Einstein Montefiore

Condition

• Nonalcoholic Steatohepatitis

Eligibility

Eligible Ages

Between 18 Years and 80 Years

Eligible Genders

All

Accepts Healthy Volunteers

No

Criteria

- Participants must have a body mass index (BMI) ≥27 kilograms per square meter (kg/m²)
and ≤50 kg/m² with stable body weight for at least 3 months

- Participants with or without type 2 diabetes mellitus (T2DM)

- If with T2DM, hemoglobin A1c (HbA1c) ≤9.5%

- Participants must be willing to undergo baseline and endpoint liver biopsies

- Participants must have histologic diagnosis of NASH with stage 2 or 3 fibrosis by
liver biopsy

- Participants must not have known or suspected alcohol abuse (>14 units/week for women
and >21 units/week for men) or active substance abuse

- Participants must not have evidence of cirrhosis or other forms of liver disease

- Participants must not have heart attack, stroke, or hospitalization for congestive
heart failure in the past 6 months

- Participants must not have active cancer within the last 5 years

- Participants must not have uncontrolled high blood pressure

- Participants must not have renal impairment with estimated glomerular filtration rate
(eGFR) <30 milliters/minute/1.73m²; for participants on metformin, eGFR <45
mL/min/1.73m²

- Participants must not have a diagnosis of type 1 diabetes

- Participants must not have a history of pancreatitis (acute or chronic)

- Participants must not have calcitonin ≥35 nanograms per liter

- Participant must not have family or personal history of multiple endocrine neoplasia
type 2 or medullary thyroid carcinoma (family is defined as a first degree relative)

- Female participants must not be pregnant, breast-feeding, or intend to become pregnant
or of childbearing potential and not using adequate contraceptive method (adequate
contraceptive measures as required by local regulation or practice)

Study Contact