GLP-1 Peptide Atlas, by Delfa

Active not recruitingPhase 4

Effects of Long-Acting GLP-1 (Glucagon-like Peptide-1) or Dual Incretin (GLP-1 and GIP [Glucose-dependent Insulinotropic Peptide]) Modulation on Gastric Motor Functions

A Randomized, Placebo-Controlled Trial of the Effects of Long-Acting GLP-1 or Dual Incretin (GLP-1 and GIP) Modulation on Gastric Motor Functions

Lead sponsor

Mayo Clinic

Assets

Semaglutide / Tirzepatide

Listed sites

Recruiting sites

—

Enrollment

estimated

Study population

Obesity / overweight, Prediabetes / glucose intolerance, Type 2 diabetes

Key I/E criterion

•BMI ≥30

Primary endpoints

•Gastric emptying of solids T1/2 min•Body weight

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 IDNCT06801015

Org study ID24-011786

Timeline

Milestones

Study first posted2025-01-30actual

Study start2025-10-01actual

Last update posted2025-12-26actual

Primary completion2028-01-31estimated

Study completion2028-03-31estimated

Assets

Investigational agents

Semaglutide Tirzepatide

Study populations

Who this study enrolls

Obesity / overweightPrediabetes / glucose intoleranceType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

PLEASE NOTE: Potential participants must reside within 50 miles of Mayo Clinic for 7 consecutive months due to non-mobile GI imaging cameras.

Inclusion criteria:

•Adults (18-75 years) who have BMI >30 or >27kg/m2 who also have prediabetes or T2DM on diet treatment only

•Able to reside within 50 miles of Mayo Clinic for the duration of the study

•Not currently on treatment (exceptions below) for cardiac, pulmonary, GI, hepatic, renal, hematological, neurological, or endocrine disorders.

•Biological sex: men or women. We shall attempt to recruit equal proportions of men and women. Women of childbearing potential will be using an effective form of contraception and have negative pregnancy tests within 48 hours of enrollment and before each isotope-based radiation exposure as part of the tests for gastric emptying. In addition, monthly urine pregnancy tests will be performed in females with childbearing potential.

Exclusion criteria

•Weight exceeding 137kg (safety limit of camera for measuring gastric volumes)

•Abdominal surgery other than appendectomy, Caesarian section or tubal ligation, cholecystectomy

•Chronic GI diseases, systemic disease or medications that could affect GI motility, appetite or absorption

•Patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia II

•Patients with T2DM on GLP-1RAs, amylin agonists/analogs (e.g. pramlintide), insulin, sulfonylureas (all due to risk of hypoglycemia with semaglutide or tirzepatide treatment); or on metformin, acarbose or DPP-4 inhibitors (e.g. sitagliptin and vildagliptin).

•Past or current history of pancreatitis, gallstones, history of alcoholism, blood triglyceride levels > 500mg/dL

•Significant untreated psychiatric dysfunction or an active eating disorder (Clark et al 2007, Cunningham et al 2012) based on screening with the Hospital Anxiety and Depression Inventory [HAD (Zigmond \& Snaith 1983)], a self-administered alcoholism screening test [AUDIT-C (Bush et al 1998)], and the Questionnaire on Eating and Weight Patterns-Revised [binge eating disorders and bulimia (Yanovski et al 2015)]. If such a dysfunction is identified by a HAD score >11 on either the anxiety or depression subscales or difficulties with substance or eating disorders, the participant will be interviewed by a study investigator and, if excluded, will be given a referral letter to his/her primary care doctor for further appraisal and follow-up treatment.

•Intake of any medication (except multivitamins) within 7 days of the study. Exceptions are birth control pill, estrogen and thyroxine replacement, and medication administered for co-morbidities as long as they do not alter gastric functions. Thus, statins for hyperlipidemia, diuretics, β-adrenergic blockers, ACE inhibitors and angiotensin antagonists for hypertension are permissible. In contrast, resin sequestrants for hyperlipidemia (Psichas et al 2012), α2-adrenergic agonists for hypertension, are not permissible due to effects on stomach or appetite.

•Documented delayed gastric emptying: gastric emptying T1/2 >174 min or gastric retention at 4 hours >25% based on 5-95%ile of 319 controls' GES of the same meal (320kcal, 30% fat) (Camilleri et al 2012a, Table 1)

•Hypersensitivity to semaglutide or tirzepatide

•Participate in highly intense physical activity program that could potentially interfere with study interpretation

Endpoints (9)

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

Other (unclassified)

Weight & body composition

2 endpoints

Primary/protocol endpoint

Body weight

Time frame:Measurement at baseline, after 16 and 24 weeks' treatment, and at 28 weeks (off treatment for 4 weeks)

descriptive, improvement

Secondary/protocol endpoint

DEXA (dual energy X-ray absorptiometry) body composition

Time frame:Measurement at baseline, and after 24 weeks' treatment

Total fat mass

change from baseline, improvement

Other clinical outcomes

5 endpoints

Primary/protocol endpoint

Gastric emptying of solids T1/2 min, that is time for half meal to empty from stomach

Time frame:Measurement at baseline, after 16 and 24 weeks' treatment, and at 28 weeks (off treatment for 4 weeks)

descriptive

Secondary/protocol endpoint/low confidence

Calories to fullness, kilocalories (kcal)

Time frame:Measurement at baseline, and after 24 weeks' treatment

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Maximum tolerated calories, kilocalories (kcal)

Time frame:Measurement at baseline, and after 24 weeks' treatment

change from baseline, improvement

Secondary/protocol endpoint

Fasting gastric volume, milliliters (mL)

Time frame:Measurement at baseline, and after 24 weeks' treatment

change from baseline, descriptive

Secondary/protocol endpoint

Gastric accommodation vol (postprandial minus fasting volume), milliliters (mL)

Time frame:Measurement at baseline, and after 24 weeks' treatment

change from baseline, descriptive

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Peak postprandial GLP-1 (glucagon-like peptide-1) pmol/L

Time frame:Measurement at baseline, and after 24 weeks' treatment

descriptive

Secondary/protocol endpoint/low confidence

Peak postprandial peptide tyrosine tyrosine (PYY) pmol/L

Time frame:Measurement at baseline, and after 24 weeks' treatment

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.