A Phase 2 Randomized Trial of Survodutide in MASH and Fibrosis

Abstract:
This phase 2 trial evaluated the efficacy and safety of survodutide, a dual glucagon receptor and GLP-1 receptor agonist, in adults with biopsy confirmed MASH and fibrosis (stages F1–F3). Participants (N=293) were randomized to receive once weekly subcutaneous survodutide (2.4 mg, 4.8 mg, or 6.0 mg) or placebo for 48 weeks. The primary endpoint histologic improvement in MASH without worsening of fibrosis was achieved in 47%, 62%, and 43% of survodutide groups (vs. 14% with placebo; P<0.001). Key secondary outcomes included ≥30% reduction in liver fat (63%, 67%, and 57% vs. 14%) and fibrosis improvement (34%, 36%, and 34% vs. 22%). Common adverse events were gastrointestinal (nausea: 66% vs. 23%; diarrhea: 49% vs. 23%). The trial supports survodutide’s potential as a treatment for MASH with fibrosis, warranting phase 3 investigation.

Abstract:
This phase 2 trial evaluated the efficacy and safety of survodutide, a dual glucagon receptor and GLP-1 receptor agonist, in adults with biopsy confirmed MASH and fibrosis (stages F1–F3). Participants (N=293) were randomized to receive once weekly subcutaneous survodutide (2.4 mg, 4.8 mg, or 6.0 mg) or placebo for 48 weeks. The primary endpoint histologic improvement in MASH without worsening of fibrosis was achieved in 47%, 62%, and 43% of survodutide groups (vs. 14% with placebo; P<0.001). Key secondary outcomes included ≥30% reduction in liver fat (63%, 67%, and 57% vs. 14%) and fibrosis improvement (34%, 36%, and 34% vs. 22%). Common adverse events were gastrointestinal (nausea: 66% vs. 23%; diarrhea: 49% vs. 23%). The trial supports survodutide’s potential as a treatment for MASH with fibrosis, warranting phase 3 investigation.