Stockton

Researchers are evaluating the efficacy and safety of two different dose regimens of pegozafermin compared to a placebo in adults with metabolic dysfunction-associated steatohepatitis MASH who have liver fibrosis stage F2 or F3. This Phase 3 study aims to better understand how pegozafermin may impact liver fibrosis and steatohepatitis in this population. Participants will receive subcutaneous injections of either one of two pegozafermin regimens or a matched placebo. These treatments are given in parallel groups, and participants are randomly assigned to one of the study groups. The study compares the effects of pegozafermin on liver fibrosis and steatohepatitis over a treatment period that includes evaluations up to 52 weeks and monitoring for disease progression up to 5 years. During the study, participants will be monitored through biopsies and blood tests to assess liver fibrosis improvement, resolution of steatohepatitis, changes in liver enzyme levels, and enhanced liver fibrosis scores. Safety and disease progression are also tracked throughout the study period. The total participation duration includes treatment and long-term observation to evaluate outcomes and any potential changes in liver health.

Researchers are conducting a global Phase IV randomized study to evaluate the safety and tolerability of acalabrutinib monotherapy compared to investigators choice of treatment in adults with chronic lymphocytic leukemia CLL who also have moderate to severe heart impairment. The study focuses on patients with a left ventricular ejection fraction LVEF below 50%, categorizing cardiac impairment as moderate LVEF > 40% and < 50% or severe LVEF 40%. This trial is conducted in centers with close collaboration between Hematology and Cardiology teams. Participants are randomly assigned to receive either acalabrutinib 100 mg orally twice daily or a treatment chosen by their investigator, such as chlorambucil, venetoclax, ibrutinib, zanubrutinib, rituximab, or obinutuzumab. Treatment cycles last 28 days, with hematology visits starting every 4 weeks for the first eight cycles and then every 16 weeks. Cardiology assessments including consults, ECHO, ECG, Holter monitoring, and cardiac biomarkers occur regularly throughout treatment and annually with cardiac MRI. During the study, participants undergo safety evaluations and response assessments guided by iwCLL 2018 criteria. After treatment ends, safety follow-up visits continue with cardiac monitoring until disease progression, withdrawal, death, or study termination. Patients with disease progression are contacted every 16 weeks for survival status and additional therapy information. The study spans up to four years from the last participants enrollment.