Study Details
Hanmi Treatment for 12 Months in Subjects with Biopsy Confirmed NASH
(IRB#: IRB_00136282)
The purpose of this research study is to evaluate the effects of HM15211 in people with NASH. This study will also evaluate study drug levels in your body and the time it takes your body to eliminate the drug (pharmacokinetics or PK) and what the study drug does to the body (pharmacodynamics or PD). HM15211 is an experimental drug which is not approved by the U.S. Food and Drug Administration (FDA) for the treatment of NASH. Nonalcoholic steatohepatitis (NASH) is inflammation of the liver due to the buildup of fat in the liver cells in patients who drink little or no alcohol. Long-standing inflammation of the liver can lead to scarring (fibrosis). In some patients, NASH can lead to cirrhosis of liver and complications of liver failure. Most patients with NASH have no signs or symptoms.
- All genders
- Over 18 years old
- Volunteers with special conditions
- In Person
- Paid
Who can participate?
Gender: All genders
Age: Over 18 years old
Volunteers: Volunteers with special conditions
Location: In Person
Inclusion Criteria
- Subjects have a diagnosis of noncirrhotic NASH with liver fibrosis (Fibrosis stage F1-F3) confirmed by liver biopsy within 6 months of Day -7.
- Subject is able to complete the required MRI-PDFF scans.
- Adults 18 to 70 years.
- BMI 18 kg/m2, with stable body weight (defined as change < 5%) by history for 3 months prior to screening or since baseline liver biopsy, whichever is earlier.
Exclusion Criteria
- Any history of clinically significant chronic liver disease including esophageal varices, ascites, hepatic encephalopathy, splenomegaly, or any hospitalization for treatment of chronic liver disease; or Model for End Stage Liver Disease >12.
- Previous surgical treatment for obesity (bariatric surgery, gastric banding, etc.) or any gastrointestinal procedure for weight loss (including LAP-BAND®) within the last 2 years prior to the qualifying baseline liver biopsy, severe gastroparesis, or any uncontrolled clinically significant gastrointestinal disorders (e.g., peptic ulcers, severe GERD) at screening.
- Uncontrolled hypertension (high blood pressure) or Uncontrolled dyslipidemia (high cholesterol)
- History or current diagnosis of symptomatic heart failure (New York Heart Association class III or IV), myocardial infarction, unstable angina requiring medication, transient ischemic attack, cerebral infarct, or cerebral hemorrhage or invasive cardiovascular procedure, such as coronary artery bypass graft surgery, or angioplasty/percutaneous coronary intervention within 6 months of screening. (A diagnostic cardiac catheterization without any intervention does not exclude the subject.)
Will I be paid for my time?
Yes
IRB#: IRB_00136282
PI: Juan Gallegos-Orozco
Department: GASTROENTEROLOGY
Approval Date: 2021-04-15 06:00:00
Specialties: Gastroenterology