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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Obesity	Drug: exenatide; Drug: placebo	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	163 participants
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
Study Start Date :	June 2007
Actual Primary Completion Date :	February 2008
Actual Study Completion Date :	February 2008

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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 :

1. 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)
2. 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.
3. 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%)
4. 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)
5. 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)
6. 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)
7. 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)
8. 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)
9. 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)
10. 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.
11. 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.
12. 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
13. 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
14. 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)
15. 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)

Eligibility Criteria

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rosenstock J, Klaff LJ, Schwartz S, Northrup J, Holcombe JH, Wilhelm K, Trautmann M. Effects of exenatide and lifestyle modification on body weight and glucose tolerance in obese subjects with and without pre-diabetes. Diabetes Care. 2010 Jun;33(6):1173-5. doi: 10.2337/dc09-1203. Epub 2010 Mar 23.

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00500370 History of Changes
Other Study ID Numbers:	H8O-MC-GWBP
First Posted:	July 12, 2007
Results First Posted:	September 4, 2009
Last Update Posted:	April 7, 2015
Last Verified:	March 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