US pharmaceutical company Amgen (NASDAQ:AMGN) on Monday reported full results from Part 1 of the Phase 2 study of MariTide (maridebart cafraglutide, formerly AMG 133), a long-acting, peptide-antibody conjugate subcutaneously administered monthly or less frequently.
In addition to these data, complete results from the primary analysis of the Phase 1 pharmacokinetics low dose initiation (PK-LDI) study evaluating lower starting doses of MariTide were presented as part of an Symposium at the 85th American Diabetes Association (ADA) 85th Scientific Sessions and simultaneously published in The New England Journal of Medicine.
Amgen said that in the Phase 2 study, MariTide demonstrated up to ~20% average weight loss in people living with obesity without Type 2 diabetes (T2D) compared with 2.6% in the placebo arm, and up to ~17% average weight loss in people living with obesity with T2D, compared with 1.4% in the placebo arm, per the efficacy estimand. Weight loss had not plateaued by 52 weeks, indicating the potential for further weight reduction. In addition to meaningful weight loss, MariTide demonstrated a robust and sustained reduction in haemoglobin A1c (HbA1c) of up to 2.2% in people living with obesity and T2D. Weight loss with MariTide was also accompanied by improvements across pre-specified cardiometabolic measures, including waist circumference, blood pressure, high-sensitivity C-reactive protein (hs-CRP) and select lipid parameters.
The company added that no new safety signals were identified in the Phase 2 study and tolerability was consistent with the GLP-1 class.
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