Phase 3 trial assessing pegozafermin in SHTG

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 16 Mar 2023

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At a glance

10 Mar 2023 According to 89bio media release, initiation of this first Phase 3 trial is planned in the second quarter of 2023 based on feedback from the FDA
04 Jan 2023 According to 89bio media release, company received feedback from the FDA supporting the advancement of pegozafermin into Phase 3. Company has incorporated the feedback into the protocol.recommended conducting two Phase 3 trials in SHTG, each of one year duration as part of the efficacy and safety database required to support the registration package. The primary endpoint in the planned Phase 3 trials is anticipated to be assessed at week 26.
11 Aug 2022 According to 89bio media release, trial is expected to begin pending end of Phase 2 meeting with the FDA.

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