IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients
This study has been completed.
Sponsor:
AstraZeneca
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00500370
First received: July 10, 2007
Last updated: March 19, 2015
Last verified: March 2015
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Obesity | Drug: exenatide Drug: placebo | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients |
Resource links provided by NLM:
MedlinePlus related topics:
Body Weight
Drug Information available for:
Exenatide
U.S. FDA Resources
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Change in Body Weight [ Time Frame: 24 weeks ]Change in body weight from baseline after 24 weeks of treatment (i.e., body weight at week 24 minus body weight at week 0)
Secondary Outcome Measures:
- Change in Body Mass Index (BMI) [ Time Frame: 24 weeks ]Change in BMI from baseline after 24 weeks of treatment (i.e., BMI at week 24 minus BMI at week 0)
- Change in Waist-to-hip Ratio [ Time Frame: 24 weeks ]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.
- Percentage of Patients Experiencing >=5% Weight Loss [ Time Frame: 24 weeks ]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%)
- Change in Total Cholesterol [ Time Frame: 24 weeks ]Change in total cholesterol from baseline after 24 weeks of treatment (i.e., total cholesterol at week 24 minus total cholesterol at week 0)
- Change in High Density Lipoprotein (HDL) Cholesterol [ Time Frame: 24 weeks ]Change in HDL cholesterol from baseline after 24 weeks of treatment (i.e., HDL cholesterol at week 24 minus HDL cholesterol at week 0)
- Ratio of Endpoint (LOCF) to Baseline for Fasting Triglycerides (Logarithmically Transformed) [ Time Frame: 24 weeks ]Ratio of triglycerides at week 24 compared to triglycerides at week 0 (i.e., triglycerides at week 24 divided by triglycerides at week 0)
- Change in Low Density Lipoprotein (LDL) Cholesterol [ Time Frame: 24 weeks ]Change in LDL cholesterol from baseline following 24 weeks of treatment (i.e., LDL cholesterol at week 24 minus LDL cholesterol at week 0)
- Change in Fasting Serum Glucose [ Time Frame: 24 weeks ]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)
- Change in Serum Glucose AUC Levels Following Oral Glucose Tolerance Test (OGTT) [ Time Frame: 24 weeks ]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)
- Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Beta Cell (HOMA-B) (Logarithmically Transformed) [ Time Frame: 24 weeks ]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.
- Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) (Logarithmically Transformed) [ Time Frame: 24 weeks ]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.
- Incidence of Patients That Demonstrate Overt Signs of Diabetes Mellitus Diagnosis [ Time Frame: 24 weeks ]Number of patients in each treatment group that demonstrate overt signs of diabetes mellitus diagnosis by week 24
- Incidence of Patients That Demonstrate Normalization of Impaired Fasting Glucose (IFG) and/or Impaired Glucose Tolerance (IGT) [ Time Frame: 24 weeks ]Number of patients in each treatment group that demonstrate normalization of IFG and/or IGT by week 24
- Change in High Sensitivity C-reactive Protein (hsCRP) [ Time Frame: 24 weeks ]Change in hsCRP levels from baseline following 24 weeks of treatment (i.e., hsCRP at week 24 minus hsCRP at week 0)
- Change in Glycosylated Hemoglobin (HbA1c) [ Time Frame: 24 weeks ]Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)
| Enrollment: | 163 |
| Study Start Date: | June 2007 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Group A |
Drug: exenatide
subcutaneous injection (5mcg or 10mcg), twice a day
Other Name: Byetta
|
| Placebo Comparator: Group B |
Drug: placebo
subcutaneous injection (equivalent volume to active dose), twice a day
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00500370
Please refer to this study by its ClinicalTrials.gov identifier: NCT00500370
Locations
| United States, Arizona | |
| Research Site | |
| Peoria, Arizona, United States | |
| Research Site | |
| Tucson, Arizona, United States | |
| United States, California | |
| Research Site | |
| Santa Ana, California, United States | |
| United States, Indiana | |
| Research Site | |
| Indianapolis, Indiana, United States | |
| United States, Kansas | |
| Research Site | |
| Topeka, Kansas, United States | |
| Research Site | |
| Wichita, Kansas, United States | |
| United States, Louisiana | |
| Research Site | |
| Baton Rouge, Louisiana, United States | |
| United States, Missouri | |
| Research Site | |
| St. Louis, Missouri, United States | |
| United States, Oklahoma | |
| Research Site | |
| Oklahoma City, Oklahoma, United States | |
| United States, South Carolina | |
| Research Site | |
| Goose Creek, South Carolina, United States | |
| Research Site | |
| Spartanburg, South Carolina, United States | |
| United States, Texas | |
| Research Site | |
| Dallas, Texas, United States | |
| Research Site | |
| San Antonio, Texas, United States | |
| United States, Washington | |
| Research Site | |
| Renton, Washington, United States | |
| Puerto Rico | |
| Research Site | |
| Ponce, Puerto Rico | |
| Research Site | |
| San Juan, Puerto Rico | |
Sponsors and Collaborators
AstraZeneca
Eli Lilly and Company
Investigators
| Study Director: | James Malone, MD | Eli Lilly and Company |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00500370 History of Changes |
| Other Study ID Numbers: |
H8O-MC-GWBP |
| Study First Received: | July 10, 2007 |
| Results First Received: | February 26, 2009 |
| Last Updated: | March 19, 2015 |
Keywords provided by AstraZeneca:
|
exenatide obesity diabetes Amylin Lilly |
Additional relevant MeSH terms:
|
Body Weight Signs and Symptoms Exenatide Hypoglycemic Agents |
Physiological Effects of Drugs Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on August 23, 2017