Sayama

This research aims to evaluate the effectiveness and safety of AZD1163, a new bispecific antibody, in adults with moderately-to-severely active rheumatoid arthritis RA who are positive for anti-citrullinated peptide antibodies ACPA. The study focuses on patients who have had an inadequate or lost response or intolerance to certain standard treatments. The trial is a Phase II, randomized, double-blind, placebo-controlled study conducted at multiple centers to assess AZD1163s impact on RA disease activity. Participants will be randomly assigned to one of four groups to receive subcutaneous injections of either one of three doses of AZD1163 or a matching placebo. All participants will continue their standard care treatments, which may include conventional synthetic disease-modifying antirheumatic drugs csDMARDs or tumor necrosis factor inhibitors TNFi with or without csDMARDs. The treatment period lasts 24 weeks, followed by a 28-week safety follow-up phase. Throughout the study, participants will undergo assessments including disease activity scores such as DAS28-CRP, American College of Rheumatology response criteria ACR20 and ACR50, and clinical disease activity indexes. Researchers will also evaluate the pharmacokinetics and immunogenicity of AZD1163. Safety monitoring continues during the follow-up period, and total participation spans approximately 52 weeks.

Researchers are studying maridebart cafraglutide to evaluate its effect on reducing cardiovascular problems and death in people with atherosclerotic cardiovascular disease who are also overweight or obese. This Phase 3 trial compares maridebart cafraglutide to a placebo, both given alongside standard care, to see if maridebart cafraglutide works better in lowering heart-related risks. Participants will receive either maridebart cafraglutide or a placebo, both administered by subcutaneous injection. The study lasts for up to approximately 35 months, during which researchers monitor several heart and health outcomes. These include heart attacks, strokes, death rates, hospitalizations, blood pressure, body measurements, blood sugar control, cholesterol levels, kidney function, and inflammatory markers. During the trial, participants will have regular assessments including physical exams, blood tests, and monitoring of heart events. Researchers track the time to first major heart-related events and changes in health markers over the study period. Safety is also monitored by recording any adverse events. The total participation time can last nearly three years, allowing careful observation of the effects of the study drug compared to placebo.