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CompletedPhase 3Results posted

Effect of GLP-1 Receptor Agonism After Sleeve Gastrectomy

Effect of GLP-1 Receptor Agonism on Weight and Caloric Intake in Subjects After Sleeve Gastrectomy

Lead sponsor

Mayo Clinic

Assets

GLP-1 / incretin class catch-all / Liraglutide

Listed sites

1

Recruiting sites

Enrollment

46

actual

Study population

Bariatric Surgery, Obesity / overweight

Key I/E criterion

Primary endpoint

Body weight, absolute change (kg)

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 IDNCT03115424
Org study ID16-004253

Timeline

Milestones

Study first posted2017-04-14actual
Study start2017-06-22actual
Primary completion2023-10-04actual
Study completion2024-05-30actual
Last update posted2024-09-27actual
Results first posted2024-09-27actual

Assets

Investigational agents

Study populations

Who this study enrolls

Bariatric SurgeryObesity / overweight

Eligibility

Who can enroll

Minimum age20 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

1. Age 20-65 years of age

2. Seen at Mayo Clinic Nutrition Clinic and have received authorization for bariatric surgery.

3. No active physical illness which will interfere with mobility or weight loss after bariatric surgery.

4. Females who are sexually active and able to become pregnant must agree to use birth control for duration of study if randomized to Saxenda/Placebo.

Exclusion criteria

1. Prior use of glucose lowering medication in the 3 months prior to screening.

2. A fasting glucose ≥ 126mg/dl or an HbA1c ≥ 6.5% will be taken as evidence of type 2 diabetes and therefore patients will be deemed ineligible for participation.

3. Prior abdominal surgery other than cholecystectomy, appendectomy or hysterectomy.

4. Pregnancy or active consideration of pregnancy during the period of study. Subjects will be discontinued if they become pregnant during the study.

5. Hypersensitivity to liraglutide or any product components.

6. Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2.

7. Prior history of pancreatitis, cholelithiasis or cholecystitis.

8. Concurrent use of insulin or any other GLP-1 receptor agonist.

9. Active, severe psychiatric disease

Endpoints (8)

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.

Coverage by outcome category

Cardiometabolic biomarkers
6
Weight & body composition
2

Weight & body composition

2 endpoints
Primary/registry result

Weight

Time frame:baseline and 36 months

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), kilograms95% CI
Sleeve Gastrectomy Saxendabaseline127
36 months75
Sleeve Gastrectomy Placebobaseline130
36 months107
Roux-en-Y Gastric (RYGB)baseline126
36 months98
Primary/protocol endpoint

Weight

Time frame:baseline and 36 months

Body weight, absolute change (kg)

change from baseline, improvement

Cardiometabolic biomarkers

6 endpoints
Secondary/registry result

Systolic Blood Pressure

Time frame:baseline and 36 months

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

GroupValue (mean), Millimeters of Mercury95% CI
Sleeve Gastrectomy Saxendabaseline129
36 months112
Sleeve Gastrectomy Placebobaseline130
36 months128
Roux-en-Y Gastric (RYGB)baseline123
36 months122
Secondary/registry result

Diastolic Blood Pressure

Time frame:baseline and 36 months

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

GroupValue (mean), Millimeters of Mercury95% CI
Sleeve Gastrectomy Saxendabaseline86
36 months84
Sleeve Gastrectomy Placebobaseline83
36 months93
Roux-en-Y Gastric (RYGB)baseline76
36 months82
Secondary/registry result

Low-density Lipoprotein (LDL)

Time frame:baseline and 36 months

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Posted result

GroupValue (mean), mg/dL95% CI
Sleeve Gastrectomy Saxendabaseline114
36 months106
Sleeve Gastrectomy Placebobaseline101
36 months68
Roux-en-Y Gastric (RYGB)baseline99
36 months90
Secondary/protocol endpoint

Systolic Blood Pressure

Time frame:baseline and 36 months

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Diastolic Blood Pressure

Time frame:baseline and 36 months

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Low-density Lipoprotein (LDL)

Time frame:baseline and 36 months

LDL-C, change

change from baseline, improvement

LOINC 13457-7

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.