A Phase IIa Double-blind, Placebo-controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 3802876 in Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Study to Test if BI 3802876 is Tolerated in People W/ Compensated Liver Cirrhosis Due to Metabolic Dysfunction-Associated Steatohepatitis
Sponsor: Boehringer Ingelheim
Enrolling: Male and Female Patients
IRB Number: ACYY0835
U.S. Govt. ID: NCT07325526
Contact: Transplant Clinical Research Center: 212-305-3839 / tcrcstudyreferral@cumc.columbia.edu
Additional Study Information: The purpose of this research study is to determine how well BI3802876 is tolerated in people living with cirrhosis due to a liver condition called metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH). The study medication, BI3802876, is investigational, meaning it has not yet been approved by the United States Food and Drug Administration (FDA). Participants will be randomly assigned to take either BI3802876 or placebo (inactive substance). This is a double-blind study, so the study doctors and participants will not know whether or not they are receiving BI3802876 or placebo. Study participation will last about 6 months. If you have any questions regarding this study, please contact the Transplant Clinical Research Center (TCRC).
Investigator
Julia Wattacheril, MD, MPH
Do You Qualify?
Are you between 18 and 75 years old? Yes No
Have you been diagnosed with metabolic dysfunction-associated steatohepatitis (MASH) Yes No
Have you been diagnosed with cirrhosis of the liver? Yes No
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For more information, please contact:
Transplant Clinical Research Center
tcrcstudyreferral@cumc.columbia.edu
212-305-3839