A Study to Test Whether BI 3802876 is Tolerated in People With Compensated Liver Cirrhosis Due to Metabolic Dysfunction- Associated Steatohepatitis (MASH) (NCT07325526)
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)
🩺 Plain-English Summary (8th-Grade Level)
This study is open to adults with a type of confirmed liver condition called compensated cirrhosis due to Metabolic Dysfunction-Associated Steatohepatitis (MASH). The purpose of this study is to find out how well a study medicine called BI 3802876 is tolerated in people with this condition. The study looks at how different doses of BI 3802876 are handled by the body. BI 3802876 is being developed to improve liver health in people living with this liver condition. Participants are put in 3 different dose groups randomly, which means by chance. Participants within a group get BI 3802876 or placebo. Placebo looks like BI 3802876 but does not contain any medicine. Participants have more than twice the chance of receiving BI 3802876 than placebo. The study medicine is given as an infusion into a vein. Participants are in the study for about half a year. During this time, they visit the study site 12 times. At 2 visits, participants get the study medicine. Doctors collect information on any health problems and take blood samples to check how BI 3802876 is handled by the body. They compare results between the groups.
Who can join: Review the eligibility criteria below.
Location: Arizona Clinical Trials - Chandler — Chandler, Arizona
Age range: 18 Years to 75 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (27 Sites)
Showing the first 25 of 27 sites.
- Arizona Clinical Trials - Chandler — Chandler, Arizona
- Southern California Research Center — Coronado, California
- Velocity Clinical Research, San Diego — La Mesa, California
- Kaiser Permanente - Los Angeles Medical Center — Los Angeles, California
- Catalina Research Institute, LLC — Montclair, California
- Peak Gastroenterology Associates — Colorado Springs, Colorado
- Schiff Center Liver Diseases — Miami, Florida
- Panax Clinical Research — Miami Lakes, Florida
- Covenant Metabolic Specialists, LLC - University Park — University Park, Florida
- Centricity Research Columbus Georgia Multispecialty — Columbus, Georgia
- University of Iowa Hospitals and Clinics — Iowa City, Iowa
- University of Kansas Medical Center — Kansas City, Kansas
- Johns Hopkins Hospital — Baltimore, Maryland
- Mayo Clinic, Rochester — Rochester, Minnesota
- Columbia University Medical Center — New York, New York
- Lucas Research, Inc. — Morehead City, North Carolina
- Medical University of South Carolina — Charleston, South Carolina
- Nashville General Hospital — Nashville, Tennessee
- Texas Clinical Research Institute, LLC — Arlington, Texas
- Epic Medical Research - Carrollton — Carrollton, Texas
- The Liver Institute at Methodist Dallas — Dallas, Texas
- Baylor Scott & White Research Institute — Dallas, Texas
- Epic Medical Research - Fort Worth — Fort Worth, Texas
- Houston Methodist Hospital — Houston, Texas
- Pioneer Research Solutions, Inc. — Houston, Texas
📞 Contact the Study Coordinator
Phone: (800) 243-0127
Email: clintriage.rdg@boehringer-ingelheim.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.