The 1501-0004 Study is testing an investigational drug to see if it could help people with scarring on their liver (cirrhosis) due to a build-up of fat, called MASH (metabolic dysfunction-associated steatohepatitis), previously known as NASH. The investigational drug will be compared with a placebo. A placebo looks like the investigational drug but contains no active ingredients. A placebo is used to help researchers find out if an investigational drug is effective.
The 1501-0004 Study could last up to 25 weeks, including:
- 3-week screening period: you will have tests at your nearest study center to see if you can take part.
- 12-week study treatment period: if the study criteria match your condition, you will receive either the investigational drug or placebo and visit the study center for further tests.
- 10-week follow-up period: you will visit the study center 2 more times so that the study team can check on your health and well-being.
A computer will decide randomly whether you receive the investigational drug or placebo. You will have a 50% (1 in 2) chance of receiving the investigational drug and a 50% chance of receiving placebo. You cannot choose and you will not know whether you are receiving the investigational drug or placebo.
Both the investigational drug and placebo will be given via intravenous infusion – delivered slowly into your bloodstream through a tube in your vein. You will receive 1 infusion every 3 weeks (total of 4 infusions).
Over the course of the study, you will be asked to visit the study center approximately 16 times. Visits during which you receive an infusion will last approximately 3–5 hours with the exception of two visits that will last longer. All other visits will last approximately 1–2 hours.