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Heart Failure With Preserved Ejection FractionPhase 2HFpEFNCT05284617

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

A Phase 2 study testing HU6 in people with Heart Failure With Preserved Ejection Fraction, run by Rivus Pharmaceuticals, Inc. at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase 2A, randomized, parallel-group, placebo-controlled, double-blind, within subject dose escalation trial with 3 dose levels of HU6 and placebo. Subjects will be randomized (1:1) either to HU6 or placebo. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
HU6
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
67 participants
Where
15 sitesUnited States
Study dates
30 Oct 2022to 30 May 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Body mass index (BMI) ≥30 kg/m2;
  • Signs and symptoms of HF in the judgement of the Investigator, and meets the following disease severity criteria:
  • KCCQ OSS ≤80; b. NYHA Classification Class II-III; c. Baseline peak VO2 ≤18 mL/kg/min for females or ≤20 mL/kg/min for males; d. Respiratory exchange ratio (respiratory quotient) (RER [RQ]) at baseline of >1.0; e. Left ventricular ejection fraction (EF) ≥50%; f. At least 1 of the following objective criteria for HF: i. Documented hospitalization with HF as primary cause within in last year, or if greater than the past year, then with addition of structural heart disease on echocardiography (increased left atrial volume size or left ventricular hypertrophy, with sex-specific cut-points as per Lang, 2015) as follows:
  • Left ventricular hypertrophy (LVH):
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  • Men: Either septal wall thickness (cm) either ≥1.1 or posterior wall thickness ≥1.1;
  • Women: Either septal wall thickness (cm) either ≥ 1.0 or posterior wall thickness ≥1.0;
  • Left atrial dilation (LAD): AP dimension (cm): ≥4.0 in men; >3.8 in women; ii. Pulmonary capillary wedge pressure (PCWP) at rest >15 mmHg (or left ventricular end-diastolic pressure [LVEDP] ≥18 mmHg) or >25 mmHg (or 2.0 mmHg/L/min) with exercise in the last year; iii. E/e' ratio ≥14 at septal annulus at rest on Doppler and tissue Doppler imaging in the last year; or iv. Currently elevated NT-proBNP defined as >125 pg/mL without atrial fibrillation and >350 pg/mL for subjects with chronic controlled atrial fibrillation.
  • Participants should maintain their stable level of physical activity throughout the duration of the study and must agree to not enroll in an exercise training program during the study.
  • Participants should maintain their stable diet and no plan to enter into a weight loss program prior to or during the course of the study.
  • Euthyroid as assessed by a thyroid profile utilizing thyroid stimulating hormone (TSH) and free thyroxine (T4) testing at screening. Subjects with a stable history of thyroid disease and who have been on stable doses of thyroid medications for a minimum of 4 months can be enrolled.
  • Ambulatory (not wheelchair- or scooter-dependent) and able to perform upright exercise testing including a 6 MWT.
  • Stable doses of medications (defined as no new medication or change in existing dose of medication ≥50%) for 30 days prior to screening, with additional specific criteria for the diuretics:
  • If treated with a loop or thiazide diuretic, must be on stable regimen, which dose permits a flexible diuretic dosing schedule.

Who cannot join

  • Life expectancy <1 year due to non-cardiovascular reasons, in the judgement of the Investigator.
  • History of malignancy within 5 years (except non-high-grade skin cancers, carcinoma-in-situ, or low-grade prostate cancer).
  • Weight change (gain or loss) of ≥10 pounds either by self-reporting or documented weight loss within the past 90 days.
  • Bariatric surgery prior to screening or planned bariatric surgery during the course of the study.
  • Treatment with GLP-1 receptor antagonist begun within 1 year of screening.
  • Treatment with SGLT2 inhibitors begun within 6 months of screening.
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  • Intolerance to MRI or with conditions contraindicated for MRI procedures including but not limited to:
  • Having surgical clips/metallic implants/shrapnel/internal electric implants; or
  • Inability to fit into MRI scanner due to subject habitus or exceeding weight tolerance limit of the scanner (generally, 350 or 400 lbs, dependent on manufacturer); or
  • Claustrophobia: history of severe claustrophobia that would lead to inability to conduct MRI.
  • Current acute decompensated HF requiring intravenous (IV) diuretics or recent (<1 month before screening) hospitalization for HF.
  • Primary cardiomyopathy (e.g., constrictive, restrictive, infiltrative, toxic, hypertrophic [congenital], congenital, or any other primary cardiomyopathy, in the judgement of the Investigator.
  • Active myocarditis (COVID-induced or otherwise).
  • Active collagen vascular disease.
  • Current greater than moderate left- or right sided valve disease, in the opinion of the Investigator.
  • Planned cardiac surgery or catheter intervention during the time of trial participation.
  • Prior documented EF <40% within the last 3 years.
  • Tachycardia (>110 beats/minute) at screening.
  • Atrial fibrillation or atrial flutter with an uncontrolled heart rate response or with a resting heart rate greater than 110 bpm by ECG at screening. Subjects may rescreen after appropriate adjustment of medication to manage the atrial fibrillation. A maximum of 16 subjects with this condition can be enrolled in this study.
  • Untreated, life-threatening dysrhythmia.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • National Heart Institute

