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Completed

NCT Number: NCT00500370

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

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.

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Key information

Conditions

Obesity Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Ponce, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exenatide

Drug

subcutaneous injection (5mcg or 10mcg), twice a day

Other names: Byetta

Placebo

Drug

subcutaneous injection (equivalent volume to active dose), twice a day

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 12, 2007
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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