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A phase III trial of Pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH)

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Trial Profile

A phase III trial of Pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH)

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 05 Jan 2026

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At a glance

  • Drugs Pemvidutide (Primary)
  • Indications Non-alcoholic steatohepatitis
  • Focus Registrational; Therapeutic Use
  • Acronyms MASH
  • Sponsors Altimmune

Most Recent Events

  • 19 Dec 2025 According to an Altimmune media release, the company announced that it held a productive End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) which resulted in alignment on the parameters for a registrational Phase 3 trial of pemvidutide for MASH patients with moderate to advanced liver fibrosis. With the FDA's recent qualification of AIM-MASH AI Assist, the Agency was open to the Company's intent to integrate use of this AI tool into the Phase 3 trial.
  • 11 Dec 2025 New trial record
  • 06 Nov 2025 According to Altimmune media release, during the End-of-Phase 2 Meeting the Company is seeking alignment with the Agency on its proposed Phase 3 trial design and study endpoints

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