A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16)

Summary

This is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. The objective of this study is to evaluate the efficacy, safety and tolerability of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. Efficacy is measured by change from baseline in pulmonary vascular resistance (PVR, primary endpoint) and 6-minute walk distance (6MWD, key secondary endpoint).

Timeline

Start

2021-12-29

Primary completion

2025-09-05

Completion

2026-04-09

Publications

• Results Gomberg-Maitland M, Tedford RJ, Langleben D, Rosenkranz S, Miller B, Jones AD, Urbinati A, McMullan CJ, Cornell AG, Vachiery JL. Sotatercept for Combined Post- and Precapillary Pulmonary Hypertension Associated With Heart Failure: Results From the Phase 2, Randomized, Placebo-Controlled CADENCE Study. Circulation. 2026 May 12;153(19):1446-1459. doi: 10.1161/CIRCULATIONAHA.126.079918. Epub 2026 Mar 29.

Drugs

Indications