NCT06017609

Evaluate Efficacy, Safety and Tolerability of JTT-861 in Subjects With Heart Failure With Reduced Ejection Fraction

A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety and Tolerability of JTT-861 Administered for 12 Weeks in Subjects With Heart Failure With Reduced Ejection Fraction

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 314 (actual)
• Sponsor: Akros Pharma Inc. · Industry
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy, safety, tolerability and pharmacokinetics of JTT-861 administered once daily for 12 weeks in subjects with heart failure with reduced ejection fraction (HFrEF) who are on a stable, guideline-directed medical therapy for heart failure.

Conditions

• Chronic Heart Failure

Interventions

Type	Name	Description
DRUG	JTT-861 Capsules	Active drug capsules containing JTT-861
DRUG	Placebo Capsules	Placebo capsules matching in appearance to the active drug capsules

Timeline

• Start date: 2023-12-20
• Primary completion: 2026-05-01
• Completion: 2026-12-01
• First posted: 2023-08-30
• Last updated: 2026-02-09

Locations

75 sites across 6 countries: United States, Bulgaria, Czechia, Poland, Romania, Spain

Regulatory

• FDA-regulated drug study