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 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT06007651
Eligibility Criteria:
Inclusion Criteria:
Parts A \& B
* Males, or females of not of childbearing potential,
* On a stable diet for the 3 months prior to randomization and willing to continue the same stable diet during the study.
Part A
* Dyslipidemia with the following fasted blood levels at screening: 150 mg/dL ≤ triglycerides \<500 mg/dL, AND LDL-cholesterol ≥100 mg/dL,
* Body mass index (BMI) in range of 18.5 to 45.0 kg/m2. Part B
* NAFLD with liver fat content ≥8% as determined by magnetic resonance imaging proton density fat fraction (MRI-PDFF),
* BMI in range of 27 to 45.0 kg/m2
Exclusion Criteria:
Parts A \& B
* History or presence of medical illness including, but not limited to, any cardiovascular, thromboembolism or bleeding disorder, hepatic, respiratory, hematological, endocrine, immune, psychiatric, or neurological disease, convulsions, or any clinically significant laboratory abnormality that, in the judgment of the Investigator, indicate a medical problem that would preclude study participation,
* Uncontrolled hypertension with a resting blood pressure ≥ 160 mmHg systolic or ≥ 100 mmHg diastolic at visit 1,
* Alanine transaminase (ALT) or aspartate aminotransferase (AST) \>3.0 × ULN for the reference range,
* Alkaline phosphatase (ALP) \>1.5 × ULN for the reference range,
* Total bilirubin (TBL) \>1.5 × ULN for the reference range,
* Taken drugs associated with hepatic steatosis (e.g., amiodarone, valproic acid, methotrexate, tamoxifen) for more than 2 weeks in the 3 months prior to screening visit,
* Type 1 diabetes mellitus (T1DM) or any other type of diabetes mellitus other than T2DM,
* Poorly controlled T2DM with glycated hemoglobin (HbA1c) of \>9.0%,
* Treatment with GLP-1 RA and GIP/GLP-1 RA and approved or experimental agents that target PCSK9 within 9 months prior to screening visit.
Part B
* Evidence of other forms of chronic liver disease,
* Initiated treatment with, or changed dose of, medications that may cause significant weight gain or weight loss, within 3 months prior to the screening visit,
* Have a self-reported change in body weight \>5 kg (11 pounds) within 3 months prior to screening visit
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06007651
Study Brief:
Protocol Section:
NCT06007651