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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Non-Alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis, Fatty Liver

In brief

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).

Key facts

Study ID: NCT05979779
Run by: Rivus Pharmaceuticals, Inc.
People needed: 219
Starts: 2023-09-05
Expected to finish: 2025-06-01
Last updated by the study team: 2025-04-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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).
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.

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.
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).

Where it is running

ProSciento CRU — Chula Vista, California, United States
Velocity Clinical Research — Los Angeles, California, United States
Catalina Research Institute — Montclair, California, United States
Northern California Research Center — Sacramento, California, United States
Metro Clinical Trials — San Bernardino, California, United States
Synergy Healthcare — Bradenton, Florida, United States
ABMED Clinical Research Corp. — Cape Coral, Florida, United States
Southwest General Healthcare Center — Fort Myers, Florida, United States
Miami Clinical Research — Miami, Florida, United States
Advanced Clinical Research — Miami, Florida, United States
Century Research, LLC — Miami, Florida, United States
Entrust Clinical Research — Miami, Florida, United States
Panax Clinical Research — Miami Lakes, Florida, United States
Tandem Clinical Research — Marrero, Louisiana, United States
CenExel HRI — Berlin, New Jersey, United States
Lillestol Research — Fargo, North Dakota, United States
IMA Clinical Research-Austin — Austin, Texas, United States
Mt Olympus Medical Research — Houston, Texas, United States
Houston Research Institute — Houston, Texas, United States
Texas Liver Institute — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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