NCT06264310

To Evaluate the Safety, Tolerability and Efficacy of R2R01 Combined With SOC as Compared to SOC Alone in Outpatients With Worsening Heart Failure (WHF)

A Phase 2, Double-Blind, Placebo-Controlled, Dose Range Finding Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of the Relaxin Agonist R2R01 Combined With Standard of Care Versus Standard of Care Alone in Outpatients With Worsening Heart Failure (WHF)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: River 2 Renal Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Study Aims to Evaluate the Safety, Tolerability and Efficacy of R2R01 Combined With SOC as Compared to SOC Alone in Outpatients With Worsening Heart Failure (WHF)

Detailed description

This is a Phase 2, Double-Blind, Placebo-Controlled, Dose Range Finding Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of the Relaxin Agonist R2R01 combined with Standard of Care versus Standard of Care Alone in Outpatients with Worsening Heart Failure (WHF). Each patient will undergo a screening period of up to 21 days, an active treatment period of 7 days, and a follow up period of 23 days after the last dose (30 days after the first dose), i.e., a total of up to 51 days total study duration. This study is a four-parallel-cohort study. All patients will be randomized to one of the following Cohorts: 1. Cohort 1 (N=8): Placebo once daily SC for 7 days. 2. Cohort 2 (N=8): 5.0 mg R2R01 once daily SC for 7 days. 3. Cohort 3 (N=8): 7.5 mg R2R01 once daily SC for 7 days. 4. Cohort 4 (N=8): 10.0 mg R2R01 once daily SC for 7 days. All patients will present with worsening heart failure with congestion requiring SOC. The patient, in the opinion of the investigator, should be able to be treated for their symptoms without being admitted to the hospital. The planned 3-day hospitalization is to adequately manage any potential sign of hypotension and should not be required to treat the patient for the intensification of the diuretic therapy or same day IV loop diuretics. During the treatment period no new treatments for WHF should be initiated. This study will be conducted across approximately 8 centers in the US.

Conditions

• Heart Failure
• Worsening Heart Failure (WHF)

Interventions

Type	Name	Description
DRUG	Placebo	Matching placebo SC injection
DRUG	R2R01	Pharmaceutical Form: sterile 2R vials containing 10 mg of R2R01 for SC injection.

Timeline

• Start date: 2024-03-01
• Primary completion: 2024-11-04
• Completion: 2024-11-25
• First posted: 2024-02-16
• Last updated: 2024-11-29

Locations

18 sites across 3 countries: United States, Germany, Italy

Regulatory

• FDA-regulated drug study