GLP-1 Peptide Atlas, by Delfa

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CompletedPhase 3Results posted

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

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

Lead sponsor

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

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

150

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoints

•Energy intake kcal day•24h EE

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00856609

Org study ID999909095

Secondary ID09-DK-N095

Timeline

Milestones

Study start2009-03-03

Study first posted2009-03-06estimated

Primary completion2016-09-19actual

Study completion2016-09-19actual

Results first posted2018-01-12actual

Last update posted2019-06-04actual

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•INCLUSION CRITERIA:

•Premenopausal women and men < 55 years of age

•BMI >30 kg/m(2)

•Expressed desire for weight loss

•Stable weight (variation < 2.3 kg within past 6 months)

•Ability to provide informed consent

•Ability to follow verbal and written instructions

•Nonsmoker

•Ability to commute to study site on a regular basis for short outpatient visits over 5 weeks

•For females, use of a medically approved form of contraception. For oral contraceptives, subjects will need to be on an established dose for at least 3 months to ensure stable weight and will be asked not to switch contraceptive methods during study participation.

Exclusion criteria

•Age < 18 years

•Use of other medications to treat obesity including medications obtained over the counter or internet, orlistat (Xenical, Alli), sibutramine (Meridia), topiramate (with or without phentermine (Qsymia), phentermine (Adipex P) or lorcaserin (Belviq) within the past 6 months

•History of an eating disorder including anorexia or bulimia

•History of surgery for the treatment of obesity (gastric banding, gastric bypass)

•Diagnosis of type 1 or type 2 diabetes mellitus according to American Diabetes Association guidelines

•Previous exposure to exenatide

•Uncontrolled hypertension as defined by a blood pressure of 150/90 on two or more occasions or use of antihypertensive medications which may affect energy expenditure including alpha blockers, beta blockers, angiotensin receptor blockers or inhibitors of angiotensin converting enzyme

•Current use of tobacco products, marijuana, amphetamines, cocaine or intravenous drug use

•Chronic ethanol use (> 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

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Cardiometabolic biomarkers

Weight & body composition

2 endpoints

Primary/protocol endpoint

Energy Intake

Time frame:Day 6-7-8 (at baseline) and Day 12-13-14 (3 days after starting study intervention)

energy intake kcal day

change from baseline, improvement

Posted result

Group	Value (mean), kcal/day	95% CI
Exenatide	1016.1	—
Placebo	245.1	—

Slope-624.895% CI-901.8 – -347.8p0.01ANCOVA

Secondary/protocol endpoint

Body Weight

Time frame:5 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kg	95% CI
Exenatide	1.6	—
Placebo	0.27	—

Slope-1.4895% CI-3.02 – 0.05p0.05ANCOVA

Cardiometabolic biomarkers

1 endpoint

Primary/protocol endpoint

Twenty-four-hour Energy Expenditure

Time frame:Day 5 and Day 11

24h EE

change from baseline, improvement

Posted result

Group	Value (mean), kcal/day	95% CI
Exenatide	51.6	—
Placebo	28.9	—

Slope-2495% CI-89.7 – 41.4p0.01ANCOVA

Publications (6)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Urinary Norepinephrine Is a Metabolic Determinant of 24-Hour Energy Expenditure and Sleeping Metabolic Rate in Adult Humans.
The Journal of clinical endocrinology and metabolism2020 Apr 1PMID32002540doi:10.1210/clinem/dgaa047via clinicaltrials gov reference derived + pubmed nct search
Cognitive dietary restraint, disinhibition, and hunger are associated with 24-h energy expenditure.
International journal of obesity (2005)2019 Jul (month)PMID30651576doi:10.1038/s41366-018-0305-9via clinicaltrials gov reference derived + pubmed nct search
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.
Metabolism: clinical and experimental2018 Aug (month)PMID29596853doi:10.1016/j.metabol.2018.03.017via clinicaltrials gov reference derived + pubmed nct search
Efficacy and safety of incretin therapy in type 2 diabetes: systematic review and meta-analysis.
JAMA2007 Jul 11PMID17622601doi:10.1001/jama.298.2.194via CT.gov background
Metabolic effects of two years of exenatide treatment on diabetes, obesity, and hepatic biomarkers in patients with type 2 diabetes: an interim analysis of data from the open-label, uncontrolled extension of three double-blind, placebo-controlled trials.
Clinical therapeutics2007 Jan (month)PMID17379054doi:10.1016/j.clinthera.2007.01.015via CT.gov background
Effects of exenatide (exendin-4) on glycemic control over 30 weeks in sulfonylurea-treated patients with type 2 diabetes.
Diabetes care2004 Nov (month)PMID15504997doi:10.2337/diacare.27.11.2628via CT.gov background

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.