Interventions (Intention to Treat)
Number of participants referred to Tier 4 for bariatric surgery over the 104 weeks study period
Measured: 104 weeks
Referral to Other Obesity Interventions by Site (Intention to Treat)
Referrals for bariatric surgery by 104 weeks, stratified by study site.
Measured: 104 weeks
Bariatric Surgery Completion (Intention to Treat)
Number of participants who underwent bariatric surgery by 104 weeks.
Measured: 104 weeks
Weight Loss of ≥5% From Baseline (Complete Cases)
Proportion of participants reaching weight loss of ≥5% from baseline, at 16 weeks.
Measured: 16 weeks
Weight Loss of ≥5% From Baseline (Complete Cases)
Proportion of participants reaching weight loss of ≥5% from baseline, at 32 weeks.
Measured: 32 weeks
Weight Loss of ≥5% From Baseline (Complete Cases)
Proportion of participants reaching weight loss of ≥5% from baseline, at 52 weeks.
Measured: 52 weeks
Weight Loss of ≥5% From Baseline (Complete Cases)
Proportion of participants reaching weight loss of ≥5% from baseline, at 104 weeks.
Measured: 104 weeks
Weight Loss of ≥10% From Baseline (Complete Cases)
Proportion of participants reaching weight loss of ≥10% from baseline, at 16 weeks.
Measured: 16 weeks
Weight Loss of ≥10% From Baseline (Complete Cases)
Proportion of participants reaching weight loss of ≥10% from baseline, at 32 weeks.
Measured: 32 weeks
Weight Loss of ≥10% From Baseline (Complete Cases)
Proportion of participants reaching weight loss of ≥10% from baseline, at 52 weeks.
Measured: 52 weeks
Weight Loss of ≥10% From Baseline (Complete Cases)
Proportion of participants reaching weight loss of ≥10% from baseline, at 104 weeks.
Measured: 104 weeks
Weight Loss of ≥15% From Baseline (Complete Cases)
Proportion of participants reaching weight loss of ≥15% from baseline at 16 weeks.
Measured: 16 weeks
Weight Loss of ≥15% From Baseline (Complete Cases)
Proportion of participants reaching weight loss of ≥15% from baseline at 32 weeks.
Measured: 32 weeks
Weight Loss of ≥15% From Baseline (Complete Cases)
Proportion of participants reaching weight loss of ≥15% from baseline at 104 weeks.
Measured: 104 weeks
Maintenance of ≥15% Weight Loss Until 104 Weeks (Complete Cases)
Proportion of participants maintaining weight loss of ≥15% among those who lost ≥15% at 52 weeks
Measured: 104 weeks
Absolute Weight Change (Complete Cases)
Absolute change in weight (kg) from baseline
Measured: 16 weeks
Absolute Weight Change (Complete Cases)
Absolute change in weight (kg) from baseline
Measured: 32 weeks
Absolute Weight Change (Complete Cases)
Absolute change in weight (kg) from baseline
Measured: 52 weeks
Absolute Weight Change (Complete Cases)
Absolute change in weight (kg) from baseline
Measured: 104 weeks
Percentage Weight Change (Complete Cases)
Percentage change in weight from baseline
Measured: 16 weeks
Percentage Weight Change (Complete Cases)
Percentage change in weight from baseline
Measured: 32 weeks
Percentage Weight Change (Complete Cases)
Percentage change in weight from baseline
Measured: 52 weeks
Percentage Weight Change (Complete Cases)
Percentage change in weight from baseline
Measured: 104 weeks
Absolute BMI Change (Complete Cases)
Absolute change in BMI (kg/m2) from baseline
Measured: 52 weeks
Absolute BMI Change (Complete Cases)
Absolute change in BMI (kg/m2) from baseline
Measured: 104 weeks
Absolute Waist Circumference Change (Complete Cases)
Absolute change in waist circumference (cm) from baseline
Measured: 52 weeks
Absolute Waist Circumference Change (Complete Cases)
Absolute change in waist circumference (cm) from baseline
Measured: 104 weeks
Kings College Obesity Staging (KCOS) Score (Complete Cases)
Kings College Obesity Staging (KCOS) score; range 0 to 3. A higher value corresponds with higher complications and worse outcomes.
