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Delfa

← All trials/NCT04325581

CompletedPhase 3

Laparocopic Sleeve Gastrectomy With or Without Liraglutide in Obese Patients

Effect of Laparoscopic Sleeve Gastrectomy and Liraglutide on Glucose Homeostasis and Intrapancreatic Fat in Obese Patients

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

0

Recruiting sites

-

Actual enrollment

16

Study population

Bariatric Surgery, Obesity / overweight

Eligibility highlights

•BMI ≥27.5

Primary endpoints

•Incretin change•HOMA-IR (insulin sensitivity)•Pancreatic steatosis

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 IDNCT04325581
Org study IDpgi123

Timeline

Milestones

Study start2016-08-01actual
Primary completion2018-12-31actual
Study completion2018-12-31actual
Study first posted2020-03-27actual
Last update posted2020-03-27actual

Assets

Investigational agents

Liraglutide

Who this study enrolls

Bariatric SurgeryObesity / overweight

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Subjects diagnosed with obesity who have elected to undergo bariatric surgery
•Body mass index greater than 27.5kg/mt2
•Ability and willingness to co-operate with follow up.

Exclusion criteria

Decompensated liver disease ( child-turcotte pugh score >7)

•Impaired renal function, defined as eGFR< 45 ml/min/m2
•Clinically significant active cardiovascular disease including history of myocardial infarction within the past 6 months and/or heart failure (New York Heart Association (NYHA) class III and IV)
•Recurrent major hypoglycemic episodes
•Use of drugs like systemic corticosteroids, thiazolidinediones, DPPIV inhibitors
•Pregnancy or lactation
•History of pancreatitis or pancreatic cancer
•History of medullary thyroid cancer
•Family history of medullary thyroid cancer
•Contraindications to liraglutide or any of its excipients
•Hypersensitivity to liraglutide or similar drugs
•Patients currently using GLP-1 analogs
•Suspected or known abuse of alcohol
•Presence of secondary cause of obesity.
•Presence of an eating disorder or other psychiatric disorder.
•Prior gastric surgery.
•Unfit for surgery due to severe cardiac, pulmonary diseases or due to any reason.
•Contraindications to MRI scanning

Endpoints (4)

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

Other (unclassified)
2
Weight & body composition
1
Glycemic / diabetes
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

body weight

Time frame:baseline and 6 weeks, 12weeks, 18weeks and 24weeks after surgery

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint

Changes in indices of insulin resistance

Time frame:baseline and at 6weeks and 6months after laparoscopic sleeve gastrectomy

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Other (unclassified)

2 endpoints
Primary/protocol endpoint/low confidence

Incretin change

Time frame:baseline and at 6weeks and 6months after laparoscopic sleeve gastrectomy

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in pancreatic steatosis

Time frame:baseline and 6months after laparoscopic sleeve gastrectomy

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.