此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Bimagrumab 和 Semaglutide 在超重或肥胖成人中的安全性和有效性

2026年6月11日 更新者：Eli Lilly and Company

一项随机、双盲、安慰剂对照的多中心研究，单独或联合开放标签皮下注射 Semaglutide 静脉注射 Bimagrumab，以研究超重或肥胖男性和女性的疗效和安全性

一项 2 期研究，旨在评估单独使用 bimagrumab 或联合 semaglutide 评估超重或肥胖男性和女性的疗效和安全性

研究概览

地位

完全的

条件

干预/治疗

详细说明

本研究调查除了标准治疗方案 semaglutide 之外的 bimagrumab 是否能够在存在体重和/或脂肪量减少的情况下保持/增加肌肉量。 预计腰围的减少将遵循与接受比马鲁单抗和索马鲁肽联合治疗的受试者体重减轻类似的模式。

研究类型

介入性

注册 (实际的)

507

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 新西兰
      • Auckland、新西兰、2025
        • Middlemore Hospital
      • Auckland、新西兰、1010
        • Optimal Clinical Trials
      • Auckland、新西兰、1010
        • New Zealand Clinical Research Auckland
      • Christchurch、新西兰、8011
        • New Zealand Clinical Research Christchurch
      • Hamilton、新西兰、3200
        • Lakeland Clinical Trials Waikato
      • Nelson、新西兰、7011
        • Southern Clinical Trials Tasman
    • Canterbury
      • Beckenham, Christchurch、Canterbury、新西兰、8013
        • Southern Clinical Trials Ltd
    • Wellington Region
      • Newtown、Wellington Region、新西兰、6242
        • P3 Research
  • 澳大利亚
      • Camberwell、澳大利亚、3124
        • Emeritus Research
    • New South Wales
      • Brookvale、New South Wales、澳大利亚、2100
        • Northern Beaches Clinical Research
      • Saint Leonards、New South Wales、澳大利亚、2065
        • Royal North Shore Hospital
    • Queensland
      • Morayfield、Queensland、澳大利亚、4506
        • University of The Sunshine Coast Morayfield
      • Sippy Downs、Queensland、澳大利亚、04556
        • University of the Sunshine Coast Clinical Trial Centre
      • South Brisbane、Queensland、澳大利亚、4101
        • University of The Sunshine Coast South Brisbane
      • Southport、Queensland、澳大利亚、4215
        • Gold Coast University Hospital
    • Victoria
      • Heidelberg Heights、Victoria、澳大利亚、3081
        • Austin Health
  • 美国
    • Alabama
      • Anniston、Alabama、美国、36207
        • Pinnacle Research Group, LLC
      • Cullman、Alabama、美国、35055
        • Cullman Clinical Trials
    • Florida
      • Hialeah、Florida、美国、33012
        • Indago Research & Health Center, Inc
      • Jacksonville、Florida、美国、32256
        • Clinical Neuroscience Solutions Inc
      • Lake Worth、Florida、美国、33461
        • Altus Research
    • Louisiana
      • Baton Rouge、Louisiana、美国、70808
        • Pennington Biomedical Research Center
    • New York
      • New York、New York、美国、10021
        • Weill Cornell Medical College
    • North Carolina
      • Monroe、North Carolina、美国、28112
        • Monroe Biomedical Research
    • South Carolina
      • Columbia、South Carolina、美国、29322
        • SPICA Clinical
    • Texas
      • Sugar Land、Texas、美国、77479
        • Mt. Olympus Medical Research

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

不

描述

纳入标准：

  • 在进行任何与研究相关的评估之前，必须获得书面知情同意书。

  • 18 至 80 岁的男性和女性，包括在内；有生育潜力的妇女（定义为未绝经后或手术后绝育的妇女）必须满足以下两项标准：

    • 两次妊娠试验阴性（在筛选和随机分组时，给药前）
    • 使用宫内节育器，从筛选前至少 3 个月到最后一次静脉注射比麦单抗/安慰剂后至少 4 个月，以及额外的避孕（屏障）方法
  • 体重指数 (BMI) ≥ 30 或 BMI ≥ 27 并伴有一种或多种肥胖相关合并症（例如高血压、胰岛素抵抗、睡眠呼吸暂停或血脂异常）
  • 筛选后 90 天内体重稳定（± 5 公斤），体重
  • 有至少一次自我报告的减肥失败行为史
  • 能够与研究者良好沟通，遵守研究要求并在研究期间坚持饮食和活动计划

