GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT02160990

CompletedPhase 4Results posted

Effect of Exenatide in Obese Patients With Accelerated Gastric Emptying

Lead sponsor

Mayo Clinic

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight

Key I/E criteria

•BMI ≥30•Healthy volunteers

Primary endpoint

•Gastric Emptying Half-time (T 1/2) of Solids

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 IDNCT02160990

Org study ID14-002683 Exenatide

Secondary IDR01DK067071

Timeline

Milestones

Study first posted2014-06-11estimated

Last update posted2016-08-09estimated

Results first posted2016-08-09estimated

Study start2014-06 (month precision)

Primary completion2015-03actual (month precision)

Study completion2015-03actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Obese subjects with BMI> 30 Kg/m^2: Otherwise healthy individuals who are not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, endocrine (other than hyperglycemia not requiring medical therapy) and unstable psychiatric disease.

•Women of childbearing potential will have negative pregnancy test before initiation of medication.

•Gastric emptying (GE): Accelerated GE T1/2 < 79 minutes or GE 1h>35 %

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

•Concomitant use of appetite suppressants (i.e., caffeine based or diethylpropion) or orlistat (Xenical®)

•Uncontrolled hypertension (Blood pressure greater than 160/90 mmHg)

•Use of anti-diabetic drugs including metformin,

•History of nephrolithiasis,

•Recurrent major depression, presence or history of suicidal behavior or ideation with intent to act, and current substantial depressive symptoms (Patient Health Questionnaire (PHQ-9) total score ≥10).

•Gastroparesis

•Inflammatory bowel disease or irritable bowel syndrome

•Malignancy treated with chemotherapy within the past 3 years

•History of pancreatitis

•Renal insufficiency (eGFR less than 50 ml/min)

•Concomitant use of monoamine oxidase inhibitors (i.e., phenelzine, selegiline), serotonergic agents, and other centrally acting appetite suppressants

•Significant psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Scale (HADS) self-administered alcoholism screening test (SAAST, substance abuse) and the questionnaire on eating and weight patterns (binge eating disorders and bulimia). If such a dysfunction is identified by a HADS score ≥11 in any of the subscales or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up.

•Intake of medication that could interfere with the interpretation of the study or cause drug interaction (i.e., ketoconazole, erythromycin). Specifically, birth control pill, estrogen replacement therapy, and thyroxine replacement are permissible.

Endpoints (7)

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

Other clinical outcomes

Weight & body composition

Patient-reported / QoL

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change in Body Weight

Time frame:baseline, day 30

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (median), kg	95% CI
Exenatide	-0.95	-2.1 – -0.7
Placebo	-0.55	-2.1 – 0.3

p0.23ANCOVA

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Aggregate Satiation Symptom Score

Time frame:Visit 3, approximately 30 min after ingestion of nutrient drink test

descriptive, improvement

componentspostprandial fullness vas, nausea vas, bloating vas, abdominal pain vas

Posted result

Group	Value (median), mm	95% CI
Exenatide	145	133.5 – 204
Placebo	172	110 – 237

Other clinical outcomes

5 endpoints

Primary/protocol endpoint

Gastric Emptying Half-time (T 1/2) of Solids

Time frame:time frame is 30 days after the initiation of dose.

descriptive

Posted result

Group	Value (median), minutes	95% CI
Exenatide	187	141 – 240
Placebo	86	73 – 125

p<.001ANCOVA

Secondary/protocol endpoint

Percentage of Gastric Contents Emptied at 1 Hour

Time frame:Visit 4, approximately 1 hours after radiolabeled meal was ingested

descriptive

Posted result

Group	Value (median), percentage of meal emptied	95% CI
Exenatide	12.4	8 – 18.5
Placebo	38.2	26.6 – 42.1

p<.001ANCOVA

Secondary/protocol endpoint/low confidence

Satiation Expressed as Volume to Fullness

Time frame:Visit 3, approximately 30 minutes after liquid meal

descriptive

Posted result

Group	Value (median), mL	95% CI
Exenatide	705	510 – 795
Placebo	675	413 – 825

Secondary/protocol endpoint

Maximum Tolerated Volume

Time frame:Visit 3, approximately 30 minutes after liquid meal

descriptive, improvement

Posted result

Group	Value (median), mL	95% CI
Exenatide	1244	918 – 1452
Placebo	1052	859.1 – 1422

Secondary/protocol endpoint

Buffet Meal Intake (kcal)

Time frame:Visit 4, approximately 30 minutes after start of "all you can eat" meal

descriptive

Posted result

Group	Value (median), kcal	95% CI
Exenatide	977	713 – 1336
Placebo	1110	680.3 – 1658

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

Exenatide in obesity with accelerated gastric emptying: a randomized, pharmacodynamics study.
Physiological reports2015 Nov (month)PMID26542264doi:10.14814/phy2.12610via CT.gov reference

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.