OverweightPhase 2NCT03856047
Research Study Investigating How Well NNC0174-0833 Works in People Suffering From Overweight or Obesity.
A Phase 2 study testing NNC0174-0833 and Liraglutide 3.0 mg in people with Overweight and Obesity, run by Novo Nordisk A/S at 54 sites in 10 countries.
Trial summary
This study will look at the change in body weight in people taking NNC0174-0833, liraglutide and "dummy" medicine, from the start to the end of the study. As well as taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- NNC0174-0833 and Liraglutide 3.0 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 706 participants
- Where
- 54 sitesin 10 countries
- Study dates
- 1 Mar 2019to 25 Mar 2021
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older at the time of signing the informed consent.
- Female subject of non-childbearing potential or Male subject who is surgically sterilised (vasectomy) or who is willing to use adequate contraceptive methods (as required by local regulation or practice) throughout the trial (until 'end of trial').
- BMI equal to 30.0 kg/m^2 or greater or BMI equal to 27.0 kg/m^2 or greater with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension or dyslipidaemia (to be assessed at the investigator's discretion).
Who cannot join
- HbA1c equal to 48 mmol/mol (6.5 percentage) or greater as measured by the central laboratory at screening.
- A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days prior to screening irrespective of medical records.
Trial locations and contacts
54 sites in 10 countries.
54 sites in 10 countries
United States22 sites
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
Washington Center For Weight Management And Research,Inc.
Arlington, Virginia, 22206
Holston Medical Group Pc
Bristol, Tennessee, 37620-7352
Medical University of South Carolina
Charleston, South Carolina, 29425
Cedar-Crosse Research Center
Chicago, Illinois, 60607
Nature Coast Clinical Research
Crystal River, Florida, 34429
Centennial Medical Group
Elkridge, Maryland, 21075-6437
Prestige Clinical Research
Franklin, Ohio, 45005
Spectrum Medical Research, LLC
Gaffney, South Carolina, 29341
PharmQuest
Greensboro, North Carolina, 27408
Jacksonville Center For Clinical Research
Jacksonville, Florida, 32216
Albert J Weisbrot
Mason, Ohio, 45040-6815
Lynn Institute of Norman
Norman, Oklahoma, 73069
Infinity Medical Research
North Dartmouth, Massachusetts, 02747
South Broward Research LLC
Pembroke Pines, Florida, 33027
St Johns Center For Clinical Research
Ponte Vedra, Florida, 32081
National Clinical Research Inc.
Richmond, Virginia, 23294
Rochester Clinical Research, Inc.
Rochester, New York, 14609
Texas Diabetes & Endocinology
Round Rock, Texas, 78681
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
Encompass Clinical Research
Spring Valley, California, 91978
Family Practice Center of Wadsworth, Inc.