排除标准：

  • 单克隆抗体药物的历史或已知的超敏反应或 semaglutide（Ozempic® 或 Wegovy®）的禁忌症
  • 在入组时或入组后 30 天或 5 个半衰期内（以较长者为准）或当地法规要求时使用其他研究药物
  • 在筛选前的过去 30 天内接受过任何肥胖指征的药物治疗
  • 需要当前使用任何抗糖尿病药物的糖尿病诊断（例如，HbA1c ≥ 6.5%）注意：即使使用二甲双胍或 SGLT2 抑制剂等抗糖尿病药物进行治疗，代谢综合征也不排除在外。 仅通过非药物方法（例如，饮食和运动）进行管理的前驱糖尿病或糖耐量异常的诊断不排除在外。
  • 任何可能干扰研究进行或解释的慢性感染，例如乙型肝炎 (HBV)、丙型肝炎 (HCV) 或人类免疫缺陷病毒 (HIV)。 甲型或丙型肝炎成功治疗的病史并不是排他性的。 活跃的 COVID-19 感染。
  • 首次给药前 8 周内献血或失血 400 mL 或更多，或根据当地法规要求更长时间，或首次给药前 14 天内献血或血浆献血（> 250 mL）
  • 任何其他排除标准未涵盖的任何障碍、不愿意或无能力，在研究者看来，这可能危及受试者的安全或对方案的遵守

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：阶乘赋值
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：Placebo/30 mg/kg Bimagrumab
Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64.
其他：安慰剂
安慰剂
实验性的：10/30 mg/kg Bimagrumab
Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64.
生物：比马珠单抗
激活素受体 II 型人单克隆抗体
实验性的：30 mg/kg Bimagrumab
Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
生物：比马珠单抗
激活素受体 II 型人单克隆抗体
实验性的：Placebo + 1.0 mg Semaglutide

Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:

  • Weeks 1 to 4: 0.25 mg
  • Weeks 5 to 8: 0.5 mg
  • Weeks 9 to 71: 1.0 mg
其他：安慰剂
安慰剂
药品：索马鲁肽
胰高血糖素样肽-1 (GLP-1) 受体激动剂
其他名称：
  • 臭氧层
  • 维高威
实验性的：Placebo + 2.4 mg Semaglutide

Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly per the below dose escalation schedule:

  • Weeks 1 to 4: 0.25 mg
  • Weeks 5 to 8: 0.5 mg
  • Weeks 9 to 12: 1.0 mg
  • Weeks 13 to 16: 1.7 mg
  • Weeks 17 to 71: 2.4 mg
其他：安慰剂
安慰剂
药品：索马鲁肽
胰高血糖素样肽-1 (GLP-1) 受体激动剂
其他名称：
  • 臭氧层
  • 维高威
实验性的：10 mg/kg Bimagrumab + 1.0 mg Semaglutide

Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:

  • Weeks 1 to 4: 0.25 mg
  • Weeks 5 to 8: 0.5 mg
  • Weeks 9 to 71: 1.0 mg
药品：索马鲁肽
胰高血糖素样肽-1 (GLP-1) 受体激动剂
其他名称：
  • 臭氧层
  • 维高威
生物：比马珠单抗
激活素受体 II 型人单克隆抗体
实验性的：10 mg/kg Bimagrumab + 2.4 mg Semaglutide

Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:

  • Weeks 1 to 4: 0.25 mg
  • Weeks 5 to 8: 0.5 mg
  • Weeks 9 to 12: 1.0 mg
  • Weeks 13 to 16: 1.7 mg
  • Weeks 17 to 71: 2.4 mg
药品：索马鲁肽
胰高血糖素样肽-1 (GLP-1) 受体激动剂
其他名称：
  • 臭氧层
  • 维高威
生物：比马珠单抗
激活素受体 II 型人单克隆抗体
实验性的：30 mg/kg Bimagrumab + 1.0 mg Semaglutide

Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:

  • Weeks 1 to 4: 0.25 mg
  • Weeks 5 to 8: 0.5 mg
  • Weeks 9 to 71: 1.0 mg
药品：索马鲁肽
胰高血糖素样肽-1 (GLP-1) 受体激动剂
其他名称：
  • 臭氧层
  • 维高威
生物：比马珠单抗
激活素受体 II 型人单克隆抗体
实验性的：30 mg/kg Bimagrumab + 2.4 mg Semaglutide

Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly as per the below dose escalation schedule:

  • Weeks 1 to 4: 0.25 mg
  • Weeks 5 to 8: 0.5 mg
  • Weeks 9 to 12: 1.0 mg
  • Weeks 13 to 16: 1.7 mg
  • Weeks 17 to 71: 2.4 mg
药品：索马鲁肽
胰高血糖素样肽-1 (GLP-1) 受体激动剂
其他名称：
  • 臭氧层
  • 维高威
生物：比马珠单抗
激活素受体 II 型人单克隆抗体

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change From Baseline in Body Weight at Week 48
大体时间：Baseline, Week 48
Least Square mean was determined by MMRM model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 48

次要结果测量

结果测量
措施说明
大体时间
基线和第48周有体重指数（BMI）类别的参与者的百分比
大体时间：基线，第48周

BMI类别：

我。健康体重：18.5公斤（kg）/米（m）²至24.9 kg/m²II。 超重：25千克/平方米至29.9 kg/m²III。 肥胖1：30 kg/m²至34.9 kg/m²IV。 肥胖II级：35千克/平方米至39.9 kg/m²诉肥胖症III类：≥40kg/m2
基线，第48周
基线腰围比（WTHR）类别的参与者百分比为<0.5，其腰围比基线的变化（WHTR比）类别在第48周（WHTR比率）类别
大体时间：基线长达48周
WHTR比率类别：<0.5; 0.5-0.59; ≥0.6
基线长达48周
基线WTHR类别为0.5-0.59的参与者百分比在第48周的腰围与高度比率（WHTR比率）类别的比例为
大体时间：基线长达48周
WHTR比率类别：<0.5; 0.5-0.59; ≥0.6
基线长达48周
基线WTHR类别≥0.6的参与者的百分比从基线的腰围比（WHTR比）类别发生变化，第48周
大体时间：基线长达48周
WHTR比率类别：<0.5; 0.5-0.59; ≥0.6
基线长达48周
从基准质量中的基线变化短表36版2（SF-36V2）急性形式的身体功能域分数在第24周
大体时间：基线，第24周
SF-36V2急性形式评估了8个领域与健康相关的生活质量（HRQOL）：身体功能，角色 - 物理，身体疼痛，一般健康，活力，社交功能，角色情感和心理健康。 物理功能域评估由于健康“现在”而引起的局限性，并由10个项目组成，每个项目都以3分李克特量表进行了评分。 该域的评分是基于规范的，并以T分数的形式呈现，平均为50，标准偏差为10；更高的分数表明功能水平更好。 不能在基于规范的分数中指定范围。
基线，第24周
生活质量的基线变化SF-36V2急性形式的身体功能域分数48
大体时间：基线，第48周
SF-36V2急性形式评估了8个领域的HRQOL：身体功能，角色物理，身体疼痛，一般健康，活力，社交功能，角色情感和心理健康。 物理功能域评估由于健康“现在”而引起的局限性，并由10个项目组成，每个项目都以3分李克特量表进行了额定额定评分。 该域的评分是基于规范的，并以T分数的形式呈现，平均为50，标准偏差为10；更高的分数表明功能水平更好。 不能在基于规范的分数中指定范围
基线，第48周
生活质量的基线变化SF-36V2急性形式在第48周的总分
大体时间：基线，第48周
SF-36是一项评估参与者健康状况的参与者报告的结果指标。 它包括36个涵盖8个领域的项目：身体功能，身体的角色，角色情感，身体疼痛，活力，社交功能，心理健康和一般健康。 项目以不同长度的李克特量表进行回答。 将8个域重组为MC和PC，以获得从0到100的总分数，得分较高，表明功能水平和/或更好的健康水平。
基线，第48周
重量对生活质量质量临床试验版本的影响（IWQOL-LITE-CT）的物理功能得分和总分在第24周24
大体时间：基线，第24周
IWQOL-LITE-CT是一种20个项目，特定于肥胖的Pro仪器，用于肥胖临床试验。 它评估了与肥胖相关健康相关的生活质量（HRQOL）的2个主要领域：物理（7个项目）和社会心理（13个项目）。 每个项目的评分从0（最差）到100（最佳），得分较高，表明功能水平更好。 IWQOL-LITE-CT为每个域提供了复合分数以及总分，范围从0到100。 较高的分数反映了更好的功能和生活质量。 此端点显示了“身体功能得分”和“总分”的结果。
基线，第24周
IWQOL-LITE-CT物理功能得分和48周总分从基线变化
大体时间：基线，第48周
IWQOL-LITE-CT是一种20个项目，特定于肥胖的Pro仪器，用于肥胖临床试验。 它评估了与肥胖相关健康相关的生活质量（HRQOL）的2个主要领域：物理（7个项目）和社会心理（13个项目）。 每个项目的评分从0（最差）到100（最佳），得分较高，表明功能水平更好。 IWQOL-LITE-CT为每个域提供了复合分数以及总分，范围从0到100。 较高的分数反映了更好的功能和生活质量。 此端点显示了“身体功能得分”和“总分”的结果。
基线，第48周
IWQOL-LITE-CT物理功能得分和总分在第72周的基线变化
大体时间：基线，第72周
IWQOL-LITE-CT是一种20个项目，特定于肥胖的Pro仪器，用于肥胖临床试验。 它评估了与肥胖相关健康相关的生活质量（HRQOL）的2个主要领域：物理（7个项目）和社会心理（13个项目）。 每个项目的评分从0（最差）到100（最佳），得分较高，表明功能水平更好。 IWQOL-LITE-CT为每个域提供了复合分数以及总分，范围从0到100。 较高的分数反映了更好的功能和生活质量。 此端点显示了“身体功能得分”和“总分”的结果。
基线，第72周
Change From Baseline in Waist Circumference at Week 48
大体时间：Baseline, Week 48
Waist circumference was measured in standing position with a non-stretchable measuring tape to the nearest 0.1 centimeter (cm). Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 48
Change From Baseline in Waist Circumference at Week 72
大体时间：Baseline, Week 72
Waist circumference was measured in standing position with a non-stretchable measuring tape to the nearest 0.1 cm. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 72
Change From Baseline in Total Body Fat Mass in Kilograms (kg) at Week 48
大体时间：Baseline, Week 48
Change from baseline in total body fat mass in kg was assessed by Dual energy X-ray absorptiometry (DXA). Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 48
Change From Baseline in Total Body Fat Mass in kg at Week 72
大体时间：Baseline, Week 72
Change from baseline in total body fat mass in kg was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 72
