A Study of LY3305677 in Participants With Type 2 Diabetes

What Was Tested

This registered phase 1 trial tested Mazdutide.

The main purpose of this study is to learn more about the safety and side effects of LY3305677 when it is given as an injection just under the skin to participants with type 2 diabetes.

The study will last about 20 weeks for each participant, not including screening.

It had two arms (groups): LY3305677 (experimental) and Placebo (placebo comparator).

LY3305677 administered SC.

Placebo administered SC.

The registry classes the interventions as drug.

Who Took Part

24 actual participants took part.

It was open to people of any sex aged from 20 years up to 69 years.

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

Examples of who could join: Have Type II diabetes. Body mass index (BMI) of 25-40 kilograms per square meter (kg/m²), inclusive. Have a body weight of \<150 kilograms (kg).

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: have type 1 diabetes or latent autoimmune diabetes in adults; have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization for 6 months prior to screening; have poorly controlled hypertension at screening; or a change in antihypertensive medication within 30 days of screening.

How the Study Was Run

Design: randomized, sequential and double-blind.

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

As a double-blind Mazdutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2019-10-27 with completion listed for 2021-07-08.

It ran at 1 site in Germany.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug (time frame: Baseline through 24 weeks).

It also tracked 4 secondary outcomes, for example PK: Area Under the Concentration-Time Curve (AUC) of LY3305677 and PD: Change from Baseline in Fasting Plasma Insulin.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Mazdutide in 24 people.

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

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

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