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A Study of Carbon-14-Labelled [14C] LY3437943 in Healthy Male Participants
Plain-language guide to NCT05757531: phase 1 non-randomized trial of Retatrutide, 7 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05757531
- Phase
- phase 1
- Status
- completed
- Start
- 2023-03-17
- Completion (planned or actual)
- 2023-06-23
- Participants
- 7 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), 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.
The main purpose of this study is to is to look at how much LY3437943 gets into the bloodstream and how long the body takes to get rid of it in healthy male participants.
The study will last up to approximately 15 weeks including the screening period of 28 days.
It had 1 arm (groups): [¹⁴C]-LY3437943 (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 7 actual participants took part.
It was open to men only aged from 18 years up to 55 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Male participants who are overtly healthy as determined by medical evaluation. Have a body mass index within the range 18.5 to 32.0 kilograms per meter squared (kg/m²). Have venous access sufficient to allow for blood sampling as per the protocol. Are willing to receive study treatment by SC injections. Have a history of a minimum of 1 bowel movement per day.
The full record lists 7 inclusion and 10 exclusion criteria; among the exclusions: show evidence of hiv infection and/or positive hiv antibodies, hepatitis c and/or positive hepatitis c antibody, hepatitis b and/or positive hepatitis b surface antigen; have a history of constipation or have had acute constipation within 3 weeks prior to check-in; have participated in any clinical trial involving a radiolabeled substance within the past 12 months.
How the Study Was Run
It was run as a non-randomized, single-group and open-label study.
Nothing was hidden in this open-label Retatrutide study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2023-03-17 with completion listed for 2023-06-23.
It ran at 1 site in United States.
Its stated primary purpose is basic science.
What Was Measured
It also tracked 4 secondary outcomes, for example PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC (0-∞)) of Total Radioactivity and [¹⁴C]-LY3437943, PK: Maximum Concentration (Cmax) of Total Radioactivity and [¹⁴C]-LY3437943, Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable) and Total Number of Metabolites of LY3437943.
What This Means in Plain Language
Put simply, this is a phase 1, non-randomized trial of Retatrutide in 7 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.