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The Effect of Exenatide on Weight and Hunger in Obese, Healthy Women
The Effect of Exenatide on Body Weight, Energy Expenditure and Hunger in Obese Women Without Diabetes Mellitus
Lead sponsor
Asset
Exenatide
GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
41
actual
Study population
Obesity / overweight, Prediabetes / glucose intolerance
Key I/E criteria
•BMI 28-35•Female
Primary endpoints
•Body weight, absolute change (kg)•BMI, change
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. Females aged 25-60
2. BMI 28-35 kg/m2
3. No known diagnosis of diabetes
4. No known diagnosis of coronary heart disease
5. Self-described sedentary lifestyle with minimal regular cardiovascular exercise (no more than 1 hour per week)
6. Stable weight (variation < 3 kg within 6 months of screening visit)
7. Ability to give informed consent
8. Ability to follow verbal and written instructions
9. Use of medically approved form of contraception (monophasic oral contraception, intra uterine device, surgical sterilization or 2 combined barrier methods)
10. Nonsmoker (tobacco, marijuana)
11. Outpatient visits every 2 weeks throughout the study period are required. While most of these visits are short (15 minutes)ability to commute to the performance site in Boston, on a regular basis, is necessary.
Exclusion criteria
1. Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes Association criteria
2. Coronary heart disease (history of myocardial infarction or unstable angina pectoris)
3. Uncontrolled hypertension hypertension (BP > 150/90 mmHg on or off antihypertensive medication)
4. Uncontrolled dyslipidemia (LDL > 200 or TG > 400 on or off lipid lowering medication)
5. Tobacco, marijuana or intravenous drug use
6. Shift workers (night shift or alternating day/night shifts)
7. Recent weight loss (> 3 kg within 4 months of the screening visit)
8. Gastroparesis
9. Inflammatory bowel disease
10. Malignancy treated with chemotherapy within the past 3 years
11. History of pancreatitis
12. Depression requiring hospitalization or diagnosis of psychosis
13. Renal insufficiency (creatinine clearance < 50 ml/min)
14. Transaminases > 2x above the normal range
15. Pregnancy within 6 months of the screening visit
16. Breastfeeding
17. Failure to use medically approved contraceptive methods
18. History of an eating disorder (anorexia, bulimia or laxative abuse)
19. History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling)
20. New diagnosis of hypo or hyperthyroidism within 1 year of screening visit
21. Previous participation in a clinical study with exenatide
22. Presence or history of allergic reaction to multiple drugs
Endpoints (13)
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
5 endpointsChange in Weight
Time frame:16 weeks after the beginning of each treatment
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Value (mean), kilograms | 95% CI |
|---|---|---|
| Exenatide | -2.49 | — |
| Placebo | 0.43 | — |
Change in Body Mass Index
Time frame:16 weeks from the start of each treatment period.
BMI, change
change from baseline, improvement
Posted result
| Group | Value (mean), Kg/m^2 | 95% CI |
|---|---|---|
| Exenatide | -0.93 | -1.44 – -0.41 |
| Placebo | 0.18 | -0.31 – 0.68 |
Change in Waist Circumference
Time frame:16 weeks from the start of each treatment period.
Waist circumference, change
change from baseline, improvement
Posted result
| Group | Value (mean), centimeters | 95% CI |
|---|---|---|
| Exenatide | -1.68 | -3.3 – -0.07 |
| Placebo | 0.94 | -0.59 – 2.47 |
Changes in Body Composition
Time frame:16 weeks after the beginning of each treatment
percent change from baseline, improvement
Posted result
| Group | Value (mean), per cent | 95% CI |
|---|---|---|
| Exenatide | -0.4 | -1.5 – 0.7 |
| Placebo | -0.7 | -1.8 – 0.3 |
REE
Time frame:16 weeks from the start of each treatment period.
REE kcal
change from baseline, improvement
Posted result
| Group | Value (mean), Kilocalories | 95% CI |
|---|---|---|
| Exenatide | -13.7 | -60.6 – 33.2 |
| Placebo | 6.5 | -38.0 – 51.0 |
Glycemic / diabetes
4 endpointsChange in Insulin
Time frame:16 weeks from the start of each treatment period.
change from baseline, improvement
Posted result
| Group | Value (mean), microunits per liter | 95% CI |
|---|---|---|
| Exenatide | 1.1 | -0.6 – 2.8 |
| Placebo | 0.4 | -1.3 – 2.0 |
Change in Fasting Glucose
Time frame:16 weeks from the start of each treatment period.
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Posted result
| Group | Value (mean), mg/dl | 95% CI |
|---|---|---|
| Exenatide | 0.5 | -3.6 – 4.5 |
| Placebo | 3.1 | -0.7 – 7.0 |
Change in Two Hour Glucose
Time frame:16 weeks from the start of each treatment period.
Postprandial glucose
change from baseline, improvement
Posted result
| Group | Value (mean), mg/dl | 95% CI |
|---|---|---|
| Exenatide | -10 | -21 – 1.2 |
| Placebo | -0.5 | -11 – 10 |
HOMA Score
Time frame:16 weeks from the start of each treatment period.
HOMA-IR (insulin sensitivity)
change from baseline, improvement
Posted result
| Group | Value (mean), Ratio fasting glucose to insulin | 95% CI |
|---|---|---|
| Exenatide | 0.2 | -0.3 – 0.6 |
| Placebo | 0.2 | -0.3 – 0.6 |
Cardiometabolic biomarkers
4 endpointsSystolic Blood Pressure
Time frame:16 weeks after the beginning of each treatment
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
Posted result
| Group | Value (mean), mm of mercury | 95% CI |
|---|---|---|
| Exenatide | -2.5 | -6.6 – 1.6 |
| Placebo | -1.3 | -5.2 – 2.6 |
Changes in Leptin
Time frame:16 weeks from the start of each treatment period.
Leptin, change
change from baseline, improvement
Posted result
| Group | Value (mean), ng/ml | 95% CI |
|---|---|---|
| Exenatide | -3.7 | -7.4 – 0.05 |
| Placebo | -0.2 | -3.8 – 3.3 |
Diastolic Blood Pressure
Time frame:16 weeks after the beginning of each treatment
Diastolic BP, change
change from baseline, improvement
LOINC 8462-4
Posted result
| Group | Value (mean), mm of mercury | 95% CI |
|---|---|---|
| Exenatide | -1.2 | -3.6 – 1.1 |
| Placebo | -0.4 | -2.6 – 1.9 |
Adiponectin
Time frame:16 weeks after the beginning of each treatment
Adiponectin, change
change from baseline, improvement
Posted result
| Group | Value (mean), microgram per ml | 95% CI |
|---|---|---|
| Exenatide | 0.4 | -0.3 – 1.0 |
| Placebo | 0.07 | -0.5 – 0.7 |
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
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.