Measured: 52 weeks
Kings College Obesity Staging (KCOS) Score (Complete Cases)
Kings College Obesity Staging (KCOS) score; range 0 to 3. A higher value corresponds with higher complications and worse outcomes.
Measured: 104 weeks
Patient Health Questionnaire-9 (Complete Cases)
Patient health questionnaire-9 (PHQ-9) score; range 0 to 27. A higher value corresponds with higher complications and worse outcomes.
Measured: 52 weeks
Patient Health Questionnaire-9 (Complete Cases)
Patient health questionnaire-9 (PHQ-9) score; range 0 to 27. A higher value corresponds with higher complications and worse outcomes.
Measured: 104 weeks
Epworth Sleepiness Scale (Complete Cases)
Epworth sleepiness scale, used to diagnose obstructive sleep apnoea; scale 0 to 24.
A higher value corresponds with a worse outcome.
Measured: 52 weeks
Epworth Sleepiness Scale (Complete Cases)
Epworth sleepiness scale, used to diagnose obstructive sleep apnoea; scale 0 to 24.
A higher value corresponds with a worse outcome.
Measured: 104 weeks
Stop Bang Questionnaire (Complete Cases)
Stop Bang questionnaire, used to diagnose obstructive sleep apnoea; scale 0 to 8.
A higher value corresponds with a worse outcome.
Measured: 52 weeks
Stop Bang Questionnaire (Complete Cases)
Stop Bang questionnaire, used to diagnose obstructive sleep apnoea; scale 0 to 8.
A higher value corresponds with a worse outcome.
Measured: 104 weeks
Glycaemic Status (Complete Cases)
Glycaemic status, as determined by plasma glucose concentration. The glycaemic status definition states that a participant cannot be categorised as 'diabetes remission' if they are currently using liraglutide 3mg, which means that the absence of diabetes remission cases at follow-up in the intervention group is partly by definition of glycaemic status.
Measured: 52 weeks
Glycaemic Status (Complete Cases)
Glycaemic status, as determined by plasma glucose concentration. The glycaemic status definition states that a participant cannot be categorised as 'diabetes remission' if they are currently using liraglutide 3mg, which means that the absence of diabetes remission cases at follow-up in the intervention group is partly by definition of glycaemic status.
Measured: 104 weeks
HbA1c ≤7% for Those With Diabetes at Baseline (Complete Cases)
Proportion of participants HbA1c ≤7% at 52 weeks, among those with diabetes at baseline.
Measured: 52 weeks
HbA1c ≤7% for Those With Diabetes at Baseline (Complete Cases)
Proportion of participants HbA1c ≤7% at 104 weeks, among those with diabetes at baseline.
Measured: 104 weeks
HbA1c ≤6.5% for Those With Diabetes at Baseline (Complete Cases)
Proportion of participants HbA1c ≤6.5% at 52 weeks, among those with diabetes at baseline.
Measured: 52 weeks
HbA1c ≤6.5% for Those With Diabetes at Baseline (Complete Cases)
Proportion of participants HbA1c ≤6.5% at 104 weeks, among those with diabetes at baseline.
Measured: 104 weeks
Hypertension (Complete Cases)
Proportion of participants with hypertension at 52 weeks.
Measured: 52 weeks
Hypertension (Complete Cases)
Proportion of participants with hypertension at 104 weeks.
Measured: 104 weeks
Weight Loss of ≥5% From Baseline (Responder Population)
Proportion of participants reaching weight loss of ≥5% from baseline at 16 weeks.
Measured: 16 weeks
Weight Loss of ≥5% From Baseline (Responder Population)
Proportion of participants reaching weight loss of ≥5% from baseline at 32 weeks.
Measured: 32 weeks
Weight Loss of ≥5% From Baseline (Responder Population)
Proportion of participants reaching weight loss of ≥5% from baseline at 52 weeks.
