Phase 1 AMG 133 (maridebart cafraglutide) single- and multiple-ascending-dose study in obesity
The publication reported acceptable safety/tolerability and dose-dependent weight loss; in multiple-ascending-dose cohorts, weight loss was maintained for up to 150 days after the last dose.
What this study tells us
Participants were assigned to comparison groups by chance, usually with placebo and/or blinding to reduce bias. This is a strong design for testing cause and effect, but the population, duration and endpoints still limit what can be concluded.
Adults with obesity; the registry enrolled 110 participants and the publication reports the principal single- and multiple-ascending-dose cohorts
n=110 enrolled in registry; 75 in published principal SAD/MAD cohorts
The publication reported acceptable safety/tolerability and dose-dependent weight loss; in multiple-ascending-dose cohorts, weight loss was maintained for up to 150 days after the last dose.
Early Phase 1 study with small cohorts and exploratory weight outcomes; not designed as a definitive efficacy trial.
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Key result
The publication reported acceptable safety/tolerability and dose-dependent weight loss; in multiple-ascending-dose cohorts, weight loss was maintained for up to 150 days after the last dose.