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Trial · Interventional

CompletedPhase 4Results postedRegistry data

The Effect of Exenatide on Weight and Hunger in Obese, Healthy Women

NCTNCT00456885 (opens ClinicalTrials.gov in a new tab)Other id2006P000361Other idBFA912
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
41 participants (actual)
Sponsor
Beth Israel Deaconess Medical Center · Other
Design
Randomized · Double masking
Countries
1 country

United States

Start
Apr 2007
Primary completion
Sept 2010
Completion
Sept 2010
First posted
5 Apr 2007 (estimated)
Last update posted
11 Sept 2017
Conditions
Obesity · Impaired Glucose Tolerance

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20072008200920102011
  1. Ph 4

    The Effect of Exenatide on Weight and Hunger in Obese, Healthy Women

    NCT00456885

    Apr 2007 to Sept 2010

Registry summary

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

This study will look at the effect of exenatide, a drug which has been approved for the treatment of type 2 diabetes, on body weight, appetite and energy expenditure among moderately obese women without diabetes. The study is 35 weeks long and includes 19 outpatient visits. Participants will receive exenatide for 16 weeks and placebo for 16 weeks with a 3 week rest period in between. Neither participants nor investigators will know whether exenatide or placebo is being administered. Participants will be started randomly on either exenatide or placebo. Our hypothesis is that treatment with exenatide will curb appetite and lead to weight loss and may lead to changes in energy expenditure.

Interventions

  • exenatideDrug
  • PlaceboDrug

Arms2

  • Placebo comparator

    Exenatide First

    Started on Exenatide, 3 week washout, start placebo

  • Experimental

    Placebo First

    Started on placebo, 3 week washout, start exenatide

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Change in Weight

    Time frame · 16 weeks after the beginning of each treatment

    Registry description

    Change in weight at the end of each treatment period.

  2. Change in Body Mass Index

    Time frame · 16 weeks from the start of each treatment period.

Secondary outcomes(11)

  1. Change in Waist Circumference

    Time frame · 16 weeks from the start of each treatment period.

  2. Systolic Blood Pressure

    Time frame · 16 weeks after the beginning of each treatment

    Registry description

    Blood pressure was measured using a Dynamap automated monitoring device. The change is reported as the blood pressure measured at the beginning of the treatment group and after 16 weeks. We are reporting the change in the systolic blood presssure recorded.

  3. Changes in Body Composition

    Time frame · 16 weeks after the beginning of each treatment

    Registry description

    Per cent body body fat was assessed using bio-electrical impedance with a BIA; RJL System Quantum II Bioelectrical Body Composition Analyzer. The data is reported as per cent body fat.

  4. Changes in Leptin

    Time frame · 16 weeks from the start of each treatment period.

  5. Diastolic Blood Pressure

    Time frame · 16 weeks after the beginning of each treatment

  6. Adiponectin

    Time frame · 16 weeks after the beginning of each treatment

  7. Change in Insulin

    Time frame · 16 weeks from the start of each treatment period.

  8. Change in Fasting Glucose

    Time frame · 16 weeks from the start of each treatment period.

  9. Change in Two Hour Glucose

    Time frame · 16 weeks from the start of each treatment period.

  10. HOMA Score

    Time frame · 16 weeks from the start of each treatment period.

  11. REE

    Time frame · 16 weeks from the start of each treatment period.

    Registry description

    Resting Energy Expenditure

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 outcomeMean· 16 weeks after the beginning of each treatment

Change in Weight

GroupValue (kilograms)Spread
Exenatide-2.490.66
Placebo0.430.63
Primary outcomeMean· 16 weeks from the start of each treatment period.

Change in Body Mass Index

GroupValue (Kg/m^2)
Exenatide-0.93
Placebo0.18
Secondary and other outcome results(6)
Secondary outcomeMean· 16 weeks from the start of each treatment period.

Change in Waist Circumference

GroupValue (centimeters)
Exenatide-1.68
Placebo0.94
Secondary outcomeMean· 16 weeks after the beginning of each treatment

Systolic Blood Pressure

GroupValue (mm of mercury)
Exenatide-2.5
Placebo-1.3
Secondary outcomeMean· 16 weeks after the beginning of each treatment

Changes in Body Composition

GroupValue (per cent)
Exenatide-0.4
Placebo-0.7
Secondary outcomeMean· 16 weeks from the start of each treatment period.

Changes in Leptin

GroupValue (ng/ml)
Exenatide-3.7
Placebo-0.2
Secondary outcomeMean· 16 weeks after the beginning of each treatment

Diastolic Blood Pressure

GroupValue (mm of mercury)
Exenatide-1.2
Placebo-0.4
Secondary outcomeMean· 16 weeks after the beginning of each treatment

Adiponectin

GroupValue (microgram per ml)
Exenatide0.4
Placebo0.07

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
All Study Participants0 / 410 / 4131 / 41

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 · 2012

9 results

Short-term exenatide treatment leads to significant weight loss in a subset of obese women without diabetes.

Dushay et al. 2012Diabetes carecited by 96

PMID 22040840PMC3241299DOI 10.2337/dc11-0931PUB-22040840

Free to read · publisher termsCC BY-NC-ND9 results
Read at sourceSee results (9)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 25 Years up to 60 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Females aged 25-60 2. BMI 28-35 kg/m2 3. No known diagnosis of diabetes 4. No known diagnosis of coronary heart disease 5. Self-described sedentary lifestyle with minimal regular cardiovascular exercise (no more than 1 hour per week) 6. Stable weight (variation \< 3 kg within 6 months of screening visit) 7. Ability to give informed consent 8. Ability to follow verbal and written instructions 9. Use of medically approved form of contraception (monophasic oral contraception, intra uterine device, surgical sterilization or 2 combined barrier methods) 10. Nonsmoker (tobacco, marijuana) 11. Outpatient visits every 2 weeks throughout the study period are required. While most of these visits are short (15 minutes)ability to commute to the performance site in Boston, on a regular basis, is necessary. Exclusion Criteria: 1. Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes Association criteria 2. Coronary heart disease (history of myocardial infarction or unstable angina pectoris) 3. Uncontrolled hypertension hypertension (BP \> 150/90 mmHg on or off antihypertensive medication) 4. Uncontrolled dyslipidemia (LDL \> 200 or TG \> 400 on or off lipid lowering medication) 5. Tobacco, marijuana or intravenous drug use 6. Shift workers (night shift or alternating day/night shifts) 7. Recent weight loss (\> 3 kg within 4 months of the screening visit) 8. Gastroparesis 9. Inflammatory bowel disease 10. Malignancy treated with chemotherapy within the past 3 years 11. History of pancreatitis 12. Depression requiring hospitalization or diagnosis of psychosis 13. Renal insufficiency (creatinine clearance \< 50 ml/min) 14. Transaminases \> 2x above the normal range 15. Pregnancy within 6 months of the screening visit 16. Breastfeeding 17. Failure to use medically approved contraceptive methods 18. History of an eating disorder (anorexia, bulimia or laxative abuse) 19. History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling) 20. New diagnosis of hypo or hyperthyroidism within 1 year of screening visit 21. Previous participation in a clinical study with exenatide 22. Presence or history of allergic reaction to multiple drugs

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