Measured: 52 weeks
Weight Loss of ≥5% From Baseline (Responder Population)
Proportion of participants reaching weight loss of ≥5% from baseline at 104 weeks.
Measured: 104 weeks
Weight Loss of ≥10% From Baseline (Responder Population)
Proportion of participants reaching weight loss of ≥10% from baseline at 16 weeks.
Measured: 16 weeks
Weight Loss of ≥10% From Baseline (Responder Population)
Proportion of participants reaching weight loss of ≥10% from baseline at 32 weeks.
Measured: 32 weeks
Weight Loss of ≥10% From Baseline (Responder Population)
Proportion of participants reaching weight loss of ≥10% from baseline at 52 weeks.
Measured: 52 weeks
Weight Loss of ≥10% From Baseline (Responder Population)
Proportion of participants reaching weight loss of ≥10% from baseline at 104 weeks.
Measured: 104 weeks
Weight Loss of ≥15% From Baseline (Responder Population)
Proportion of participants reaching weight loss of ≥15% from baseline at 16 weeks.
Measured: 16 weeks
Weight Loss of ≥15% From Baseline (Responder Population)
Proportion of participants reaching weight loss of ≥15% from baseline at 32 weeks.
Measured: 32 weeks
Weight Loss of ≥15% From Baseline (Responder Population)
Proportion of participants reaching weight loss of ≥15% from baseline at 52 weeks.
Measured: 52 weeks
Weight Loss of ≥15% From Baseline (Responder Population)
Proportion of participants reaching weight loss of ≥15% from baseline at 104 weeks.
Measured: 104 weeks
Maintenance of ≥15% Weight Loss Until 104 Weeks (Responder Population)
Proportion of participants who maintained weight loss of ≥15% among those who lost ≥15% at 52 weeks.
Measured: 104 weeks
Percentage Weight Change (Responder Population)
Percentage change in weight from baseline
Measured: 16 weeks
Percentage Weight Change (Responder Population)
Percentage change in weight from baseline
Measured: 32 weeks
Percentage Weight Change (Responder Population)
Percentage change in weight from baseline
Measured: 52 weeks
Percentage Weight Change (Responder Population)
Percentage change in weight from baseline
Measured: 104 weeks
Absolute BMI Change (Responder Population)
Absolute change in BMI (kg/m2) from baseline
Measured: 52 weeks
Absolute BMI Change (Responder Population)
Absolute change in BMI (kg/m2) from baseline
Measured: 104 weeks
Absolute Waist Circumference Change (Responder Population)
Absolute change in waist circumference (cm) from baseline
Measured: 52 weeks
Absolute Waist Circumference Change (Responder Population)
Absolute change in waist circumference (cm) from baseline
Measured: 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start28 Nov 2017
- Primary completion28 Feb 2021
- Study completion25 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Sponsor
- Investigators
- Melanie Davies, Prof, Principal investigator, Univesrity of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036800
- Sponsor's protocol ID
- 0626
- Acronym
- STRIVE
- Status last verified
- Jan 2023
- First submitted
- 20 Dec 2016
- Last updated
- 13 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Papamargaritis D, Al-Najim W, Lim JZM, Crane J, Bodicoat DH, Barber S, Lean M, McGowan B, O'Shea D, Webb DR, Wilding JPH, le Roux CW, Davies MJ. Effectiveness of integrating a pragmatic pathway for prescribing liraglutide 3.0 mg in weight management services (STRIVE study): a multicentre, open-label, parallel-group, randomized controlled trial. Lancet Reg Health Eur. 2024 Feb 9;39:100853. doi: 10.1016/j.lanepe.2024.100853. eCollection 2024 Apr.
PubMed 38803628Papamargaritis D, Al-Najim W, Lim J, Crane J, Lean M, le Roux C, McGowan B, O'Shea D, Webb D, Wilding J, Davies MJ. Effectiveness and cost of integrating a pragmatic pathway for prescribing liraglutide 3.0 mg in obesity services (STRIVE study): study protocol of an open-label, real-world, randomised, controlled trial. BMJ Open. 2020 Feb 13;10(2):e034137. doi: 10.1136/bmjopen-2019-034137.
PubMed 32060156
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTIVENESS AND COST OF INTEGRATING A PROTOCOL WITH USE OF LIRAGLUTIDE 3.0 MG INTO AN OBESITY SERVICE: (STRIVE Study)
- ClinicalTrials.gov ID
- NCT03036800
- Acronym / sponsor ID
- STRIVE / 0626
- Conditions
- Obesity, Weight Loss, Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 25 Feb 2022 (actual)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Posted 13 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A two year, parallel, two group, open-label, real-world randomised controlled trial (RCT) design for subjects with severe and complex obesity who are referred to a Tier 3 or equivalent specialist weight management/obesity service. Participants will be randomised to receive 1) standard care (obesity-specialist care), or 2) targeted prescribing pathway (obesity-specialist care plus targeted use of Liraglutide 3.0mg [LIRA 3mg] with pre-specified stopping rules for the medication). The aim of the study is to compare the effectiveness, budget impact, and cost-effectiveness between the two groups in a real-world setting among otherwise largely unselected patients.
Detailed description
Summary of Trial Design A two year, parallel, two group, open-label, real-world, RCT design for patients with severe and complex obesity who are referred to a Tier 3 obesity service (including patients who are referred to a Tier 3 service as part of the bariatric surgery pathway). The total duration of participation will be 104 weeks (+/-2 weeks).
The first 52 weeks of the study (after randomisation) will determine whether using the targeted prescribing pathway in a Tier 3 setting will result in more participants attaining ≥15% weight loss compared with standard care. The second 52 weeks of the study will assess whether patients who lose ≥15% of their baseline weight by the first 52 weeks are more likely to maintain ≥15% weight loss for another 52 weeks in the targeted prescribing pathway compared with standard care. Further, budget impact, cost-effectiveness, improvement in obesity-related co-morbidities, complementary aspects of safety, effectiveness, adherence, and treatment satisfaction of both treatment groups will be assessed and compared.
Participants will be randomised in a 2:1 fashion to either the intervention (targeted prescribing pathway + standard care) or control (standard care) group (2 intervention: 1 control). The control group will receive standard care in a specialist obesity service (Tier 3 or equivalent), according to the best practice in each site and can include total or partial meal replacement strategies. The intervention group will receive the same standard care as the control group (i.e. according to the best practice in each site) plus all participants will initially receive LIRA with pre-specified stopping rules. The targeted prescribing pathway: participants who do not meet the definition of a 'early and good responder' (defined as achieving ≥5% weight loss at 16 weeks, ≥10% weight loss at 32 weeks and ≥15% weight loss at 52 weeks) will have their LIRA 3mg treatment stopped. It is important to note that all participants will be analysed in the group to which they are randomised; in particular, participants in the intervention group who stop receiving LIRA 3mg will remain in the intervention group and will continue to receive standard care for the remainder of the study as per the targeted prescribing pathway (albeit, the part of the pathway where LIRA 3mg is not prescribed; see Figure 1).
The study is intentionally designed to reflect a pragmatic "real-world" scenario and each Tier 3 provider may require a different number of visits for their programme. However, study appointments for data collection, titration reviews, application of the stopping rules of LIRA 3mg, and dispensing will be standardised for all of the five sites.
Intervention (Targeted Prescribing Pathway)
The NHS Weight Management pathway is divided into four distinct tiers:
Tier 1: health promotion Tier 2: lifestyle interventions Tier 3: specialist multidisciplinary weight management services Tier 4: bariatric surgery
Across the UK, each region has a specialist Tier 3 obesity and/or weight management service or equivalent, usually referred to as Tier 3. This includes a clinician led multidisciplinary team approach, potentially including a specialist physician, nurse, dietician, psychologist, physiotherapist, etc. From this point forwards, Tier 3 specialist weight management and/or equivalent services will be referred to as 'Tier 3' throughout the remainder of this protocol.
