CompletedPhase 4Results posted

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

Lead sponsor

NYU Langone Health

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

132

Study population

Bariatric Surgery, Obesity / overweight

Eligibility highlights

Primary endpoint

•≥5% weight-loss responders

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03048578

Org study ID16-01527

Timeline

Milestones

Study first posted2017-02-09estimated

Study start2017-05-22actual

Primary completion2021-03-02actual

Study completion2021-03-02actual

Results first posted2022-03-22actual

Last update posted2022-12-09actual

Assets

Investigational agents

Liraglutide

Who this study enrolls

Bariatric SurgeryObesity / overweight

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Weight & body composition

2 endpoints

Primary/registry result

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

Time frame:12 Months

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Number · percentage of participants	95% CI
Saxenda	76	-
Placebo	17	-

Primary/protocol endpoint

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

Time frame:12 Months

≥5% weight-loss responders

threshold achievement, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.