ObesityLIBARNCT04643301
Liraglutide for Low-responders After Bariatric Surgery
A study testing Liraglutide Pen Injector in people with Obesity and Obesity, Morbid, run by Zuyderland Medisch Centrum.
Trial summary
To study the effect of Liraglutide (3.0 mg daily) on 9-month weight loss in low responders 3-months after bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity, Obesity, Morbid
- What is being tested?
- Liraglutide Pen Injector
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 21 Dec 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- BMI before surgery was ≥ 35.0 kg/m2
- Patient is treated with group consultation at the NOK
- Patient has undergone a primary Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG)
- Patient is in the lowest %TWL quartile, 3 months after surgery and will be enrolled in the plus module.
Who cannot join
- Type 1 or type 2 diabetes
- Decreased renal function (creatinine clearance < 30 ml/min)
- Liver failure (all)
- Congestive heart failure or angina pectoris NYHA class III and IV
- Malignancy in history
- Pancreatitis (in history)
Show all 10Show fewer
- Pregnancy / breast-feeding
- Inflammatory Bowel Disease
- Thyroid malignancy in history
- Use of warfarin or other coumarin derivates
About this study
To study the effect of Liraglutide (3.0 mg daily) on 9-month weight loss in low responders 3-months after bariatric surgery.
Read the detailed description
Rationale: In 20 - 30% of the patients sufficient weight loss is not achieved (low responders) after bariatric surgery. Secondary and/or tertiary bariatric procedures can lead to successful weight loss and resolution of comorbid conditions though, morbidity and mortality rates of these procedures are high. Therefore, additional pharmacotherapy has been suggested. Liraglutide is one of the medications that might improve outcome in the post-bariatric population. It is a Glucagon-like peptide-1 receptor analogue developed to treat type 2 diabetes which causes glucose-dependent insulin secretion and promotes satiety and inhibits glucagon secretion. In obese (non-bariatric) patients, Liraglutide has shown to improve glycemic control, decrease blood pressure, lower cardiovascular risk and decrease body weight. There are only a few small retrospective trials assessing the effect of additional pharmacotherapy in low responders after bariatric surgery. These trials show promising results, with weight loss up to 9.7 % and limited side-effects.
Objective: To study the effect of Liraglutide (3.0 mg daily) on 9-month weight loss in low responders 3-months after bariatric surgery.
Study design: Pragmatic trial.
Study population: Bariatric patients with a pre-operative BMI ≥ 35.0 kg/m2 who have undergone a primary Roux-en-Y gastric bypass or sleeve gastrectomy, are treated with group consultations by the Nederlandse Obesitas Kliniek and are low responders at 3-months follow-up for which they will be treated with the plus module. A low responder is defined by comparing the measured percentage total weight loss (%TWL) at the 3-month follow-up with the expected weight loss. When %TWL is below the 25% quartile of expected weight loss the patient is considered a low responder. The plus module is an extra intervention our clinic provides for the patients who are considered low responders at the 3-month follow-up moment after surgery, this is part of our standard care program.
Intervention: Addition of Liraglutide 3.0 mg daily for 6 months to standard care.
Main study parameters/endpoints: The primary objective is to study the effect of Liraglutide (3.0 mg daily) on 9-month weight loss in low responders after bariatric surgery. The secondary objectives are the description of persistence of therapy and used daily dose, gastro-intestinal symptoms and eating habits and weight loss up to 36 months after surgery.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden of participation consists of extra usage of medication which patients have to administer subcutaneously daily, the extra consultations and two questionnaires. The risks consist of the mainly gastro-intestinal side-effects.
- Conditions
- Obesity, Obesity, Morbid
- Being tested
- Liraglutide Pen Injector
- Keywords
- Obesity, Liraglutide, GLP-1, Bariatric Surgery, Weight loss, Low-responders
- Medical subject headings
- Obesity, Obesity, Morbid, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liraglutide Pen InjectorDrug
Also called Saxenda
Daily subcutaneous injection of 3.0mg liraglutide (GLP-1 antagonist) for low-responders 3 months after bariatric surgery.
| Study group | Role | What they receive |
|---|---|---|
| Adding Liraglutide to current treatment program | Experimental | Adding 3,0mg of Liraglutide to the current treatment program of low-responders 3 months after bariatric surgery. Receives: Drug: Liraglutide Pen Injector |
What is being measured
The primary outcome is the main question the study is designed to answer.
%TWL (%TWL)
To study of the effect of six months treatment with Liraglutide (3.0 mg daily) on 9-month weight loss (%TWL) in low responders after bariatric surgery.
Measured: 6 months
Secondary outcomes (5)
Persistence
To describe the persistence of therapy. Number and percentage of patients who are able to tolerate the treatment throughout the study.
Measured: 6 months
GI symptoms
To describe the gastro-intestinal symptoms of the study group. Gastro-intestinal symptoms and eating habits of the patients will be assessed in two ways, first by adverse event rapportage and second with the "eating habits and physical problems" scales of the BODY-Q questionnaire (see F1 questionnaire) which will be administered at study start and at 14 weeks after study start.
Measured: 6 months
%TWL
To study the weight change at 12, 18, 24 and 36 months after surgery
Measured: 12, 18, 24 and 36 months
Dosage in mg
To describe the average daily dose patients use:
- Number and percentage of patients in whom dose escalation was according to protocol.
- Number and percentage of patients who used 3.0 mg as a daily dose for 22 weeks.