    Beverly Hills, California, 90211

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Medical University of South Carolina

    Charleston, South Carolina, 29403

  • Northwestern University

    Chicago, Illinois, 60611

  • The University of Chicago Medical Center

    Chicago, Illinois, 60637

  • The Lindner Center for Research and Education at The Christ Hospital

    Cincinnati, Ohio, 45219

  • University of Texas Southwestern

    Dallas, Texas, 75390

  • New Generation of Medical Research

    Hialeah, Florida, 33002

  • Saint Luke's Mid America Heart Institute

    Kansas City, Missouri, 64111

  • Weill Cornell Medicine

    New York, New York, 10012

  • Broward Research Center

    Pembroke Pines, Florida, 33029

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center

    Torrance, California, 90502

  • Wake Forest

    Winston-Salem, North Carolina, 27105

Other trials in United States

About this study

Official title: Exploratory Phase 2A, Double-blind, Placebo-Controlled, Dose Escalation Study to Determine the Safety, Tolerability, PD, and PK of HU6 for the Treatment of Subjects With Obese Heart Failure With Preserved Ejection Fraction (HFpEF)

This is a Phase 2A, randomized, parallel-group, placebo-controlled, double-blind, within subject dose escalation trial with 3 dose levels of HU6 and placebo. Subjects will be randomized (1:1) either to HU6 or placebo. Two dose levels will be administered in sequential order (150 mg daily followed by 300 mg daily), each for 20 days, to reach the third and highest dose of 450 mg daily if safety and tolerability are demonstrated at the lower 2 preceding doses. Administration of the 450 mg high dose will continue for a total of 94 days, with a safety follow-up visit within ~14 days of the last dose.

Read the detailed description

This is a Phase 2A, randomized, parallel-group, placebo-controlled, double-blind, within subject dose escalation trial with 3 dose levels of HU6 and placebo. Subjects will be randomized (1:1) either to HU6 or placebo. Two dose levels will be administered in sequential order (150 mg daily followed by 300 mg daily), each for 20 days, to reach the third and highest dose of 450 mg daily if safety and tolerability are demonstrated at the lower 2 preceding doses. Administration of the 450 mg high dose will continue for a total of 94 days, with a safety follow-up visit within ~14 days of the last dose.

Subjects will be screened over a 40-day period to determine their eligibility based on specific history, physical, laboratory, and imaging evaluations as per the Schedule of Assessments. While a single screening clinical site visit is indicated, an additional visit may be necessary to complete the screening procedures due to scheduling issues. A number of these assessments will serve as the baseline prior to drug administration. A central laboratory will be used for all assessments, including MRI, DEXA, clinical blood/plasma measures, transthoracic echocardiography, and CPET.

Being tested
HU6, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HU6Drug

    HU6 is being evaluated for its efficacy in improving cardiovascular function in obese subjects with HF with preserved ejection fraction (HFpEF).

  • PlaceboDrug

    Placebo

Study groups in NCT05284617
Study groupRoleWhat they receive
Active Treatment: HU6 Planned doses of HU6; N = 31ExperimentalNot described
Receives: Drug: HU6
Placebo Comparator Non-active study drug N = 31Placebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate weight reduction while on HU6 treatment

    Assess the rate and amount of body weight loss over the course of HU6 treatment

    Measured: 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2022
  2. Study start30 Oct 2022
  3. Primary completion24 May 2024
  4. Study completion30 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a Phase 2A, randomized, parallel-group, placebo-controlled, double-blind, within subject dose escalation trial with 3 dose levels of HU6 and placebo. Subjects will be randomized (1:1) either to HU6 or placebo.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05284617
Sponsor's protocol ID
RIV-HU6-2201
Acronym
HFpEF
Status last verified
Aug 2024
First submitted
9 Mar 2022
Last updated
26 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Pandey A, Lewis GD, Borlaug BA, Shah SJ, Sauer AJ, Litwin S, Sharma K, Jorkasky DK, Tarka EA, Khan SM, Kitzman DW. Novel Controlled Metabolic Accelerator for Obesity-Related HFpEF: The HuMAIN-HFpEF Randomized Clinical Trial. JAMA Cardiol. 2025 Jun 1;10(6):609-616. doi: 10.1001/jamacardio.2025.0103.

    PubMed 40072462

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HU6 in people with Heart Failure With Preserved Ejection Fraction, run by Rivus Pharmaceuticals, Inc. at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate weight reduction while on HU6 treatment (time frame: 5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05284617, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.

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