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Active Treatment: HU6 Planned doses of HU6; N = 31 for Heart Failure (HFpEF Trial)

Phase 2
Recruiting
Research Sponsored by Rivus Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 days
Treatment 4 months
Follow Up 14 days

Summary

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.

Eligible Conditions
  • Heart Failure

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 days
Treatment ~ 4 months
Follow Up ~14 days
This trial's timeline: 3 days for screening, 4 months for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluate weight reduction while on HU6 treatment

Side effects data

From 2021 Phase 2 trial • 80 Patients • NCT04874233
42%
Flushing
32%
Diarrhoea
16%
Palpitations
16%
Night sweats
11%
Dizziness
11%
Abdominal Pain
5%
Decreased appetite
5%
Nausea
5%
Dyspnoea
5%
Presyncope
5%
Fatigue
5%
Pyrexia
5%
Vessel puncture site haemorrhage
5%
Oropharyngeal pain
5%
Rhinitis
5%
Myalgia
5%
Arthralgia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Active: HU6 450mg
Active: HU6 150mg
Active: HU6 300mg
Placebo Comparator

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Treatment: HU6 Planned doses of HU6; N = 31Experimental Treatment1 Intervention
Group II: Placebo Comparator Non-active study drug N = 31Placebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HU6
2021
Completed Phase 2
~180

Find a Location

Who is running the clinical trial?

Rivus Pharmaceuticals, Inc.Lead Sponsor
8 Previous Clinical Trials
532 Total Patients Enrolled
Shaharyar Khan, PhDStudy DirectorRivus Pharmaceuticals, Inc.

Media Library

HU6 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05284617 — Phase 2
Heart Failure Research Study Groups: Placebo Comparator Non-active study drug N = 31, Active Treatment: HU6 Planned doses of HU6; N = 31
Heart Failure Clinical Trial 2023: HU6 Highlights & Side Effects. Trial Name: NCT05284617 — Phase 2
HU6 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05284617 — Phase 2
Heart Failure Patient Testimony for trial: Trial Name: NCT05284617 — Phase 2
~21 spots leftby Nov 2025
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