Percent Change From Baseline for Fat Mass by DXA at Week 48
大体时间：Baseline, Week 48
Percent change from baseline for fat mass was assessed by DXA. Least Square mean was determined by MMRM model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 48
Percent Change From Baseline for Fat Mass by DXA at Week 72
大体时间：Baseline, Week 72
Percent change from baseline for fat mass was assessed by DXA. Least Square mean was determined by MMRM model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 72
Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48
大体时间：Baseline, Week 48
Change from baseline in VAT, SAT and trunk fat mass was assessed by DXA. Least Square mean was determined by MMRM model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 48
Change From Baseline in VAT, SAT and Trunk Fat Mass by DXA at Week 72
大体时间：Baseline, Week 72
Change from baseline in VAT, SAT and trunk fat mass was assessed by DXA. Least Square mean was determined by MMRM model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 72
Percentage of Participants With Reduction in Waist Circumference Greater Than or Equal to (≥) 5 cm at Week 48
大体时间：Week 48
Waist circumference was measured in a standing position with a non-stretchable measuring tape to the nearest 0.1 cm. Only participants with non-missing baseline value were included in analysis.
Week 48
Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48
大体时间：Week 48
Body weight was measured in kgs to the nearest 0.1 kg. Only participants with non-missing baseline value were included in analysis.
Week 48
Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48
大体时间：Week 48
Only participants with non-missing baseline value were included in analysis.
Week 48
Percentage of Participants Achieving Fat Mass ≥ 10% Reduction With <5% Decrease in Lean Mass by DXA at Week 48
大体时间：Week 48
Only participants with non-missing baseline value were included in analysis.
Week 48
Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48
大体时间：Week 48
Fat Lost Index = % change in fat mass/% change in lean mass + % change in fat mass. Only participants with non-missing baseline value were included in analysis.
Week 48
Change From Baseline in Body Fat Mass by Bioelectrical Impedance Analysis (BIA) at Week 48
大体时间：Baseline, Week 48
Change from baseline in body fat mass was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis.
Baseline, Week 48
Change From Baseline in Body Fat Mass by BIA at Week 72
大体时间：Baseline, Week 72
Change from baseline in body fat mass was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis.
Baseline, Week 72
Percent Change From Baseline in Body Fat by BIA at Week 48
大体时间：Baseline, Week 48
Percent change from baseline in Body fat was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis.
Baseline, Week 48
Percent Change From Baseline in Body Fat by BIA at Week 72
大体时间：Baseline, Week 72
Percent change from baseline in Body fat was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis.
Baseline, Week 72
Change From Baseline in Lean Mass by DXA at Week 48
大体时间：Baseline, Week 48
Change from baseline in lean mass was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 48
Change From Baseline in Lean Mass by DXA at Week 72
大体时间：Baseline, Week 72
Change from baseline in lean mass was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 72
Percent Change From Baseline in Lean Body Mass by DXA at Week 48
大体时间：Baseline, Week 48
Percent change from baseline in lean body mass was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 48
Percent Change From Baseline in Lean Body Mass by DXA at Week 72
大体时间：Baseline, Week 72
