Actively Recruiting
A Trial to Investigate Safety, Exposure, and Efficacy of HU6 Compared With Placebo in Adult Participants With Metabolic Dysfunction-associated Steatohepatitis (MASH)
Led by Rivus Pharmaceuticals, Inc. · Updated on 2026-03-24
180
Participants Needed
33
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Rivus Pharmaceuticals. Inc. is sponsoring this research study to assess the safety and tolerability of HU6 as a possible treatment for patients diagnosed with metabolic dysfunction-associated steatohepatitis (MASH). The study will also assess safety, pharmacokinetics (PK) and changes in liver fat content related to patients diagnosed with MASH.
CONDITIONS
Official Title
A Trial to Investigate Safety, Exposure, and Efficacy of HU6 Compared With Placebo in Adult Participants With Metabolic Dysfunction-associated Steatohepatitis (MASH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female 30 years of age or older at time of signing the informed consent.
- Diagnosed with metabolic dysfunction-associated steatohepatitis (MASH).
- Women of childbearing potential must not be pregnant or breastfeeding and must use and agree to continue to use a highly effective contraceptive method throughout time on study.
- Body Mass Index (BMI) 27.0 kg/m2 to 44 kg/m2.
You will not qualify if you...
- Have acute or chronic hepatitis, signs, and symptoms of any other liver disease (eg, Wilson's disease) other than MASH.
- Cholecystectomy or any other surgical or medical condition or history that may potentially alter the absorption, metabolism, or excretion of study treatment.
- History (including any family history) of malignant hyperthermia.
- 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.
- 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.
- Monogenetic diabetes or type 1 diabetes.
- History of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to Screening.
- History of agranulocytosis.
- History of or active evidence of ophthalmological conditions.
- Untreated, uncontrolled, or unstable hypertension.
- Use of any of the following medications/therapies: Vitamin E: use of ursodiol or high-dose vitamin E (>400 IU/day) for a duration of >1 month within 6 months or started high dose vitamin E for any duration within 3 months prior to screening.
- Within 3 months prior to screening or plan to use prior to coming off study drug: resmetirom (Rezdiffra®), GLP 1 agonists and gastric inhibitory polypeptide (GIP)/GLP-1 agonists, Weight loss medications/therapies including: herbal preparation, over the counter (OTC) drug, mail order or prescription drug, Oral antidiabetic medications/therapies including: insulin, meglitinides, thiazolidinediones. Prescription or OTC stimulants. Recent or current use of obeticholic acid (Ocaliva®), systemic corticosteroids, methotrexate, tamoxifen, amiodarone, or long-term use of tetracyclines. Warfarin, heparin, factor Xa inhibitors due to risk of bleeding, Medications with high risk of idiosyncratic drug-induced neutropenia (IDIN) or agranulocytosis.
- History of hepatitis or human immunodeficiency virus (HIV1 & HIV2).
- Intolerance to MRI or with conditions contraindicated for MRI procedures.
- Participation in another clinical trial at the time of screening or exposure to any investigational product, including topical agents, within 28 days prior to starting study treatment.
- Additional inclusion/exclusion criteria could apply.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 33 locations
1
Arizona Liver Health - Chandler
Chandler, Arizona, United States, 85224
Not Yet Recruiting
2
Arizona Liver Health - Peoria
Peoria, Arizona, United States, 85381
Not Yet Recruiting
3
Arizona Liver Health - Tucson
Tucson, Arizona, United States, 85712
Not Yet Recruiting
4
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States, 72205
Not Yet Recruiting
5
Ark Clinical Research - Fountain Valley
Fountain Valley, California, United States, 92708
Not Yet Recruiting
6
National Institute of Clinical Research
Garden Grove, California, United States, 92844
Actively Recruiting
7
Ark Clinical Research - Long Beach
Long Beach, California, United States, 90815
Not Yet Recruiting
8
Catalina Research Institute
Montclair, California, United States, 91763
Actively Recruiting
9
Knowledge Research Center
Orange, California, United States, 92868
Actively Recruiting
10
Charter Research LLC - Orlando
Orlando, Florida, United States, 32803
Not Yet Recruiting
11
Charter Research LLC - Chicago
Chicago, Illinois, United States, 60618
Not Yet Recruiting
12
Delta Research Partners of Bastrop, LLC
Bastrop, Louisiana, United States, 71220
Not Yet Recruiting
13
Delta Research Partners of West Monroe, LLC
West Monroe, Louisiana, United States, 71291
Not Yet Recruiting
14
Clinical Research Institute of Michigan
Clinton Township, Michigan, United States, 48038
Actively Recruiting
15
Nucleus Network Minneapolis
Saint Paul, Minnesota, United States, 55114
Actively Recruiting
16
Kansas City Research Institute
Kansas City, Missouri, United States, 64131
Not Yet Recruiting
17
KAD Clinical Research
St Louis, Missouri, United States, 63123
Not Yet Recruiting
18
Jubilee Clinical Research, LLC.
Las Vegas, Nevada, United States, 89106
Not Yet Recruiting
19
Coastal Research Institute
Fayetteville, North Carolina, United States, 28304
Not Yet Recruiting
20
Clinical Research Institute of Ohio, LLC (CRIOH)
Westlake, Ohio, United States, 44145
Active, Not Recruiting
21
Tekton Research - Yukon
Yukon, Oklahoma, United States, 73099
Not Yet Recruiting
22
Innovative Clinical Research, LLC
Clarksville, Tennessee, United States, 37040
Not Yet Recruiting
23
IMA Clinical Research (Austin)
Austin, Texas, United States, 78745
Not Yet Recruiting
24
Pinnacle Clinical Research - Austin
Austin, Texas, United States, 78757
Not Yet Recruiting
25
Bellaire Clinical Research, LLC
Bellaire, Texas, United States, 77401
Not Yet Recruiting
26
Pinnacle Clinical Research - Corpus Christi
Corpus Christi, Texas, United States, 78404
Not Yet Recruiting
27
Pinnacle Clinical Research - Georgetown
Georgetown, Texas, United States, 78626
Not Yet Recruiting
28
HRI - Medical Center, LLC
Houston, Texas, United States, 77030
Not Yet Recruiting
29
Houston Research Institute
Houston, Texas, United States, 77079
Not Yet Recruiting
30
HRI - Pasadena, LLC
Pasadena, Texas, United States, 77505
Not Yet Recruiting
31
Quality Research
San Antonio, Texas, United States, 78209
Actively Recruiting
32
Pinnacle Clinical Research - San Antonio
San Antonio, Texas, United States, 78229
Not Yet Recruiting
33
HRI - Sugarland, LLC
Sugar Land, Texas, United States, 77478
Not Yet Recruiting
Research Team
C
Clinical Operations Lead
CONTACT
V
VP, Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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