On July 27, 2023, Lilly announced that the Mount-3 study of Tirzepatide for treating obese patients and the Mount-4 study for maintaining weight loss of obese patients had reached the primary end point and the key secondary end point. This is the third and fourth successful phase III research obtained by Tirzepatide after Mount-1 and Mount-2.
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.
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.
Post time: Sep-18-2023