Participants in the intervention group will receive the same standard care as those in the control group, i.e. the best medical practice delivered by the Tier 3 service at each site. Additionally, at baseline, LIRA 3mg will be prescribed to all of the participants in the intervention group at a starting dose of 0.6mg daily. Dose escalation of Liraglutide will occur according to a pre-specified titration protocol, from 0.6mg to a maximum of 3.0mg daily. Liraglutide dose will be initiated at 0.6mg and then increased to 1.2mg in Week 2, 1.8mg in Week 3, 2.4mg in Week 4, and 3.0mg in Week 5. Participants in the intervention group will be aware that the LIRA 3mg treatment may be stopped at various time points throughout the duration of the study and that continued use of LIRA 3mg is based upon their response to the treatment in terms of them achieving pre-defined weight loss targets at 16, 32 and 52 weeks.. Specifically, participants in the intervention group will continue to be prescribed LIRA 3mg for the 104 week duration of the study, unless one of the following stopping rules applies:
- st stopping rule: After 16 weeks (± 14 days) on the medication, only those participants who have lost ≥5% of their baseline weight will be offered further treatment with LIRA 3mg for another 16 weeks. Participants who have not met this weight loss target will have their LIRA 3mg treatment stopped but will still continue in the targeted prescribing pathway but will receive standard care only during the remainder of the study.
- nd stopping rule: After 32 weeks (± 14 days) on the medication, only those participants who have lost ≥10% of their baseline weight and are still on treatment with LIRA 3mg will be offered another 20 weeks on LIRA 3mg. Participants who have not met this weight loss target will have their LIRA 3mg treatment stopped but will still continue in the targeted prescribing pathway but will receive standard care only during the remainder of the study.
- rd stopping rule: After the first year of treatment (week 52; ± 14 days), only those participants who have lost ≥15% of their baseline weight and are still on treatment with LIRA 3mg will be offered another 52 weeks on LIRA 3mg. Participants who have not met this weight loss target will have their LIRA 3mg treatment stopped but will still continue in the targeted prescribing pathway but will receive standard care only during the remainder of the study.
Participants who fail to reach the pre-defined weight-loss targets to continue LIRA 3mg treatment, or who choose to stop receiving LIRA 3mg, will continue to be offered the standard care provided by the Tier 3 service. These participants will still attend the Clinical Review Visits but not the additional visits for participants who are still on LIRA 3mg (e.g. Weeks 65 \& 91) because these visits will not be relevant to them; visits at Weeks 65 and 91 are intended to provide a new prescription of LIRA 3mg and to discuss adherence and any side effects;; see Appendices 2 \& 3).
Participants will remain routinely in the Tier 3 service in-line with NICE guidance throughout the duration of the research study. Participants may be offered treatment options within the duration of the study, including bariatric surgery, as per NICE guidance and according to the decision of the local Tier 3 Multidisciplinary Team. Participants who have undergone bariatric surgery after randomisation will only be included in the intention to treat (ITT) analysis. This decision was made because the proportion of participants undergoing bariatric surgery is likely to be unbalanced between the treatment groups (i.e. more participants in the control group are expected to have bariatric surgery than in the targeted prescribing pathway treatment group), and thus weight loss in these individuals could unduly influence the study results. Participants who have been prescribed and start anti-obesity medication (such as Orlistat) will be ineligible for LIRA 3mg treatment.
