Rivus Pharmaceuticals has concluded subject enrolment in its Phase IIa HuMAIN clinical trial of a new controlled metabolic accelerator (CMA), HU6, for patients with the obese phenotype of heart failure with preserved ejection fraction (HFpEF).
The parallel-group, randomised, placebo-controlled, double-blind, dose-escalation trial will assess the tolerability, pharmacodynamics, safety and pharmacokinetics of HU6.
Being carried out at 14 US study centres, the trial will administer ascending doses of 150mg, 300mg, and 450mg daily to participants.
A total of 65 individuals with a body mass index (BMI) greater than 30kg/m² were randomised into a 1:1 ratio to receive either HU6 or a placebo.
A reduction in weight is the trial’s primary outcome.
Rivus Pharmaceuticals CEO Jayson Dallas said: “A disease-modifying treatment is urgently needed for this at-risk patient population which tends to be older, obese, and less mobile, with multiple metabolic co-morbidities.
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“By increasing metabolism and, thus, significantly reducing adiposity, a key underlying cause of HFpEF, HU6 has the potential to modify the underlying disease progression.
“We plan to announce topline data in mid-2024 and initiate a Phase III trial in 2025.”
In parallel with the HuMAIN trial, Rivus is enrolling participants in its Phase IIb M-ACCEL trial of HU6.
This trial is designed to enrol patients with obesity and Type 2 diabetes at metabolic dysfunction-associated steatohepatitis (MASH) risk.
It will have nearly 280 adults who will be randomised into a 2:1:2:2 ratio to receive the treatment for six months.
M-ACCEL’s primary endpoint is the per cent variation in liver fat from baseline at six months.
Secondary endpoints comprise HU6’s effects on glycaemic control, weight, liver fibrosis and fat, metabolic and inflammatory parameters, patient-reported outcomes and body composition.
This trial will also assess tolerability, safety, pharmacokinetics and pharmacodynamics with topline findings anticipated early next year.
In February 2022, the company reported positive data from a Phase IIa trial in which HU6 demonstrated fat and weight reduction in obese subjects.