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

NCTNCT03048578Other id16-01527

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Overview

Status: Completed
Phase: Phase 4
Enrollment: 132 participants (actual)
Sponsor: NYU Langone Health · Other
Design: Randomized · Double masking
Countries: 1 country
United States
Start: 22 May 2017
Primary completion: 2 Mar 2021
Completion: 2 Mar 2021
First posted: 9 Feb 2017 (estimated)
Last update posted: 9 Dec 2022
Conditions: Obesity

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201720182019202020212022

Ph 4
Clinical Efficacy and Safety of Using 3.0mg Liraglutide to Treat Weight Regain After Roux-en-Y Gastric Bypass Surgery
NCT03048578
22 May 2017 to 2 Mar 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

SaxendaDrug
PlaceboDrug

Arms2

Experimental
Saxenda
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
Placebo comparator
Placebo
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

Primary outcomes1

Outcomes the sponsor listed as primary.

Percentage of Participants Losing at Least 5% Enrollment Body Weight Measured Using Cochran-Mantel-Haenszel (CMH) Test
Time frame · 12 Months
Registry description
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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 12 Months

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

Group	Value (percentage of participants)
Saxenda	76
Placebo	17

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
SaxendaWeek 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 Saxenda: 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	0 / 89	4 / 89	40 / 89
PlaceboWeek 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 Placebo: Subcutaneous Saline Solution	0 / 43	6 / 43	26 / 43

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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