A Study of LY3305677 in Participants With Obesity Or Overweight

What Was Tested

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

The main purpose of this study is to learn about the safety and tolerability of LY3305677 when given to participants with obesity or overweight.

Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.

Each enrolled participant will receive injections of LY3305677 or placebo given just under the skin.

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

LY3305677 administered subcutaneously (SC).

Placebo administered SC.

The registry classes the interventions as drug.

Who Took Part

32 actual participants took part.

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

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Participants who are overtly healthy as determined by medical evaluation. Participants with stable weight for 3 months and body mass index of 27.0 and 50.0 kilograms per square meter (kg/m²).

The full record lists 2 inclusion and 1 exclusion criteria; among the exclusions: have history of type 1 diabetes mellitus or type 2 diabetes mellitus, ketoacidosis, or hyperosmolar state or coma.

How the Study Was Run

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

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

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2022-11-16 with completion listed for 2023-06-27.

It ran at 3 sites in United States (3).

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline through Week 20).

It also tracked 3 secondary outcomes, for example PK: Area Under the Concentration Versus Time Curve (AUC) of LY3305677.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Mazdutide in 32 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.