Akero Therapeutics Announces Publication of Phase 2b SYMMETRY Cohort D Study in Clinical Gastroenterology and Hepatology
As reported previously, the addition of EFX to GLP-1 receptor agonist therapy had a safety and tolerability profile comparable to that of EFX alone and led to statistically significant improvements in non-invasive markers of liver injury and fibrosis and of metabolic health
Results indicate potential of EFX to improve resolution of steatohepatitis and fibrosis for patients with MASH and type 2 diabetes already taking a GLP-1 receptor agonist
Excerpt from the Press Release:
SOUTH SAN FRANCISCO, Calif., March 07, 2024 (GLOBE NEWSWIRE) — Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease, today announced publication of results in Clinical Gastroenterology and Hepatology from an expansion cohort (Cohort D, N=31) of the Phase 2b SYMMETRY study.
The publication, available online, reports results of the 12-week study to assess safety and tolerability of efruxifermin (EFX) compared to placebo when added to a stable dose of GLP-1 receptor agonist (GLP-1RA) in patients with Type 2 diabetes (T2D) and F1-F3 liver fibrosis due to metabolic dysfunction-associated steatohepatitis (MASH), formerly known as NASH.
Tolerability of EFX on top of GLP-1RA (N=21 patients) was generally comparable to GLP-1RA alone (placebo, N=10). The most frequent adverse events for EFX-treated patients were grade 1 or 2 gastrointestinal events (diarrhea, nausea, and increased appetite). One patient treated with EFX discontinued due to nausea and one EFX-treated patient withdrew consent prior to Week 12. There were no drug-related serious adverse events. The overall tolerability profile was similar to that observed in Akero’s prior BALANCED and HARMONY studies in patients with MASH (F1-F3). Patients treated with EFX plus GLP-1RA showed a similar mean weight loss from baseline relative to patients treated with GLP-1RA alone.
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