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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00500370
• Other study ID #: H8O-MC-GWBP
• Status: Completed
• Phase: Phase 2
• First received: July 10, 2007
• Last updated: March 19, 2015
• Start date: June 2007
• Est. completion date: February 2008

Study information

• Verified date: March 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Obesity

Intervention

Drug:
• exenatide
subcutaneous injection (5mcg or 10mcg), twice a day
• placebo
subcutaneous injection (equivalent volume to active dose), twice a day

Locations

Country	Name	City	State
Puerto Rico	Research Site	Ponce
Puerto Rico	Research Site	San Juan
United States	Research Site	Baton Rouge	Louisiana
United States	Research Site	Dallas	Texas
United States	Research Site	Goose Creek	South Carolina
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Peoria	Arizona
United States	Research Site	Renton	Washington
United States	Research Site	San Antonio	Texas
United States	Research Site	Santa Ana	California
United States	Research Site	Spartanburg	South Carolina
United States	Research Site	St. Louis	Missouri
United States	Research Site	Topeka	Kansas
United States	Research Site	Tucson	Arizona
United States	Research Site	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No