El sucesor del exitoso fármaco dietético Somaglutida

El 27 de julio de 2023, Lilly anunció que el estudio Mount-3 de tirzepatida para el tratamiento de pacientes obesos y el estudio Mount-4 para mantener la pérdida de peso de pacientes obesos habían alcanzado el criterio de valoración principal y el criterio de valoración secundario clave. Esta es la tercera y cuarta investigación exitosa de fase III obtenida con Tirzepatide después de Mount-1 y Mount-2.
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SURMOUNT-3 (NCT04657016) is a multicenter, randomized, double-blind, parallel, placebo-controlled trial enrolling a total of 806 participants designed to demonstrate Tirzepatide's superiority over placebo in terms of the percentage change in weight change after randomization and the percentage of participants who lost ≥5% after randomization at 72 weeks. The SURMOUNT-3 study results showed that Tirzepatide met all endpoints, namely that after 72 weeks of dosing treatment, patients in the Tirzepatide group achieved a higher percentage of weight loss from baseline compared to placebo, and a higher percentage of patients in the Tirzepatide group achieved a percentage weight loss greater than 5%. Specific clinical data showed that patients treated with Tirzepatide lost an average of 21.1% of body weight compared to placebo; Combined with the 12-week intervention period, patients treated with Tirzepatide lost an average of 26.6 percent of their body weight. In addition, 94.4% of patients lost ≥5% of their weight in the Tirzepatide group, compared with 10.7% in the placebo group. SURMOUNT-4 (NCT04660643) is a multicenter, randomized, double-blind, parallel, placebo-controlled trial enrolling a total of 783 participants designed to demonstrate that Tirzepatide was superior to placebo in percentage weight change at 88-week randomization. The results showed that after the double-blind period of 37~88 weeks, patients in the Tirzepatide group lost more weight than in the placebo group. In terms of safety, neither the SURMOUNT-3 nor SURMOUNT-4 studies observed new safety signals. Since the launch of Novo Nordisk's blockbuster diet drug Semaglutide, coupled with Musk's strong endorsement, it has become a phenomenal Internet celebrity product and the current weight loss king. The weight loss market demand is huge, and there are only two GLP-1 weight loss drugs currently on the market, Liraglutide and Semaglutide, but Liraglutide is a short-acting preparation, which cannot compete with long-acting preparations in terms of patient compliance, and the current weight loss world temporarily belongs to Semaglutide.
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Also the king of the GLP-1 field, Lilly covets the blue ocean of the weight loss market - so Lilly launched a challenge and first bet on Tirzepatide to seize a place in the weight loss market.   Tirzepatide is a weekly GIPR/GLP-1R dual agonist, GIP (glucose-dependent insulin stimulating polypeptide) is another member of the glucagon peptide family, with the effect of promoting insulin secretion in an insulin-dependent manner and stimulating glucagon secretion in a hypoglycemic state, GIPR/GLP-1R dual agonist can produce blood sugar control, weight loss and other effects by stimulating both GIP and GLP-1 downstream pathways. Tirzepatide has been approved by the FDA in 2022-5 (trade name: Mounjaro) for use in combination with diet and exercise to improve glycemic control in adults with type 2 diabetes.

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