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

NCT05117489 | Completed Phase 1 FDA Drug

• 1 other identifier: CORT118335-861
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 9

Brief Summary

This phase 1b, Open-Label Study is to assess the safety, efficacy of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH)

Conditions

Nonalcoholic Steatohepatitis (NASH)

Keywords

Nonalcoholic Steatohepatitis; NASH; Nonalcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• Relative change from Baseline in liver-fat content assessed by MRI-PDFF compared to Baseline.

  Baseline Day 1 up to Week 24

Secondary Outcomes (4)

• Change from Baseline in aspartate aminotransferase (AST).

  Baseline Day 1 up to Week 24

• Change from Baseline in alanine aminotransferase (ALT).

  Baseline Day 1 up to Week 24

• Change from Baseline in gamma-glutamyl transferase (GGT).

  Baseline Day 1 up to Week 24

• Change from baseline in enhanced liver fibrosis score (ELF).

  Baseline Day 1 up to Week 24

Study Arms (11)

Cohort 1 - 150 mg of miricorilant for 24 weeks

EXPERIMENTAL

Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 150 mg once daily, for 24 weeks.

Drug: Miricorilant 150 mg

Cohort 2 - 150 mg of miricorilant for 12 weeks

EXPERIMENTAL

Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 150 mg once daily, for 12 weeks.

Drug: Miricorilant 150 mg

Cohort 3 - 100 mg daily miricorilant for 2 weeks, followed by 100 mg every MWF for 10 weeks

EXPERIMENTAL

Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 100 mg once daily for 2 weeks, followed by 100 mg of miricorilant every Monday, Wednesday and Friday for 10 weeks.

Drug: Miricorilant 100 mg

Cohort 4 - 100 mg daily miricorilant for 2 weeks, followed by 100 mg every MF for 10 weeks

EXPERIMENTAL

Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 100 mg once daily, for 2 weeks, followed by 100 mg of miricorilant every Monday and Friday for 10 weeks.

Drug: Miricorilant 100 mg

Cohort 5 - 100 mg of miricorilant every MWF for 12 weeks

EXPERIMENTAL

Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant of 100 mg every Monday, Wednesday and Friday for 12 weeks.

Drug: Miricorilant 100 mg

Cohort 6 - 100 mg of miricorilant every MF for 12 weeks

EXPERIMENTAL

Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant of 100 mg every Monday and Friday for 12 weeks.

Drug: Miricorilant 100 mg

Cohort 7 - 50 mg of miricorilant daily for 12 weeks

EXPERIMENTAL

Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 50 mg once daily, for 12 weeks.

Drug: Miricorilant 50 mg

Cohort 8 - 100 mg of miricorilant daily for 12 weeks

EXPERIMENTAL

Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 100 mg once daily, for 12 weeks.

Drug: Miricorilant 50 mg

Cohort 9 - 30 mg of miricorilant daily for 12 weeks

EXPERIMENTAL

Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 30 mg once daily, for 12 weeks.

Drug: Miricorilant 10 mg

Cohort 10 - 200 mg of miricorilant once a week for 12 weeks

EXPERIMENTAL

Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 200 mg once weekly, for 12 weeks.

Drug: Miricorilant 50 mg

Cohort 11 - 150 mg of miricorilant twice weekly for 12 weeks

EXPERIMENTAL

Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 150 mg twice weekly for 12 weeks.

Drug: Miricorilant 50 mg

Interventions

Miricorilant 150 mg DRUG

Miricorilant 150 mg for oral dosing

Also known as: CORT118335

Cohort 1 - 150 mg of miricorilant for 24 weeks; Cohort 2 - 150 mg of miricorilant for 12 weeks

Miricorilant 100 mg DRUG

Miricorilant 100 mg for oral dosing

Also known as: CORT118335

Cohort 3 - 100 mg daily miricorilant for 2 weeks, followed by 100 mg every MWF for 10 weeks; Cohort 4 - 100 mg daily miricorilant for 2 weeks, followed by 100 mg every MF for 10 weeks; Cohort 5 - 100 mg of miricorilant every MWF for 12 weeks; Cohort 6 - 100 mg of miricorilant every MF for 12 weeks

Miricorilant 50 mg DRUG

Miricorilant 50 mg for oral dosing

Also known as: CORT118335

Cohort 10 - 200 mg of miricorilant once a week for 12 weeks; Cohort 11 - 150 mg of miricorilant twice weekly for 12 weeks; Cohort 7 - 50 mg of miricorilant daily for 12 weeks; Cohort 8 - 100 mg of miricorilant daily for 12 weeks

Miricorilant 10 mg DRUG

Miricorilant 10 mg for oral dosing.

Also known as: CORT118335

Cohort 9 - 30 mg of miricorilant daily for 12 weeks

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (9)

Site 207

Chandler, Arizona, 85224, United States

Location

Site 209

Tucson, Arizona, 85712, United States

Location

Site 214

Panorama City, California, 91402, United States

Location

Site 233

Santa Ana, California, 92704, United States

Location

Site 211

Austin, Texas, 78757, United States

Location

Site 213

Edinburg, Texas, 78539, United States

Location

Site 305

Houston, Texas, 77079, United States

Location

Site 212

San Antonio, Texas, 78229, United States

Location

226

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

CORT118335

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Kavita Juneja, MD

  Corcept Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: November 11, 2021
• Study Start: November 23, 2021
• Primary Completion: January 29, 2024
• Study Completion: January 29, 2024
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)