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临床试验/NCT05616013
NCT05616013已完成2 期

A Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of Intravenous Bimagrumab, Alone or in Addition to Open Label Subcutaneous Semaglutide, to Investigate the Efficacy and Safety in Overweight or Obese Men and Women

Eli Lilly and Company48 个研究点 分布在 3 个国家目标入组 507 人开始时间: 2022年11月16日最近更新:
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试验速览

阶段
2 期
状态
已完成
入组人数
507
试验地点
48
主要终点
Change From Baseline in Body Weight at Week 48
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验相关资讯

研究概览

简要总结

A phase 2 study to assess the efficacy of bimagrumab alone or in addition to semaglutide to assess efficacy and safety in overweight or obese men and women

详细描述

This study investigates if bimagrumab in addition to semaglutide is able to preserve/increase muscle mass in the presence of weight and/or fat mass loss.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

In regard to bimagrumab and placebo-bimagrumab, the participants, Investigator and Sponsor will be blinded.

Due to semaglutide being pre-filled, packaged and labeled by manufacturer, it is not possible to blind semaglutide.

入排标准

年龄范围
18 Years 至 80 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •A written informed consent must be obtained before any study-related assessments are performed.
  • •Men and women between 18 and 80 years, inclusive; women of child-bearing potential (defined as those who are not post-menopausal or post-surgical sterilization) must meet both of the following criteria:
  • •Two negative pregnancy tests (at screening and at randomization, prior to dosing)
  • •Use of intrauterine device, from at least 3 months before the baseline visit through at least 4 months after the last dose of bimagrumab/placebo i.v., and an additional contraceptive (barrier) method from screening through at least 4 months after the last dose of bimagrumab/placebo i.v.
  • •Body mass index (BMI) ≥ 30 or BMI ≥ 27 with one or more obesity-associated comorbidities (e.g., hypertension, insulin resistance, sleep apnea, or dyslipidemia)
  • •Stable body weight (± 5 kg) within 90 days of screening, and body weight <150 kg
  • •Have a history of at least one self-reported unsuccessful behavioral effort to lose body weight
  • •Able to communicate well with the Investigator, comply with the study requirements and adhere to the diet and activity programs for the study duration

排除标准

  • •History of, or known hypersensitivity to, monoclonal antibody drugs or a contraindication to semaglutide (Ozempic® or Wegovy®)
  • •Use of other investigational drugs at the time of enrollment or within 30 days or 5 half-lives of enrollment, whichever is longer, or longer if required by local regulations
  • •Treatment with any medication for the indication of obesity within the past 30 days before screening
  • •Diagnosis of diabetes requiring current use of any antidiabetic drug or HbA1c ≥ 6.5% Note: Metabolic syndrome is not an exclusion, even if managed with an anti-diabetic drug such as metformin or an SGLT2 inhibitor. A diagnosis of prediabetes or impaired glucose tolerance managed exclusively with non-pharmacologic approaches (e.g., diet and exercise) is not an exclusion.
  • •Any chronic infections likely to interfere with study conduct or interpretation such as hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV). History of hepatitis A or hepatitis C successfully treated is not exclusionary. Active COVID-19 infection.
  • •Donation or loss of 400 mL or more of blood within 8 weeks prior to initial dosing, or longer if required by local regulation, or plasma donation (> 250 mL) within 14 days prior to the first dose
  • •Any disorder, unwillingness, or inability not covered by any of the other exclusion criteria, which in the Investigator's opinion, might jeopardize the participant's safety or compliance with the protocol

结局指标

主要结局

Change From Baseline in Body Weight at Week 48

时间窗: Baseline, Week 48

Least square (LS) Mean was determined by analysis of covariance (ANCOVA) model using Baseline + Gender (Male, Female) + Country (Australia, New Zealand, United States of America) + Treatment (Type III sum of squares) as variables. Only participants with non-missing baseline value were included in analysis. Missing values at Week 48 were imputed 100 times based on observed data in the Placebo arm

Change From Baseline in Body Weight at Week 48

时间窗: 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.

次要结局

  • Change From Baseline in Waist Circumference at Week 48(Baseline, Week 48)
  • Change From Baseline in Waist Circumference at Week 72(Baseline, Week 72)
  • Change From Baseline in Total Body Fat Mass in Kilograms (kg) at Week 48(Baseline, Week 48)
  • Change From Baseline in Total Body Fat Mass in kg at Week 72(Baseline, Week 72)
  • Change From Baseline in Body Fat Percentage at Week 48(Baseline, Week 48)
  • Change From Baseline in Body Fat Percentage at Week 72(Baseline, Week 72)
  • Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48(Baseline, Week 48)
  • Change From Baseline in VAT, SAT and Trunk Fat Mass by DXA at Week 72(Baseline, Week 72)
  • Percentage of Participants With Reduction in Waist Circumference ≥ 5 cm at Week 48(Week 48)
  • Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48(Week 48)
  • Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48(Week 48)
  • Percentage of Participants With Reduction in Fat Mass ≥ 10% With <5% Decrease (or an Increase) in Lean Mass by DXA at Week 48(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(Week 48)
  • Change From Baseline in Body Fat Mass by Bioelectrical Impedance Analysis (BIA) at Week 48(Baseline, Week 48)
  • Change From Baseline in Body Fat Mass by BIA at Week 72(Baseline, Week 72)
  • Change From Baseline in Body Fat Percentage by BIA at Week 48(Baseline, Week 48)
  • Change From Baseline in Body Fat Percentage by BIA at Week 72(Baseline, Week 72)
  • Change From Baseline in Lean Mass by DXA at Week 48(Baseline, Week 48)
  • Change From Baseline in Lean Mass by DXA at Week 72(Baseline, Week 72)
  • Change From Baseline in Lean Body Mass Percentage by DXA at Week 48(Baseline, Week 48)
  • Change From Baseline in Lean Body Mass Percentage by DXA at Week 72(Baseline, Week 72)
  • Change From Baseline in Appendicular Lean Mass by DXA at Week 48(Baseline, Week 48)
  • Change From Baseline in Appendicular Lean Mass by DXA at Week 72(Baseline, Week 72)
  • Change From Baseline in Lean Mass (kg) by BIA at Week 48(Baseline, Week 48)
  • Change From Baseline in Lean Mass (kg) by BIA at Week 72(Baseline, Week 72)
  • Change From Baseline in Percentage Lean Body Mass by BIA at Week 48(Baseline, Week 48)
  • Change From Baseline in Percentage Lean Body Mass by BIA at Week 72(Baseline, Week 72)
  • Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48(Baseline, Week 48)
  • Percentage of Participants With Baseline Waist-to-Height Ratio (WtHR) Category of <0.5 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48(Baseline up to 48 weeks)
  • Percentage of Participants With Baseline WtHR Category of 0.5-0.59 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48(Baseline up to 48 weeks)
  • Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48(Baseline up to 48 weeks)
  • Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 48(Baseline, 48 weeks)
  • Change From Baseline in Quality of Life Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score at Week 24(Baseline, Week 24)
  • Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score Week 24(Baseline, Week 24)
  • Change From Baseline in Quality of Life SF-36v2 Acute Form Physical Functioning Domain Score Week 48(Baseline, Week 48)
  • Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score at Week 48(Baseline, Week 48)
  • Change From Baseline in Quality of Life SF-36v2 Acute Form Physical Functioning Domain Score and Total Score at Week 72(Baseline, Week 72)
  • Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Score and Total Score at Week 24(Baseline, Week 24)
  • Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 48(Baseline, Week 48)
  • Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 72(Baseline, Week 72)
  • Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 48(Baseline, Week 48)
  • Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 72(Baseline, Week 72)
  • Change From Baseline in Total Body Fat Mass in kg at Week 72(Baseline, Week 72)
  • Change From Baseline in Waist Circumference at Week 48(Baseline, Week 48)
  • Change From Baseline in Waist Circumference at Week 72(Baseline, Week 72)
  • Change From Baseline in Total Body Fat Mass in Kilograms (kg) at Week 48(Baseline, Week 48)
  • Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48(Baseline, Week 48)
  • Change From Baseline in VAT, SAT and Trunk Fat Mass by DXA at Week 72(Baseline, Week 72)
  • Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48(Week 48)
  • Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48(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(Week 48)
  • Change From Baseline in Body Fat Mass by Bioelectrical Impedance Analysis (BIA) at Week 48(Baseline, Week 48)
  • Change From Baseline in Body Fat Mass by BIA at Week 72(Baseline, Week 72)
  • Change From Baseline in Lean Mass by DXA at Week 48(Baseline, Week 48)
  • Change From Baseline in Lean Mass by DXA at Week 72(Baseline, Week 72)
  • Change From Baseline in Lean Mass (kg) by BIA at Week 48(Baseline, Week 48)
  • Change From Baseline in Lean Mass (kg) by BIA at Week 72(Baseline, Week 72)
  • Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48(Baseline, Week 48)
  • Percentage of Participants With Baseline Waist-to-Height Ratio (WtHR) Category of <0.5 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48(Baseline up to 48 weeks)
  • Percentage of Participants With Baseline WtHR Category of 0.5-0.59 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48(Baseline up to 48 weeks)
  • Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48(Baseline up to 48 weeks)
  • Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 48(Baseline, 48 weeks)
  • Change From Baseline in Quality of Life Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score at Week 24(Baseline, Week 24)
  • Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score Week 24(Baseline, Week 24)
  • Change From Baseline in Quality of Life SF-36v2 Acute Form Physical Functioning Domain Score Week 48(Baseline, Week 48)
  • Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score at Week 48(Baseline, Week 48)
  • Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Score and Total Score at Week 24(Baseline, Week 24)
  • Percent Change From Baseline for Fat Mass by DXA at Week 48(Baseline, Week 48)
  • Percent Change From Baseline for Fat Mass by DXA at Week 72(Baseline, Week 72)
  • Percentage of Participants With Reduction in Waist Circumference Greater Than or Equal to (≥) 5 cm at Week 48(Week 48)
  • Percentage of Participants Achieving Fat Mass ≥ 10% Reduction With <5% Decrease in Lean Mass by DXA at Week 48(Week 48)
  • Percent Change From Baseline in Body Fat by BIA at Week 48(Baseline, Week 48)
  • Percent Change From Baseline in Body Fat by BIA at Week 72(Baseline, Week 72)
  • Percent Change From Baseline in Lean Body Mass by DXA at Week 48(Baseline, Week 48)
  • Percent Change From Baseline in Lean Body Mass by DXA at Week 72(Baseline, Week 72)
  • Percent Change From Baseline in Appendicular Lean Mass by DXA at Week 48(Baseline, Week 48)
  • Percent Change From Baseline in Appendicular Lean Mass by DXA at Week 72(Baseline, Week 72)
  • Percent Change From Baseline in Lean Body Mass by BIA at Week 48(Baseline, Week 48)
  • Percent Change From Baseline in Lean Body Mass by BIA at Week 72(Baseline, Week 72)
  • Change From Baseline in Quality of Life SF-36v2 Acute Form Physical Functioning Domain Score Week 72(Baseline, Week 72)
  • Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score at Week 72(Baseline, Week 72)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (48)

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