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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

1

Recruiting sites

Enrollment

132

actual

Study population

Bariatric Surgery, Obesity / overweight

Key I/E criterion

Primary endpoint

≥5% weight-loss responders

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. 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

Study populations

Who this study enrolls

Bariatric SurgeryObesity / overweight

Eligibility

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

GroupValue (number), percentage of participants95% CI
Saxenda76
Placebo17
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 1, 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 1, 2026 snapshot.