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Clinical trial

A Phase 1b, Open-Label Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Adult Patients With Presumed Nonalcoholic Steatohepatitis (NASH)

ID
Name
CORT118335-861
Description
This phase 1b, Open-Label Study is to assess the safety, efficacy of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH)
Trial arms
Trial start
2021-11-23
Estimated PCD
2024-08-01
Trial end
2024-08-01
Status
Recruiting
Phase
Early phase I
Treatment
Miricorilant 150 mg
Miricorilant 150 mg for oral dosing
Arms:
Cohort 1 - 150 mg of miricorilant for 24 weeks, Cohort 2 - 150 mg of miricorilant for 12 weeks
Other names:
CORT118335
Miricorilant 100 mg
Miricorilant 100 mg for oral dosing
Arms:
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
Other names:
CORT118335
Miricorilant 50 mg
Miricorilant 50 mg for oral dosing
Arms:
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
Other names:
CORT118335
Miricorilant 10 mg
Miricorilant 10 mg for oral dosing.
Arms:
Cohort 9 - 30 mg of miricorilant daily for 12 weeks
Other names:
CORT118335
Size
70
Primary endpoint
Relative change from Baseline in liver-fat content assessed by MRI-PDFF compared to Baseline.
Baseline Day 1 up to Week 24
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 70, 'type': 'ESTIMATED'}}
Updated at
2023-10-02

1 organization

1 product

1 indication

Product
Miricorilant
Indication
Nonalcoholic Steatohepatitis
Organization
Corcept Therapeutics