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

Phase 4

Not yet recruiting

• Conditions: Obesity
• Interventions: Drug: Semaglutide; Drug: Tirzepatide; Drug: Placebo

• Registration Number: NCT06801015
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-24
• Study First Submitted QC: 2025-01-24
• Study First Posted: 2025-01-30
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-04
• Study Start: 2025-04-15
• Primary Completion: 2028-01-31
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
semaglutide	Semaglutide	Administered by subcutaneous injection once per week in accordance with FDA approved escalation as well as maintenance treatment
Tirzepatide	Tirzepatide	Administered by subcutaneous injection once per week in accordance with FDA approved escalation as well as maintenance treatment
placebo	Placebo	Administered by subcutaneous injection once per week

Primary Outcome Measures

Name	Time	Method
Gastric emptying of solids T1/2 min, that is time for half meal to empty from stomach	Measurement at baseline, after 16 and 24 weeks' treatment, and at 28 weeks (off treatment for 4 weeks)	Gastric emptying of an egg meal measured by scintigraphy
Body weight	Measurement at baseline, after 16 and 24 weeks' treatment, and at 28 weeks (off treatment for 4 weeks)	Measurement of body weight using weight scales

Secondary Outcome Measures

Name	Time	Method
Calories to fullness, kilocalories (kcal)	Measurement at baseline, and after 24 weeks' treatment	Measurement of kilocalorie intake at comfortable fullness based on Ensure liquid nutrient
Maximum tolerated calories, kilocalories (kcal)	Measurement at baseline, and after 24 weeks' treatment	Measurement of kilocalorie intake at maximal fullness based on Ensure liquid nutrient
Fasting gastric volume, milliliters (mL)	Measurement at baseline, and after 24 weeks' treatment	Measurement of gastric volume during fasting using 99mTc-SPECT (single photon emission computed tomography) imaging
Gastric accommodation vol (postprandial minus fasting volume), milliliters (mL)	Measurement at baseline, and after 24 weeks' treatment	Measurement of gastric volume following 300 mL of Ensure using 99mTc-SPECT (single photon emission computed tomography) imaging
Peak postprandial GLP-1 (glucagon-like peptide-1) pmol/L	Measurement at baseline, and after 24 weeks' treatment	GLP-1 measured fasting, and 15, 45, and 90 minutes postprandially
Peak postprandial peptide tyrosine tyrosine (PYY) pmol/L	Measurement at baseline, and after 24 weeks' treatment	PYY measured fasting, and 15, 45, and 90 minutes postprandially
DEXA (dual energy X-ray absorptiometry) body composition	Measurement at baseline, and after 24 weeks' treatment	Body composition (including total body fat) by dual-energy X-ray absorptiometry (DEXA) technology

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States