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A Study of LY3437943 in Participants With Impaired and Normal Liver Function

Plain-language guide to NCT05916560: phase 1 non-randomized trial of Retatrutide, 43 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05916560
Phase
phase 1
Status
completed
Start
2023-07-13
Completion (planned or actual)
2025-03-02
Participants
43 (actual)
Design
non-randomized, open label (everyone knows who gets what), basic_science
Conditions studied
Healthy; Hepatic Insufficiency
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 measure how much of LY3437943 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function compared to healthy participants with normal liver function.

The safety and tolerability of LY3437943 will also be evaluated.

The study may last up to 9 weeks for each participant including the screening period.

It had four arms (groups): LY3437943 (Normal Hepatic Function) (experimental), LY3437943 (Severe Hepatic Impairment) (experimental), LY3437943 (Moderate Hepatic Impairment) (experimental) and LY3437943 (Mild Hepatic Impairment) (experimental).

LY3437943 administered subcutaneously (SC).

LY3437943 administered SC.

LY3437943 administered SC.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 43 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

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

Examples of who could join: Have a body mass index within the range 19.0 to 42.0 kilograms per meter squared (kg/m²), inclusive. Healthy or various degrees of hepatic impairment depending on the study group.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: have or are anticipating an organ transplant within the next 6 months; requires needle evacuation of ascites fluid more than 2 times per month.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Retatrutide study: the participants and staff both knew the treatment.

It started in 2023-07-13 with completion listed for 2025-03-02.

It ran at 5 sites in United States (5).

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: PK: Maximum observed concentration (Cmax) of LY3437943 (time frame: Predose up to 30 days postdose).

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Retatrutide in 43 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.