2 research outputs found
A phase IIa active-comparator-controlled study to evaluate the efficacy and safety of efinopegdutide in patients with non-alcoholic fatty liver disease
Background & Aims: This study assessed the effects of the glucagon-like peptide-1 (GLP-1)/glucagon receptor co-agonist
efinopegdutide relative to the selective GLP-1 receptor agonist semaglutide on liver fat content (LFC) in patients with nonalcoholic fatty liver disease (NAFLD).
Methods: This was a phase IIa, randomized, active-comparator-controlled, parallel-group, open-label study. A magnetic resonance imaging-estimated proton density fat fraction assessment was performed to determine LFC at screening and Week 24.
Participants with an LFC of >−10% at screening were randomized 1:1 to efinopegdutide 10 mg or semaglutide 1 mg, both
administered subcutaneously once weekly for 24 weeks. Participants were stratified according to the concurrent diagnosis of type
2 diabetes mellitus (T2DM). Both drugs were titrated to the target dose over an 8-week time period. The primary efficacy endpoint
was relative reduction from baseline in LFC (%) after 24 weeks of treatment.
Results: Among 145 randomized participants (efinopegdutide n = 72, semaglutide n = 73), 33.1% had T2DM. At baseline, mean
BMI was 34.3 kg/m2 and mean LFC was 20.3%. The least squares (LS) mean relative reduction from baseline in LFC at Week 24
was significantly (p <0.001) greater with efinopegdutide (72.7% [90% CI 66.8–78.7]) than with semaglutide (42.3% [90% CI
36.5–48.1]). Both treatment groups had an LS mean percent reduction from baseline in body weight at Week 24 (efinopegdutide
8.5% vs. semaglutide 7.1%; p = 0.085). Slightly higher incidences of adverse events and drug-related adverse events were
observed in the efinopegdutide group compared with the semaglutide group, primarily related to an imbalance in gastrointestinal
adverse events.
Conclusions: In patients with NAFLD, treatment with efinopegdutide 10 mg weekly led to a significantly greater reduction in LFC
than semaglutide 1 mg weekly