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Non-Alcoholic Fatty Liver DiseasePhase 2NCT05979779

Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis

A Phase 2 study testing HU6 in people with Non-Alcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis, run by Rivus Pharmaceuticals, Inc. at 20 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a phase 2 randomized, double-blind, placebo-controlled parallel group study of 3 dose levels of HU6 in subjects with nonalcoholic steatohepatitis (NASH). Six months (26 weeks) of dosing is planned, and subjects will be followed for safety, efficacy, pharmacodynamics (PD), and pharmacokinetics (PK) during this… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
HU6
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
219 participants
Where
20 sitesUnited States
Study dates
5 Sep 2023to Jun 2025
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • Able to understand the procedures and requirements of the study and provide written informed consent and authorization for protected health information disclosure.
  • Willing and able to comply with the requirements of the study protocol.
  • Male or female ≥18 years of age at time of informed consent.
  • Subject has a screening Fibroscan® CAP score >306 decibels per meter (dB/m) and interquartile range to median ratio (IQR/Med) <30%.
  • Subject has ≥8% liver fat determined by screening Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF).
  • Subject has moderate to advanced liver fibrosis based on documented history of biopsy score of F2 or F3 within 12 months prior to Screening, or subject has a screening Fibroscan® vibration-controlled transient elastography (VCTE) score ≥ 7.0 to ≤ 15.0 kPa.
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  • Body mass index (BMI) ≥27.0 kg/m2.
  • Clinically euthyroid as assessed by a thyroid profile utilizing TSH and T4 testing at screening as assessed by the investigator based on the medical history of the subject.
  • Subjects with a diagnosis of glaucoma must be controlled and stable (no changes in treatment regimen within 3 months prior to Screening).
  • Inclusion as per investigator assessment of general medical status and as documented by medical history, physical examination, vital sign assessments, 12-lead ECG, clinical laboratory assessments, and general observations.

