Dosing starts in Phase 2 trial of oral therapy HU6 for MASH
Treatment aims to reduce liver fat, lower weight while preserving muscle
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A Phase 2 clinical trial testing Rivus Pharmaceuticals‘ experimental oral therapy HU6 in people with metabolic dysfunction-associated steatohepatitis (MASH), a severe form of steatotic liver disease, has begun dosing participants.
The study, AMPLIFY (NCT07491458), expects to enroll up to 180 adults aged 30 and older with MASH. Participants are actively being recruited at sites in the U.S.
“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,” Jorge Bartolome, CEO of Rivus, said in a company press release. “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.”
Rivus expects results from the trial next year, which will inform the company’s plans for future development of HU6.
“Looking ahead to top-line AMPLIFY data in mid-2027, we are actively planning for HU6’s late-stage development and potential commercialization,” Bartolome said. “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.”
Treatment aims to boost fat burn
MASH is a severe manifestation of steatotic liver disease in which the buildup of liver fat leads to inflammation and scarring (fibrosis) in the liver, which can set the stage for life-threatening complications like liver failure and cancer.
HU6 aims to increase the amount of energy the body uses during normal metabolism. The goal is to trigger the body to burn more fat for energy, reducing the amount of fat that builds in the liver and drives disease.
The earlier Phase 2 M-ACCEL clinical trial (NCT05979779) evaluated the safety and efficacy of various doses of HU6 against a placebo, taken once a day, in more than 200 adults 18 years and older with MASH.
Results indicated that HU6 was generally safe and significantly reduced liver fat compared with the placebo. Most patients receiving the therapy experienced a 30% or greater reduction in liver fat content, a change deemed clinically significant. The treatment was also shown to promote weight loss without decreasing muscle mass.
AMPLIFY participants are randomly assigned to take either one of two doses of HU6 (300 or 450 mg) or a placebo, daily for about six months.
The study’s main goals are to assess the therapy’s safety, movement into, through, and out of the body, along with effects on liver fat content, including the proportion of patients achieving a 30% or greater drop in liver fat. Key secondary goals include changes in weight and body composition and in markers of liver fibrosis, inflammation, and metabolism.
