A Study to Evaluate the Effect of Retatrutide on Insulin Secretion and Insulin Sensitivity in Adult Participants With Type 2 Diabetes Mellitus

What Was Tested

This registered phase 1 trial tested Retatrutide and Semaglutide.

The primary objective of Study GZQG is to compare the effect of retatrutide and placebo on total clamp disposition index (cDI) after 28 weeks of treatment.

It had three arms (groups): Retatrutide (experimental), Semaglutide (active comparator) and Placebo (placebo comparator).

Retatrutide administered subcutaneously (SC).

Semaglutide administered SC.

Placebo administered SC.

The registry classes the interventions as drug.

Who Took Part

The registry lists 95 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Have been diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 6 months prior to screening. Have a HbA1c value at screening of:. Have venous access sufficient to allow for blood sampling as per the protocol. Have a body mass index (BMI) between 25 kilograms per meter squared (kg/m²) and 45 kg/m², both inclusive, at screening.

The full record lists 9 inclusion and 35 exclusion criteria; among the exclusions: have type 1 diabetes mellitus (t1dm); have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma requiring hospitalisation within the 6 months prior to screening; have acute or chronic pancreatitis or a history of acute idiopathic pancreatitis.

How the Study Was Run

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

The participants were allocated by chance, so the Retatrutide group and the comparison group should start out alike.

The Retatrutide 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 Retatrutide.

Those kept unaware of assignments: participant and investigator.

It started in 2025-06-02 with completion listed for 2027-01.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change from Baseline in Total Clamp Disposition Index (cDI) for Comparison of Retatrutide With Placebo (time frame: Baseline, Week 28).

It also tracked 12 secondary outcomes, for example Change from Baseline in cDI for Comparison Between Retatrutide and Semaglutide, Change from Baseline in Hyperinsulinemic Euglycemic Clamp M-value, Change from Baseline in First Phase Incremental Insulin Secretion Rate (ISR), Change from Baseline in Second Phase Total ISR, Change from Baseline in Total ISR and Change from Baseline in Insulin Response to Arginine [Incremental Insulin Area Under the Curve (AUC) arginine, 0-10minutes].

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Retatrutide and Semaglutide in 95 people.

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

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