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

Primary Purpose

Obesity

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
exenatide
placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring exenatide, obesity, diabetes, Amylin, Lilly

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
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  • Research Site
  • Research Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group A

Group B

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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.
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%)
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)
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)
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)
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)
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)
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)
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.
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.
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
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
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)
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)

Full Information

First Posted
July 10, 2007
Last Updated
March 19, 2015
Sponsor
AstraZeneca
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00500370
Brief Title
A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients
Official Title
A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
exenatide, obesity, diabetes, Amylin, Lilly

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
163 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Title
Group B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
exenatide
Other Intervention Name(s)
Byetta
Intervention Description
subcutaneous injection (5mcg or 10mcg), twice a day
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
subcutaneous injection (equivalent volume to active dose), twice a day
Primary Outcome Measure Information:
Title
Change in Body Weight
Description
Change in body weight from baseline after 24 weeks of treatment (i.e., body weight at week 24 minus body weight at week 0)
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change in Body Mass Index (BMI)
Description
Change in BMI from baseline after 24 weeks of treatment (i.e., BMI at week 24 minus BMI at week 0)
Time Frame
24 weeks
Title
Change in Waist-to-hip Ratio
Description
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.
Time Frame
24 weeks
Title
Percentage of Patients Experiencing >=5% Weight Loss
Description
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%)
Time Frame
24 weeks
Title
Change in Total Cholesterol
Description
Change in total cholesterol from baseline after 24 weeks of treatment (i.e., total cholesterol at week 24 minus total cholesterol at week 0)
Time Frame
24 weeks
Title
Change in High Density Lipoprotein (HDL) Cholesterol
Description
Change in HDL cholesterol from baseline after 24 weeks of treatment (i.e., HDL cholesterol at week 24 minus HDL cholesterol at week 0)
Time Frame
24 weeks
Title
Ratio of Endpoint (LOCF) to Baseline for Fasting Triglycerides (Logarithmically Transformed)
Description
Ratio of triglycerides at week 24 compared to triglycerides at week 0 (i.e., triglycerides at week 24 divided by triglycerides at week 0)
Time Frame
24 weeks
Title
Change in Low Density Lipoprotein (LDL) Cholesterol
Description
Change in LDL cholesterol from baseline following 24 weeks of treatment (i.e., LDL cholesterol at week 24 minus LDL cholesterol at week 0)
Time Frame
24 weeks
Title
Change in Fasting Serum Glucose
Description
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)
Time Frame
24 weeks
Title
Change in Serum Glucose AUC Levels Following Oral Glucose Tolerance Test (OGTT)
Description
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)
Time Frame
24 weeks
Title
Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Beta Cell (HOMA-B) (Logarithmically Transformed)
Description
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.
Time Frame
24 weeks
Title
Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) (Logarithmically Transformed)
Description
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.
Time Frame
24 weeks
Title
Incidence of Patients That Demonstrate Overt Signs of Diabetes Mellitus Diagnosis
Description
Number of patients in each treatment group that demonstrate overt signs of diabetes mellitus diagnosis by week 24
Time Frame
24 weeks
Title
Incidence of Patients That Demonstrate Normalization of Impaired Fasting Glucose (IFG) and/or Impaired Glucose Tolerance (IGT)
Description
Number of patients in each treatment group that demonstrate normalization of IFG and/or IGT by week 24
Time Frame
24 weeks
Title
Change in High Sensitivity C-reactive Protein (hsCRP)
Description
Change in hsCRP levels from baseline following 24 weeks of treatment (i.e., hsCRP at week 24 minus hsCRP at week 0)
Time Frame
24 weeks
Title
Change in Glycosylated Hemoglobin (HbA1c)
Description
Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Malone, MD
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Peoria
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Santa Ana
State/Province
California
Country
United States
Facility Name
Research Site
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Research Site
City
Topeka
State/Province
Kansas
Country
United States
Facility Name
Research Site
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
Research Site
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Research Site
City
Goose Creek
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Spartanburg
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Renton
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Ponce
Country
Puerto Rico
Facility Name
Research Site
City
San Juan
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
20332357
Citation
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.
Results Reference
derived

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

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