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CompletedPhase 4Results posted

Bioenergetic Alterations After Exenatide Administration

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

28

actual

Study population

Obesity / overweight

Key I/E criterion

BMI 30-40

Primary endpoint

Energy Intake Measured Before Treatment and at the End of Treatment

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 IDNCT00623545
Org study IDH-2007-0235

Timeline

Milestones

Study first posted2008-02-26estimated
Last update posted2015-01-09estimated
Results first posted2015-01-09estimated
Study start2008-01 (month precision)
Primary completion2010-04actual (month precision)
Study completion2010-04actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

18-65 years of age
BMI between 30 and 40 kg/m2
Women with a negative pregnancy test at baseline, who are sterile, using contraceptives or in a committed relationship with someone who is sterile or using contraception
Absence of weight change greater than 3 kg in the previous 6 months

Exclusion criteria

Women who are pregnant or lactating
Current or recent (6 months) enrollment in a commercial or self prescribed weight loss or exercise program
Use of weight loss medication
A history of metabolic disease i.e. renal, endocrine, hepatic or gastrointestinal disease that would impact the outcome of the study
Presence of medical conditions that are known to affect energy expenditure (i.e. hyperthyroidism, rheumatoid arthritis, AIDS among others)
History of hypoglycemia
A history of psychiatric or eating disorder
Abnormal EKG
Previous history of pancreatitis
Previous history of gastroparesis or GI motility disorder
Use of medications that can affect GI motility
History of organ transplantation
Other comorbid conditions which may preclude the subject's ability to complete the study
Use of a carbonic anhydrase inhibitor such as acetazolamide

Endpoints (2)

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

2 endpoints
Primary/protocol endpoint

Change in Energy Intake Measured Before Treatment and at the End of Treatment.

Time frame:3 months

change from baseline, improvement

Posted result

GroupValue (mean), kcal/d95% CI
Exenitide Treatment-167
Mean Difference (Net)185p0.001ANOVA
Mean Difference (Final Values)0p<0.05t-test, 2 sided
Secondary/protocol endpoint

Weight Loss After Administration of Exenatide.

Time frame:3 months

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), kg95% CI
Exenitide Treatment-2.0
p< 0.05t-test, 2 sided

The null hypothesis was that energy intake was unchanged between the period before treatment and at the end of treatment.

Mean Difference (Final Values)0p<0.05t-test, 2 sided

Publications (2)

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

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.