A Randomized Double-Blind Placebo-Controlled Phase 2 Study Comparing the Efficacy and Safety of Tirzepatide versus Placebo in Patients with Nonalcoholic Steatohepatitis (NASH)

Brief description of study

Tirzepatide is a 39-amino acid synthetic peptide with agonist activity at both the glucosedependent insulinotropic polypeptide gastric inhibitory polypeptide (GIP) receptor and the glucagon-like peptide-1 receptor. Its structure is based on the GIP sequence and includes a C20 fatty diacid moiety. It is administered once weekly by subcutaneous (SC) injection. Treatment with tirzepatide results in glucose lowering, weight loss, and improved metabolic health in patients with type 2 diabetes mellitus (Frias et al. 2018). The beneficial effects of weight loss in patients with nonalcoholic steatohepatitis (NASH) are well-characterized (Promrat et al. 2010; Vilar-Gomez et al. 2015). This study I8F-MC-GPHR (GPHR) will investigate the effects of 52-week treatment with tirzepatide in patients with biopsy-proven NASH. The primary endpoint is NASH resolution with no worsening of fibrosis, based on liver histology. These data will support dose selection for Phase 3. The study is a Phase 2, multicenter, randomized, double-blind, parallel group, placebo controlled, treat-through study to evaluate the safety and efficacy of tirzepatide compared with placebo in patients with nonalcoholic steatohepatitis. This is a parallel, double-blinded treatment study with 4 treatment groups.


Clinical Study Identifier: s19-01282
ClinicalTrials.gov Identifier: NCT04166773
Principal Investigator: Ira M. Jacobson.
Other Investigators: Monique Julia Carasso, Ilyse Haberman, Viviana Figueroa Diaz, Anam Qureshi, Mary Christine Olson.


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