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

NCT00456885 | Completed Phase 4 Results

• 2 other identifiers: 2006P000361BFA912
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Impaired Glucose Tolerance

Keywords

obesity; double blind; placebo controlled; weight loss; appetite; energy expenditure

Outcome Measures

Primary Outcomes (2)

• Change in Weight

  Change in weight at the end of each treatment period.

  16 weeks after the beginning of each treatment

• Change in Body Mass Index

  16 weeks from the start of each treatment period.

Secondary Outcomes (11)

• Change in Waist Circumference

  16 weeks from the start of each treatment period.

• Systolic Blood Pressure

  16 weeks after the beginning of each treatment

• Changes in Body Composition

  16 weeks after the beginning of each treatment

• Changes in Leptin

  16 weeks from the start of each treatment period.

• Diastolic Blood Pressure

  16 weeks after the beginning of each treatment

Study Arms (2)

Exenatide First

PLACEBO COMPARATOR

Started on Exenatide, 3 week washout, start placebo

Drug: exenatide; Drug: Placebo

Placebo First

EXPERIMENTAL

Started on placebo, 3 week washout, start exenatide

Drug: exenatide; Drug: Placebo

Interventions

exenatide DRUG

5 microgram twice a day for two week and then 10 mcg for remaining 15 weeks

Also known as: Byetta

Exenatide First; Placebo First

Placebo DRUG

Twice daily injection of placebo

Exenatide First; Placebo First

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Females aged 25-60
• BMI 28-35 kg/m2
• No known diagnosis of diabetes
• No known diagnosis of coronary heart disease
• Self-described sedentary lifestyle with minimal regular cardiovascular exercise (no more than 1 hour per week)
• Stable weight (variation \< 3 kg within 6 months of screening visit)
• Ability to give informed consent
• Ability to follow verbal and written instructions
• Use of medically approved form of contraception (monophasic oral contraception, intra uterine device, surgical sterilization or 2 combined barrier methods)
• Nonsmoker (tobacco, marijuana)
• 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.

You may not qualify if:

• Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes Association criteria
• Coronary heart disease (history of myocardial infarction or unstable angina pectoris)
• Uncontrolled hypertension hypertension (BP \> 150/90 mmHg on or off antihypertensive medication)
• Uncontrolled dyslipidemia (LDL \> 200 or TG \> 400 on or off lipid lowering medication)
• Tobacco, marijuana or intravenous drug use
• Shift workers (night shift or alternating day/night shifts)
• Recent weight loss (\> 3 kg within 4 months of the screening visit)
• Gastroparesis
• Inflammatory bowel disease
• Malignancy treated with chemotherapy within the past 3 years
• History of pancreatitis
• Depression requiring hospitalization or diagnosis of psychosis
• Renal insufficiency (creatinine clearance \< 50 ml/min)
• Transaminases \> 2x above the normal range
• Pregnancy within 6 months of the screening visit

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Amylin Pharmaceuticals, LLC.: collaborator
• Eli Lilly and Company: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Dushay J, Gao C, Gopalakrishnan GS, Crawley M, Mitten EK, Wilker E, Mullington J, Maratos-Flier E. Short-term exenatide treatment leads to significant weight loss in a subset of obese women without diabetes. Diabetes Care. 2012 Jan;35(1):4-11. doi: 10.2337/dc11-0931. Epub 2011 Oct 31.

  PMID: 22040840 RESULT

MeSH Terms

Conditions

Obesity; Glucose Intolerance; Weight Loss

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Body Weight Changes

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Jody Dushay
• Organization: BIDMC

jdushay@bidmc.harvard.edu

6177353343

Study Officials

• Eleftheria Maratos-Flier, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 4, 2007
• First Posted: April 5, 2007
• Study Start: April 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: September 11, 2017
• Results First Posted: September 11, 2017

Record last verified: 2017-08

Locations

US (1)