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:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-26 @ 1:16 PM
NCT ID:
NCT04857606
Eligibility Criteria:
* Inclusion Criteria
* Men and women age ≥ 18 to ≤ 70 years of age at the time of signing the informed consent
* Body mass index (BMI) of ≥ 27 kg/m2 to ≤ 45.0 kg/m2
* Liver steatosis, measured by MRI-PDFF, greater than 8%
* Exclusion Criteria
* Evidence of other liver disease (eg, viral hepatitis, primary sclerosing cholangitis, primary biliary cholangitis, autoimmune chronic hepatitis, Wilson's disease, alpha-1 anti-trypsin deficiency, haemochromatosis, drug-induced liver injury, bile duct obstruction, known or suspected hepatocellular carcinoma).
* Significantly elevated LFTs (more than 1.5x ULN)
* Uncontrolled diabetes (HgbA1c \> 9%) or uncontrolled hypertension.
* History of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers occurring more than 5 years prior to randomization or 3 years prior to randomization for basal cell carcinoma.
* Females of reproductive potential.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04857606
Study Brief:
Protocol Section:
NCT04857606