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 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT03466203
Eligibility Criteria:
Inclusion Criteria:
* Body mass index (BMI) within the range of 30 to 45 kg/m2, inclusive, with ethnic adjustment (≥27.5 kg/m2 for Asian individuals).
* Fasting triglyceride 150 - 500 mg/dL (1.69 - 5.65 mmol/L), inclusive, at screening.
* Able to communicate well with the investigator, to understand and comply with the requirements of the study.
Exclusion Criteria:
* History of hepatobilliary disease.
* Liver disease or liver injury as indicated by abnormal liver function tests.
* Chronic infection with Human Immunodeficiency Virus (HIV), Hepatitis B (HBV) or Hepatitis C (HCV).
* Fasting triglycerides greater than or equal to 500 mg/dL \[5.65 mmol/L\], or concomitant use of drug treatment for hypertriglyceridemia (fibrates, omega-3 fatty acids, nicotinic acid).
* History of pancreatic injury or pancreatitis.
* History of hypersensitivity to drugs of similar biological class, FGF21 protein analogue, or Fc fusion proteins.
* History of bone disorders or low vitamin D level.
* Contraindications to MRI.
* Change in body weight (more than 5% self-reported OR 5 kg self-reported change during the previous 3 months).
* Use of weight loss drugs.
* Enrollment in a diet, weight loss or exercise programs.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03466203
Study Brief:
Protocol Section:
NCT03466203