A Study to Investigate the Response of Participants With Type 2 Diabetes Mellitus on Once-Weekly Retatrutide to Hypoglycemia

What Was Tested

In this phase 1 trial, researchers set out to test Retatrutide.

The purpose of this study is to measure the effect of retatrutide versus placebo, administered every week, on time to recovery from hypoglycemia during hypoglycemic clamp in participants with Type 2 Diabetes Mellitus (T2DM) following 16 weeks of treatment.

It had two arms (groups): Retatrutide (experimental) and Placebo (placebo comparator).

Participants will receive matching placebo administered SC QW.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 80 actual participants took part.

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 T2DM for at least 6 months prior to screening. Treated with diet and exercise and stable treatment with metformin with or without 1 additional allowed oral antihyperglycemic medications (OAM), 3 months prior to screening. Allowed OAMs include dipeptidyl peptidase-4 (DPP-IV) inhibitors, sodium-glucose co-transporter-2 (SGLT2) inhibitors, glinides, or sulfonylureas. Have a hemoglobin A1c value at screening of. Have a BMI within the range 25.0 kg/m2 and 45.0 kg/m2 kg/m2 (both inclusive).

The full record lists 9 inclusion and 11 exclusion criteria; among the exclusions: have type 1 diabetes mellitus; have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma requiring hospitalization within the 6 months prior to screening; have acute or chronic pancreatitis or a history of acute idiopathic pancreatitis.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Retatrutide and who got the comparison, which limits bias.

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

Neither the participants nor the staff measuring them knew who was on Retatrutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2025-06-06 with completion listed for 2026-05-04.

It ran at 1 site in Austria.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 4 secondary outcomes, for example Hypoglycemic Symptoms Score at set PG Concentration Points and Percentage of Participants Who Experienced Hypoglycemic Awareness at Set PG Points.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Retatrutide in 80 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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