Amgen registers new Phase 3 maridebart cafraglutide vs. semaglutide trial in type 2 diabetes

Amgen had three registry entries reflecting different stages of development.

• A new Phase 3 trial, "MARITIME-T2D-3," will compare maridebart cafraglutide given once monthly against semaglutide given once weekly as add-on therapy to metformin, with or without an SGLT-2 inhibitor, in participants with type 2 diabetes. The study is not yet recruiting, with an estimated start date of 2026-11-02 and estimated primary completion of 2028-09-04¹, and plans to enroll 1300 participants¹, with its main goal being to test whether maridebart cafraglutide is non-inferior to semaglutide in improving glycemic control in participants with type 2 diabetes (T2D) who are receiving metformin treatment, with or without a sodium-glucose cotransporter-2 (SGLT-2) inhibitor.¹
• The Phase 1 single and multiple ascending dose study of AMG 513 in participants with obesity has reached completed status, with primary completion and study completion both dated 2026-09-16². The trial enrolled 82 participants² and assessed the safety and tolerability of AMG 513 after single and multiple doses², administered subcutaneously or intravenously in Part A and subcutaneously in Part B².
• The Phase 1 trial comparing romosozumab (AMG 785, Evenity) given as a single subcutaneous injection versus two split injections remains in recruiting status. The study plans to enroll 308 participants³, with primary completion estimated for 2027-01-14³, and lists one site, QPS Miami in Miami, Florida, United States³.