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Multicenter, Double-blind, Parallel-group, Randomized, 48 Weeks, Dose-ranging, Placebo-controlled Phase II Trial to Evaluate Efficacy, Safety and Tolerability of Multiple Subcutaneous (s.c.) Doses of BI 456906 in Patients With Non-alcoholic Steatohepatitis (NASH) and Fibrosis

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Multicenter, Double-blind, Parallel-group, Randomized, 48 Weeks, Dose-ranging, Placebo-controlled Phase II Trial to Evaluate Efficacy, Safety and Tolerability of Multiple Subcutaneous (s.c.) Doses of BI 456906 in Patients With Non-alcoholic Steatohepatitis (NASH) and Fibrosis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 10 Oct 2024

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At a glance

  • Drugs Survodutide (Primary)
  • Indications Hepatic fibrosis; Non-alcoholic steatohepatitis
  • Focus Therapeutic Use
  • Sponsors Boehringer Ingelheim

    • Most Recent Events

    • 08 Oct 2024 According to Boehringer Ingelheim Media Release, company announced today that the U.S. (FDA) has granted Breakthrough Therapy designation for survodutide (BI 456906) for the treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and moderate or advanced fibrosis, based on survodutide groundbreaking results from Phase II study.
    • 07 Jun 2024 Results presented in a Zealand Pharma Media Release.
    • 07 Jun 2024 According to Boehringer Ingelheim Media Release, data from this trial published in The New England Journal of Medicine

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