Akero Therapeutics ((AKRO)) announced an update on their ongoing clinical study.
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Study Overview: Akero Therapeutics is conducting a Phase 3 study titled A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis. The study aims to assess the safety and effectiveness of efruxifermin in treating NASH/MASH patients with fibrosis, a condition with significant unmet medical needs.
Intervention/Treatment: The study tests efruxifermin, a drug administered via subcutaneous injection, designed to treat NASH/MASH with fibrosis. Two experimental doses, 28 mg and 50 mg, are compared against a placebo.
Study Design: This is an interventional study with a randomized, parallel assignment. It employs quadruple masking, meaning the participant, care provider, investigator, and outcomes assessor are blinded. The primary goal is treatment-focused.
Study Timeline: The study began on December 6, 2023, with a primary completion date set for October 16, 2025. These dates are crucial as they indicate the timeline for data collection and analysis, impacting when results might influence the market.
Market Implications: The ongoing recruitment and potential success of this study could significantly impact Akero Therapeutics’ stock performance. Positive results may enhance investor confidence and position Akero as a leader in the NASH treatment market, a field with limited effective therapies. Competitors in the NASH space will be closely monitoring these developments.
The study is currently recruiting, with further details available on the ClinicalTrials portal.