Wadsworth, Ohio, 44281
United Kingdom7 sites
The Health Centre
Bradford on Avon, BA15 1DQ
Southmead Hospital
Bristol, BS10 5NB
WISDEM Centre
Coventry, CV2 2DX
University Hospital Aintree
Liverpool, L9 7AL
Guys Hospital
London, SE1 9RT
UCL - Obesity
London, WC1E 6JF
Clifton Medical Centre
Rotherham, S65 1DA
Canada5 sites
University of Calgary
Calgary, Alberta, T2T 5C7
C-endo Diabetes & Endocrinology Clinic
Calgary, Alberta, T2V 4J2
C-endo Diabetes & Endocrinology Clinic
Edmonton, Alberta, T6H 2L4
The Wharton Medical Clinic Clinical Trials
Hamilton, Ontario, L8L 5G8
Hamilton Medical Research Group
Hamilton, Ontario, L8M 1K7
South Africa5 sites
FARMOVS (Pty) LTD
Bloemfontein, Free State, 9300
Dr Wilhase's rooms
Boksburg, Gauteng, 1466
Dr Vawda's site
Durban, KwaZulu-Natal, 4091
Dr J Reddy
Durban, KwaZulu-Natal, 4450
Dr R Dulabh
Johannesburg, Gauteng, 1812
Finland4 sites
StudyCor
Jyväskylä, 40620
Itä-Suomen yliopisto
Kuopio, 70211
Turku University Hospital
Turku, 20520
Obesity Research Unit
University of Helsinki, 00014
Japan3 sites
Tokyo-Eki Center-building Clinic
Tokyo, 103-0027
Tokyo Center Clinic
Tokyo, 103-0028
ToCROM Clinic
Tokyo, 160-0008
Poland3 sites
Gabinet Leczenia Otylosci i Chorob Dietozaleznych
Bialystok, 15-281
Centrum Medyczne Salvia
Katowice, 40-001
Centrum Zdrowia Metabolicznego
Poznan, 60-589
Denmark2 sites
Aarhus Universitetshospital Diabetes og Hormonsygdomme
Aarhus N, 8200
Hvidovre Hospital Endokrinologisk forsknings afsnit 159
Hvidovre, 2650
Serbia2 sites
Endocrinology, Diabetes and Metabolism Diseases Clinic
Belgrade, 11000
Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.
Novi Sad, 21000
Ireland1 site
Clinical Research Centre, St. Vincent's University Hospital,
Dublin, DUBLIN 4
About this study
Official title: Investigation of Safety and Efficacy of NNC0174-0833 for Weight Management - a Dose Finding Trial.
This study will look at the change in body weight in people taking NNC0174-0833, liraglutide and "dummy" medicine, from the start to the end of the study. As well as taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight. Participants will either take NNC0174-0833, liraglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants will need to take one injection once a week or once a day, depending on the treatment. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 8 months. Participants will have 12 clinic visits with the study doctor.
- Conditions
- Overweight, Obesity
- Being tested
- NNC0174-0833, Placebo (NNC0174-0833), Liraglutide 3.0 mg, Placebo (Liraglutide 3.0 mg)
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0174-0833Drug
Participants will get one dose of NNC0174-0833 once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.
Placebo (NNC0174-0833)Drug
Participants will get one dose of Placebo (NNC0174-0833) once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.
Liraglutide 3.0 mgDrug
Participants will get one dose of liraglutide 3.0 mg once daily. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using pre-filled PDS290 pen-injector. Participants will gradually increase their dose every week until they reach the target dose of 3.0 mg daily. The participants will continue on 3.0 mg of liraglutide, once daily up to 26 weeks.
Placebo (Liraglutide 3.0 mg)Drug
Participants will get one dose of Placebo (liraglutide 3.0 mg) once daily. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using pre-filled PDS290 pen-injector. Participants will gradually increase their dose every week until they reach the target dose of 3.0 mg. The participants will continue on Placebo (liraglutide 3.0 mg), once daily up to 26 weeks.
