Jul 09, 2025
Summary
Amgen’s Phase II trial (NCT05669599) of MariTide (maridebart cafraglutide), a monthly peptide‑antibody conjugate targeting GLP‑1 activation and GIP inhibition, demonstrated strong and ongoing weight loss—including up to ~20% in people with obesity without diabetes and ~17% in those with T2D—alongside cardiometabolic improvements. A lower-dose initiation approach significantly improved tolerability without affecting efficacy. These findings are now guiding a 72-week Phase III program and several outcomes studies.
Trial Design
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Results
KOL Views
“It is encouraging that substantial weight reduction continues through week 52 without signs of plateau. This suggests that sustained, monthly dosing of MariTide could provide long‑term metabolic management in people with and without T2D.” – Expert Opinion
“The Phase II efficacy and safety outcomes, coupled with dose‑escalation tolerability data, directly informed the Phase III MARITIME protocol. Monthly or less frequent administration represents a meaningful advance in real‑world obesity treatment adherence.” – Expert Opinion
Conclusion
MariTide shows promise as a monthly (or less frequent) obesity and T2D treatment—with robust, ongoing weight loss, meaningful cardiometabolic improvements, and enhanced tolerability through dose titration. The data support the design of Amgen’s Phase II MARITIME studies (72-week duration, structured dose escalation) and upcoming trials in cardiovascular disease, heart failure, and sleep apnea.
Article in PDF
Jul 09, 2025
Summary
Amgen’s Phase II trial (NCT05669599) of MariTide (maridebart cafraglutide), a monthly peptide‑antibody conjugate targeting GLP‑1 activation and GIP inhibition, demonstrated strong and ongoing weight loss—including up to ~20% in people with obesity without diabetes and ~17% in those with T2D—alongside cardiometabolic improvements. A lower-dose initiation approach significantly improved tolerability without affecting efficacy. These findings are now guiding a 72-week Phase III program and several outcomes studies.
Trial Design
Results
KOL Views
“It is encouraging that substantial weight reduction continues through week 52 without signs of plateau. This suggests that sustained, monthly dosing of MariTide could provide long‑term metabolic management in people with and without T2D.” – Expert Opinion
“The Phase II efficacy and safety outcomes, coupled with dose‑escalation tolerability data, directly informed the Phase III MARITIME protocol. Monthly or less frequent administration represents a meaningful advance in real‑world obesity treatment adherence.” – Expert Opinion
Conclusion
MariTide shows promise as a monthly (or less frequent) obesity and T2D treatment—with robust, ongoing weight loss, meaningful cardiometabolic improvements, and enhanced tolerability through dose titration. The data support the design of Amgen’s Phase II MARITIME studies (72-week duration, structured dose escalation) and upcoming trials in cardiovascular disease, heart failure, and sleep apnea.