Tirzepatide臨床試驗SURMOUNT-1結果出爐！！

以下內容僅轉載​Healio.com 不代表新德大藥局之任何意見

以下內容摘自​Healio.com

SURMOUNT-1: Adults achieve weight loss of 16% or more at 72 weeks with tirzepatide


Adults with overweight or obesity taking the once-weekly GIP/GLP-1 receptor agonist tirzepatide achieved a mean weight loss of at least 16% at 72 weeks, according to topline results from the SURMOUNT-1 clinical trial.

In a phase 3 trial with 2,539 participants, tirzepatide (Eli Lilly) met both primary endpoints for mean percentage change in body weight from baseline and percentage of participants with a 5% reduction in body weight compared with placebo. Adults randomly assigned to receive tirzepatide had a mean weight loss of 16% with 5 mg, 21.4% with 10 mg, and 22.5% with 15 mg compared with a 2.4% mean weight loss for those assigned placebo. Of those assigned tirzepatide, 89% achieved a weight loss of at least 5% compared with 28% in the placebo group.

Louis J. Aronne, MD, FACP, DABOM
Aronne is the Sanford I. Weill Professor of Metabolic Research at Weill Cornell Medicine at New York-Presbyterian/Weill Cornell Medical Center and investigator in the SURMOUNT-1 trial.
“This study shows that highly significant weight loss, in line with what is achieved with surgical procedures, can be achieved with tirzepatide,” Louis J. Aronne, MD, FACP, DABOM, the Sanford I. Weill Professor of Metabolic Research at Weill Cornell Medicine at New York-Presbyterian/Weill Cornell Medical Center and investigator in the SURMOUNT-1 trial, told Healio. “The mean BMI was about 38 kg/m2 to start and was reduced to about 30 kg/m2 with many subjects getting into the normal range.” 

Tirzepatide met all key secondary endpoints, with 55% of those receiving 10 mg and 63% of those receiving 15 mg achieving a body weight reduction of at least 20% compared with 1.3% of the placebo group. In an additional secondary endpoint analysis not controlled for type 1 error, 32% of those receiving 5 mg tirzepatide lost at least 20% of body weight, according to the release.

“For perspective, a 5% weight loss reduces the risk of developing diabetes by 50%, and a 10% weight loss reduces it by 80%,” Aronne said. “Lap band produces about 17% weight loss, and sleeve gastrectomy 25% mean weight loss. The gap between diets and bariatric surgery is being filled by medical therapy.”

The safety and tolerability profile for tirzepatide was similar to that those of other incretin-based therapies approved for obesity treatment. Most side effects were mild to moderate; the most common were nausea, diarrhea, constipation and vomiting.

Participants with prediabetes at the start of the trial will remain enrolled for an additional 104 weeks beyond the initial 72-week trial period to evaluate the impact of body weight and potential differences in type 2 diabetes progression with tirzepatide compared with placebo.

The SURMOUNT-1 results will be presented at an upcoming medical meeting and submitted to a peer-reviewed journal, according to the release. Additional studies are ongoing.

根據 SURMOUNT-1 臨床試驗的一線結果，每週服用一次 GIP/GLP-1 受體激動劑替西帕肽的超重或肥胖成人在 72 週時平均體重減輕至少 16%。

在一項有 2,539 名參與者的 3 期試驗中，tirzepatide (Eli Lilly) 達到了兩個主要終點，即體重相對於基線的平均百分比變化和與安慰劑相比體重減輕 5% 的參與者百分比。隨機分配接受 tirzepatide 的成年人平均體重減輕 16%（5 毫克）、21.4%（10 毫克）和 22.5%（15 毫克），而安慰劑組平均體重減輕 2.4%。在分配替西帕肽的患者中，89% 的患者體重減輕至少 5%，而安慰劑組為 28%。

“這項研究表明，使用 tirzepatide 可以顯著減輕體重，與外科手術所達到的效果一致，”威爾康奈爾大學 Sanford I. Weill 代謝研究教授Louis J. Aronne 醫學博士、FACP、DABOM紐約長老會/威爾康奈爾醫學中心的醫學和 SURMOUNT-1 試驗的調查員告訴 Healio。“開始時的平均 BMI 約為 38 kg/m 2 ，隨著許多受試者進入正常範圍，隨後降至約 30 kg/m 2。 ” 

Tirzepatide 達到了所有關鍵的次要終點，55% 的接受 10 mg 的患者和 63% 的接受 15 mg 的患者實現了至少 20% 的體重減輕，而安慰劑組為 1.3%。根據發布的消息，在另一項未對 1 型錯誤進行控制的次要終點分析中，接受 5 mg 替西帕肽的患者中有 32% 的人體重減輕了至少 20%。

“從長遠來看，減重 5% 可將患糖尿病的風險降低 50%，減重 10% 可降低 80%，”Aronne 說。“膝帶可減輕約 17% 的體重，袖狀胃切除術平均減輕 25% 的體重。飲食和減肥手術之間的差距正在通過藥物治療來填補。”

替西帕肽的安全性和耐受性與其他批准用於肥胖治療的腸促胰島素療法相似。大多數副作用為輕度至中度；最常見的是噁心、腹瀉、便秘和嘔吐。

在試驗開始時患有前驅糖尿病的參與者將在最初的 72 週試驗期之後再加入 104 週，以評估體重的影響以及 tirzepatide 與安慰劑相比對 2 型糖尿病進展的潛在差異。

據新聞稿稱，SURMOUNT-1的結果將在即將召開的醫學會議上公佈，並提交給同行評審的期刊。其他研究正在進行中。​

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