Rivus Pharmaceuticals Announces First Patients Dosed in AMPLIFY Phase 2 Trial for HU6 in MASH
- Top-line data expected in mid-2027; Actively planning for HU6’s late-stage development in MASH -
- HU6 is potential best-in-class oral MASH therapy designed to address unmet needs in MASH through a unique energy expenditure approach -
CHARLOTTESVILLE, Va., and SOUTH SAN FRANCISCO, Calif., April 14, 2026 (GLOBE NEWSWIRE) -- Rivus Pharmaceuticals Inc., a clinical-stage biopharmaceutical company focused on advancing cardiometabolic health, today reported first patients dosed in the AMPLIFY Phase 2 clinical trial for HU6, a potential best-in-class oral MASH therapy.
“We are excited to dose the first patients in our AMPLIFY Phase 2 trial, marking an important clinical milestone for HU6’s development for MASH,” said Jorge Bartolome, Chief Executive Officer, Rivus Pharmaceuticals. “AMPLIFY builds on the positive data from our M-ACCEL trial, showing HU6’s best-in-class potential as an oral MASH therapy with robust liver-centric effects and unique fat-selective, muscle preserving weight loss. Looking ahead to top-line AMPLIFY data in mid-2027, we are actively planning for HU6’s late-stage development and potential commercialization. As we execute our plans for HU6, Rivus is uniquely positioned with a platform focused on increasing energy expenditure as we aim to deliver improved and sustained cardiometabolic health.”
HU6 AMPLIFY Phase 2 Trial for MASH
- First patients were recently dosed in the AMPLIFY Phase 2 trial for HU6 oral therapy in MASH (metabolic dysfunction-associated steatohepatitis).
- This randomized, double-blind, placebo-controlled trial will enroll up to 180 patients with F2/F3 MASH. Patients will be randomized in a 2:1:2:1 ratio to receive HU6 at 450 mg daily or 300 mg twice daily versus placebo for six months to assess safety, exposure, and efficacy.
- The primary efficacy endpoint is change in liver fat as measured by MRI-PDFF and percentage of patients with >30% reduction in liver fat at six months. Key secondary endpoints include changes in body composition and weight, measures of liver fibrosis, metabolic and inflammatory parameters, and pharmacodynamics.
- Top-line data from AMPLIFY is anticipated in mid-2027 to confirm dosing ahead of planned late-stage clinical trials for HU6 in MASH.
- AMPLIFY builds upon the positive M-ACCEL Phase 2 trial data presented last year as a late-breaker oral presentation at the 2025 AASLD Liver Meeting. At the six-month endpoint, data in 228 patients showed:
- Robust liver-centric effects, with significant reductions in liver fat. The majority of patients achieved >30% liver fat reduction, which has been shown to be a clinically meaningful outcome associated with MASH resolution and fibrosis improvement.
- Fat-selective weight loss with preservation of skeletal muscle mass.
- Favorable efficacy, safety, and tolerability profile, supporting HU6’s potential long-term use in treating individuals living with this chronic disease.
About the Phase 2 AMPLIFY Trial
The randomized, double-blind, placebo-controlled Phase 2 AMPLIFY trial (ClinicalTrials.gov: NCT07491458) will evaluate HU6 at 450 mg daily and 300 mg twice daily versus placebo for six months in adults with F2/F3 MASH. The safety, tolerability, and pharmacokinetic (PK) profile of HU6 will be assessed. The primary efficacy endpoint is percent change from baseline in liver fat as measured by MRI-PDFF and percentage of patients with >30% reduction in liver fat at six months. Key secondary endpoints include changes in body composition and weight, measures of liver fibrosis, metabolic and inflammatory parameters, and pharmacodynamics. Patients can continue in the open-label extension for an additional six months.
About MASH (Metabolic Dysfunction-Associated Steatohepatitis)
MASH (formerly known as nonalcoholic steatohepatitis or NASH) is a serious, chronic liver disease. MASH is caused by an accumulation of excess fat in the liver (steatosis), which can lead to chronic inflammation and scarring (fibrosis). Left untreated, MASH can progress to cirrhosis, liver failure, hepatocellular carcinoma, liver transplantation, and premature death. MASH is an independent driver of cardiovascular disease, the leading cause of mortality for patients, underscoring the close association between MASH and a patient’s overall cardiometabolic health. There is an unmet need for therapies that address both hepatic and systemic metabolic dysfunction.
Approximately 5% of U.S. adults have MASH,1,2 which is rapidly becoming the leading cause of liver transplantation, although diagnosis and treatment rates remain low. With rates of cardiometabolic diseases rising worldwide, MASH is predicted to have a significant, growing impact on global health.
About HU6
Rivus’ lead therapy HU6 is a potential best-in-class oral therapy for MASH, a serious, chronic metabolic disease of unmet need driven by excess liver fat and inflammation. HU6 is currently being evaluated in the Phase 2 AMPLIFY trial in MASH. In prior Phase 2 trials, HU6 resulted in robust liver-centric effects, fat-selective, muscle-preserving weight loss, and improvements in cardiovascular risk markers. With over 500 patients treated to date, HU6 has demonstrated a favorable safety and tolerability profile. HU6 results have been published in The Lancet Gastroenterology & Hepatology, presented in a late-breaker oral presentation at AASLD, and published in JAMA Cardiology.
About Rivus Pharmaceuticals
Rivus Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on advancing cardiometabolic health. The company’s lead candidate, HU6, is a potential best-in-class oral therapeutic to treat MASH currently advancing in the Phase 2 AMPLIFY trial. Rivus is also advancing RV-8451, the industry’s first muscle-preserving, oral GLP-1, in preclinical development to treat obesity. Rivus’ proprietary platform is focused on developing oral medicines that incorporate energy expenditure to deliver improved and sustained cardiometabolic health. Follow Rivus on LinkedIn and X and visit www.rivuspharma.com.
References
1. Younossi ZM, Golabi P, Paik JM, Henry A, Van Dongen C, Henry L. The global epidemiology of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH): a systematic review. Hepatology. 2023;77(4):1335-1347. doi: 10.1097/HEP.0000000000000004.
2. Harrison SA, Gawrieh S, Roberts K, et al. Prospective evaluation of the prevalence of non-alcoholic fatty liver disease and steatohepatitis in a large middle-aged US cohort. J Hepatol. 2021;75(2):284-291. doi: 10.1016/j.jhep.2021.02.034.
Company Contact: Amy Figueroa, CFA Rivus Pharmaceuticals afigueroa@rivuspharma.com Media Contact: Matt Wright Real Chemistry mwright@realchemistry.com
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