Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2025-12-24 @ 1:14 PM
NCT ID:
NCT04147195
Eligibility Criteria:
Inclusion Criteria:
Phenotypic diagnosis of NASH based on the presence of all of the following:
* ALT ≥ 43 IU/L (males) or ≥ 28 IU/L (females)
* BMI ≥ 27 kg/m2 (race other than Asian) or ≥ 23 kg/m2 (Asian race)
* History of type 2 diabetes mellitus with HbA1c ≤ 9%
* ELF test score ≥ 8.5 and ≤ 10.5
* Liver fat ≥ 8%
* Patients must weigh between 40 kg (88 lbs.) and 150 kg (330 lbs.)
Exclusion Criteria:
* Use of other investigational drugs within 5 half-lives of randomization or within 3 months, whichever is longer
* Use of obeticholic acid (OCA) or pharmacologically-active weight loss drugs within 1 month of randomization
* Use of strong CYP3A4/5 inhibitors or strong CYP3A4 inducers within 5 half-lives or 7 days of randomization, whichever is longer
* History or presence of other concomitant liver diseases
* History or current diagnosis of ECG abnormalities
* Patients with contraindications to MRI imaging
* Current or history of significant alcohol consumption
* Clinical evidence of hepatic decompensation or severe liver impairment
* Women of child bearing potential (unless on highly effective methods of contraception)
* Presence of liver cirrhosis
* Use of OAT3 inhibitors within 5 half-lives or 7 days of randomization, whichever is longer
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04147195
Study Brief:
Protocol Section:
NCT04147195