Clinical trial NCT05117489: A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)
Official title: A Phase 1b, Open-Label Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Adult Patients With Presumed Nonalcoholic Steatohepatitis (NASH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Nonalcoholic Steatohepatitis (NASH)
Keywords: Nonalcoholic Steatohepatitis
NASH
Nonalcoholic Fatty Liver Disease
Lead sponsor: Corcept Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-11-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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

Detailed description: This phase 1b, Open-Label Study 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 CORT-118335-861 will be enrolled on Day 1 into 1 of 11 cohorts and receive:

* Cohort 1 - a daily dose of 150 mg of miricorilant over 24 weeks.
* Cohort 2 - a daily dose of 150 mg of miricorilant over 12 weeks.
* Cohort 3 - a daily dose of 100 mg of miricorilant over 2 weeks, followed by 10 weeks of dosing at 100 mg miricorilant every Monday, Wednesday and Friday.
* Cohort 4 - a daily dose of 100 mg of miricorilant over 2 weeks, followed by 10 weeks of dosing at 100 mg miricorilant every Monday and Friday.
* Cohort 5 - a thrice weekly dose of 100 mg of miricorilant over 12 weeks every Monday, Wednesday, and Friday.
* Cohort 6 - a twice weekly dose of 100 mg of miricorilant over 12 weeks every Monday and Friday.
* Cohort 7 - a daily dose of 50 mg of miricorilant over 12 weeks.
* Cohort 8 - a daily dose of 100 mg of miricorilant over 12 weeks.
* Cohort 9 - a daily dose of 30 mg of miricorilant over 12 weeks.
* Cohort 10 - a once weekly dose of 200 mg of miricorilant over 12 weeks.
* Cohort 11 - a twice weekly dose of 150 mg miricorilant over 12 weeks.

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/m2
* 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 MRI-PDFF compared to Baseline.
timeFrame: Baseline Day 1 up to Week 24
Secondary outcomes:
measure: Change from Baseline in aspartate aminotransferase (AST).
timeFrame: Baseline Day 1 up to Week 24
measure: Change from Baseline in alanine aminotransferase (ALT).
timeFrame: Baseline Day 1 up to Week 24
measure: Change from Baseline in gamma-glutamyl transferase (GGT).
timeFrame: Baseline Day 1 up to Week 24
measure: Change from baseline in enhanced liver fibrosis score (ELF).
timeFrame: Baseline Day 1 up to Week 24
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Site 207
state: Arizona
city: Tucson
country: United States
facility: Site 209
state: Arizona
city: Panorama City
country: United States
facility: Site 214
state: California
city: Santa Ana
country: United States
facility: Site 233
state: California
city: Austin
country: United States
facility: Site 211
state: Texas
city: Edinburg
country: United States
facility: Site 213
state: Texas
city: Houston
country: United States
facility: Site 305
state: Texas
city: San Antonio
country: United States
facility: Site 212
state: Texas
city: Seattle
country: United States
facility: 226
state: Washington
Study officials:
affiliation: Corcept Therapeutics
name: Kavita Juneja, MD
role: STUDY_DIRECTOR
References: