Saroglitazar

The primary endpoint is a biochemical surrogate, not a direct measure of transplantation or survival. The topline release reports 149 randomized participants, whereas the later NDA-supporting report gives a phase 3 trial population of 148; these totals are not reconciled in the retrieved evidence. The combined-study registry enrollment of 196 is a different population. Pruritus improvement was not statistically significant at 12 months.

This study targets ALP above ULN but below 1.67 times ULN, rather than the higher ALP population in EPICS-III. Planned enrollment is 89 participants. The report contains a study design and eligibility record, but no treatment-effect estimates or observed safety results.

The planned study evaluates clinical outcomes over 48 months in a population with cirrhosis. Estimated enrollment is 386 participants. The retrieved evidence does not yet establish an effect on clinical events, and its cirrhotic eligibility population differs from the biochemical-response populations of earlier trials.

This 37-participant trial lasted 16 weeks and tested 2 mg and 4 mg, not the later 1 mg magnesium regimen. Four participants discontinued treatment because of aminotransferase increases. The conference report describes one participant requiring immune suppression for suspected overlap syndrome, whereas the journal abstract summarizes recovery after discontinuation. Neither report establishes a long-term clinical-outcome benefit.

Only seven participants were enrolled, all female, and the study ended because of lack of enrollment. Its open-label, single-arm design cannot separate treatment effects from changes that would have occurred without saroglitazar. The 16-week biochemical assessment does not establish a transplantation or survival benefit.

Eligibility requires completion of the parent double-blind trial. This selects participants able to complete earlier treatment and does not recreate a randomized untreated comparator. The registry reports 102 participants, but the report contains no extension results.

This is comparator evidence, not a randomized comparison against saroglitazar. The primary endpoint was biochemical response after 12 months, and the pruritus analysis concerned a subgroup with baseline scores of at least 4. The prescribing information does not establish improved survival or prevention of liver decompensation.

This comparator trial does not provide a head-to-head estimate against saroglitazar. Its primary endpoint was biochemical response at 52 weeks. The population was 96% female, and eligibility excluded decompensated cirrhosis, limiting extrapolation to that population.

This 100-participant comparator trial lasted 24 months and evaluated bezafibrate added to UDCA, not saroglitazar. Its complete biochemical-response definition differs from the EPICS-III composite, so the response percentages are not interchangeable across studies.

This single-dose study enrolled healthy volunteers, not participants with PBC. Its 96 unique participants included eight men who participated in both parts, so the part-specific enrollments should not be added without accounting for overlap. It does not establish efficacy or repeated-dose safety in PBC.

The study evaluated a single 4 mg tablet in healthy volunteers under fed and fasting conditions. Fifty of 54 enrolled participants completed and were analyzed. These results do not directly establish food effects after repeated 1 mg dosing in PBC.

Single-dose pharmacokinetics do not establish repeated-dose safety or clinical efficacy. The 32 participants with hepatic impairment and 23 controls describe the published hepatic-impairment cohorts, not every cohort subsequently reported under this protocol. Severe impairment increased exposure, limiting extrapolation from mild or moderate impairment.

The study was open-label and lasted four weeks. It characterizes short-term pharmacokinetics rather than comparative clinical efficacy. Increased exposure in moderate hepatic impairment and the small cohort restrict extrapolation to longer treatment or broader cirrhotic populations.

This single-dose comparison included eight participants with severe renal impairment and eight controls. It does not establish repeated-dose safety, PBC efficacy, or dosing in participants with combined hepatic and renal impairment.

The planned study contains six participants and no randomized control group. It evaluates alternate-day administration in moderate hepatic impairment. The record provides no observed pharmacokinetic or safety results.