Effects of Long-Acting GLP-1 (Glucagon-like Peptide-1) or Dual Incretin (GLP-1 and GIP [Glucose-d… (NCT06801015) | Clinical Trial Compass
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
United States30 participantsStarted 2025-10-01
Plain-language summary
The purpose of this study is to compare effects of weekly SQ semaglutide 2.4mg SQ, SQ tirzepatide 10mg, and placebo administered for 24 weeks on GES measured repeatedly at baseline, 16 weeks, 24 weeks, 28 weeks, 4 weeks after stopping the medication, and accommodation and satiation at 24 weeks compared to baseline.
Who can participate
Age range18 Years – 75 Years
SexALL
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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 semagluti…
What they're measuring
1
Gastric emptying of solids T1/2 min, that is time for half meal to empty from stomach
Timeframe: Measurement at baseline, after 16 and 24 weeks' treatment, and at 28 weeks (off treatment for 4 weeks)
2
Body weight
Timeframe: Measurement at baseline, after 16 and 24 weeks' treatment, and at 28 weeks (off treatment for 4 weeks)