Control (Standard Care) Participants in the control group will follow the best medical care provided by the Tier 3 service at the relevant site. This typically involves dietary advice to reduce energy intake (and may include a period of partial or total meal replacement), accompanied - if available - by a physical activity programme, both supported by behavioural change techniques with regular professional contacts. The nature of the standard care will vary between the different Tier 3 services at each site, as this is a pragmatic 'real-world' study. Clinician input will include the medical assessment of participants for severe and complicated obesity and the prescription of anti-obesity drugs (such as Orlistat) as per local Tier 3 service policy. As with the LIRA 3mg group those patients taking antihypertensive or antidepressant medication will be assessed and it will be at the clinician's discretion as to whether these medications are changed. Participants will remain routinely in the Tier 3 service in-line with NICE guidance throughout the duration of the research study. Participants may be offered treatment options within the duration of the study, including bariatric surgery, as per NICE guidance and according to the decision of the local Tier 3 Multidisciplinary Team.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Experimental | Drug: Saxenda, Other: Specialist Obesity Management ServicesStandard care plus targeted use of the intervention Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply |
| Standard Care | Active comparator | Other: Specialist Obesity Management Servicesstandard Tier 3 obesity specialist service care |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- be aged between 18-75 years old (inclusive)
- understand written and spoken English
- be able to give in informed consent
- a body mass index ≥35 kg/m2,
- have been referred to Tier 3 weight management or equivalent service in one of the five participating sites,
Key exclusion criteria (26 listed)
- Diagnosis of Type 1 diabetes
- Type 2 diabetes with treatment on DPP-IV or insulin currently
- Treatment with GLP-1 receptor agonists within the last 6 months and/or have a history of GLP-1 receptor agonist intolerance.
- Treatment with anti-obesity drugs within the last 12 weeks prior to randomisation
- eGFR ≤30ml/min/1.73m2 on serum testing over the last 26 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SaxendaAlso: Liraglutide 3mgstandard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose) | Drug | Targeted Prescribing Pathway (LIRA 3mg + Standard Care) |
| Specialist Obesity Management ServicesSpecialist Obesity Management Services standard of care | Other | Standard Care, Targeted Prescribing Pathway (LIRA 3mg + Standard Care) |
Primary outcome
Weight Loss of ≥15% From Baseline (Complete Cases)
Time frame: 52 weeks
Proportion of participants with severe and complicated obesity achieving weight loss of ≥15% at 52 weeks with the use of a targeted prescribing pathway (i.e. use of LIRA 3mg according to a pre-specified protocol in combination with standard care provided in Tier 3 services) versus standard care alone in a Tier 3 service.
Weight Loss of ≥15% From Baseline (Intention to Treat)
Time frame: 52 weeks
Proportion of participants with severe and complicated obesity achieving weight loss of ≥15% at 52 weeks with the use of a targeted prescribing pathway (i.e. use of LIRA 3mg according to a pre-specified protocol in combination with standard care provided in Tier 3 services) versus standard care alone in a Tier 3 service.
Weight Loss of ≥15% From Baseline (Per Protocol)
Time frame: 52 weeks
Proportion of participants with severe and complicated obesity achieving weight loss of ≥15% at 52 weeks with the use of a targeted prescribing pathway (i.e. use of LIRA 3mg according to a pre-specified protocol in combination with standard care provided in Tier 3 services) versus standard care alone in a Tier 3 service.
Weight Loss of ≥15% From Baseline (Per Protocol Without Excluded Concomitant Medications)
Time frame: 52 weeks
Proportion of participants with severe and complicated obesity achieving weight loss of ≥15% at 52 weeks with the use of a targeted prescribing pathway (i.e. use of LIRA 3mg according to a pre-specified protocol in combination with standard care provided in Tier 3 services) versus standard care alone in a Tier 3 service.
