Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)
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ClinicalTrials.gov Identifier: NCT03823703 |
Recruitment Status :
Recruiting
First Posted : January 30, 2019
Last Update Posted : December 11, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Nonalcoholic Steatohepatitis (NASH) | Drug: Miricorilant Drug: Placebo | Phase 2 |
This is a randomized, double-blind, placebo-controlled study that will assess the safety efficacy and pharmacokinetics (PK) of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH).
Patients who meet the criteria for the Study CORT118335-860 will be randomized on Day 1 to receive 900 mg miricorilant, 600 mg miricorilant, or placebo for 12 weeks.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Masking Description: | Subject, Investigator and Outcomes Assessor |
Primary Purpose: | Treatment |
Official Title: | A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH) |
Actual Study Start Date : | November 4, 2020 |
Estimated Primary Completion Date : | April 2022 |
Estimated Study Completion Date : | April 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Miricorilant- 900 mg
Patients who meet the entry criteria for the Study CORT118335-860 will be randomized to receive 900 mg miricorilant once daily for 12 weeks.
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Drug: Miricorilant
Miricorilant 900 mg for oral dosing
Other Name: CORT118335 |
Experimental: Miricorilant- 600 mg
Patients who meet the entry criteria for the Study CORT118335-860 will be randomized to receive 600 mg miricorilant plus placebo once daily for 12 weeks.
|
Drug: Miricorilant
Miricorilant 600 mg for oral dosing
Other Name: CORT118335 Drug: Placebo Placebo tablets for oral dosing |
Placebo Comparator: Placebo
Patients who meet the entry criteria for the Study CORT118335-860 will be randomized to receive placebo once daily for 12 weeks.
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Drug: Placebo
Placebo tablets for oral dosing |
- Relative change from Baseline in LFC (liver fat content) assessed by MRI-PDFF. [ Time Frame: Baseline Day 1 to Week 12 ]
- Proportion of patients achieving a relative reduction in LFC of ≥30% by MRI-PDFF [ Time Frame: Baseline Day 1 to week 12 ]
- Change from Baseline in propeptide of type III collagen (pro-C3) [ Time Frame: Baseline Day 1 to week 12 ]
- Change from Baseline in enhanced liver fibrosis (ELF) score and its components (hyaluronic acid, tissue inhibitor of metalloproteinases-1 [TIMP-1], type III procollagen [PIIINP]) [ Time Frame: Baseline Day 1 to Week 12 ]
- Change from Baseline in aspartate aminotransferase (AST) [ Time Frame: Baseline Day 1 to Week 12 ]
- Change from Baseline in alanine aminotransferase (ALT) [ Time Frame: Baseline Day 1 to Week 12 ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03823703
Contact: Clinical Trial Lead | 650-327-3270 | study860ct.gov@corcept.com |
United States, Arizona | |
Site 207 | Recruiting |
Chandler, Arizona, United States, 85224 | |
Site 208 | Recruiting |
Glendale, Arizona, United States, 85306 | |
Site 209 | Recruiting |
Tucson, Arizona, United States, 85712 | |
United States, California | |
Site 227 | Recruiting |
Los Angeles, California, United States, 90057 | |
Site 214 | Recruiting |
Panorama City, California, United States, 91402 | |
Site 233 | Recruiting |
Santa Ana, California, United States, 92704 | |
United States, Florida | |
Site 234 | Not yet recruiting |
Port Orange, Florida, United States, 32127 | |
Site 210 | Not yet recruiting |
Sarasota, Florida, United States, 34240 | |
United States, Missouri | |
Site 228 | Not yet recruiting |
Kansas City, Missouri, United States, 61434 | |
United States, New York | |
Site 232 | Not yet recruiting |
East Syracuse, New York, United States, 13057 | |
United States, Texas | |
Site 211 | Recruiting |
Austin, Texas, United States, 78757 | |
Site 213 | Recruiting |
Edinburg, Texas, United States, 78539 | |
Site 215 | Not yet recruiting |
Edinburg, Texas, United States, 78539 | |
Site 212 | Recruiting |
San Antonio, Texas, United States, 78229 | |
United States, Washington | |
Site 226 | Not yet recruiting |
Seattle, Washington, United States, 98105 |
Study Director: | Ada Lee, MD | Corcept Therapeutics |
Responsible Party: | Corcept Therapeutics |
ClinicalTrials.gov Identifier: | NCT03823703 |
Other Study ID Numbers: |
CORT118335-860 |
First Posted: | January 30, 2019 Key Record Dates |
Last Update Posted: | December 11, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Nonalcoholic Steatohepatitis NASH Nonalcoholic Fatty Liver Disease |
Fatty Liver Non-alcoholic Fatty Liver Disease Liver Diseases |
Digestive System Diseases Cortisone Anti-Inflammatory Agents |