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 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
NCT ID:
NCT04073368
Eligibility Criteria:
Key Inclusion Criteria:
* Willing to participate in the study and provide written informed consent.
* Male and female adults aged \> 18 years.
* Subjects must not have participated in any diet/lifestyle intervention or observational studies, or engaged in any body weight altering regimens that resulted in body weight fluctuations (i.e. body weight loss or gain by 5%) in the preceding 3 months prior to Screening.
* A screening MRI consistent with liver inflammation and fibrosis.
Key Exclusion Criteria:
* Current or history of significant alcohol consumption.
* History or presence of liver disease (other than NAFLD/NASH).
* History or presence of cirrhosis and/or history or presence of hepatic decompensation.
* Any diabetes other than Type 2.
* Other poorly controlled medical condition (for example, uncontrolled hypertension with a systolic blood pressure \> 100 mmHg).
* Known sensitivity and/or history of clinically significant food intolerance/allergies to proteins (including whey, soy, casein, amino acids, etc.).
* Unable or unwilling to adhere to contraception requirements.
* Any contraindications to a MRI scan.
* Any other condition that, in the opinion of the Investigator, renders the subject at risk for compliance, compromises the well-being of the subject, or hinders study completion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04073368
Study Brief:
Protocol Section:
NCT04073368