Rivus Pharmaceuticals to Present Phase 2a MASH Trial Data for Novel Metabolic Accelerator HU6 at AASLD 2025
核心洞察
Rivus Pharmaceuticals (搜索) will present clinical data from its Phase 2a M-ACCEL trial evaluating HU6 in MASH (搜索) patients as a late-breaker oral presentation at AASLD The Liver Meeting in November 2025.
The presentation follows positive topline results disclosed in June 2025, showing HU6 reduced liver fat and improved adiposity markers in adults with metabolic dysfunction-associated steatohepatitis (搜索).
HU6 represents a new class of oral Controlled Metabolic Accelerators (搜索) designed to induce fat-selective, muscle-preserving weight loss through mitochondrial uncoupling (搜索) mechanisms.
Rivus Pharmaceuticals (搜索) announced that clinical data from its Phase 2a M-ACCEL trial evaluating HU6 in patients with MASH (搜索) (metabolic dysfunction-associated steatohepatitis (搜索)) will be presented as a late-breaker oral presentation at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting being held November 7-11, 2025 in Washington, DC. The presentation follows positive topline results disclosed by the company in June 2025.
Trial Design and Patient Population
The randomized, double-blind, placebo-controlled, parallel-group Phase 2a M-ACCEL trial evaluated HU6 at three dose levels: 150 mg, 300 mg, and 450 mg once daily for 26 weeks in adults with MASH (搜索). Participants were randomized in a 2:1:2:2 ratio across placebo and the three HU6 dose groups. Eligible patients had liver fat ≥8% by MRI-PDFF and a VCTE score of 7–15 kPa, targeting fibrosis stages F2-F3.
The primary endpoint was percent change from baseline in liver fat as measured by MRI-PDFF at six months. Secondary and exploratory endpoints included proportion of patients achieving ≥30% liver fat reduction, changes in body weight, body composition, glycemic control, blood pressure, and metabolic and inflammatory markers.
Novel Mechanism of Action
HU6 belongs to a new class of oral medicines called Controlled Metabolic Accelerators (搜索) (CMAs (搜索)) developed by Rivus for obesity (搜索) and cardiometabolic diseases. The CMAs are designed to induce sustained, fat-selective, muscle-preserving weight loss through a precision-controlled mechanism that safely increases resting metabolic rate.
These oral small molecule therapeutics leverage the natural metabolic process of mitochondrial uncoupling (搜索) to increase energy expenditure primarily from fat. The mechanism increases resting metabolic rate in a manner that is precision-controlled and imperceptible to the patient, according to the company.
Broader Clinical Development Program
HU6 has demonstrated positive results and a well-tolerated safety profile across three Phase 2 clinical trials in MASH (搜索), MASLD (搜索) (metabolic dysfunction-associated steatotic liver disease (搜索)), and HFpEF (搜索) (heart failure with preserved ejection fraction (搜索)). The drug functions as an ANT-channel (搜索) activator within the mitochondrial uncoupling (搜索) pathway.
Conference Presentations
The AASLD presentation, titled "HU6 Oral Investigational Therapy Reduces Liver Fat and Improves Adiposity Markers in Adults with MASH (搜索): Top-Line Results from a Phase 2 Randomized Placebo-Controlled Trial (M-ACCEL)," will be delivered by Mazen Noureddin, M.D., Professor of Medicine at Houston Methodist Hospital and Co-Chairman of the Board of the Summit and Pinnacle Clinical Research Networks, on Monday, November 10, 2025, from 2:00-2:15 p.m. ET.
Additionally, Rivus will present preclinical data from its CMA pipeline at ObesityWeek organized by The Obesity (搜索) Society, being held November 4-7, 2025 in Atlanta, GA. The poster presentation, titled "Oral Controlled-Metabolic Accelerator Drives Fat-Specific Weight Loss and Augments GLP-1 Effect," will be presented by Sol Collado, Ph.D., Senior Director of Drug Discovery at Rivus Pharmaceuticals (搜索), on Tuesday, November 4, 2025, from 7:30-8:30 p.m. ET.
Pipeline Development
Beyond HU6, Rivus is developing a pipeline of novel CMAs (搜索) in preclinical development for obesity (搜索) and cardiovascular disease (搜索). The clinical-stage biotechnology company positions itself as a leader in mitochondrial biology, focusing on developing investigational therapies for sustained, fat-selective, muscle-preserving weight loss to address obesity and resulting cardiometabolic diseases.