Phase 3
Completed N=80
The Effects of Exenatide (Byetta ) on Energy Expenditure and Weight Loss in Nondiabetic Obese Subjects
Source: ClinicalTrials.gov NCT00856609 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcomePrimary: Energy Intake — 1016.1; 245.1 kcal/day — p=0.01
◆ Published Evidence
Established
38citations · ~5 / year
Exenatide has a pronounced effect on energy intake but not energy expenditure in non-diabetic subjects with obesity: A randomized, double-blind, placebo-controlled trial.
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.
Linked Publications (3)
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Exenatide has a pronounced effect on energy intake but not energy expenditure in non-diabetic subjects with obesity: A randomized, double-blind, placebo-controlled trial.
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Cognitive dietary restraint, disinhibition, and hunger are associated with 24-h energy expenditure.
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Urinary Norepinephrine Is a Metabolic Determinant of 24-Hour Energy Expenditure and Sleeping Metabolic Rate in Adult Humans.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Energy Intake |
1016.1; 245.1 | 0.01 sig |
| PRIMARY Twenty-four-hour Energy Expenditure |
51.6; 28.9 | 0.01 sig |
| SECONDARY Body Weight |
1.6; 0.27 | 0.05 |
Eligibility Criteria
- INCLUSION CRITERIA:
- Premenopausal women and men 30 kg/m(2)
- Expressed desire for weight loss
- Stable weight (variation 3 drinks /day)
- Endocrine disorders including hypo or hyperthyroidism (including subclinical disease), Cushing s disease, growth hormone deficiency or other pituitary diseases
- History of pancreatitis
- Personal or family history of multiple endocrine neoplasia (MEN)-2 or medullary thyroid cancer
- History of unresolved gallstones
- Hyperamylasemia
- Fasting triglyceride level greater than or equal to 500
- Gastroparesis
- Inflammatory bowel disease or malabsorption disorders
- Malignancy treated with chemotherapy or radiation within the past 5 years
- Current clinical depression, diagnosis of psychosis or recent use of psychotropic medication
- Pregnancy within past 6 months
- Breastfeeding
- Failure to use medically approved contraceptive methods if subject is female
- Liver function abnormalities (transaminases greater than twice normal)
- Renal insufficiency (creatinine clearance < 50 ml/min)
- History of chronic infection including tuberculosis, coccidiomycoses, lyme disease or HIV infection
- Pulmonary disorders, including chronic obstructive pulmonary disease, which would limit ability to follow the protocol (investigator judgment)
- Cardiovascular disease including history of myocardial infarction, unstable angina or heart failure
- Central nervous system disease, including history of cerebrovascular accidents, dementia, and neurodegenerative disorders
- Weight <450 pounds (maximum weight of the DXA machine as per manufacturer s manual)
- Sensitivity to exenatide or any inert components in its formulation
- Sensitivity to acetaminophen
- Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the investigators
Data sourced from ClinicalTrials.gov (NCT00856609) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.