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Study for Adults with Nonalcoholic Fatty Liver Disease
Protocol: STUDY00009099
Full Title
A phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of efruxifermin in subjects with non-cirrhotic nonalcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis
Description
The University at Buffalo (UB) is looking for adults with non-alcoholic fatty liver disease (NAFLD) for a new study. NAFLD is caused by the buildup of fat in the liver. For some people, this build-up can cause swelling and damage to liver cells. The goal of the study is to see if a new medicine can help treat NAFLD.

This study will include 3 months for screening, 4 years and 7 months of study treatment, and a 30-day follow-up. There will be up to 36 visits with the study doctor as follows: every week for the first month, once a month for the following year, and every 3 months afterwards. There will also be 2 surveys about your quality of life throughout the study.

Participants will be randomly assigned (which happens by chance, like flipping a coin) to one of the following study groups:
-Group 1: will receive a placebo which looks like the study medicine but does not contain any active medication.
-Group 2: study medicine dose of 28 mg
-Group 3: study medicine dose of 50 mg

The placebo/study medicine will be injected by a short needle into the soft tissue under the skin in the stomach or upper thigh once a week.

Participants will be paid up to total of $1,400.
Compensation: Yes
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Compensation may include cash, checks, gift cards, debit cards, or incentives like gift baskets, technology items, or merchandise.
Eligibility
*Adult males or nonpregnant females subjects with F2 or F2 fibrosis due to NASH/MASH confirmed by liver biopsy.
*Previous or current history of T2D or 2 out of the 4 components of metabolic syndrome.
*BMI of 25 kg/m2 or greater.
Cohort 1 - must have a FibroScan LSM > 8.5 kPa, ELF > or = 9.8, AST >35 U/L at screening
Cohort 2 - must have a FibroScan LSM >9 kPa, ELF > or =9.8, AST >35 U/L at screening
Age Group: Adults
Principal Investigator: AJAY CHAUDHURI
ClinicalTrials.gov: Open Study
Contact(s)
RICHARD REJMAN
rmrejman@buffalo.edu
+1 716-878-3320

Want to Learn More?

Let us know how the study team can reach you. If you do not hear back within 2 business days, then reach out to the study team directly at the contact information above and someone will assist you.

Your information will be shared only with the research study team and administrative staff for recruitment and will remain confidential. Your information will be stored until study recruitment is closed. Should you no longer want this information to be provided in the aforementioned ways, please contact the study team directly.

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