Comuna 2

This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.

Researchers are evaluating the effect of Seladelpar on clinical outcomes in patients with Primary Biliary Cholangitis (PBC) who have compensated cirrhosis. This Phase 3 study focuses on adults with PBC and cirrhosis classified as Child-Pugh (CP) score A or B to better understand how Seladelpar may impact the disease course compared to placebo treatment. Participants will be assigned to receive either Seladelpar or a placebo daily for up to 36 months. Those with CP-A cirrhosis will take 10 mg of Seladelpar once daily, while those with CP-B cirrhosis will take 5 mg once daily. The placebo group will take one capsule daily for the same duration. This randomized, double-blind, placebo-controlled design ensures that the effects of Seladelpar can be assessed rigorously against a control. Throughout the study, participants will be monitored regularly with scheduled assessments to evaluate their health and response to treatment. Researchers will measure Event Free Survival over 36 months as the primary outcome. Safety and liver function will be closely observed through laboratory tests and clinical evaluations. Participants must comply with study requirements and complete all scheduled visits during the treatment period.