| Study group | Role | What they receive |
|---|---|---|
| NNC0174-0833, 4.5 mg | Experimental | Patients will receive 4.5 mg of NNC0174-0833 once a week as injections for 26 weeks. Receives: Drug: NNC0174-0833 |
| NNC0174-0833, 2.4 mg | Experimental | Patients will receive 2.4 mg of NNC0174-0833 once a week as injections for 26 weeks. Receives: Drug: NNC0174-0833 |
| NNC0174-0833, 1.2 mg | Experimental | Patients will receive 1.2 mg of NNC0174-0833 once a week as injections for 26 weeks. Receives: Drug: NNC0174-0833 |
| NNC0174-0833, 0.6 mg | Experimental | Patients will receive 0.6 mg of NNC0174-0833 once a week as injections for 26 weeks. Receives: Drug: NNC0174-0833 |
| NNC0174-0833 0.3 mg | Experimental | Patients will receive 0.3 mg of NNC0174-0833 once a week as injections for 26 weeks. Receives: Drug: NNC0174-0833 |
| Placebo 2.4 mg (NNC0174-0833) | Placebo comparator | Patients will receive 2.4 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks. Receives: Drug: Placebo (NNC0174-0833) |
| Placebo 4.5 mg (NNC0174-0833) | Placebo comparator | Patients will receive 4.5 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks. Receives: Drug: Placebo (NNC0174-0833) |
| Placebo 1.2 mg (NNC0174-0833) | Placebo comparator | Patients will receive 1.2 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks. Receives: Drug: Placebo (NNC0174-0833) |
| Placebo 0.6 mg (NNC0174-0833) | Placebo comparator | Patients will receive 0.6 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks. Receives: Drug: Placebo (NNC0174-0833) |
| Placebo 0.3 mg (NNC0174-0833) | Placebo comparator | Patients will receive 0.3 mg of NNC0174-0833 once a week as injections for 26 weeks. Receives: Drug: Placebo (NNC0174-0833) |
| Liraglutide 3.0 mg | Active comparator | Patients will receive 3.0 mg of liraglutide once daily as injections for 26 weeks. Receives: Drug: Liraglutide 3.0 mg |
| Placebo 3.0 mg (Liraglutide) | Placebo comparator | Patients will receive placebo 3.0 mg(liraglutide) once daily as injections for 26 weeks. Receives: Drug: Placebo (Liraglutide 3.0 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight (%)
Change in body weight (%) from week 0 to week 26 is presented. For descriptive analysis and statistical analysis the endpoint was evaluated based on the data from in-trial period and treatment adherent period, respectively. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. Treatment-adherent: a participant is treatment adherent until the first time of non-adherence defined as: participant has not been dosed with trial product within the prior 14 days; participant has received other weight management drug or bariatric surgery; participant has not reached target dose at a pre-specified week; After the pre-specified evaluation week for the target dose, the participant has not received the target dose ±10% within the prior 14 days.
Measured: From baseline (week 0) to week 26
Secondary outcomes (26)
Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 26 Weeks
Percentage of participants who achieved a weight loss of greater than or equal to (≥) 5% of baseline (week 0) body weight at 26 weeks is presented. The numbers presented are predictions from a logistic regression model.
Measured: Week 26
Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 26 Weeks
Percentage of participants who achieved a weight loss ≥ 10% of baseline (week 0) body weight at 26 weeks is presented. The numbers presented are predictions from a logistic regression model.
Measured: Week 26
Change in Body Weight (Kg)
Change in body weight (Kg) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.
Measured: From baseline (week 0) to week 26
Change in Waist Circumference
Change in waist circumference from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.
Measured: From baseline (week 0) to week 26
Change in Total Cholesterol
Change in total cholesterol from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.
Measured: From baseline (week 0) to week 26
Change in High Density Lipoprotein (HDL) Cholesterol
Change in HDL cholesterol from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.
Measured: From baseline (week 0) to week 26
Change in Low Density Lipoprotein (LDL) Cholesterol
Change in LDL cholesterol from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.
Measured: From baseline (week 0) to week 26
Change in Very Low Density Lipoprotein (VLDL) Cholesterol
Change in VLDL cholesterol from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.
Measured: From baseline (week 0) to week 26
Change in Triglycerides
Change in triglycerides from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.
Measured: From baseline (week 0) to week 26
Change in Glycosylated Haemoglobin (HbA1c) (%-Point)
Change in HbA1c (measured as percentage point of HbA1c) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.
Measured: From baseline (week 0) to week 26
Change in HbA1c (mmol/Mol)
Change in HbA1c (measured as millimoles per mole (mmol/mol)) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.
Measured: From baseline (week 0) to week 26
Change in Fasting Plasma Glucose (FPG) (mmol/L)
Change in FPG (measured as mmol/L)) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.
Measured: From baseline (week 0) to week 26
Change in FPG (mg/dL)
Change in FPG (measured as milligrams per decilitre (mg/dL)) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.
