Study Details
Testing the Drug HM15211 for People with Nonalcoholic Steatohepatitis
(IRB#: IRB_00136282)
Nonalcoholic Steatohepatitis (NASH) is swelling of the liver due to the buildup of fat in the liver cells of people who drink little or no alcohol. If swelling of the liver lasts it can lead to scarring (fibrosis) and serious medical issues. The study will test a drug called HM15211 to treat people with this condition. The study wants to see if the drug will help people with the condition and is safe. People in the study will be randomly assigned to one of four groups. Three of the groups will be treated with a different dose of the drug and one group will receive a placebo. The placebo looks like the study drug but does not have the medication. Being in the study requires up to 21 visits at the study clinic for about 65 weeks. People will write in a journal and complete other medical tests to track their health.
- 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
- Age 18 to 70 years and old
- Diagnosis of Nonalcoholic Steatohepatitis (NASH) with liver fibrosis
- Stable body weight at least 3 months before participation
- Able to participate in an MRI (a medical device used to scan the body)
- Able to attend in person at a study clinic
Exclusion Criteria
- History of serious chronic liver disease
- Surgery for obesity (body being overweight) 2 years before participation
- Take other specific medications that affect study participation
- Uncontrolled hypertension (high blood pressure) or uncontrolled dyslipidemia (high cholesterol)
- History or diagnosis of heart failure 6 months before participation
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