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AMG 133 Phase 1 SAD/MAD PHASE1 COMPLETED n=75
Drug: MariTide · AMGN
Study Design
DesignRandomized, double-blind, placebo-controlled
Randomization3:1 (drug:placebo)
BlindingDouble-blind
Enrollment75
Duration12 weeks
NCTNCT04478708
Treatment Arms
SAD Cohorts 6 ascending single doses, SC n=49
MAD 140mg Q4W 140 mg SC every 4 weeks n=9
MAD Mid-dose Q4W Mid-dose SC every 4 weeks n=9
MAD 420mg Q4W 420 mg SC every 4 weeks n=8
Placebo Placebo SC n=26
Primary Endpoints
[{"id":"safety","name":"Safety and tolerability","type":"PRIMARY","results":[{"value":"Most TEAEs mild and transient; no increase with dose","arm_id":"mad-420"}],"timepoint":"Day 85","description":"Incidence of treatment-emergent adverse events. Most AEs were mild, transient GI events (nausea, vomiting) resolving within 48 hours."}]
Assessment
KEY FINDINGS: - 420mg Q4W: -14.5% weight loss by Day 85 (only ~3 months) - Weight loss maintained for 150+ days AFTER last dose — durability signal - GI AEs mild, transient, no dose-dependent worsening Source: Nature Metabolism Feb 2024, WCIRDC 2022
Background & Context
First-in-human dose finding for novel GLP-1 agonist / GIP antagonist bispecific antibody-peptide conjugate
Data from Supabase · Updated 2026-03-24