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UnknownPhase 2, PHASE3The Effects of Exenatide After Gastric Restriction
A Pilot Study of the Effects of BYETTA® (Exenatide) on Weight Loss in Morbidly Obese Non Diabetic Patients Following Adjustable Gastric Banding
Lead sponsor
Assets
Efpeglenatide / Exenatide
Listed sites
2
Recruiting sites
2
Enrollment
28
estimated
Study population
Bariatric Surgery, Obesity / overweight
Key I/E criterion
•BMI ≥40
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Age ≥ 18 years,
2. Have a body mass index ≥ 40 kg/m2 or ≥ 35 kg/m2 with comorbidities (1991 NIH Guidelines for Bariatric Surgery),
3. For women of childbearing age, must have a negative pregnancy test at screening, and agree to use barrier contraceptives for the duration of the study, AND
4. Are able to understand and comply with the study process, and give informed consent.
Exclusion criteria
1. A diagnosis of type 1 diabetes mellitus,
2. A diagnosis of type 2 diabetes mellitus (A diagnosis of T2DM will be a previous fasting plasma glucose greater than or equal to 126 mg/dL, or a random plasma glucose greater than 200 mg/dL),
3. Have experienced hypersensitivity reaction or a worsening of glycemic control on Byetta® (exenatide),
4. Patients with end stage renal disease or severe renal impairment,
5. Patients with severe gastrointestinal disease, including gastroparesis,
6. Liver function tests 2.5 standard deviations above normal values,
7. Contraindication for bariatric surgery,
8. Treatment with exenatide (Byetta) in the last three months,
9. Currently using or have used within three months before this trial: sibutramine, orlistat, or phentermine(patients must also agree to not use these medications for the duration of the study),
10. Treatment with any investigational drug in the last 30 days,
11. Active malignancy, liver of kidney failure, symptomatic coronary heart disease, or severe psychiatric disease,
12. History of malignancy other than basal cell skin carcinoma, OR
13. In the opinion of the investigator, patient is abusing alcohol and/or drugs.
Endpoints (5)
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
Weight & body composition
3 endpointsTo describe change in body weight in non-diabetic morbidly obese patients after laparoscopic adjustable gastric banding (LAGB) with twice daily exenatide plus lifestyle modification plan or placebo plus lifestyle modification plan.
Time frame:52 weeks
Body weight, absolute change (kg)
change from baseline, improvement
Body Mass Index (BMI)
Time frame:52 Weeks
BMI, change
change from baseline, improvement
Waist circumference
Time frame:52 Weeks
Waist circumference, change
change from baseline, improvement
Cardiometabolic biomarkers
1 endpointCarotid intima media thickness(CIMT)
Time frame:52 Weeks
change from baseline, improvement
Other (unclassified)
1 endpointChanges in: 2 hour Oral Glucose Tolerance Test; Lipid panel; Comprehensive metabolic panel; Glycosylated hemoglobin A1c
Time frame:52 Weeks
change from baseline, improvement
componentsPostprandial glucose, Total cholesterol, change, LDL-C, change, HDL-C, change, Triglycerides, change, HbA1c, change
Provenance
Sources
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.