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

NCT03048578 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 16-01527
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

Roux-en-Y gastric bypass (RYGB)

Outcome Measures

Primary Outcomes (1)

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

  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

  12 Months

Study Arms (2)

Saxenda

EXPERIMENTAL

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

Drug: Saxenda

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

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

Also known as: Victoza

Saxenda

Placebo DRUG

Subcutaneous Saline Solution

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

New York University Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Holly F. Lofton, MD
• Organization: NYU Langone Health - Weight Management Program

Holly.Lofton@nyulangone.org

(212) 263-3166

Study Officials

• Holly Lofton, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization will be 2:1 (drug:placebo) with stratification by gender and percent post-operative TBWL (25%, 25 - 49.9%).

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 9, 2017
• Study Start: May 22, 2017
• Primary Completion: March 2, 2021
• Study Completion: March 2, 2021
• Last Updated: December 9, 2022
• Results First Posted: March 22, 2022

Record last verified: 2022-12

Locations

US (1)