In short
Clinical trials are investigating Seladelpar in people with primary biliary cholangitis, including those with compensated cirrhosis. These studies are looking at safety, tolerability, and whether treatment can improve clinical outcomes over time.
Key points
- Clinical trials of Seladelpar in the source data are studying people with primary biliary cholangitis, and one study also includes compensated cirrhosis. Both trials are Phase 3 and are authorised. One trial focuses on long-term safety and tolerability, while the other looks at event-free survival, which tracks major liver-related outcomes over time. The larger trial includes 339 participants, and the other includes 168 participants. These studies are designed to learn whether Seladelpar can improve clinical outcomes and how safe it is in these patient groups.
Trial overview
Two authorised Phase 3 clinical trials are studying Seladelpar in people with primary biliary cholangitis (PBC). One study also includes patients with compensated cirrhosis, which means liver scarring that is still stable.
These trials are interventional, so researchers give a study treatment and then measure what happens. The main aim is to learn about safety, long-term tolerability, and whether Seladelpar can improve clinical outcomes in these patient groups.
Who the studies include
Both trials focus on people with PBC. The AFFIRM study, NCT06051617, specifically includes patients with PBC and compensated cirrhosis.
This target group is important because the studies are not looking at the general public; they are focused on patients who already have a defined liver condition.
What researchers measure
In NCT06051617, the main outcome is event-free survival (EFS), which means the time from the start of treatment until the first major liver-related event happens. The events include death from any cause, liver transplantation, a MELD score of 15 or higher, ascites needing treatment, or hospitalization for certain complications such as variceal bleeding, hepatic encephalopathy, or spontaneous bacterial peritonitis.
The same trial also measures safety over 156 weeks. In NCT03301506, the main outcome is treatment-emergent adverse events, along with biochemistry and hematology results, which are lab tests that help researchers see how the body responds to treatment.
How the trials are designed
NCT06051617 is a randomized, double-blind, placebo-controlled study. Randomized means participants are assigned by chance, double-blind means neither the participant nor the study team knows which treatment is given, and placebo-controlled means the study compares Seladelpar with a look-alike treatment that has no active medicine.
This study compares Seladelpar 5 mg and 10 mg oral treatment with matching placebos. NCT03301506 is also an interventional Phase 3 study and evaluates Seladelpar 10 mg oral treatment in people with PBC.
Trial status and size
Both trials are listed as Authorised in the source data. NCT06051617 plans to include 168 participants, while NCT03301506 plans to include 339 participants.
The larger enrollment in NCT03301506 may help researchers collect more safety and tolerability data over time. The AFFIRM study is focused on long-term clinical outcomes over 156 weeks, which is a little over three years.
Key patient terms
- Ascites means fluid builds up in the belly and may need treatment.
- Hepatic encephalopathy is a brain problem caused by severe liver disease that can affect thinking and alertness.
- Spontaneous bacterial peritonitis is an infection of the fluid in the belly.
- Biochemistry and hematology are blood tests that help researchers check liver-related chemicals and blood cells.
- Tolerability means how well people can take the study treatment without major problems.