89Bio Inc ((ETNB)) announced an update on their ongoing clinical study.
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Study Overview: The ENTRUST Study, officially titled A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia (SHTG), aims to assess the impact of Pegozafermin on fasting serum triglyceride levels in individuals with severe hypertriglyceridemia. This study is significant as it explores a potential treatment for a condition associated with increased cardiovascular risk.
Intervention/Treatment: The study tests Pegozafermin, a drug administered via subcutaneous injection, in two dosages (30mg and 20mg) once a week. The purpose is to lower triglyceride levels in patients, with a placebo group included for comparison.
Study Design: This Phase 3 study is interventional, with participants randomly assigned to different groups (Pegozafermin or placebo). It uses a parallel model and quadruple masking, meaning participants, care providers, investigators, and outcomes assessors are unaware of group assignments. The primary goal is treatment-focused.
Study Timeline: The study began on June 15, 2023, with primary completion expected by August 5, 2025. These dates are crucial for tracking progress and anticipating results that could impact future treatment options.
Market Implications: This study update could influence 89Bio Inc.’s stock, as positive results may boost investor confidence and market value. The study’s outcome could also affect the competitive landscape in the treatment of hypertriglyceridemia, potentially impacting other companies in the sector.
The study is ongoing, with further details available on the ClinicalTrials portal.