- Average daily dose of all patients (after the dose escalation)
Measured: 6 months
Eating habits
To describe the eating habits of the study group. Gastro-intestinal symptoms and eating habits of the patients will be assessed in two ways, first by adverse event rapportage and second with the "eating habits and physical problems" scales of the BODY-Q questionnaire (see F1 questionnaire) which will be administered at study start and at 14 weeks after study start.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start21 Dec 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Why it stopped: Cancellation by sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study cohort will be compared to a retrospective matched cohort based on BMI before surgery, gender and type of surgery
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zuyderland Medisch Centrum
- Sponsor type
- University, hospital or other
- Collaborators
- Nederlandse Obesitas Kliniek
- Responsible party
- Sponsor
- Investigators
- J.W. Greve, MD, PHD, Principal investigator, Nederlandse Obesitas Kliniek/Zuyderland Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643301
- Sponsor's protocol ID
- NOK0020
- Acronym
- LIBAR
- Status last verified
- Apr 2021
- First submitted
- 2 Nov 2020
- Last updated
- 26 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liraglutide for Low-responders After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04643301
- Acronym / sponsor ID
- LIBAR / NOK0020
- Conditions
- Obesity, Obesity, Morbid
- Keywords
- Obesity, Liraglutide, GLP-1, Bariatric Surgery, Weight loss, Low-responders
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Cancellation by sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Collaborators
- Nederlandse Obesitas Kliniek
- Study start
- 21 Dec 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 25 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the effect of Liraglutide (3.0 mg daily) on 9-month weight loss in low responders 3-months after bariatric surgery.
Detailed description
Rationale: In 20 - 30% of the patients sufficient weight loss is not achieved (low responders) after bariatric surgery. Secondary and/or tertiary bariatric procedures can lead to successful weight loss and resolution of comorbid conditions though, morbidity and mortality rates of these procedures are high. Therefore, additional pharmacotherapy has been suggested. Liraglutide is one of the medications that might improve outcome in the post-bariatric population. It is a Glucagon-like peptide-1 receptor analogue developed to treat type 2 diabetes which causes glucose-dependent insulin secretion and promotes satiety and inhibits glucagon secretion. In obese (non-bariatric) patients, Liraglutide has shown to improve glycemic control, decrease blood pressure, lower cardiovascular risk and decrease body weight. There are only a few small retrospective trials assessing the effect of additional pharmacotherapy in low responders after bariatric surgery. These trials show promising results, with weight loss up to 9.7 % and limited side-effects.
Objective: To study the effect of Liraglutide (3.0 mg daily) on 9-month weight loss in low responders 3-months after bariatric surgery.
Study design: Pragmatic trial.
Study population: Bariatric patients with a pre-operative BMI ≥ 35.0 kg/m2 who have undergone a primary Roux-en-Y gastric bypass or sleeve gastrectomy, are treated with group consultations by the Nederlandse Obesitas Kliniek and are low responders at 3-months follow-up for which they will be treated with the plus module. A low responder is defined by comparing the measured percentage total weight loss (%TWL) at the 3-month follow-up with the expected weight loss. When %TWL is below the 25% quartile of expected weight loss the patient is considered a low responder. The plus module is an extra intervention our clinic provides for the patients who are considered low responders at the 3-month follow-up moment after surgery, this is part of our standard care program.
Intervention: Addition of Liraglutide 3.0 mg daily for 6 months to standard care.
Main study parameters/endpoints: The primary objective is to study the effect of Liraglutide (3.0 mg daily) on 9-month weight loss in low responders after bariatric surgery. The secondary objectives are the description of persistence of therapy and used daily dose, gastro-intestinal symptoms and eating habits and weight loss up to 36 months after surgery.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden of participation consists of extra usage of medication which patients have to administer subcutaneously daily, the extra consultations and two questionnaires. The risks consist of the mainly gastro-intestinal side-effects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study cohort will be compared to a retrospective matched cohort based on BMI before surgery, gender and type of surgery
| Arm | Type | Receives |
|---|---|---|
| Adding Liraglutide to current treatment program | Experimental | Drug: Liraglutide Pen InjectorAdding 3,0mg of Liraglutide to the current treatment program of low-responders 3 months after bariatric surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI before surgery was ≥ 35.0 kg/m2
- Patient is treated with group consultation at the NOK
- Patient has undergone a primary Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG)
- Patient is in the lowest %TWL quartile, 3 months after surgery and will be enrolled in the plus module.
Key exclusion criteria (10 listed)
- Type 1 or type 2 diabetes
- Decreased renal function (creatinine clearance < 30 ml/min)
- Liver failure (all)
- Congestive heart failure or angina pectoris NYHA class III and IV
- Malignancy in history
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 |
|---|---|---|
| Liraglutide Pen InjectorAlso: SaxendaDaily subcutaneous injection of 3.0mg liraglutide (GLP-1 antagonist) for low-responders 3 months after bariatric surgery. | Drug | Adding Liraglutide to current treatment program |
Primary outcome
%TWL (%TWL)
Time frame: 6 months
To study of the effect of six months treatment with Liraglutide (3.0 mg daily) on 9-month weight loss (%TWL) in low responders after bariatric surgery.
5 secondary outcomes
Persistence
Time frame: 6 months
GI symptoms
Time frame: 6 months
%TWL
Time frame: 12, 18, 24 and 36 months
Dosage in mg
Time frame: 6 months
Eating habits
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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.
J.W. Greve, MD, PHD principal investigator
Nederlandse Obesitas Kliniek/Zuyderland Medisch Centrum
Questions about this trial
What is this clinical trial studying?
A study testing Liraglutide Pen Injector in people with Obesity and Obesity, Morbid, run by Zuyderland Medisch Centrum.
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 4 inclusion and 10 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: withdrawn, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
%TWL (%TWL) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2021.