← Human Trials & Peer-Reviewed Studies

A Study of LY3437943 in Chinese Participants With Obesity Or Overweight

Plain-language guide to NCT05548231: phase 1 randomized trial of Retatrutide, 32 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05548231
Phase
phase 1
Status
completed
Start
2022-10-24
Completion (planned or actual)
2023-07-27
Participants
32 (actual)
Design
randomized, double-blind, basic_science
Conditions studied
Overweight; Obesity
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 1) is built around Retatrutide.

The main purpose of this study is to learn about the safety and tolerability of LY3437943 when given to Chinese participants with overweight body mass index (BMI) or obesity.

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 LY3437943 or placebo given just under the skin.

It had two arms (groups): LY3437943 (experimental) and Placebo (placebo comparator).

LY3437943 administered subcutaneously (SC).

Placebo administered SC.

The registry classes the interventions as drug.

Who Took Part

The registry lists 32 actual participants took part.

It was open to people of any sex aged from 20 years up to 65 years.

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

Examples of who could join: Are native Chinese males or females. Have a body mass index of ≥27 and ≤40 kilograms per square meter (kg/m²). Have not modified diet or adopted any nutritional lifestyle modification for 3 months. Have stable body weight for the last three months. Male participants must agree to use contraception during the study and for 4 months afterward and female participants must be woman of nonchildbearing potential.

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: have other serious or unstable illnesses; have had an episode of severe hypoglycemia; current or chronic history of liver disease.

How the Study Was Run

Design: randomized, sequential and double-blind.

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

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 2022-10-24 with completion listed for 2023-07-27.

It ran at 2 sites in China (2).

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 2 secondary outcomes, for example PK: Area Under the Concentration Versus Time Curve (AUC) of LY3437943.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Retatrutide 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 Retatrutide compound page, all human trials.

Our Notes on the Compound

Retatrutide: A single-molecule triple agonist (GLP-1, GIP and glucagon receptors).

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.