Trial Profile

Second phase 3 trial assessing pegozafermin in SHTG

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 16 Aug 2023

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At a glance

09 Aug 2023 According to 89bio media release, this SHTG Phase 3 program is expected to support the safety database requirements at the time of BLA submission.
06 Jan 2023 New trial record
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.

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