Clin2
NCT05045482Possibly a fitRecruiting

Study drug in people with cirrhosis from blocked bile flow

Hepatic ImpairmentCirrhosisCholestatic Liver Disease

Treatments studied

Part of Digestive system clinical trials.

This Phase 1 trial studies how saroglitazar magnesium works in people with liver scarring (cirrhosis) caused by a bile-flow problem. It helps doctors understand safety and how the body handles the medicine in this specific liver condition.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 1
Enrollment
30 people
Ages
18 years to 80 years
Study type
Interventional

Who can take part

  • You can understand the study and sign the consent form.
  • You’re between 18 and 80 years old, and your body size (BMI) is 18 to 48.
  • You can safely swallow and keep down pills by mouth.
  • If you’re able to get pregnant, you must not be pregnant or breastfeeding, and you must use very reliable birth control during the study; if not, you still must use birth control as instructed.
  • For the cirrhosis-from-bile-problem groups, specific blood tests must be high enough/low enough for safety (including liver enzymes, blood counts, and a cancer blood test that fits the rules).
  • You should not have other major causes of liver disease, recent major health changes, recent bleeding, severe fluid buildup needing frequent drainage, or certain recent surgeries/medications that affect drug handling.

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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