GLP-1 Peptide Atlas, by Delfa

CompletedPhase 4Results posted

Weight Loss With Exenatide Treatment

A Prospective Study of Patterns, Predictors, and Mechanisms of Weight Loss With Exenatide Treatment in Overweight and Obese Women Without Diabetes

Lead sponsor

Jody Dushay

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

249

actual

Study population

Obesity / overweight

Key I/E criteria

•BMI 28-48•Female

Primary endpoint

•Body weight, absolute change (kg)

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 IDNCT01590433

Org study ID2011P000310

Timeline

Milestones

Study first posted2012-05-03estimated

Results first posted2020-02-12actual

Last update posted2021-06-23actual

Study start2012-03 (month precision)

Primary completion2019-01actual (month precision)

Study completion2019-01actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexFemale

Healthy volunteersAccepted

Inclusion criteria

•Females age 18-70

•BMI 28-48 kg/m^2

•Stable weight (greater than 3 kg weight gain or loss within 6 months of screening visit).

•Ability to give informed consent and follow verbal and written instructions in English.

Exclusion criteria

•Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes Association criteria

•Unstable heart disease as evidenced by ongoing angina

•Congestive heart failure

•Uncontrolled hypertension (BP greater than 170/100 mmHg on or off antihypertensive medication)

•Uncontrolled dyslipidemia (LDL greater than 200 or TG greater than 400 on or off lipid lowering medication)

•Tobacco, marijuana, cocaine, or intravenous drug use

•Shift workers (night shift or alternating day/night shifts)

•Gastroparesis

•Inflammatory bowel disease or irritable bowel syndrome

•Malignancy treated with chemotherapy within the past 3 years

•History of pancreatitis

•Depression requiring hospitalization or diagnosis of psychosis

•Renal insufficiency (eGFR less than 50)

•Transaminases greater than 2 times above the normal range

•Pregnancy within 6 months of the screening visit

•Lactation

•Failure to use medically approved contraceptive methods (monophasic oral contraception, intra uterine device, surgical sterilization or 2 combined barrier methods)

•History of an eating disorder (anorexia, bulimia or laxative abuse)

•Treatment with FDA-approved or over-the-counter weight loss medication within 6 months, with the exception of Xenical if there was no weight loss

•History of gastric bypass surgery or gastric stapling

•Biochemical evidence of hyper or hypothyroidism, or new diagnosis of hypo or hyperthyroidism within 3 months of screening visit

•Previous treatment with exenatide

•Discretion of the PI

Endpoints (1)

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.

Weight & body composition

1 endpoint

Primary/protocol endpoint

Change in Body Weight

Time frame:12 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), percentage weight loss	95% CI
Exenatide	6.5	—
Placebo	7.5	—

p<0.05t-test, 2 sided

Publications (1)

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

Weight Loss Outcomes Among Early High Responders to Exenatide Treatment: A Randomized, Placebo Controlled Study in Overweight and Obese Women.
Frontiers in endocrinology2021 (year)PMID34867786doi:10.3389/fendo.2021.742873via clinicaltrials gov reference derived + pubmed nct search

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.