77 secondary outcomes
Participant Attendance at Appointments (Intention to Treat)
Time frame: 52 weeks
Participant Attendance at Appointments (Intention to Treat)
Time frame: 104 weeks
Cessation of Treatment Due to Adverse Effects (Intention to Treat)
Time frame: 52 weeks
Cessation of Treatment Due to Adverse Effects (Intention to Treat)
Time frame: 104 weeks
Participant Compliance With Treatment (Intention to Treat)
Time frame: 52 weeks
Participant Compliance With Treatment (Intention to Treat)
Time frame: 104 weeks
Patient Stopping of Treatment (Intention to Treat)
Time frame: 16 weeks
Patient Stopping of Treatment (Intention to Treat)
Time frame: 32 weeks
Patient Stopping of Treatment (Intention to Treat)
Time frame: 52 weeks
Completion of Tier 3 Despite Liraglutide Cessation by 16 Weeks (Intention to Treat)
Time frame: 52 weeks
Completion of Tier 3 Despite Liraglutide Cessation by 32 Weeks (Intention to Treat)
Time frame: 52 weeks
Started on Anti-obesity Drugs at 52 Weeks (Intention to Treat)
Time frame: 52 weeks
Started on Anti-obesity Drugs at 104 Weeks (Intention to Treat)
Time frame: 104 weeks
Referral to Other Obesity Interventions (Intention to Treat)
Time frame: 104 weeks
Referral to Other Obesity Interventions by Site (Intention to Treat)
Time frame: 104 weeks
Bariatric Surgery Completion (Intention to Treat)
Time frame: 104 weeks
Weight Loss of ≥5% From Baseline (Complete Cases)
Time frame: 16 weeks
Weight Loss of ≥5% From Baseline (Complete Cases)
Time frame: 32 weeks
Weight Loss of ≥5% From Baseline (Complete Cases)
Time frame: 52 weeks
Weight Loss of ≥5% From Baseline (Complete Cases)
Time frame: 104 weeks
Weight Loss of ≥10% From Baseline (Complete Cases)
Time frame: 16 weeks
Weight Loss of ≥10% From Baseline (Complete Cases)
Time frame: 32 weeks
Weight Loss of ≥10% From Baseline (Complete Cases)
Time frame: 52 weeks
Weight Loss of ≥10% From Baseline (Complete Cases)
Time frame: 104 weeks
Weight Loss of ≥15% From Baseline (Complete Cases)
Time frame: 16 weeks
Weight Loss of ≥15% From Baseline (Complete Cases)
Time frame: 32 weeks
Weight Loss of ≥15% From Baseline (Complete Cases)
Time frame: 104 weeks
Maintenance of ≥15% Weight Loss Until 104 Weeks (Complete Cases)
Time frame: 104 weeks
Absolute Weight Change (Complete Cases)
Time frame: 16 weeks
Absolute Weight Change (Complete Cases)
Time frame: 32 weeks
Absolute Weight Change (Complete Cases)
Time frame: 52 weeks
Absolute Weight Change (Complete Cases)
Time frame: 104 weeks
Percentage Weight Change (Complete Cases)
Time frame: 16 weeks
Percentage Weight Change (Complete Cases)
Time frame: 32 weeks
Percentage Weight Change (Complete Cases)
Time frame: 52 weeks
Percentage Weight Change (Complete Cases)
Time frame: 104 weeks
Absolute BMI Change (Complete Cases)
Time frame: 52 weeks
Absolute BMI Change (Complete Cases)
Time frame: 104 weeks
Absolute Waist Circumference Change (Complete Cases)
Time frame: 52 weeks
Absolute Waist Circumference Change (Complete Cases)
Time frame: 104 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38803628Papamargaritis D, Al-Najim W, Lim JZM, Crane J, Bodicoat DH, Barber S, Lean M, McGowan B, O'Shea D, Webb DR, Wilding JPH, le Roux CW, Davies MJ. Effectiveness of integrating a pragmatic pathway for prescribing liraglutide 3.0 mg in weight management services (STRIVE study): a multicentre, open-label, parallel-group, randomized controlled trial. Lancet Reg Health Eur. 2024 Feb 9;39:100853. doi: 10.1016/j.lanepe.2024.100853. eCollection 2024 Apr.
- Derived from this study: PubMed 32060156Papamargaritis D, Al-Najim W, Lim J, Crane J, Lean M, le Roux C, McGowan B, O'Shea D, Webb D, Wilding J, Davies MJ. Effectiveness and cost of integrating a pragmatic pathway for prescribing liraglutide 3.0 mg in obesity services (STRIVE study): study protocol of an open-label, real-world, randomised, controlled trial. BMJ Open. 2020 Feb 13;10(2):e034137. doi: 10.1136/bmjopen-2019-034137.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie Davies, Prof principal investigator
Univesrity of Leicester
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Saxenda and Specialist Obesity Management Services in people with Obesity and Weight Loss, run by University of Leicester at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Loss of ≥15% From Baseline (Complete Cases) (time frame: 52 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03036800, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.