A Study of LY3463251 in Healthy Participants

Phase 1 Terminated 118 enrolled Eli Lilly and Company

RandomizedParallel-groupDouble-blindBasic science

Summary

The purpose of this study is to evaluate the safety and tolerability (side effects) of single (Part A) and multiple (Part B) doses of the study drug when it is administered subcutaneously (under the skin) into the abdomen. This is a two-part study. Participants will enroll in only one part. For each participant, Part A will last about 10 weeks and Part B will last about 23 weeks, including screening.

Timeline

Start: 2018-12-06
Primary completion: 2020-12-07
Completion: 2020-12-07

Outcome

Outcome not reported

Stopped: “Trial was terminated due to an insufficient benefit/tolerability ratio”

Publications

Benichou O, Coskun T, Gonciarz MD, Garhyan P, Adams AC, Du Y, Dunbar JD, Martin JA, Mather KJ, Pickard RT, Reynolds VL, Robins DA, Zvada SP, Emmerson PJ. Discovery, development, and clinical proof of mechanism of LY3463251, a long-acting GDF15 receptor agonist. Cell Metab. 2023 Feb 7;35(2):274-286.e10. doi: 10.1016/j.cmet.2022.12.011. Epub 2023 Jan 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	LY3463251	Unknown	0.01 mg	Subcutaneous
Subject	LY3463251	Unknown	0.03 mg	Subcutaneous
Subject	LY3463251	Unknown	0.1 mg	Subcutaneous
Subject	LY3463251	Unknown	0.3 mg	Subcutaneous
Subject	LY3463251	Unknown	1 mg	Subcutaneous
Subject	LY3463251	Unknown	3 mg	Subcutaneous
Subject	LY3463251	Unknown	9 mg	Subcutaneous
Subject	LY3463251	Unknown	10 mg	Subcutaneous
Subject	LY3463251	Unknown	24 mg	Subcutaneous

Indications

No indication recorded.