Amgen announced new Phase 1 data from AMG 133, a novel bispecific glucose-dependent insulinotropic polypeptide receptor antagonist and glucagon-like peptide-1 receptor agonist molecule. This first-in-human study was designed to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of AMG 133 in people with obesity and without diabetes. These data will be presented as part of an oral presentation on Saturday, Dec. 3 at the 20th World Congress of Insulin Resistance, Diabetes and Cardiovascular Disease Hybrid Conference. Participants were randomized to receive subcutaneous AMG 133 or placebo either as a single ascending dose or multiple ascending doses. The MAD cohorts showed mean percent changes in body weight, ranging from -7.2% at the lowest dose, to -14.5% at the highest dose by day 85. A substantial degree of weight loss was maintained beyond the treatment period, which will be shared as part of the oral presentation. Most treatment emergent adverse events were mild and transient. The majority of the TEAEs were GI-related with the most common being nausea and vomiting, most events resolved within 48 hours. Based on these data, a Phase 2 trial will be initiated early next year to further study the attributes of this molecule.
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