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胰高糖素样肽 - 1(GLP - 1)
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速递|礼来口服GLP-1新药头对头试验,再次击败阿斯利康
GLP1减重宝典· 2025-10-16 14:05
Core Viewpoint - Eli Lilly's oral GLP-1 therapy orforglipron has demonstrated superior efficacy in treating type 2 diabetes compared to AstraZeneca's SGLT2 inhibitor Farxiga, achieving significant reductions in A1C levels and weight loss in recent trials [2][4]. Group 1: Clinical Trial Results - In the latest Phase III trial ACHIEVE-2, orforglipron was tested on 962 adult participants with type 2 diabetes who had inadequate blood sugar control after metformin. The study compared three doses of orforglipron against Farxiga, with the primary goal of demonstrating non-inferiority in A1C reduction after 40 weeks [2][4]. - All doses of orforglipron met the primary and all key secondary endpoints, significantly lowering A1C levels and promoting weight loss. Specifically, the 3 mg dose resulted in a 1.3% reduction in A1C, while the 12 mg and 36 mg doses achieved a 1.7% reduction. In contrast, Farxiga only resulted in a 0.8% reduction [4]. - Another late-stage study, ACHIEVE-5, also showed positive results for orforglipron compared to placebo in patients with insufficient blood sugar control who were using titrated insulin glargine. The 3 mg dose led to a 1.5% reduction in A1C, the 12 mg dose achieved a 2.1% reduction, and the 36 mg dose resulted in a 1.9% reduction, while placebo only saw a 0.8% reduction [4]. Group 2: Safety and Tolerability - The safety and tolerability of orforglipron in both studies were consistent with previous findings, with stable discontinuation rates. The most common adverse reactions were gastrointestinal symptoms, which were generally mild to moderate, and no liver safety issues were observed [4]. Group 3: Future Developments - Detailed data from the two studies will be presented at an upcoming medical conference. The final global registration study of the ACHIEVE program, ACHIEVE-4, is expected to be completed in the first quarter of 2026, paving the way for orforglipron's market application in type 2 diabetes [5]. - Additionally, the application for orforglipron's use in obesity treatment is set to be initiated by the end of this year [6].
速递 | 减肥狠活!透明塑料袋装的减肥药竟是毒品
GLP1减重宝典· 2025-09-27 04:11
Core Insights - The article highlights the discovery of a large quantity of illegal weight loss drugs containing methamphetamine, a controlled substance, by customs officials in Hefei [2][4]. Group 1: Regulatory Issues - Methamphetamine is classified as a first-class psychoactive drug in China, known for its addictive properties and is the active ingredient in ice drugs [4]. - According to the Drug Administration Law of the People's Republic of China, the import and export of narcotic drugs and certain psychoactive substances require permits issued by the State Drug Administration [4]. Group 2: Industry Context - The article emphasizes the growing concern over the illegal trade of weight loss drugs, particularly those containing harmful substances, which poses risks to public health [2][4]. - The GLP-1 drug class is mentioned as a new category of weight loss and diabetes management medications, which work by enhancing insulin secretion and suppressing appetite [11].
全球第二款!司美格鲁肽获FDA批准治疗MASH
GLP1减重宝典· 2025-08-16 03:04
Core Viewpoint - Novo Nordisk's weight loss drug Wegovy has received accelerated approval from the FDA for the treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH), solidifying the company's position in the metabolic disease sector [6][8]. Summary by Sections FDA Approval and Market Position - Wegovy is the first GLP-1 class drug approved for MASH, a serious liver disease affecting approximately 5% of U.S. adults according to the American Liver Foundation [6]. - Novo Nordisk is now one of only two FDA-approved therapies for MASH, with the other being Madrigal Pharmaceuticals' Rezdiffra, approved in 2024 [6]. Clinical Study Results - In a study, 62.9% of patients treated with 2.4 mg semaglutide experienced relief from steatohepatitis without worsening fibrosis, compared to 34.3% in the placebo group, showing a significant difference of 28.7% (P<0.001) [7]. - For the second primary endpoint, 36.8% of the semaglutide group showed improvement in fibrosis without worsening fatty liver, versus 22.4% in the placebo group, with a difference of 14.4% (P<0.001) [7]. - The study's first part highlights the potential of semaglutide to delay the progression of cirrhosis and end-stage liver disease [7]. Treatment Availability and Future Plans - Wegovy is now available in the U.S. for adults with MASH and moderate to severe fibrosis, requiring a balanced diet and exercise [8]. - Novo Nordisk is working with insurers to expand coverage but has not disclosed specific pricing [8]. - The company has applied for approval in Europe and Japan based on the study's first part results, with complete data from the second part expected in 2029 [8]. Competitive Landscape - Eli Lilly is also developing treatments for MASH, with its active ingredient tirzepatide showing that up to 74% of patients achieved resolution of MASH without worsening fibrosis in a mid-stage study [8].