Measured: From baseline (week 0) to week 26
Change in Fasting Insulin
In the below table, fasting insulin data at week 0 and at week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.
Measured: From baseline (week 0) to week 26
Percentage Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Percentage change in HOMA-IR from week 0 to week 26 is presented. Insulin resistance is a condition in which cells fail to respond to normal actions of hormone in body. HOMA-IR is calculated using a subject's fasting plasma insulin and glucose levels. HOMA-IR = fasting serum insulin (micro international units per milliliter (μU/ml)) × fasting plasma glucose (millimoles per liter (mmol/l)) / 22.5. HOMA-IR scores are classified as follows: less than 1.0: considered Insulin sensitive, 0.5-1.4: considered Healthy, Above 1.8: considered Early insulin resistance; Above 2.7 is considered significant insulin resistance. HOMA-IR score ranges from 0-infinity (no upper limit). Higher the score, higher the level of insulin resistance. Endpoint was evaluated based on data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in in-trial period.
Measured: From baseline (week 0) to week 26
Change in Homeostatic Model Assessment of Beta-cell Function (HOMA-beta)
Change between the value of HOMA-beta cell function collected at Week 26 and HOMA-beta cell function collected at Week 0 is presented. The homeostatic model assessment estimates steady state beta cell function as a percentage of a normal reference population (%B). HOMA %B = 20 * insulin (micro international units per milliliter (µIU/mL)) / fasting plasma glucose (millimoles per liter (mmol/L)) - 3.5. HOMA-beta score ranges from minus infinity to infinity (no limits). The higher the score the better beta-cell function for HOMA-beta. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.
Measured: From baseline (week 0) to week 26
Number of Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or used a medicinal product, whether or not considered related to the medicinal product or usage. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide.
Measured: From week 0 to week 32
Number of Treatment-emergent Serious Adverse Events (TESAEs)
An AE was any untoward medical occurrence in a clinical trial participant administered or used a medicinal product, whether or not considered related to the medicinal product or usage. Serious AE is an AE that resulted in death, life threatening, persistent or significant incapacity or substantial disruption of ability to conduct normal life functions, hospitalization or prolongation of existing hospitalization, congenital anomaly or birth defect, important medical events that may not result in death, be life threatening, or require hospitalization. All SAEs reported in the below table are TESAEs. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide.
Measured: From week 0 to week 32
Number of Participants With Occurrence of Anti-drug Antibodies Towards Cagrilintide
Number of participants with occurrence of anti-drug antibodies towards cagrilintide from randomisation from week 0 to week 32 is presented. The endpoint was evaluated based on the data from in-trial period. The in-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. This endpoint is applicable only for the cagrilintide treatment arms.
Measured: From week 0 to week 32
Change in Diastolic Blood Pressure (DBP)
Blood pressure was measured in a sitting position after 5 minutes of rest. The end point is evaluated while the subject is treatment-adherent. A participant is treatment adherent until the first time of non-adherence defined as: a) the participant has not been dosed with trial product within the prior 14 days; b) the participant has received other weight management drug or bariatric surgery c) the participant has not reached target dose at a pre-specified week d) After the pre-specified evaluation week for the target dose, the participant has not received the target dose +/- 10 % within the prior 14 days. This endpoint is applicable only for the cagrilintide treatment arms.
Measured: From baseline (week 0) to week 26
Change in Systolic Blood Pressure (SBP)
Blood pressure was measured in a sitting position after 5 minutes of rest. The end point is evaluated while the subject is treatment-adherent. A participant is treatment adherent until the first time of non-adherence defined as: a) the participant has not been dosed with trial product within the prior 14 days; b) the participant has received other weight management drug or bariatric surgery c) the participant has not reached target dose at a pre-specified week d) After the pre-specified evaluation week for the target dose, the participant has not received the target dose +/- 10 % within the prior 14 days. This endpoint is applicable only for the cagrilintide treatment arms.
