Amgen (AMGN) Status Update summary

Clinical Progress, Efficacy, and Outcomes

• MariTide demonstrated up to 20% average weight loss at 52 weeks with no plateau, with robust efficacy across all doses and schedules, including every other month dosing.

• Nearly all participants achieved at least 5% weight reduction, and in type II diabetes patients, up to 17% weight loss was observed, the highest reported in this population.

• Statistically significant weight loss was achieved in all treatment arms for both patients with and without Type 2 diabetes.

• Significant improvements in cardiometabolic parameters were seen, including reductions in hemoglobin A1c, blood pressure, triglycerides, and inflammatory markers.

• In non-diabetic patients, 70–96% with prediabetes achieved HbA1c <5.7%.

Safety, Tolerability, and Dose Escalation

• MariTide is well tolerated at target doses, with GI events primarily mild and short-lived, especially after implementing dose escalation strategies.

• Dose escalation strategies (one-step, two-step, and planned three-step) significantly reduced vomiting incidence and improved tolerability, with three-step escalation over eight weeks used in phase III.

• Discontinuation rates due to GI events were low, especially with dose escalation.

• Overall safety profile is consistent with the GLP-1 class.

Phase III Program, Study Design, and Future Directions

• Two phase III studies are underway for chronic weight management in adults with and without type II diabetes, featuring 72-week treatment and three-step dose escalation.

• Additional phase III studies will assess MariTide in atherosclerotic cardiovascular disease, heart failure, and sleep apnea.

• Maintenance and flexible dosing regimens, including quarterly dosing, are being explored, and a high rollover rate (94%) was seen in long-term extension studies.

• Phase 2 study included 592 adults, with and without Type 2 diabetes, across multiple dosing regimens and escalation arms.

• Topline Phase 2 results previously announced in November 2024 informed the Phase 3 program design.