A 16 Week Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Type 2 Diabetes Mellitus

Summary

This multicenter, randomized, double-blind, placebo controlled, parallel group study is being conducted to provide data on efficacy, safety, tolerability and pharmacokinetics (PK) of multiple dose levels of PF-06882961 in adults with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin and/or diet and exercise. In addition, the study is intended to enable selection of efficacious doses for future clinical development of PF-06882961.

Timeline

Start

2019-10-15

Primary completion

2021-06-08

Completion

2021-07-07

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs PF-06882961 120 mg BID; p <.0001; Difference in LS Mean -1.16 (90% CI -1.47 to -0.86); Mixed Models Analysis NCT03985293 ↗

paper For all danuglipron doses, HbA1c and FPG were statistically significantly reduced at week 16 vs placebo PMID 37213102 ↗

Publications

• Saxena AR, Frias JP, Brown LS, Gorman DN, Vasas S, Tsamandouras N, Birnbaum MJ. Efficacy and Safety of Oral Small Molecule Glucagon-Like Peptide 1 Receptor Agonist Danuglipron for Glycemic Control Among Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2314493. doi: 10.1001/jamanetworkopen.2023.14493.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Danuglipron	Small molecule	2.5 mg	Oral
Subject	Danuglipron	Small molecule	10 mg	Oral
Subject	Danuglipron	Small molecule	40 mg	Oral
Subject	Danuglipron	Small molecule	80 mg	Oral
Subject	Danuglipron	Small molecule	120 mg	Oral

Indications