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A Safety Study of LY3437943 Given as a Single Injection in Healthy Participants

Plain-language guide to NCT03841630: phase 1 randomized trial of Retatrutide, 45 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03841630
Phase
phase 1
Status
completed
Start
2019-03-13
Completion (planned or actual)
2019-07-25
Participants
45 (actual)
Design
randomized, double-blind, basic_science
Conditions studied
Healthy
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 1) is built around Retatrutide.

This study is being conducted to determine the side effects related to LY3437943 given as a single injection under the skin to healthy participants.

Blood tests will be performed to check how much LY3437943 gets into the bloodstream and how long the body takes to get rid of it.

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

Matching placebo administered as an injection under the skin in healthy participants.

The registry classes the interventions as drug.

Who Took Part

45 actual participants took part.

It was open to people of any sex aged from 21 years up to 65 years.

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

Examples of who could join: Overtly healthy male or a female who cannot get pregnant. Have a body mass index (BMI) between 19 and 40 kilograms per square meter (kg/m²), inclusive, at screening. Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study. Have veins suitable for ease of blood sampling.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: have previously completed or withdrawn from this study; smoke more than the equivalent of 10 cigarettes per day and are unwilling to stop smoking during the inpatient stay in the study; have been treated with weight loss medications within 3 months of screening.

How the Study Was Run

Design: 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.

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

Those kept unaware of assignments: participant and investigator.

It started in 2019-03-13 with completion listed for 2019-07-25.

It ran at 1 site in Singapore.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline through final follow-up at approximately Day 43).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Retatrutide in 45 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.

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.