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

What Was Tested

The trial (phase 4) is built around Tirzepatide and Semaglutide.

It had three arms (groups): semaglutide (experimental), Tirzepatide (experimental) and placebo (placebo comparator).

Administered by subcutaneous injection once per week in accordance with FDA approved escalation as well as maintenance treatment.

Administered by subcutaneous injection once per week in accordance with FDA approved escalation as well as maintenance treatment.

Administered by subcutaneous injection once per week.

The registry classes the interventions as drug.

Who Took Part

30 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adults (18-75 years) who have BMI \>30 or \>27kg/m2 who also have prediabetes or T2DM on diet treatment only. Not currently on treatment (exceptions below) for cardiac, pulmonary, GI, hepatic, renal, hematological, neurological, or endocrine disorders.

The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this Tirzepatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Tirzepatide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Tirzepatide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2025-10-01 with completion listed for 2028-01-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: 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)). Body weight (time frame: Measurement at baseline, after 16 and 24 weeks' treatment, and at 28 weeks (off treatment for 4 weeks)).

It also tracked 7 secondary outcomes, for example Calories to fullness, kilocalories (kcal), Maximum tolerated calories, kilocalories (kcal), Fasting gastric volume, milliliters (mL), Gastric accommodation vol (postprandial minus fasting volume), milliliters (mL), Peak postprandial GLP-1 (glucagon-like peptide-1) pmol/L and Peak postprandial peptide tyrosine tyrosine (PYY) pmol/L.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Tirzepatide and Semaglutide in 30 people.

Its size is small, so on its own it can only give an early look.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page and the Semaglutide compound page, all human trials.