MariTide Phase 2 Dose-Ranging - Study

Study Design

DesignRandomized, double-blind, placebo-controlled, dose-ranging

RandomizationCohort A: 3:3:3:2:2:2:3; Cohort B: 1:1:1:1

BlindingDouble-blind

Enrollment592

Duration52 weeks

NCTNCT05669599

Treatment Arms

A: 140mg Q4W (fixed) 140 mg SC Q4W n=80

A: 280mg Q4W (fixed) 280 mg SC Q4W n=80

A: 420mg Q4W (fixed) 420 mg SC Q4W n=80

A: 420mg Q8W 420 mg SC every 8 weeks n=53

A: 420mg (4wk esc) 70mg escalating to 420mg Q4W over 4 weeks n=53

A: 420mg (12wk esc) 70mg escalating to 420mg Q4W over 12 weeks n=53

A: Placebo Placebo SC n=66

B (T2D): 140mg 140 mg SC Q4W n=32

B (T2D): 280mg 280 mg SC Q4W n=32

B (T2D): 420mg 420 mg SC Q4W n=32

B (T2D): Placebo Placebo SC n=31

[{"id":"wl-52wk","name":"Body weight change at Week 52 (ITT)","type":"PRIMARY","unit":"%","results":[{"ci":"-15.0 to -9.7","unit":"%","value":-12.3,"arm_id":"a-140-fixed"},{"unit":"%","value":-14.6,"arm_id":"a-280-fixed"},{"ci":"-18.9 to -13.5","unit":"%","value":-16.2,"arm_id":"a-420-fixed"},{"unit":"%","value":-13.1,"arm_id":"a-420-q8w"},{"unit":"%","value":-15.4,"arm_id":"a-420-esc4"},{"unit":"%","value":-14.6,"arm_id":"a-420-esc12"},{"ci":"-4.2 to -0.7","unit":"%","value":-2.5,"arm_id":"a-placebo"},{"ci":"-11.0 to -5.7","unit":"%","value":-8.4,"arm_id":"b-140"},{"unit":"%","value":-11.2,"arm_id":"b-280"},{"ci":"-15.3 to -9.2","unit":"%","value":-12.3,"arm_id":"b-420"},{"ci":"-2.9 to -0.6","unit":"%","value":-1.7,"arm_id":"b-placebo"}],"timepoint":"Week 52","description":"Treatment policy estimand (ITT). Weight loss NOT plateaued at 52 weeks."}]

GI AEs mild, transient, first-dose. Disc. rate: 12-27% fixed dose, ~7.8% with escalation, 0% with PK-LDI. No BMD changes. Favorable fat:lean ratio.

KEY: Weight not plateaued at 52wk. 280mg arm had HIGHEST efficacy estimand (19.9%). Dose escalation cut discontinuation from 27% to 7.8%. Stock sold off on ADA publication. Source: NEJM 10.1056/NEJMoa2504214