Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)

• Status: Terminated
• Trial end date: 2021-04-05
• Target enrollment: 0
• Participant gender: All

Summary

This phase 2, double blind, placebo-controlled, randomized study is to assess the safety and efficacy of miricorilant (CORT118335) in patients with presumed Nonalcoholic Steatohepatitis (NASH).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Corcept Therapeutics
• Treatments: Cortisone; Cortisone acetate

Criteria

Inclusion Criteria:

• Have a diagnosis of NASH based on a biopsy obtained within the last year OR

• Have a diagnosis of presumed NASH based on blood tests and scans

Exclusion Criteria:

• Have participated in another clinical trial within the last year and received active treatment for NASH

• Have participated in another clinical trial for any other indication within the last 3 months

• Are pregnant or lactating women

• Have a BMI <18 kg/m2

• Have had liver transplantation or plan to have liver transplantation during the study

• Have type 1 diabetes or poorly controlled type 2 diabetes.