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The Effects of Exenatide (Byetta ) on Energy Expenditure and Weight Loss in Nondiabetic Obese Subjects

NCT00856609 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2019-06-04

Study results available
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Summary

Exenatide is an incretin-like drug that has been approved for treatment of type 2 diabetes; it improves glycemia by increasing insulin and decreasing glucagon secretion by pancreatic islet cells and delaying gastric emptying. This randomized, placebo-controlled study is to evaluate whether exenatide over a 5 week period in non-diabetic obese subjects may lead to weight loss. To control for variability in individual response to weight loss treatment, this study will assess the role of exenatide in changing food intake and energy expenditure as possible sources of weight loss. This study will also evaluate the safety profile of exenatide in non-diabetic obese people. Additional assessments will evaluate changes in body fat and hormones involved in the sensations of hunger and fullness.

Conditions

Interventions

DRUG

Byetta (exenatide)

Exenatide is an injectable medication

BEHAVIORAL

Weight loss

Because response to weight loss

OTHER

Metabolic Chamber

The subject stays in the small room

DRUG

Placebo

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Jonathan Krakoff, M.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-03
Primary Completion
2016-09-19
Completion
2016-09-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00856609 on ClinicalTrials.gov