Who cannot join

  • Subjects will be excluded from the study if any of the following criteria are met:
  • The subject has a history of cirrhosis and/or hepatic decompensation, including ascites, hepatic encephalopathy, or variceal bleeding.
  • The subject has a history of acute pancreatitis within 1 year of Screening or chronic pancreatitis of any cause.
  • History of any bariatric surgery intervention, including but not limited to lap banding, intragastric balloon, duodenal-jejunal sleeve, or bariatric surgery or plans for bariatric surgery prior to conclusion of study participation.
  • Have obesity induced by other endocrinologic disorders (e.g., Cushing Syndrome, polycystic ovarian syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., Melanocortin 4 Receptor deficiency or Prader-Willi Syndrome).
  • Any surgical or medical condition or history that, in the opinion of the investigator in consultation with the medical monitor, may potentially alter the absorption, metabolism, or excretion of study treatment.
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  • History of or treatment for clinically significant gastroparesis, inflammatory bowel disease, or any surgery of the upper gastrointestinal tract with the exception of cholecystectomy, or minor gastric procedures that are approved by the medical monitor.
  • History (including any family history) of malignant hyperthermia.
  • History of chronic serious recurrent skin rashes of unknown cause.
  • History of malignancy within 5 years (except cutaneous basal or squamous cell carcinoma, carcinoma-in-situ, or low-grade prostate cancer).
  • History of the following cardiovascular conditions within 3 months prior to randomization: acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, hospitalization due to congestive heart failure (CHF), or acute CHF.
  • NYHA Functional Class II, III, or IV heart failure.
  • Subject has a pacemaker.
  • Active kidney disease requiring therapy, kidney transplant, or eGFR <45 mL/min/1.73 m2 based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation.
  • Significant and unstable lung disease (chronic obstructive pulmonary disease [COPD], emphysema, pulmonary fibrosis, or asthma) requiring oxygen or chronic daily medication. Note that mild, stable COPD and asthma on inhalers are allowed.
  • Subject has a diagnosed history of obstructive sleep apnea or uses continuous positive airway pressure (CPAP).
  • Subject has a history of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to Screening.
  • Subject has any history of agranulocytosis.
  • Subject has Wilson's disease.
  • Familial (mother/father/sibling) and/or personal history of retinal detachment any time in the past.
  • Subject has history of prior vitrectomy due to prior retinal condition.
  • Subject has a contraindication to dilation for ophthalmologic examination.
  • Evidence of the following on screening ophthalmologic examination:
  • Peripheral retinal pathology, retinal tears, lattice, or nondiabetic ocular condition that requires treatment or intervention within 3 months of Screening.
  • Diabetic retinopathy with macular exudates or macular edema (evidence of microaneurysms is not an exclusion).
  • Any active macular disease that affects the vision, including macular pucker (epiretinal membrane), retinal vein occlusion, and macular degeneration.
  • Subjects with significant visual impairment due to lens opacity from cataracts such that surgery will be required within the duration of the study in the opinion of the consulting ophthalmologist. (Subjects with cataract surgery >3 months prior to Screening may be included.)
  • Subject has substantial media opacities that preclude successful retinal imaging.
  • Any condition (e.g., ongoing substance, drug, or alcohol abuse) that may interfere with participation or safety of investigations, in the opinion of the Investigator.
  • A history of moderate alcohol consumption defined as drinking ≥ 2 drinks per day for men or ≥ 1 drink per day for women. (A drink is defined as 12 ounces of beer, 5 ounces of wine, 1.5 ounces of distilled spirits.).
  • Subjects with untreated, uncontrolled, or unstable hypertension (systolic blood pressure [SBP] >160 and/or diastolic blood pressure [DBP] >100 mmHg upon repeat evaluation at screening). If subject is treated with antihypertensive medication, the regimen must be stable at least 1 month prior to screening.
  • Subjects with untreated or persistent hypotension (SBP <90 mmHg) or symptomatic hypotension (that, in the opinion of the Investigator, requires active treatment).
  • Tachycardia (>100 beats/minute) at screening.
  • QTcF > 450 msec at screening for males and QTcF > 470 msec at screening for females.
  • Use of any of the following medications:
  • The following oral antidiabetic drugs are prohibited within 3 months prior to screening and continuing throughout the study: insulin, meglitinides, thiazolidinediones, glucagon-like peptide (GLP-1) agonists, and gastric inhibitory polypeptide (GIP)/GLP-1 agonists.
  • The following are prohibited within 3 months prior to screening (or planned use during the study) when used for weight loss: herbal preparation, over the counter (OTC) drug, mail order or prescription drug.
  • Prescription or OTC stimulants including: dextroamphetamine/Dexedrine, dextroamphetamine/amphetamine combination product/Adderall, or methylphenidate (Ritalin®, Concerta®).
  • Recent (within 3 months of screening) or current use of obeticholic acid/Ocaliva, systemic corticosteroids, methotrexate, tamoxifen, amiodarone, or long-term use of tetracyclines.
  • Warfarin, heparin, factor Xa inhibitors (e.g., dabigatran, betrixaban, edoxaban, apixaban, and rivaroxaban).
  • Vitamin E: use of ursodiol or high-dose vitamin E (>400 IU/day) for at least 1 month within the previous 6 months or started high dose vitamin E within the previous 3 months of Screening.
  • Drugs with high risk of idiosyncratic drug-induced neutropenia (IDIN) or agranulocytosis (Andres 2018, Curtis 2017): antithyroid drugs (propylthiouracil and methimazole), ticlopidine, clozapine, phenothiazines, sulfasalazine, vancomycin, amoxicillin, ceftriaxone, ciprofloxacin, cotrimaxozole, piperacillin-tazobactam, and trimethoprim-sulfamethoxazole (Bactrim® or Septra®).
  • Concomitant medications that prolong the QT/QTc interval and are known to be associated with increased risk of Torsade des pointes as identified in the https://crediblemeds.org/ website list category of 'Known Risk.'
  • Have acute or chronic hepatitis, signs, and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD)/NASH, or any of the following, as determined by the central laboratory during screening:
  • International normalized ratio (INR) ≥1.3, or
  • ALT >5.0× the ULN for the reference range, or
  • AST >5.0× the ULN for the reference range, or
  • Alkaline phosphatase (ALP) >2.0× the ULN for the reference range, or
  • Total bilirubin >1.2× the ULN for the reference range (except for cases of known Gilbert's Syndrome).
  • Laboratory Values at Screening:
  • Hemoglobin <9.5 g/dL, or
  • ANC ≤1500/μL, or
  • Marked hypertriglyceridemia (>1000 mg/dL), or
  • Copper <LLN for the reference range, or
  • Ceruloplasmin <LLN for the reference range, or
  • Serologic evidence of hepatitis B based on hepatitis B surface antigen (HBsAG), or
  • Serologic evidence of hepatitis C antibody (HCV Ab) and HCV RNA, or
  • Serologic evidence of human immunodeficiency virus (HIV).
  • Hemoglobin A1c (HbA1c) > 9.5%.
  • Intolerance to MRI or with conditions contraindicated for MRI procedures including but not limited to:
  • Having surgical clips/metallic implants/shrapnel -or-
  • Claustrophobia, have a history of claustrophobia, or intolerance of closed or small spaces.
  • Participation in another clinical trial at the time of screening or exposure to any investigational agent, including topical agents, within 30 days or 5 half-lives prior to Day 1, whichever is longer.
  • For subjects with a recent active viral, bacterial, or parasitic infection, they must have discontinued any treatment for their infection at least 5 days prior to screening. Patients who test positive for COVID-19 during the screening period must have a negative rapid antigen test prior to randomization.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • IMA Clinical Research-Austin

    Austin, Texas, 78745

  • CenExel HRI

    Berlin, New Jersey, 08009

  • Synergy Healthcare

    Bradenton, Florida, 34208

  • ABMED Clinical Research Corp.

