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Compares treatment options for MASH - Metabolic Dysfunction-Associated Steatohepatitis
Official title A Trial to Investigate Safety, Exposure, and Efficacy of HU6 Compared With Placebo in Adult Participants With Metabolic Dysfunction-associated Steatohepatitis (MASH)
ClinicalTrials.gov ID: NCT07491458
What this study is testing
What is HU6?
HU6 is an investigational medicine, being studied as a potential treatment for mash - metabolic dysfunction-associated steatohepatitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Rivus Pharmaceuticals. Inc.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 and older
You may be able to join if
- Male and female ≥30 years of age 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...
- Body Mass Index (BMI) ≥27.0 kg/m2 to ≤44 kg/m2
You likely can't join if
- 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...
- 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...
- Significant and unstable lung disease (chronic obstructive pulmonary disease [COPD], emphysema, pulmonary fibrosis, or asthma) requiring oxygen or...
See the full eligibility criteria
- Male and female ≥30 years of age 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
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Chandler, Arizona, United States
- Peoria, Arizona, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Garden Grove, California, United States
- Montclair, California, United States
- Orange, California, United States
- Orlando, Florida, United States
- Chicago, Illinois, United States
- Bastrop, Louisiana, United States
- West Monroe, Louisiana, United States
- Clinton Township, Michigan, United States
- Saint Paul, Minnesota, United States
- Kansas City, Missouri, United States
- St Louis, Missouri, United States
- Las Vegas, Nevada, United States
- Fayetteville, North Carolina, United States
- Westlake, Ohio, United States
- Yukon, Oklahoma, United States
- Clarksville, Tennessee, United States
+ 8 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandler, Arizona, United States; Peoria, Arizona, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States; Garden Grove, California, United States; Montclair, California, United States and 22 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.