A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients

Study Overview
=================
Brief 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.

Official Title
-----------------
A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: exenatide
* Drug: placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br> | Drug: exenatide<br>* subcutaneous injection (5mcg or 10mcg), twice a day<br>* Other names: Byetta;|
| Placebo Comparator: Group B<br> | Drug: placebo<br>* subcutaneous injection (equivalent volume to active dose), twice a day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Weight | Change in body weight from baseline after 24 weeks of treatment (i.e., body weight at week 24 minus body weight at week 0) | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Mass Index (BMI) | Change in BMI from baseline after 24 weeks of treatment (i.e., BMI at week 24 minus BMI at week 0) | 24 weeks | 
| Change in Waist-to-hip Ratio | Waist-to-hip ratio at week 24 compared to waist-to-hip ratio at week 0 (i.e., waist-to-hip ratio at week 24 minus waist-to-hip ratio at week 0). Waist-to-hip ratio equals waist circumference at given time point divided by hip circumference at given timepoint. | 24 weeks | 
| Percentage of Patients Experiencing >=5% Weight Loss | Percentage of exenatide and placebo treated patients experiencing >=5% weight loss after 24 weeks of treatment (i.e., [weight at week 0 minus weight at week 24] divided by weight at week 0 times 100% >=5%) | 24 weeks | 
| Change in Total Cholesterol | Change in total cholesterol from baseline after 24 weeks of treatment (i.e., total cholesterol at week 24 minus total cholesterol at week 0) | 24 weeks | 
| Change in High Density Lipoprotein (HDL) Cholesterol | Change in HDL cholesterol from baseline after 24 weeks of treatment (i.e., HDL cholesterol at week 24 minus HDL cholesterol at week 0) | 24 weeks | 
| Ratio of Endpoint (LOCF) to Baseline for Fasting Triglycerides (Logarithmically Transformed) | Ratio of triglycerides at week 24 compared to triglycerides at week 0 (i.e., triglycerides at week 24 divided by triglycerides at week 0) | 24 weeks | 
| Change in Low Density Lipoprotein (LDL) Cholesterol | Change in LDL cholesterol from baseline following 24 weeks of treatment (i.e., LDL cholesterol at week 24 minus LDL cholesterol at week 0) | 24 weeks | 
| Change in Fasting Serum Glucose | Change in fasting serum glucose from baseline following 24 weeks of treatment (i.e., fasting serum glucose at week 24 minus fasting serum glucose at week 0) | 24 weeks | 
| Change in Serum Glucose AUC Levels Following Oral Glucose Tolerance Test (OGTT) | Change in serum glucose AUC following OGTT (week 24 compared to week 0) (i.e., serum glucose AUC at week 24 minus serum glucose AUC at week 0) | 24 weeks | 
| Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Beta Cell (HOMA-B) (Logarithmically Transformed) | Ratio of HOMA-B at week 24 to HOMA-B at week 0 (i.e., HOMA-B at week 24 divided by HOMA-B at week 0). HOMA-B is a measure of beta cell function. | 24 weeks | 
| Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) (Logarithmically Transformed) | Ratio of HOMA-S at week 24 to HOMA-S at week 0 (i.e., HOMA-S at week 24 divided by HOMA-S at week 0). HOMA-S is a measure of insulin sensitivity. | 24 weeks | 
| Incidence of Patients That Demonstrate Overt Signs of Diabetes Mellitus Diagnosis | Number of patients in each treatment group that demonstrate overt signs of diabetes mellitus diagnosis by week 24 | 24 weeks | 
| Incidence of Patients That Demonstrate Normalization of Impaired Fasting Glucose (IFG) and/or Impaired Glucose Tolerance (IGT) | Number of patients in each treatment group that demonstrate normalization of IFG and/or IGT by week 24 | 24 weeks | 
| Change in High Sensitivity C-reactive Protein (hsCRP) | Change in hsCRP levels from baseline following 24 weeks of treatment (i.e., hsCRP at week 24 minus hsCRP at week 0) | 24 weeks | 
| Change in Glycosylated Hemoglobin (HbA1c) | Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0) | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exenatide, obesity, diabetes, Amylin, Lilly