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

NCT05979779 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: RIV-HU6-2202
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 20

Brief 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 time. The end-of-study visit will take place approximately 4 weeks after the last dose of the study drug (Week 30).

Conditions

Non-Alcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis; Fatty Liver

Outcome Measures

Primary Outcomes (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)

  6 months

Study Arms (2)

Active Treatment: HU6 Planned doses of HU6

EXPERIMENTAL

Drug: HU6

Placebo Comparator Non-active study drug

PLACEBO COMPARATOR

Other: Placebo

Interventions

HU6 DRUG

HU6 is being evaluated for its efficacy in improving liver fat content in subjects with Nonalcoholic Steatohepatitis (NASH)

Active Treatment: HU6 Planned doses of HU6

Placebo OTHER

Placebo

Placebo Comparator Non-active study drug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Rivus Pharmaceuticals, Inc.: lead

Study Sites (20)

ProSciento CRU

Chula Vista, California, 91911, United States

Location

Velocity Clinical Research

Los Angeles, California, 90057, United States

Location

Catalina Research Institute

Montclair, California, 91763, United States

Location

Northern California Research Center

Sacramento, California, 95821, United States

Location

Metro Clinical Trials

San Bernardino, California, 92404, United States

Location

Synergy Healthcare

Bradenton, Florida, 34208, United States

Location

ABMED Clinical Research Corp.

Cape Coral, Florida, 33914, United States

Location

Southwest General Healthcare Center

Fort Myers, Florida, 33907, United States

Location

Miami Clinical Research

Miami, Florida, 33155, United States

Location

Advanced Clinical Research

Miami, Florida, 33156, United States

Location

Century Research, LLC

Miami, Florida, 33173, United States

Location

Entrust Clinical Research

Miami, Florida, 33176, United States

Location

Panax Clinical Research

Miami Lakes, Florida, 33014, United States

Location

Tandem Clinical Research

Marrero, Louisiana, 70072, United States

Location

CenExel HRI

Berlin, New Jersey, 08009, United States

Location

Lillestol Research

Fargo, North Dakota, 58104, United States

Location

IMA Clinical Research-Austin

Austin, Texas, 78745, United States

Location

Mt Olympus Medical Research

Houston, Texas, 77030, United States

Location

Houston Research Institute

Houston, Texas, 77079, United States

Location

Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Rob Schott, MD

  Rivus Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 7, 2023
• Study Start: September 5, 2023
• Primary Completion: January 21, 2025
• Study Completion: June 1, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (20)