Exploratory Ph 2A, Double-Blind, Placebo-Controlled Dose Escalation Study of Safety, Tolerability, PD, & PK of HU6 for Subjects With Obese HFpEF

(HFpEF Trial)

Recruiting at14 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Rivus Pharmaceuticals, Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests a new drug called HU6 by giving participants increasing doses to find the safest and most effective amount. It involves individuals who meet specific health criteria.

Research Team

Shaharyar Khan, PhD

Principal Investigator

Rivus Pharmaceuticals, Inc.

Eligibility Criteria

Inclusion Criteria

Adult male or female, ≥40 years of age.

Competent to understand the information given in the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved Informed Consent Form (ICF) and must sign the form prior to the initiation of any study procedures.

You have to meet at least one of the following criteria for heart failure:

Exclusion Criteria

You have a currently active autoimmune disease affecting your connective tissues.

You have a specific type of heart condition called primary cardiomyopathy as determined by the doctor.

You have a current case of heart inflammation, either caused by COVID or another reason.

Treatment Details

Interventions

• HU6 (Other)
• Placebo (Drug)

Participant Groups

Group I: Active Treatment: HU6 Planned doses of HU6; N = 31 Experimental Treatment 1 Intervention

Group II: Placebo Comparator Non-active study drug N = 31 Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Rivus Pharmaceuticals, Inc.

Lead Sponsor

Trials

9

Recruited

540+