Clinical Trial

Study of JK07 in Patients With Heart Failure and WHO Group 2 Combined Post- and Pre-Capillary Pulmonary Hypertension

Study acronym: RENEU-PH

Withdrawn Phase 2

View on ClinicalTrials.gov →

Why the trial stopped

Sponsor decision

Summary

This is a Phase 2a, open-label, multiple-dose study to assess the safety, tolerability, and efficacy of JK07 in participants 18 to 85 years of age with diagnosed HF and cpcPH. At least 20 and up to approximately 30 participants will be enrolled and receive JK07 high dose in this open-label trial.

Protocol Amendment History 5 changes

critical Trial status changed: Recruiting → Withdrawn 2026-05-16

critical Reason stopped changed: — → Sponsor decision 2026-05-16

notable Enrollment reduced: 30 -> 0 participants 2026-05-16

notable Primary completion moved earlier: 2026-09 -> 2026-04-16 2026-05-16

minor Completion moved earlier: 2027-10 -> 2026-04-16 2026-05-16

Trial Details

NCT Number	NCT07221513
Lead Sponsor	Salubris Biotherapeutics Inc
Conditions	HFrEF - Heart Failure With Reduced Ejection Fraction, HFpEF - Heart Failure With Preserved Ejection Fraction, Group 2 Pulmonary Hypertension
Start Date	2025-12-15
Primary Completion	2026-04-16 (estimated)
Study Completion	2026-04-16 (estimated)
Updated on ClinicalTrials.gov	2026-05-15