Amgen registers two Phase 3 extension trials for obesity drug maridebart cafraglutide

Amgen posted two new Phase 3 extension trials this week, both recruiting participants who took maridebart cafraglutide (MariTide, AMG 133) in earlier studies.

• "MARITIME-1-EXTENSION" (NCT07684235) is an extension of trial 20210181 (NCT06858839), following participants with obesity or overweight who continue or are re-randomized to different doses of maridebart cafraglutide.¹ The study is estimated to enroll 3200 participants¹ and its primary outcome tracks percent change in body weight from the parent trial's baseline through week 48 of the current trial, along with treatment-emergent and serious adverse events through 60 weeks.¹
• "MARITIME-2-EXTENSION" (NCT07684144) is a Phase 3 extension trial evaluating maridebart cafraglutide in participants with obesity or overweight who also have type 2 diabetes mellitus, extending trial 20210184 (NCT06858878).² The study is estimated to enroll 950 participants², with primary outcomes covering percent change in body weight from the parent trial's baseline and adverse event rates through 60 weeks.²