Measured: From baseline (week 0) to week 26
Change in Pulse
Change in pulse from week 0 to week 26 is presented. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide.
Measured: From baseline (week 0) to week 26
Change in High Sensitivity C-reactive Protein (hsCRP)
In the below table, hsCRP data at week 0 and at week 26 is presented. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide.
Measured: From baseline (week 0) to week 26
Change in Plasminogen Activator Inhibitor-1 (PAI-1) Activity
Due to the assay development issue faced by the laboratory, the Plasminogen Activator Inhibitor-1 (PAI-1) activity (mg/L) was not performed in the study.
Measured: From baseline (week 0) to week 26
Change in Renin Activity
Change in renin activity from week 0 to week 26 is presented. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide.
Measured: From baseline (week 0) to week 26
Change in Aldosterone
Change in aldosterone from week 0 to week 26 is presented. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide.
Measured: From baseline (week 0) to week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start1 Mar 2019
- Primary completion2 Mar 2020
- Study completion25 Mar 2021
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 (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a twelve-armed trial comprising of five (0.3, 0.6, 1.2, 2.4 and 4.5 mg OW) of NNC0174-0833 arms and liraglutide 3.0 mg OD arm as active treatment arms and the corresponding 6 placebo arms as comparators. Participants will be randomised 6:1 between the active treatment arms and the placebo arms. The five different NNC0174-0833 placebo arms and the one liraglutide placebo arm will be pooled into one placebo group for statistical analyses of the results.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 706 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856047
- Sponsor's protocol ID
- NN9838-4433
- Other IDs
- U1111-1214-0429, 2018-001945-14, 2018
- Status last verified
- Jul 2024
- First submitted
- 25 Feb 2019
- Last updated
- 5 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
Publications
Lau DCW, Erichsen L, Francisco AM, Satylganova A, le Roux CW, McGowan B, Pedersen SD, Pietilainen KH, Rubino D, Batterham RL. Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial. Lancet. 2021 Dec 11;398(10317):2160-2172. doi: 10.1016/S0140-6736(21)01751-7. Epub 2021 Nov 16.
PubMed 34798060
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Safety and Efficacy of NNC0174-0833 for Weight Management - a Dose Finding Trial.
- ClinicalTrials.gov ID
- NCT03856047
- Acronym / sponsor ID
- NN9838-4433
- Conditions
- Overweight, Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 706 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 2 Mar 2020 (actual)
- Study completion
- 25 Mar 2021 (actual)
- First posted
- 27 Feb 2019 (actual)
- Results
- Posted 18 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will look at the change in body weight in people taking NNC0174-0833, liraglutide and "dummy" medicine, from the start to the end of the study. As well as taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight. Participants will either take NNC0174-0833, liraglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants will need to take one injection once a week or once a day, depending on the treatment. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 8 months. Participants will have 12 clinic visits with the study doctor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 12
- Model description
- This is a twelve-armed trial comprising of five (0.3, 0.6, 1.2, 2.4 and 4.5 mg OW) of NNC0174-0833 arms and liraglutide 3.0 mg OD arm as active treatment arms and the corresponding 6 placebo arms as comparators. Participants will be randomised 6:1 between the active treatment arms and the placebo arms. The five different NNC0174-0833 placebo arms and the one liraglutide placebo arm will be pooled into one placebo group for statistical analyses of the results.
