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A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of BIO89-100 Administered Subcutaneously in Subjects With Nonalcoholic Steatohepatitis (NASH) or With Nonalcoholic Fatty Liver Disease (NAFLD) and at High Risk of NASH

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of BIO89-100 Administered Subcutaneously in Subjects With Nonalcoholic Steatohepatitis (NASH) or With Nonalcoholic Fatty Liver Disease (NAFLD) and at High Risk of NASH

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 05 Apr 2024

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At a glance

  • Drugs Pegozafermin (Primary)
  • Indications Non-alcoholic fatty liver disease; Non-alcoholic steatohepatitis
  • Focus Adverse reactions; Pharmacokinetics; Proof of concept; Therapeutic Use
  • Sponsors 89bio

Most Recent Events

  • 18 Sep 2023 Results from part 2 (n=20) published in the Alimentary Pharmacology and Therapeutics
  • 11 Sep 2023 Results of a PK/PD model analysis using data from this trial published in the Clinical Pharmacology and Therapeutics
  • 12 Dec 2022 According to a 89bio media release, Rohit Loomba is the primary investigator of the study and the lead author of The Lancet Gastroenterology & Hepatology paper.

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