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CompletedPhase 1

Effects of the GLP-1 Exenatide on Satiety in Lean and Obese Women

Effects of the GLP-1 Exenatide on Intrinsic Brain Activity in Lean and Obese Women

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

34

actual

Study population

Healthy volunteers, Obesity / overweight

Key I/E criteria

BMI 19-25Female

Primary endpoint

Resting State networks in the brain

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 IDNCT01501084
Org study ID11-002316

Timeline

Milestones

Study first posted2011-12-29estimated
Last update posted2017-11-07actual
Study start2011-12 (month precision)
Primary completion2012-12actual (month precision)
Study completion2013-02actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age40 Years
SexFemale
Healthy volunteersAccepted

Inclusion criteria

1. FEMALES 18 to 40 years of age, inclusive

2. Lean control subjects with BMI's between 19 and 25kg/m2.

3. Obese subjects with BMI's between 30 and 35kg/m2.

4. Willingness to participate in this study as evidenced by a signed, written informed consent form (ICF).

5. Willingness to avoid pregnancy and practice adequate birth control (abstinence, oral contraception, intrauterine devices, implantable devices, or barrier method with spermicide) during the time of study enrollment.

6. Negative urine pregnancy tests at all visits.

7. All subjects must be premenopausal.

8. In the follicular stage of the menstrual cycle, as determined by menstrual history at Visit 2 \&3.

9. Ambulatory outpatient (not depending exclusively on a wheelchair for mobility)

10. English is primary oral and written language.

11. Random (non fasting) Blood sugar level < 200mg/dl at screening.

12. Right-handed

Exclusion criteria

1. Evidence of structural abnormality of the gastrointestinal tract or GI diseases/conditions. Exclusionary GI conditions include but are not limited to: gastrointestinal surgery (exceptions: appendectomy, benign polypectomy, cholecystectomy), pancreatitis, irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), esophagitis (exception: symptom controlled reflux disease), celiac disease, gastrointestinal malignancy or obstruction, functional dyspepsia, peptic ulcer disease, lactose intolerance or any malabsorptive condition.

2. Clinical evidence of cardiovascular, respiratory, renal, hepatic, malignancy, hematologic, neurologic (including regular migraines defined as more than 1 migraine per month), psychiatric or any disease that the PI determines may interfere with safe participation in the study.

* Very specifically subjects with any history or symptoms of poor glucose control, osteoporosis, diabetes, thyroid, adrenal or other endocrine disorder.

3. Subjects with current psychiatric disorder, or history of such disorder in the past 5 years. This list includes but is not limited to bipolar disorder, alcohol or substance abuse/dependence, suicide attempt or behavior, or presence of anxiety or depression at the time of screening. Poorly controlled anxiety or depression will be determined as a result of MINI + interview by the clinician at screening.

4. Current history of chronic pain.

5. Use of investigational drugs, products or devices within 28 days prior to screen and through study participation.

6. Subjects with current use of any medications/drugs during the study that affect the central nervous system, gastrointestinal motility, autonomic activity or pain sensation, including but not limited to: opiates or other narcotic analgesics, THC, alpha adrenergic receptor antagonists, beta blockers, Ca+ blockers, prokinetics and sympatholytic agents, or antidepressants.

7. Subjects who have used diet aids within the last month.

8. Pregnancy, postpartum within 4 months or breast-feeding

9. Subjects who smoke more than 5 cigarettes per month.

10. Subjects with BMI of less than 20, between 26 and 29 and over 35.

11. Subjects with metal implants, dental retainers, large tattoos (e.g. full arm or back) or claustrophobia; making MRI safety not possible.

12. Any clinically significant abnormalities from the screening medical history or physical examination.

13. Subjects who exercise excessively (more than 8 hours a week on average).

14. Postmenopausal women and/or women who have had oophorectomies.

15. Any other condition that the investigator believes would jeopardize the safety or rights of the subject or would render the subject unable to comply with the study protocol.

16. Subject taking any medications that might interfere or react badly with the GLP-1 agonist: Exenatide

17. Subjects with a non-fasting blood glucose level at > 200 dl/ml.

18. MRI visits with fasting blood sugar < 65 or 126 mg/dl

19. Left handedness

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.

Other (unclassified)

2 endpoints
Primary/protocol endpoint/low confidence

Resting State networks in the brain

Time frame:one year

descriptive

Secondary/protocol endpoint/low confidence

Age and body size differences

Time frame:one year

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.