| Arm | Type | Receives |
|---|---|---|
| NNC0174-0833, 4.5 mg | Experimental | Drug: NNC0174-0833Patients will receive 4.5 mg of NNC0174-0833 once a week as injections for 26 weeks. |
| NNC0174-0833, 2.4 mg | Experimental | Drug: NNC0174-0833Patients will receive 2.4 mg of NNC0174-0833 once a week as injections for 26 weeks. |
| NNC0174-0833, 1.2 mg | Experimental | Drug: NNC0174-0833Patients will receive 1.2 mg of NNC0174-0833 once a week as injections for 26 weeks. |
| NNC0174-0833, 0.6 mg | Experimental | Drug: NNC0174-0833Patients will receive 0.6 mg of NNC0174-0833 once a week as injections for 26 weeks. |
| NNC0174-0833 0.3 mg | Experimental | Drug: NNC0174-0833Patients will receive 0.3 mg of NNC0174-0833 once a week as injections for 26 weeks. |
| Placebo 2.4 mg (NNC0174-0833) | Placebo comparator | Drug: Placebo (NNC0174-0833)Patients will receive 2.4 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks. |
| Placebo 4.5 mg (NNC0174-0833) | Placebo comparator | Drug: Placebo (NNC0174-0833)Patients will receive 4.5 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks. |
| Placebo 1.2 mg (NNC0174-0833) | Placebo comparator | Drug: Placebo (NNC0174-0833)Patients will receive 1.2 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks. |
| Placebo 0.6 mg (NNC0174-0833) | Placebo comparator | Drug: Placebo (NNC0174-0833)Patients will receive 0.6 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks. |
| Placebo 0.3 mg (NNC0174-0833) | Placebo comparator | Drug: Placebo (NNC0174-0833)Patients will receive 0.3 mg of NNC0174-0833 once a week as injections for 26 weeks. |
| Liraglutide 3.0 mg | Active comparator | Drug: Liraglutide 3.0 mgPatients will receive 3.0 mg of liraglutide once daily as injections for 26 weeks. |
| Placebo 3.0 mg (Liraglutide) | Placebo comparator | Drug: Placebo (Liraglutide 3.0 mg)Patients will receive placebo 3.0 mg(liraglutide) once daily as injections for 26 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older at the time of signing the informed consent.
- Female subject of non-childbearing potential or Male subject who is surgically sterilised (vasectomy) or who is willing to use adequate contraceptive methods (as required by local regulation or practice) throughout the trial (until 'end of trial').
- BMI equal to 30.0 kg/m^2 or greater or BMI equal to 27.0 kg/m^2 or greater with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension or dyslipidaemia (to be assessed at the investigator's discretion).
Key exclusion criteria (2 listed)
- HbA1c equal to 48 mmol/mol (6.5 percentage) or greater as measured by the central laboratory at screening.
- A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days prior to screening irrespective of medical records.
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 |
|---|---|---|
| NNC0174-0833Participants will get one dose of NNC0174-0833 once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks. | Drug | NNC0174-0833 0.3 mg, NNC0174-0833, 0.6 mg, NNC0174-0833, 1.2 mg, NNC0174-0833, 2.4 mg, NNC0174-0833, 4.5 mg |
| Placebo (NNC0174-0833)Participants will get one dose of Placebo (NNC0174-0833) once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks. | Drug | Placebo 0.3 mg (NNC0174-0833), Placebo 0.6 mg (NNC0174-0833), Placebo 1.2 mg (NNC0174-0833), Placebo 2.4 mg (NNC0174-0833), Placebo 4.5 mg (NNC0174-0833) |
| Liraglutide 3.0 mgParticipants will get one dose of liraglutide 3.0 mg once daily. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using pre-filled PDS290 pen-injector. Participants will gradually increase their dose every week until they reach the target dose of 3.0 mg daily. The participants will continue on 3.0 mg of liraglutide, once daily up to 26 weeks. | Drug | Liraglutide 3.0 mg |
| Placebo (Liraglutide 3.0 mg)Participants will get one dose of Placebo (liraglutide 3.0 mg) once daily. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using pre-filled PDS290 pen-injector. Participants will gradually increase their dose every week until they reach the target dose of 3.0 mg. The participants will continue on Placebo (liraglutide 3.0 mg), once daily up to 26 weeks. | Drug | Placebo 3.0 mg (Liraglutide) |
Primary outcome
Change in Body Weight (%)
Time frame: From baseline (week 0) to week 26
Change in body weight (%) from week 0 to week 26 is presented. For descriptive analysis and statistical analysis the endpoint was evaluated based on the data from in-trial period and treatment adherent period, respectively. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. Treatment-adherent: a participant is treatment adherent until the first time of non-adherence defined as: participant has not been dosed with trial product within the prior 14 days; participant has received other weight management drug or bariatric surgery; participant has not reached target dose at a pre-specified week; After the pre-specified evaluation week for the target dose, the participant has not received the target dose ±10% within the prior 14 days.
