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司美格鲁肽联合疗法体重平均减轻22.7%!诺和诺德下一代减重药来了
GLP1减重宝典· 2025-06-23 08:47
Core Viewpoint - The combination therapy of CagriSema (cagrilintide 2.4 mg and semaglutide 2.4 mg) shows significant weight loss results, positioning it among the most effective obesity treatments available today [2][4]. REDEFINE 1 - REDEFINE 1 is a 68-week Phase 3 double-blind clinical trial involving 3,417 adult participants, randomized to receive either CagriSema, semaglutide, cagrilintide, or a placebo, all with lifestyle intervention [4]. - The primary endpoint was the percentage change in weight and the proportion of participants achieving a weight loss of ≥5% by week 68 [5]. - Results indicated that the CagriSema group experienced an average weight loss of 20.4%, compared to 3.0% in the placebo group, a treatment difference of -17.3 percentage points (P < .001) [5]. - Notably, 50.7% of participants in the CagriSema group achieved a BMI in the non-obese range, versus 10.2% in the placebo group [5]. - The most common adverse events were gastrointestinal reactions, occurring in 79.6% of the CagriSema group, primarily mild to moderate and transient [5]. REDEFINE 2 - REDEFINE 2 is also a 68-week Phase 3 double-blind randomized trial with 1,206 participants from 12 countries, assessing CagriSema against a placebo [6]. - The primary endpoint was similar to REDEFINE 1, focusing on percentage change in weight and the proportion of participants achieving a weight loss of ≥5% [7]. - By week 68, the CagriSema group had an average weight loss of 13.7%, compared to 3.4% in the placebo group, a treatment difference of -10.4 percentage points (P < .001) [7]. - Additionally, 73.5% of the CagriSema group had HbA1c levels reduced to ≤6.5%, compared to 15.9% in the placebo group [7]. Market Expectations and Outlook - Despite strong clinical data, the results did not meet market expectations, as the management had anticipated a weight loss of approximately 25%, exceeding the 21% from competing therapies [8]. - Following the results announcement, the stock price of Novo Nordisk declined, with some investors expressing skepticism about CagriSema's ability to regain market leadership [8]. - Novo Nordisk plans to submit a marketing application for CagriSema to the FDA in early 2026, with potential market availability by early 2027 [8].