Clinical trial NCT03823703: Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Participants With Presumed Nonalcoholic Steatohepatitis (NASH)
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Nonalcoholic Steatohepatitis (NASH)
Keywords: Nonalcoholic Steatohepatitis
NASH
Nonalcoholic Fatty Liver Disease
Lead sponsor: Corcept Therapeutics
Sponsor class: INDUSTRY
First posted: 2019-01-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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). 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Relative Change From Baseline in Liver Fat Content Assessed by Magnetic Resonance Imaging-Proton Density Fat Fraction
timeFrame: Baseline and up to ~Day 95
Secondary outcomes:
measure: Number of Participants Achieving a Relative Reduction From Baseline in LFC of ≥30% by MRI-PDFF
timeFrame: Baseline and up to ~Day 95
measure: Change From Baseline in Aspartate Aminotransferase
timeFrame: Baseline and Week 6
measure: Change From Baseline in Alanine Aminotransferase
timeFrame: Baseline and Week 6
measure: Change From Baseline in Gamma-glutamyl Transferase
timeFrame: Baseline and Week 6
measure: Change From Baseline in Propeptide of Type III Collagen
timeFrame: Baseline and Week 6
measure: Change From Baseline in Enhanced Liver Fibrosis Score
timeFrame: Baseline and Week 6
Other outcomes:
measure: 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
timeFrame: Baseline and up to ~Day 95
measure: Number of Participants With Complete Resolution in Liver Fat by MRI-PDFF for Miricorilant Versus Placebo
timeFrame: Baseline and up to ~Day 95
Locations:
city: Chandler
country: United States
facility: Site 207
state: Arizona
city: Glendale
country: United States
facility: Site 208
state: Arizona
city: Tucson
country: United States
facility: Site 209
state: Arizona
city: Los Angeles
country: United States
facility: Site 227
state: California
city: Panorama City
country: United States
facility: Site 214
state: California
city: Santa Ana
country: United States
facility: Site 233
state: California
city: Port Orange
country: United States
facility: Site 234
state: Florida
city: Sarasota
country: United States
facility: Site 210
state: Florida
city: Kansas City
country: United States
facility: Site 228
state: Missouri
city: East Syracuse
country: United States
facility: Site 232
state: New York
city: Austin
country: United States
facility: Site 211
state: Texas
city: Edinburg
country: United States
facility: Site 213
state: Texas
city: Edinburg
country: United States
facility: Site 215
state: Texas
city: San Antonio
country: United States
facility: Site 212
state: Texas
city: Seattle
country: United States
facility: Site 226
state: Washington
Study officials:
affiliation: Corcept Therapeutics
name: Director
role: STUDY_DIRECTOR
References: