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Ascendis Pharma宣布TransCon™ hGH(lonapegsomatropin)在针对生长激素缺乏症成人的3期foresiGHt试验中取得优于安慰剂的统计结果

TransCon™ hGH (lonapegsomatropin) Achieved Statistically Superior Outcomes Compared to Placebo in Phase 3 foresiGHt Trial of Adults with Growth Hormone Deficiency

GlobeNewswire 等信源发布 2023-12-19 21:29

可切换为仅中文


–   On primary efficacy and key secondary endpoints, TransCon hGH demonstrated statistically significant reduction from baseline in trunk fat and increase in total body lean mass at Week 38 compared to placebo –   TransCon hGH was generally safe and well tolerated, similar to daily hGH, with no discontinuations related to study drug –   Exploratory post-hoc analysis suggests the same treatment effects on target tissues as daily hGH COPENHAGEN, Denmark, Dec.

–在主要疗效和关键次要终点方面,与安慰剂相比,TransCon hGH在第38周时躯干脂肪从基线水平显着降低,全身瘦体重增加–TransCon hGH通常安全且耐受性良好,与每日hGH相似,没有与研究药物相关的停药-探索性事后分析表明,对靶组织的治疗效果与丹麦哥本哈根每日hGH相同。

19, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced positive topline results from foresiGHt, its Phase 3 randomized, parallel-arm, placebo-controlled (double-blind) and active-controlled (open-label) trial to compare the efficacy and safety of TransCon hGH (lonapegsomatropin) with placebo and daily hGH (human growth hormone, somatropin) in adults with growth hormone deficiency (GHD).

2023年19月19日(环球通讯社)--Ascendis Pharma A/S(纳斯达克股票代码:ASND)今天宣布,其第三阶段随机平行分支foresiGHt取得了积极的结果,安慰剂对照(双盲)和主动对照(开放标签)试验,比较TransCon hGH(lonapegsomatropin)与安慰剂和每日hGH(人类生长激素,生长激素)在生长激素缺乏症(GHD)成人中的疗效和安全性。

The foresiGHt Trial evaluated 259 adults with GHD aged 23 to 80 years old, randomized 1:1:1, titrated to receive a target fixed dose of TransCon hGH, placebo, or daily hGH based on age and oral estrogen intake with approximately equivalent hGH mg/week for TransCon hGH and daily hGH. TransCon hGH demonstrated superiority on its primary efficacy endpoint at Week 38: Change from baseline in trunk percent fat as measured by dual x-ray absorptiometry (TransCon hGH -1.67% vs.

foresiGHt试验评估了259名年龄在23至80岁之间的GHD成年人,随机分为1:1:1,根据年龄和口服雌激素摄入量,滴定接受目标固定剂量的TransCon hGH,安慰剂或每日hGH,TransCon hGH和每日hGH的hGH毫克/周。TransCon hGH在第38周的主要疗效终点表现出优越性:通过双x射线吸收测定法测量的躯干脂肪百分比从基线变化(TransCon hGH-1.67%vs。

placebo +0.37%, LS mean difference = -2.04%, p < 0.0001) TransCon hGH demonstrated superiority on its key secondary efficacy endpoints at Week 38: Change from baseline in total body lean mass (TransCon hGH +1.60 kg vs placebo -0.10 kg, LS mean difference = 1.70 kg, p < 0.0001)Change from baseline in trunk fat mass (TransCon hGH -0.48 kg vs placebo +0.22 kg, LS mean difference = -0.70 kg, p = 0.0053) Exploratory post-hoc analysis at Week 38 de.

安慰剂+0.37%,LS平均差异=-2.04%,p<0.0001)TransCon hGH在第38周表现出优于其关键次要疗效终点:在第38周,全身瘦肉量(TransCon hGH+1.60 kg vs安慰剂-0.10 kg,LS平均差异=1.70 kg,p<0.0001)从基线变化(TransCon hGH-0.48 kg vs安慰剂+0.22 kg,LS平均差异=-0.70 kg,p=0.0053)探索性事后分析德国。