Phase 2
Completed N=163
A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients
Source: ClinicalTrials.gov NCT00500370 ↗Enrolled (actual)
163
Serious AEs
0.0%
Results posted
Sep 2009
Primary outcomePrimary: Change in Body Weight — 109.48; 107.64; -5.06; -1.61 kg — p=<0.0001
Summary
This is a multicenter study designed to compare the effect of exenatide plus a lifestyle modification plan versus placebo plus a lifestyle modification plan on weight loss in non-diabetic, obese subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Body Weight |
109.48; 107.64; -5.06; -1.61 | <0.0001 sig |
| SECONDARY Change in Body Mass Index (BMI) |
39.64; 39.39; -1.83; -0.58 | <0.0001 sig |
| SECONDARY Change in Waist-to-hip Ratio |
0.90; 0.90; -0.001; 0.002 | 0.6766 |
| SECONDARY Percentage of Patients Experiencing >=5% Weight Loss |
31.5; 16.5 | 0.0393 sig |
| SECONDARY Change in Total Cholesterol |
4.87; 4.88; 0.19; 0.33 | 0.1808 |
| SECONDARY Change in High Density Lipoprotein (HDL) Cholesterol |
1.27; 1.36; 0.004; 0.06 | 0.1204 |
| SECONDARY Ratio of Endpoint (LOCF) to Baseline for Fasting Triglycerides (Logarithmically Transformed) |
0.99; 0.96 | 0.6651 |
| SECONDARY Change in Low Density Lipoprotein (LDL) Cholesterol |
2.86; 2.79; 0.20; 0.34 | 0.1204 |
| SECONDARY Change in Fasting Serum Glucose |
5.37; 5.37; 0.000; -0.02 | 0.8479 |
| SECONDARY Change in Serum Glucose AUC Levels Following Oral Glucose Tolerance Test (OGTT) |
15.73; 15.19; -0.47; -0.01 | 0.2151 |
| SECONDARY Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Beta Cell (HOMA-B) (Logarithmically Transformed) |
1.06; 1.08 | 0.7619 |
| SECONDARY Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) (Logarithmically Transformed) |
0.92; 0.91 | 0.8973 |
| SECONDARY Incidence of Patients That Demonstrate Overt Signs of Diabetes Mellitus Diagnosis |
3; 2 | 0.6507 |
| SECONDARY Incidence of Patients That Demonstrate Normalization of Impaired Fasting Glucose (IFG) and/or Impaired Glucose Tolerance (IGT) |
13; 9 | 0.2593 |
| SECONDARY Change in High Sensitivity C-reactive Protein (hsCRP) |
8.61; 8.03; -1.31; -0.44 | 0.2919 |
| SECONDARY Change in Glycosylated Hemoglobin (HbA1c) |
5.61; 5.58; -0.003; 0.09 | 0.0293 sig |
Eligibility Criteria
Inclusion Criteria
- Have a Body Mass Index (BMI) >= 30kg/m^2
Exclusion Criteria
- Have ever participated in this study previously, or any other study using exenatide (AC2993/LY2148568) or GLP-1 analogs
- Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of study start (this criterion includes drugs that have not received regulatory approval for any indication at the time of study entry)
- Diagnosis of diabetes mellitus (other than gestational diabetes), or previous use of anti-diabetic medications for > 3 months
- Have had a change in prescribed lipid-lowering or blood pressure agents within 4 weeks of screening
- Used drugs for weight loss (e.g., Xenical [orlistat], Meridia [sibutramine], Acutrim [phenylpropanolamine], Accomplia [rimonabant], Alli [low-dose orlistat], or other similar over-the-counter weight loss remedies or medications) within 3 months of screening
- Are actively participating in, or have participated in a formal weight loss program within the last 3 months
- Have a history of chronic use of drugs that directly affect gastrointestinal motility, including, but not limited to Reglan (metoclopramide) and chronic macrolide antibiotics
- Have been treated with any anti-diabetic medications within 3 months of screening
- Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to study start
- Have had bariatric surgery
- Have had an organ transplant
Data sourced from ClinicalTrials.gov (NCT00500370). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.