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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT00500370 (opens ClinicalTrials.gov in a new tab)Other idH8O-MC-GWBP
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
163 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Randomized · Triple masking
Countries
2 countries

United States, Puerto Rico

Start
Jun 2007
Primary completion
Feb 2008
Completion
Feb 2008
First posted
12 Jul 2007 (estimated)
Last update posted
7 Apr 2015 (estimated)
Conditions
Obesity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200720082009
  1. Ph 2

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

    NCT00500370

    Jun 2007 to Feb 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • exenatideDrug
  • placeboDrug

Arms2

  • Experimental

    Group A

  • Placebo comparator

    Group B

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Body Weight

    Time frame · 24 weeks

    Registry 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)

Secondary outcomes(15)

  1. Change in Body Mass Index (BMI)

    Time frame · 24 weeks

    Registry description

    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

    Registry 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.

  3. Percentage of Patients Experiencing >=5% Weight Loss

    Time frame · 24 weeks

    Registry 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%)

  4. Change in Total Cholesterol

    Time frame · 24 weeks

    Registry 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)

  5. Change in High Density Lipoprotein (HDL) Cholesterol

    Time frame · 24 weeks

    Registry 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)

  6. Ratio of Endpoint (LOCF) to Baseline for Fasting Triglycerides (Logarithmically Transformed)

    Time frame · 24 weeks

    Registry 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)

  7. Change in Low Density Lipoprotein (LDL) Cholesterol

    Time frame · 24 weeks

    Registry 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)

  8. Change in Fasting Serum Glucose

    Time frame · 24 weeks

    Registry 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)

  9. Change in Serum Glucose AUC Levels Following Oral Glucose Tolerance Test (OGTT)

    Time frame · 24 weeks

    Registry 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)

  10. Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Beta Cell (HOMA-B) (Logarithmically Transformed)

    Time frame · 24 weeks

    Registry 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.

  11. Ratio of Endpoint (LOCF) to Baseline for Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) (Logarithmically Transformed)

    Time frame · 24 weeks

    Registry 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.

  12. Incidence of Patients That Demonstrate Overt Signs of Diabetes Mellitus Diagnosis

    Time frame · 24 weeks

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· 24 weeks

Change in Body Weight

GroupValue (kg)Spread
Group A (Exenatide)109.482.70
Group B (Placebo)107.642.61
Secondary and other outcome results(7)
Secondary outcomeLeast squares mean· 24 weeks

Change in Body Mass Index (BMI)

GroupValue (kg/m^2)Spread
Group A (Exenatide)39.640.82
Group B (Placebo)39.390.79
Secondary outcomeLeast squares mean· 24 weeks

Change in Waist-to-hip Ratio

GroupValue (Ratio)Spread
Group A (Exenatide)0.900.01
Group B (Placebo)0.900.01
Secondary outcomeNumber· 24 weeks

Percentage of Patients Experiencing >=5% Weight Loss

GroupValue (percentage of patients)
Group A (Exenatide)31.5
Group B (Placebo)16.5
Secondary outcomeLeast squares mean· 24 weeks

Change in Total Cholesterol

GroupValue (mmol/L)Spread
Group A (Exenatide)4.870.11
Group B (Placebo)4.880.10
Secondary outcomeLeast squares mean· 24 weeks

Change in High Density Lipoprotein (HDL) Cholesterol

GroupValue (mmol/L)Spread
Group A (Exenatide)1.270.04
Group B (Placebo)1.360.04
Secondary outcomeLeast squares mean· 24 weeks

Ratio of Endpoint (LOCF) to Baseline for Fasting Triglycerides (Logarithmically Transformed)

GroupValue (Ratio)Spread
Group A (Exenatide)0.990.06
Group B (Placebo)0.960.06
Secondary outcomeLeast squares mean· 24 weeks

Change in Low Density Lipoprotein (LDL) Cholesterol

GroupValue (mmol/L)Spread
Group A (Exenatide)2.860.10
Group B (Placebo)2.790.10

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Group A (Exenatide)exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP–0 / 7360 / 73
Group B (Placebo)placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP–0 / 7953 / 79

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2010

3 results

Effects of exenatide and lifestyle modification on body weight and glucose tolerance in obese subjects with and without pre-diabetes.

Rosenstock et al. 2010Diabetes carecited by 172

PMID 20332357PMC2875418DOI 10.2337/dc09-1203PUB-20332357

Free to read · publisher termsCC BY-NC-ND3 results
Read at sourceSee results (3)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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