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

Официальное название

A Parallel Treatment Group, Phase 2a, Double-blind, 4-arm Trial to Evaluate the Safety, Exposure, and Efficacy of HU6 Compared With Placebo in Male and Female Participants Aged 30 Years or Older With Metabolic Dysfunction-associated Steatohepatitis (MASH)

Обзор

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.

Подробное описание

This is a 2-part randomized, double-blind, placebo-controlled, multicenter trial with an open label extension (OLE) to evaluate the safety and exposure of HU6 as well as the effect of HU6 on liver fat and other symptoms associated with MASH.

The 2-part trial design consists of a blinded intervention period and, for participants who completed the blinded intervention period, an option to continue in an OLE intervention period. The blinded trial design consists of a screening period, a blinded intervention period, an end of treatment (EOT)/early termination (ET) visit, a safety follow-up visit, and two long-term follow up visits.

Вмешательства

• Препарат HU6
  HU6 is being evaluated for efficacy in MASH
• Другое Placebo
  Placebo comparator

Первичные конечные точки

• Number and Percentage of Adverse Events (AEs) [Срок оценки: 26 weeks]
• Percent change from baseline to Week 26 In Liver Fat Assessed by MRI-PDFF [Срок оценки: 26 weeks]
• Percentage of participants with Liver Fat reduction by ≥30% Assessed by MRI-PDFF [Срок оценки: 26 weeks]
• Area Under the Plasma Concentration-Time Curve (AUC) [Срок оценки: 26 weeks]
• Trough Plasma Concentration (Ctrough) [Срок оценки: 26 weeks]
• Maximum Observed Plasma Concentration (Cmax) [Срок оценки: 26 weeks]
• Time to Maximum Plasma Concentration (Tmax) [Срок оценки: 26 weeks]
• Plasma Clearance of drug after extravascular administration (CL/F) [Срок оценки: 26 weeks]
• Volume of distribution after extravascular administration (V/F) [Срок оценки: 26 weeks]
• Drug elimination half-life (t½) [Срок оценки: 26 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 31 центр

• Arizona Liver Health - Chandler — Chandler
• Arizona Liver Health - Peoria — Peoria
• Arizona Liver Health - Tucson — Tucson
• Baptist Health Center for Clinical Research — Little Rock
• National Institute of Clinical Research — Garden Grove
• Catalina Research Institute — Montclair
• Knowledge Research Center — Orange
• Charter Research LLC - Orlando — Orlando
• … и ещё 23 центра

Идентификаторы

NCT: NCT07491458 · RIV-HU6-2204

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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