A Trial to Investigate Safety, Exposure, and Efficacy of HU6 Compared With Placebo in Adult Participants With Metabolic Dysfunction-associated Steatohepatitis (MASH)

Korábbi kezelés

• 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.
• History of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to Screening.
• 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.
• 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

Más betegség

• 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).
• 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 agranulocytosis.
• History of or active evidence of ophthalmological conditions
• Untreated, uncontrolled, or unstable hypertension
• History of hepatitis or human immunodeficiency virus (HIV1 \& HIV2)
• Intolerance to MRI or with conditions contraindicated for MRI procedures

Egyéb

• Additional inclusion/exclusion criteria could apply

• 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