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

NCT03823703 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: CORT118335-860
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 15

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).

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 Magnetic Resonance Imaging-Proton Density Fat Fraction

  The change from baseline in liver fat content (LFC) by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) for each miricorilant dose level (600 mg, 900 mg) versus placebo was assessed. MRI-PDFF was performed to determine the degree of LFC reduction. The relative change is defined for each participant as %: (\[Post-Baseline LFC-Baseline LFC\]/Baseline LFC) × 100. Due to observations related to safety, the study was terminated. If the participant had at least 6 weeks of treatment, the assessment was completed at the early termination visit. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.

  Baseline and up to ~Day 95

Secondary Outcomes (6)

• Number of Participants Achieving a Relative Reduction From Baseline in LFC of ≥30% by MRI-PDFF

  Baseline and up to ~Day 95

• Change From Baseline in Aspartate Aminotransferase

  Baseline and Week 6

• Change From Baseline in Alanine Aminotransferase

  Baseline and Week 6

• Change From Baseline in Gamma-glutamyl Transferase

  Baseline and Week 6

• Change From Baseline in Propeptide of Type III Collagen

  Baseline and Week 6

Other Outcomes (2)

• Number of Participants With a Relative Reduction in Liver Fat Content ≥50% by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) for Miricorilant Versus Placebo

  Baseline and up to ~Day 95

• Number of Participants With Complete Resolution in Liver Fat by MRI-PDFF for Miricorilant Versus Placebo

  Baseline and up to ~Day 95

Study Arms (3)

Miricorilant- 900 mg

EXPERIMENTAL

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

Drug: Miricorilant

Miricorilant- 600 mg

EXPERIMENTAL

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

Drug: Miricorilant; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Participants received 6 placebo tablets orally once daily.

Drug: Placebo

Interventions

Miricorilant DRUG

Tablets taken orally

Also known as: CORT118335

Miricorilant- 600 mg; Miricorilant- 900 mg

Placebo DRUG

Placebo tablets

Miricorilant- 600 mg; Placebo

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/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.

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (15)

Site 207

Chandler, Arizona, 85224, United States

Location

Site 208

Glendale, Arizona, 85306, United States

Location

Site 209

Tucson, Arizona, 85712, United States

Location

Site 227

Los Angeles, California, 90057, United States

Location

Site 214

Panorama City, California, 91402, United States

Location

Site 233

Santa Ana, California, 92704, United States

Location

Site 234

Port Orange, Florida, 32127, United States

Location

Site 210

Sarasota, Florida, 34240, United States

Location

Site 228

Kansas City, Missouri, 61434, United States

Location

Site 232

East Syracuse, New York, 13057, United States

Location

Site 211

Austin, Texas, 78757, United States

Location

Site 213

Edinburg, Texas, 78539, United States

Location

Site 215

Edinburg, Texas, 78539, United States

Location

Site 212

San Antonio, Texas, 78229, United States

Location

Site 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

Limitations and Caveats

Due to observations related to safety, the study was terminated by the Sponsor prior to completion. The sample size at the time of study termination did not support formal tests to assess statistical differences between treatment groups, and therefore, no efficacy analyses specified in the protocol were performed. Descriptive statistics for efficacy endpoints are provided, but since no patient reached the Week 12 visit, and therefore, descriptive statistics at Week 12 are not presented.

Results Point of Contact

• Title: Medical Director
• Organization: Corcept Therapeutics Incorporated

info@corcept.com

650-327-3270

Study Officials

• Director

  Corcept Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 30, 2019
• Study Start: November 4, 2020
• Primary Completion: April 5, 2021
• Study Completion: April 5, 2021
• Last Updated: August 31, 2022
• Results First Posted: August 31, 2022

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)