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Completed

NCT Number: NCT03048578

Clinical Efficacy and Safety of Using 3.0mg Liraglutide to Treat Weight Regain After Roux-en-Y Gastric Bypass Surgery

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

New York University Medical Center

New York, 10016, United States

About this study

The specific aims of this study are to:

  • To evaluate the effects of liraglutide on body weight loss in patients who are experiencing weight regain following RYGB.
  • To evaluate the effects of liraglutide on cardiometabolic risk and quality of life in patients who are experiencing weight regain following RYGB.
  • To evaluate the safety of liraglutide in post-RYGB subjects.
  • To evaluate the changes in obesity-related comorbid conditions in patients who are experiencing weight regain following RYGB.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • < 25% TBWL at post-RYGB weight nadir
  • >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

Treatment and study plan

Saxenda

Drug

Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day

Other names: Victoza

Placebo

Drug

Subcutaneous Saline Solution

Primary outcomes

  1. Percentage of Participants Losing at Least 5% Enrollment Body Weight Measured Using Cochran-Mantel-Haenszel (CMH) Test

    Time frame: 12 Months

    CMH is a test used in the analysis of stratified or matched categorical data. It allows testing of the association between a binary predictor or treatment and a binary outcome such as case or control status while taking into account the stratification

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Novo Nordisk A/S

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Feb 9, 2017
Registry last updated
Dec 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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