A Study of LY3437943 in Participants With Type 2 Diabetes

Summary

The main purpose of this study is to evaluate the efficacy and safety of LY3437943 in participants with type 2 diabetes (T2D) who failed to achieve adequate glycemic control on diet and exercise alone or on a stable dose of metformin. This study will last about 43 weeks.

Timeline

Start

2021-05-13

Primary completion

2022-07-08

Completion

2022-10-27

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs 4 mg LY3437943 (2 mg); p <0.001; LSMean Difference -1.34 (95% CI -1.84 to -0.85); Mixed Models Analysis NCT04867785 ↗

paper HbA1c reductions with retatrutide were significantly greater (p<0·0001) than placebo in all but the 0·5 mg group PMID 37385280 ↗

Publications

• Coskun T, Wu Q, Schloot NC, Haupt A, Milicevic Z, Khouli C, Harris C. Effects of retatrutide on body composition in people with type 2 diabetes: a substudy of a phase 2, double-blind, parallel-group, placebo-controlled, randomised trial. Lancet Diabetes Endocrinol. 2025 Aug;13(8):674-684. doi: 10.1016/S2213-8587(25)00092-0. Epub 2025 Jun 30.
• Rosenstock J, Frias J, Jastreboff AM, Du Y, Lou J, Gurbuz S, Thomas MK, Hartman ML, Haupt A, Milicevic Z, Coskun T. Retatrutide, a GIP, GLP-1 and glucagon receptor agonist, for people with type 2 diabetes: a randomised, double-blind, placebo and active-controlled, parallel-group, phase 2 trial conducted in the USA. Lancet. 2023 Aug 12;402(10401):529-544. doi: 10.1016/S0140-6736(23)01053-X. Epub 2023 Jun 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Dulaglutide	Peptide	1.5 mg	Subcutaneous
Subject	Retatrutide	Protein / enzyme biologic	0.5 mg	Subcutaneous
Subject	Retatrutide	Protein / enzyme biologic	4 mg	Subcutaneous
Subject	Retatrutide	Protein / enzyme biologic	8 mg	Subcutaneous
Subject	Retatrutide	Protein / enzyme biologic	12 mg	Subcutaneous

Indications