26 secondary outcomes
Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 26 Weeks
Time frame: Week 26
Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 26 Weeks
Time frame: Week 26
Change in Body Weight (Kg)
Time frame: From baseline (week 0) to week 26
Change in Waist Circumference
Time frame: From baseline (week 0) to week 26
Change in Total Cholesterol
Time frame: From baseline (week 0) to week 26
Change in High Density Lipoprotein (HDL) Cholesterol
Time frame: From baseline (week 0) to week 26
Change in Low Density Lipoprotein (LDL) Cholesterol
Time frame: From baseline (week 0) to week 26
Change in Very Low Density Lipoprotein (VLDL) Cholesterol
Time frame: From baseline (week 0) to week 26
Change in Triglycerides
Time frame: From baseline (week 0) to week 26
Change in Glycosylated Haemoglobin (HbA1c) (%-Point)
Time frame: From baseline (week 0) to week 26
Change in HbA1c (mmol/Mol)
Time frame: From baseline (week 0) to week 26
Change in Fasting Plasma Glucose (FPG) (mmol/L)
Time frame: From baseline (week 0) to week 26
Change in FPG (mg/dL)
Time frame: From baseline (week 0) to week 26
Change in Fasting Insulin
Time frame: From baseline (week 0) to week 26
Percentage Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: From baseline (week 0) to week 26
Change in Homeostatic Model Assessment of Beta-cell Function (HOMA-beta)
Time frame: From baseline (week 0) to week 26
Number of Treatment-emergent Adverse Events (TEAEs)
Time frame: From week 0 to week 32
Number of Treatment-emergent Serious Adverse Events (TESAEs)
Time frame: From week 0 to week 32
Number of Participants With Occurrence of Anti-drug Antibodies Towards Cagrilintide
Time frame: From week 0 to week 32
Change in Diastolic Blood Pressure (DBP)
Time frame: From baseline (week 0) to week 26
Change in Systolic Blood Pressure (SBP)
Time frame: From baseline (week 0) to week 26
Change in Pulse
Time frame: From baseline (week 0) to week 26
Change in High Sensitivity C-reactive Protein (hsCRP)
Time frame: From baseline (week 0) to week 26
Change in Plasminogen Activator Inhibitor-1 (PAI-1) Activity
Time frame: From baseline (week 0) to week 26
Change in Renin Activity
Time frame: From baseline (week 0) to week 26
Change in Aldosterone
Time frame: From baseline (week 0) to week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34798060Lau DCW, Erichsen L, Francisco AM, Satylganova A, le Roux CW, McGowan B, Pedersen SD, Pietilainen KH, Rubino D, Batterham RL. Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial. Lancet. 2021 Dec 11;398(10317):2160-2172. doi: 10.1016/S0140-6736(21)01751-7. Epub 2021 Nov 16.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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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.
Clinical Reporting Anchor and Disclosure (1452) study director
Novo Nordisk A/S
54 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NNC0174-0833 and Liraglutide 3.0 mg in people with Overweight and Obesity, run by Novo Nordisk A/S at 54 sites in 10 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 3 inclusion and 2 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 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, United Kingdom, Canada, South Africa, Finland and 5 more countries. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 18 Jul 2023). 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?
Change in Body Weight (%) (time frame: From baseline (week 0) to week 26). 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 NCT03856047, which also lists 1 linked publication.
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 5 Jul 2024.