    Cape Coral, Florida, 33914

  • ProSciento CRU

    Chula Vista, California, 91911

  • Lillestol Research

    Fargo, North Dakota, 58104

  • Southwest General Healthcare Center

    Fort Myers, Florida, 33907

  • Mt Olympus Medical Research

    Houston, Texas, 77030

  • Houston Research Institute

    Houston, Texas, 77079

  • Velocity Clinical Research

    Los Angeles, California, 90057

  • Tandem Clinical Research

    Marrero, Louisiana, 70072

  • Miami Clinical Research

    Miami, Florida, 33155

  • Advanced Clinical Research

    Miami, Florida, 33156

  • Century Research, LLC

    Miami, Florida, 33173

  • Entrust Clinical Research

    Miami, Florida, 33176

  • Panax Clinical Research

    Miami Lakes, Florida, 33014

  • Catalina Research Institute

    Montclair, California, 91763

  • Northern California Research Center

    Sacramento, California, 95821

  • Texas Liver Institute

    San Antonio, Texas, 78215

  • Metro Clinical Trials

    San Bernardino, California, 92404

Other trials in United States

About this study

Official title: A 6-Month, Randomized, Double-Blind, Placebo-controlled, Phase 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis

This is a phase 2 randomized, double-blind, placebo-controlled parallel group study of 3 dose levels of HU6 in subjects with nonalcoholic steatohepatitis (NASH). Six months (26 weeks) of dosing is planned, and subjects will be followed for safety, efficacy, pharmacodynamics (PD), and pharmacokinetics (PK) during this time. The end-of-study visit will take place approximately 4 weeks after the last dose of the study drug (Week 30).

Read the detailed description

This is a phase 2 randomized, double-blind, placebo-controlled parallel group study of 3 dose levels of HU6 (150 mg, 300 mg, and 450 mg) and placebo in approximately 204 subjects with NASH.

Subjects will be screened over a 49-day period to determine their eligibility based on specific history, physical, laboratory, and imaging evaluations, which will require more than one visit during the screening period. On Day 1, subjects will be randomized 2:1:2:2 into 1 of 4 treatment groups (placebo, 150 mg HU6, 300 mg HU6, or 450 mg HU6). Six months (26 weeks) of dosing is planned, and subjects will be followed for safety, efficacy, PD, and PK during this time. The end-of-study visit will take place approximately 4 weeks after the last dose of the study drug (Week 30).

Being tested
HU6, Placebo
Medical subject headings
Non-alcoholic Fatty Liver Disease, Fatty Liver

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 liver fat content in subjects with Nonalcoholic Steatohepatitis (NASH)

  • PlaceboOther

    Placebo

Study groups in NCT05979779
Study groupRoleWhat they receive
Active Treatment: HU6 Planned doses of HU6ExperimentalNot described
Receives: Drug: HU6
Placebo Comparator Non-active study drugPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

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

  1. Percent change from baseline in liver fat, as assessed by magnetic resonance imaging liver proton density fat fraction (MRI-Liver PDFF) at 6 months (26 weeks)

    Measured: 6 months

Timeline

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

  1. First posted7 Aug 2023
  2. Study start5 Sep 2023
  3. Primary completion21 Jan 2025
  4. Study completionJun 2025 (estimated)

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 2, randomized, parallel-group, placebo-controlled, double-blind study where subjects will be randomized to one of 3 HU6 dose levels or placebo.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
219 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05979779
Sponsor's protocol ID
RIV-HU6-2202
Status last verified
Apr 2025
First submitted
31 Jul 2023
Last updated
18 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HU6 in people with Non-Alcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis, run by Rivus Pharmaceuticals, Inc. at 20 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 10 inclusion and 64 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: under way, not looking for participants, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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?

This study is still under way. Results are not available in the source record yet.

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?

Percent change from baseline in liver fat, as assessed by magnetic resonance imaging liver proton density fat fraction (MRI-Liver PDFF) at 6 months (26 weeks) (time frame: 6 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 NCT05979779.

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 18 Apr 2025.

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