Phase 4
Completed N=132
Clinical Efficacy and Safety of Using 3.0mg Liraglutide to Treat Weight Regain After Roux-en-Y Gastric Bypass Surgery
Source: ClinicalTrials.gov NCT03048578 ↗Enrolled (actual)
132
Serious AEs
7.6%
Results posted
Mar 2022
Primary outcomePrimary: Percentage of Participants Losing at Least 5% Enrollment Body Weight Measured Using Cochran-Mantel-Haenszel (CMH) Test — 76; 17 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This is a randomized, double-blinded, placebo-controlled trial of liraglutide versus placebo over a follow-up period of 12 months in patients at least 18 months following Roux-en-Y gastric bypass (RYGB) who are experiencing weight regain. This study will assess the efficacy of liraglutide in improving cardiometabolic risk profile (as indicated by serum lipids, HbA1c, and waist circumference) and quality of life (as assessed by PHQ-9 (Patient Health Questionnaire), versus placebo in patients at least 18 months following RYGB who are experiencing weight regain as well as the safety of liraglutide in this patient population.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Losing at Least 5% Enrollment Body Weight Measured Using Cochran-Mantel-Haenszel (CMH) Test |
76; 17 | — |
Eligibility Criteria
Inclusion Criteria
- ≥18 months status-post RYGB
- BMI 27 kg/m2 or greater in the presence of at least one weight-related comorbid condition
- BMI 30 kg/m2 or greater
- Regain of ≥10% of maximum TBWL post-RYGB
- Ability to provide informed consent before any trial-related activities
- Express willingness to follow protocol requirements
Exclusion Criteria
- Pregnancy at time of enrollment
- Intention of becoming pregnant or breast feeding in the next 12 months
- Females of childbearing potential who are not using adequate contraceptive methods
- Presence of acute psychiatric problems or immaturity which would compromise cooperation with the study protocol
- Presence of biliary disease
- Known or suspected allergy to liraglutide or any product components
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- History of pancreatitis
- History of alcoholism
- History of Type 1 DM (Diabetes Mellitus)
- History of previous bariatric surgery other than RYGB except h/o LAGB and band removal.
- >10 years status-post RYGB
- 50% post-operative TBWL at time of screening
- Simultaneous use of any weight loss medications
- Use of insulin at the time of enrollment
- Current use of any GLP-1 agonist medication
- History of taking any GLP-1 agonist medication
- Participation in another ongoing clinical study
- Conditions that, in the opinion of the principal investigator, may jeopardize the patient's well-being and/or the soundness of this clinical study
Data sourced from ClinicalTrials.gov (NCT03048578). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.