FDA frees Amgen’s phase 1 obesity asset from clinical trial hold

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FDA Lifts Clinical Hold on Amgen's Phase 1 Obesity Drug MariTide, Paving Way for Phase 3 Trials

The FDA has lifted its clinical hold on Amgen's Phase 1 obesity candidate, allowing further clinical development1.
Amgen's drug, MariTide, will now advance into Phase 3 trials as part of the newly announced "Maritime" program1.

- The Phase 3 program includes two major trials:

Maritime-1 will enroll 3,500 participants with obesity or overweight without Type 2 diabetes.
Maritime-2 will enroll 999 participants with obesity or overweight and Type 2 diabetes2.
- Both trials will evaluate percent change in body weight at 72 weeks as the primary endpoint and will test three different doses of MariTide in placebo-controlled settings2.
- MariTide is a monoclonal antibody linked to peptides that boost GLP-1 receptor activity and suppress GIP receptor activity, targeting dual hormonal pathways implicated in weight regulation2.
- Previous phase 2 studies showed robust weight loss in participants, but full results and details on the dosing strategy for Phase 3 have not yet been disclosed4.
- The reopening of clinical trials and progression to late-stage studies positions Amgen as a key contender in the highly competitive obesity drug market, especially following recent setbacks from competitors1.