Safety, tolerability, pharmacokinetics, and pharmacodynamics of the first-in-class GLP-1 and amylin receptor agonist, amycretin: a first-in-human, phase 1, double-blind, randomised, placebo-controlled trial

What Was Tested

Researchers studied Amycretin in this randomized controlled trial publication.

Amycretin is a novel, single-molecule GLP-1 receptor and amylin receptor agonist.

Who Took Part

According to the abstract, 60 participants were involved.

The age groups tagged for this paper are teenagers, young adults, adults and middle-aged adults, both men and women.

In this phase 1, first-in-human, randomised, double-blind, placebo-controlled multipart study, participants were recruited at a single clinical research unit in San Antonio (TX, USA).

Eligible individuals were men or women (including women of childbearing potential) aged 18-55 years at the time of signing informed consent with a BMI of 25·0-34·9 kg/m2 for parts A and B and a BMI of 27·0-39·9 kg/m2 for part C/D.

How the Study Was Run

In design terms this was a randomized, double-blind and placebo-controlled study.

The participants were allocated by chance, so the Amycretin group and the comparison group should start out alike.

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

Some participants received a placebo instead of Amycretin, giving a reference point.

Part B consisted of a 28-day screening period, a 10-day intervention period, and a 21-day follow-up period.

Part C/D consisted of a 4-week screening period, a 12-week intervention period, and a 3-week follow-up period.

The safety analysis set, comprising all participants who were exposed to treatment, was used to analyse the endpoints and assessments related to safety.

This study is registered with ClinicalTrials.gov, NCT05369390.

What Was Measured

Topics PubMed links to this paper include Glucagon-Like Peptide-1 Receptor Agonists, Amylin Receptor Agonists, Obesity, Hypoglycemic Agents, Overweight and Diabetes Mellitus, Type 2.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Amycretin in 60 participants.

The abstract goes on to report its results in about 6 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2025 (Lancet (London, England)), a journal based in England.

More context: the Amycretin compound page, all human trials.