Status:

TERMINATED

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

Lead Sponsor:

Corcept Therapeutics

Conditions:

Nonalcoholic Steatohepatitis (NASH)

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

Brief 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).

Detailed Description

This is a randomized, double-blind, placebo-controlled study that assessed the safety efficacy and pharmacokinetics (PK) of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH). ...

Eligibility Criteria

Inclusion

  • 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

  • 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/m\^2
  • Have had liver transplantation or plan to have liver transplantation during the study
  • Have type 1 diabetes or poorly controlled type 2 diabetes.

Key Trial Info

Start Date :

November 4 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 5 2021

Estimated Enrollment :

12 Patients enrolled

Trial Details

Trial ID

NCT03823703

Start Date

November 4 2020

End Date

April 5 2021

Last Update

August 31 2022

Active Locations (15)

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Page 1 of 4 (15 locations)

1

Site 207

Chandler, Arizona, United States, 85224

2

Site 208

Glendale, Arizona, United States, 85306

3

Site 209

Tucson, Arizona, United States, 85712

4

Site 227

Los Angeles, California, United States, 90057