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

NCT ID: NCT03048578

Last Updated: 2022-12-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-22

Study Completion Date

2021-03-02

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity

Keywords

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Roux-en-Y gastric bypass (RYGB)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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

Group Type EXPERIMENTAL

Saxenda

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subcutaneous Saline Solution

Interventions

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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

Intervention Type DRUG

Placebo

Subcutaneous Saline Solution

Intervention Type DRUG

Other Intervention Names

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Victoza

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Holly Lofton, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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New York University Medical Center

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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16-01527

Identifier Type: -

Identifier Source: org_study_id