MARITIME-1 PHASE3 ACTIVE n=3500
Drug: MariTide · AMGN
Study Design
DesignRandomized, double-blind, placebo-controlled
BlindingDouble-blind
Enrollment3500
Duration72 weeks
Treatment Arms
MariTide Dose 1 Target dose 1 SC Q4W (8-week escalation: 21mg -> 35mg -> 70mg -> target) n=875
MariTide Dose 2 Target dose 2 SC Q4W (8-week escalation) n=875
MariTide Dose 3 Target dose 3 SC Q4W (8-week escalation) n=875
Placebo Placebo SC n=875
Primary Endpoints
[{"id":"wl-72wk","name":"% change in body weight from baseline at Week 72","type":"PRIMARY","unit":"%","results":[],"timepoint":"Week 72","description":"Co-primary endpoint with responder rate. 72 weeks (vs 52 in Phase 2) — with weight not plateauing in Phase 2, could exceed 20%."},{"id":"responder-5pct","name":">= 5% body weight reduction at Week 72","type":"PRIMARY","unit":"%","results":[],"timepoint":"Week 72","description":"Co-primary: proportion of patients achieving at least 5% weight loss. FDA-required threshold for obesity drugs."}]
Assessment
FULLY ENROLLED as of Q4 2025. Readout expected early 2027. This is THE pivotal catalyst for AMGN obesity thesis. 72-week timepoint should show >Phase 2 results since curves were still descending at 52wk. Source: ClinicalTrials.gov NCT06858839, Amgen Q4 2025 earnings
Background & Context
Pivotal registration trial in obesity/overweight without T2D. Powered for FDA approval.
Data from Supabase · Updated 2026-03-24