NCT05093933

A Study of Vericiguat (MK-1242) in Participants With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-035)

A Pivotal Phase 3 Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of the sGC Stimulator Vericiguat/MK-1242 in Adults With Chronic Heart Failure With Reduced Ejection Fraction

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6,106 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of vericiguat in participants with chronic heart failure with reduced ejection fraction (HFrEF), specifically those with symptomatic chronic HFrEF who have not had a recent hospitalization for heart failure or need for outpatient intravenous (IV) diuretics. The primary hypothesis is that vericiguat is superior to placebo in reducing the risk of cardiovascular death or heart failure hospitalization.

Conditions

• Chronic Heart Failure With Reduced Ejection Fraction

Interventions

Type	Name	Description
DRUG	Vericiguat	2.5, 5.0, or 10.0 mg orally once daily
DRUG	Placebo	0 mg matching placebo for 2.5 mg, 5 mg, and 10 mg of vericiguat

Timeline

• Start date: 2021-11-02
• Primary completion: 2024-11-20
• Completion: 2025-02-05
• First posted: 2021-10-26
• Last updated: 2025-12-19
• Results posted: 2025-12-19

Locations

519 sites across 36 countries: United States, Argentina, Australia, Austria, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Ireland, Israel, Italy, Malaysia, Mexico, New Zealand, Peru, Poland, Puerto Rico, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study