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Exploratory Ph 2A, Double-Blind, Placebo-Controlled Dose Escalation Study of Safety, Tolerability, PD, & PK of HU6 for Subjects With Obese HFpEF (HFpEF Trial)
Phase 2
Waitlist Available
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 belowTimeline
Screening ~ 3 days2 visits
Treatment ~ 4 months8 visits
Follow Up ~ 14 days1 visit
Screening ~ 3 days
Treatment ~ 4 months
Follow Up ~14 days
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 • NCT0487423342%
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
~250
Find a Location
Who is running the clinical trial?
Rivus Pharmaceuticals, Inc.Lead Sponsor
8 Previous Clinical Trials
471 Total Patients Enrolled
Shaharyar Khan, PhDStudy DirectorRivus Pharmaceuticals, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a currently active autoimmune disease affecting your connective tissues.You have to meet at least one of the following criteria for heart failure: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.You have a serious problem with one of the valves in your heart, as determined by the doctor.You have started taking a certain type of medication called GLP-1 receptor antagonist within the past year.You have a serious heart rhythm problem that has not been treated yet and could be life-threatening.Your doctor believes that you have less than one year to live for reasons unrelated to heart problems.The doctor thinks you have signs and symptoms of heart failure, and your condition meets certain criteria to determine how severe it is.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Comparator Non-active study drug N = 31
- Group 2: Active Treatment: HU6 Planned doses of HU6; N = 31
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 4 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 14 Months after you stop receiving the treatment.
Heart Failure Patient Testimony for trial: Trial Name: NCT05284617 — Phase 2