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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00500370
First received: July 10, 2007
Last updated: June 6, 2014
Last verified: June 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change in Body Weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Genders Eligible for Study:   Both
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

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

No publications provided by AstraZeneca

Additional 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: June 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
exenatide
obesity
diabetes
Amylin
Lilly

Additional relevant MeSH terms:
Body Weight
Obesity
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Exenatide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014