In short
Clinical trials are studying SAROGLITAZAR HEMIMAGNESIUM in people with Primary Biliary Cholangitis (PBC). These studies look at safety, tolerability, and how well the treatment works compared with placebo. The trial data here focus on adults with PBC.
Key points
- SAROGLITAZAR HEMIMAGNESIUM has been studied in a Phase 4 clinical trial in people with Primary Biliary Cholangitis (PBC). The trial compared the study drug with placebo and looked at safety, tolerability, and efficacy. The main result measure was biochemical response at Week 52. This response was based on blood tests, including ALP and total bilirubin. The trial enrolled 196 participants and has been completed.
Trial overview
The source data describes one interventional trial of SAROGLITAZAR HEMIMAGNESIUM in people with Primary Biliary Cholangitis (PBC), a long-term liver disease. The study was called EPICS-III and was designed to evaluate safety, tolerability, and efficacy.
Who was studied
The trial included patients with PBC. The source does not provide more detailed participation rules such as age range, lab limits, or other entry requirements.
What was tested
The study compared SAROGLITAZAR HEMIMAGNESIUM with placebo, which is a look-alike treatment without the active study drug. The intervention list in the source also notes a 2 mg oral dose, while the brief summary states an optimal dose of 1 mg once daily; the source data does not explain this difference further.
Main endpoint and study goals
The main endpoint was the proportion of subjects with a biochemical response at Week 52. This response was based on blood test targets for ALP and total bilirubin, including ALP below 1.67 times the upper limit of normal, at least a 15% drop in ALP from baseline, and bilirubin within the normal range or direct bilirubin within the normal range for people with known Gilbert’s syndrome.
Study design and phase
This was a Phase 4 interventional study. Phase 4 studies are usually done later in clinical development and help researchers learn more about a treatment in real patients. The study enrolled 196 participants and was completed.
Results reported in the source
The provided source gives the study goal and design, but it does not include detailed outcome results. Because of that, the article can describe what the trial measured, but not whether the treatment met the endpoint.