A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus

Summary

The main purpose of this study is to evaluate the efficacy and safety of LY3502970 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 30 weeks.

Timeline

Start

2021-09-15

Primary completion

2022-09-30

Completion

2022-09-30

Outcome

Met primary endpoint

registry analysis (superiority test); 3 mg LY3502970 vs Placebo; p <0.001; LS Mean Difference -0.77 (95% CI -1.13 to -0.40); Mixed Models Analysis NCT05048719 ↗

paper HbA1c reduction was statistically superior with orforglipron versus placebo (estimated treatment difference -0·8% to -1·7%). PMID 37369232 ↗

Publications

• Wharton S, Rosenstock J, Konige M, Lin Y, Duffin K, Wilson J, Banerjee H, Pirro V, Kazda C, Mather K. Treatment with orforglipron, an oral glucagon like peptide-1 receptor agonist, is associated with improvements of CV risk biomarkers in participants with type 2 diabetes or obesity without diabetes. Cardiovasc Diabetol. 2025 Jun 6;24(1):240. doi: 10.1186/s12933-025-02781-x.
• Frias JP, Hsia S, Eyde S, Liu R, Ma X, Konig M, Kazda C, Mather KJ, Haupt A, Pratt E, Robins D. Efficacy and safety of oral orforglipron in patients with type 2 diabetes: a multicentre, randomised, dose-response, phase 2 study. Lancet. 2023 Aug 5;402(10400):472-483. doi: 10.1016/S0140-6736(23)01302-8. Epub 2023 Jun 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Dulaglutide	Peptide	1.5 mg	Subcutaneous
Subject	Orforglipron	Small molecule	3 mg	Oral
Subject	Orforglipron	Small molecule	12 mg	Oral
Subject	Orforglipron	Small molecule	24 mg	Oral
Subject	Orforglipron	Small molecule	36 mg	Oral
Subject	Orforglipron	Small molecule	45 mg	Oral

Indications