Rivus Pharmaceuticals has dosed the first patients in the AMPLIFY Phase II clinical trial evaluating HU6, an investigational oral therapy for metabolic dysfunction-associated steatohepatitis (MASH).
This double-blind, placebo-controlled, randomised trial aims to further evaluate HU6’s potential to reduce liver fat, preserve muscle mass, and improve overall cardiometabolic health.
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It will enrol around 180 adults with F2/F3 MASH. Participants will be randomised using a 2:1:2:1 ratio to receive either HU6 at 450mg daily, 300mg twice daily, or placebo for six months.
The trial’s primary efficacy endpoint is the change in liver fat, measured by MRI–proton density fat fraction (MRI‑PDFF), and the proportion of patients who achieve a greater than 30% reduction in liver fat at six months.
Key secondary outcomes will include changes in body composition and weight, liver fibrosis, metabolic and inflammatory markers, and pharmacodynamic measures.
Data from the Phase II M-ACCEL trial, presented orally at the 2025 American Association for the Study of Liver Diseases (AASLD) Liver Meeting, showed significant reductions in liver fat, along with favourable muscle preservation.
Most patients achieved more than 30% reduction in liver fat, a target linked to positive outcomes in MASH. HU6 also showed a favourable safety and tolerability profile.
After the initial six-month double-blind period, patients are eligible to continue in an open-label extension for an additional six months.
HU6 has so far been administered to more than 500 patients, and prior studies have reported favourable safety and tolerability along with improvements in cardiometabolic risk markers.
Rivus Pharmaceuticals CEO Jorge Bartolome said: “We are excited to dose the first patients in our AMPLIFY Phase II trial, marking an important clinical milestone for HU6’s development for MASH.
“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 commercialisation. 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.”
In August 2024, Rivus Pharmaceuticals reported that its Phase IIa HuMAIN clinical trial of the controlled metabolic accelerator (CMA) HU6 in patients with obesity-related heart failure with preserved ejection fraction (HFpEF) had met both its primary and secondary endpoints.