Percent change from baseline in lean body mass was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 72
Percent Change From Baseline in Appendicular Lean Mass by DXA at Week 48
大体时间：Baseline, Week 48
Percent change from baseline in appendicular lean mass was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 48
Percent Change From Baseline in Appendicular Lean Mass by DXA at Week 72
大体时间：Baseline, Week 72
Percent change from baseline in appendicular lean mass was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, Week 72
Change From Baseline in Lean Mass (kg) by BIA at Week 48
大体时间：Baseline, Week 48
Change from baseline in lean mass (kg) was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis.
Baseline, Week 48
Change From Baseline in Lean Mass (kg) by BIA at Week 72
大体时间：Baseline, Week 72
Change from baseline in lean mass (kg) was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis.
Baseline, Week 72
Percent Change From Baseline in Lean Body Mass by BIA at Week 48
大体时间：Baseline, Week 48
Percent change from baseline in lean body mass was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis.
Baseline, Week 48
Percent Change From Baseline in Lean Body Mass by BIA at Week 72
大体时间：Baseline, Week 72
Percent change from baseline in lean body mass was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis.
Baseline, Week 72
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 48
大体时间：Baseline, 48 weeks
HbA1c is the glycosylated fraction of hemoglobin A. It is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Square mean was determined by MMRM model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values.
Baseline, 48 weeks
Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score Week 24
大体时间：Baseline, Week 24
The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into (mental component score [MCS] and physical component score [PCS] to obtain a total score ranging from 0 to 100, with higher scores indicating better levels of function and/or better health.
Baseline, Week 24
Change From Baseline in Quality of Life SF-36v2 Acute Form Physical Functioning Domain Score Week 72
大体时间：Baseline, Week 72
The SF-36v2 acute form assesses HRQoL on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" and consists of 10 items, each rated on a 3-point Likert scale. Scoring of the domain is norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function. Range cannot be specified in norm-based scores
Baseline, Week 72
Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score at Week 72
大体时间：Baseline, Week 72
The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into MCS and PCS to obtain a total score ranging from 0 to 100, with higher scores indicating better levels of function and/or better health.
Baseline, Week 72

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Eli Lilly and Company

合作者

Versanis Bio, Inc.

调查人员

  • 研究主任：Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)、Eli Lilly and Company

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年11月16日

初级完成 (实际的)

2024年5月16日

研究完成 (实际的)

2025年6月14日

研究注册日期

首次提交

2022年10月16日

首先提交符合 QC 标准的

2022年11月9日

首次发布 (实际的)

2022年11月14日

研究记录更新

最后更新发布 (实际的)

2026年7月8日

上次提交的符合 QC 标准的更新

2026年6月11日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 18828
  • VER201-PH2-031 (其他标识符：Versanis)
  • J4Z-MC-GIDA (其他标识符：Eli Lilly and Company)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

研究提案获得批准并签署数据共享协议后，匿名的个体患者级别数据将在安全访问环境中提供。

IPD 共享时间框架

数据在美国和欧盟研究的适应症首次发表和批准后 6 个月提供，以较晚者为准。 数据将无限期地可供请求。

IPD 共享访问标准

研究提案必须得到独立审查小组的批准，研究人员必须签署数据共享协议。

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