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

Corcept Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Nonalcoholic Steatohepatitis (NASH)

Treatments: Drug: Placebo; Drug: Miricorilant

Study type: Interventional

Funder types: Industry

Identifiers

NCT03823703

CORT118335-860

Details and patient eligibility

About

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).

Full 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). Patients who meet the criteria for Study CORT118335-860 were randomized on Day 1 to receive 900 mg miricorilant, 600 mg miricorilant, or placebo for 12 weeks.

Due to observations related to safety, the study was terminated prior to completion and study objectives, endpoints, and procedures were modified as specified in the protocol.

Enrollment: 12 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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/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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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12 participants in 3 patient groups, including a placebo group

Miricorilant- 900 mg

Experimental group

Description:

Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.

Treatment:

Drug: Miricorilant

Miricorilant- 600 mg

Experimental group

Description:

Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.

Treatment:

Drug: Placebo

Drug: Miricorilant

Placebo

Placebo Comparator group

Description:

Participants received 6 placebo tablets orally once daily.

Treatment:

Drug: Placebo