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临床试验/NCT06299098
NCT06299098进行中（未招募）2 期

A Randomized, Double-Blind Study of The Efficacy and Safety of Trevogrumab, With or Without Garetosmab, in Addition to Semaglutide in Patients With Obesity

Regeneron Pharmaceuticals120 个研究点 分布在 1 个国家目标入组 1,005 人开始时间: 2024年3月13日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
进行中（未招募）
入组人数
1,005
试验地点
120
主要终点
Percent change in total fat mass
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is researching experimental drugs called trevogrumab and garetosmab (called "study drugs") in combination with another drug, semaglutide (Wegovy®). This study will be done in 3 parts, Part A, Part B, and Part C where different study drugs will be tested.

Part A of the study is focused on healthy participants. Part B and C of the study is focused on participants with obesity.

The aim of Part A of the study is to see how safe and tolerable the study drug is in healthy participants. The aim of Part B and Part C of the study is to see how safe and effective the study drug is when combined with Wegovy.

Parts A, B, and C of the study are looking at several other research questions, including:

  • What side effects may happen from taking the study drug
  • How much study drug is in the blood at different times
  • Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

详细描述

Part A Healthy Volunteers

Part B and Part C (starts after treatment for Part A has completed) Participants with Obesity

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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
是

入选标准

  • •Male or female participants age ≥18 to ≤55 years of age at the time of screening
  • •BMI ≥18 and ≤32 kg/m2, at the screening visit
  • •Part B and Part C
  • •Male or female participants ≥18 to ≤80 years of age at the time of screening
  • •BMI ≥30 kg/m2, at the screening visit
  • •History of 1 or more self-reported unsuccessful dietary attempts to lose weight

排除标准

  • •History of diabetes (Type 2 or Type 1). History of gestational diabetes is permitted
  • •Previous bariatric surgery or planned bariatric surgery
  • •History of hypertrophic cardiomyopathy
  • •Abnormal electrocardiogram (ECG) findings at screening that meet Cornell voltage criteria for left ventricular hypertrophy
  • •Any malignancy in the past 5 years prior to screening (except for nonmelanoma skin cancer that has been resected with no evidence of metastatic disease for 3 years prior to screening)
  • •History of poorly controlled hypertension, as defined in the protocol
  • •Have a history of any other condition (such as known drug abuse, alcohol abuse, diagnosed eating disorder, or a severe mental illness) that, in the opinion of the investigator, may preclude the participant from following and completing the protocol
  • •Have history of use of marijuana/tetrahydrocannabinol (THC) within 90 days prior to Visit 1 of enrollment and are unwilling to abstain from marijuana/THC use during the trial
  • •Has a history of any neuromuscular disorder (eg, multiple sclerosis, myasthenia gravis, myopathy, peripheral neuropathy, etc)
  • •Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

研究组 & 干预措施

Arm 1

Experimental

Part C Sema and SC placebo Randomized 1:2:2

干预措施: Matching Placebo-Trevogrumab (Drug)

Arm B0

Experimental

Part B Sema, moderate-high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1

干预措施: Semaglutide (Drug)

Placebo

Placebo Comparator

Part A Randomized 1:1

干预措施: Matching Placebo-Part A (Drug)

Arm A1

Experimental

Part B Sema and SC placebo and IV placebo followed by high dose trevogrumab (trevo) Randomized 1:1:1:1:1:1:1:1

干预措施: Trevogrumab-Part B and Part C (Drug)

Arm A1

Experimental

Part B Sema and SC placebo and IV placebo followed by high dose trevogrumab (trevo) Randomized 1:1:1:1:1:1:1:1

干预措施: Matching Placebo-Trevogrumab (Drug)

Arm A1

Experimental

Part B Sema and SC placebo and IV placebo followed by high dose trevogrumab (trevo) Randomized 1:1:1:1:1:1:1:1

干预措施: Matching Placebo-Garetosmab (Drug)

Arm B0

Experimental

Part B Sema, moderate-high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1

干预措施: Trevogrumab-Part B and Part C (Drug)

Trevogrumab

Experimental

Part A Randomized 1:1

干预措施: Trevogrumab-Part A (Drug)

Arm A0

Experimental

Part B Semaglutide (sema) and subcutaneous (SC) placebo and intravenous (IV) placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1

干预措施: Matching Placebo-Trevogrumab (Drug)

Arm A0

Experimental

Part B Semaglutide (sema) and subcutaneous (SC) placebo and intravenous (IV) placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1

干预措施: Matching Placebo-Garetosmab (Drug)

Arm 2

Experimental

Part C Sema and SC low dose trevo Randomized 1:2:2

干预措施: Matching Placebo-Trevogrumab (Drug)

Arm 2

Experimental

Part C Sema and SC low dose trevo Randomized 1:2:2

干预措施: Trevogrumab-Part B and Part C (Drug)

Arm D0

Experimental

Part B Sema, high dose trevo, and garetosmab (gareto) followed by SC placebo Randomized 1:1:1:1:1:1:1:1

干预措施: Matching Placebo-Trevogrumab (Drug)

Arm D1

Experimental

Part B Sema, high dose trevo, and gareto followed by high dose trevo Randomized 1:1:1:1:1:1:1:1

干预措施: Trevogrumab-Part B and Part C (Drug)

Arm 3

Experimental

Part C Sema and SC moderate dose trevo Randomized 1:2:2

干预措施: Trevogrumab-Part B and Part C (Drug)

Arm 3

Experimental

Part C Sema and SC moderate dose trevo Randomized 1:2:2

干预措施: Semaglutide (Drug)

Arm 2

Experimental

Part C Sema and SC low dose trevo Randomized 1:2:2

干预措施: Semaglutide (Drug)

Arm D1

Experimental

Part B Sema, high dose trevo, and gareto followed by high dose trevo Randomized 1:1:1:1:1:1:1:1

干预措施: Semaglutide (Drug)

Arm B0

Experimental

Part B Sema, moderate-high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1

干预措施: Matching Placebo-Trevogrumab (Drug)

Arm D0

Experimental

Part B Sema, high dose trevo, and garetosmab (gareto) followed by SC placebo Randomized 1:1:1:1:1:1:1:1

干预措施: Garetosmab (Drug)

Arm D0

Experimental

Part B Sema, high dose trevo, and garetosmab (gareto) followed by SC placebo Randomized 1:1:1:1:1:1:1:1

干预措施: Semaglutide (Drug)

Arm B0

Experimental

Part B Sema, moderate-high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1

干预措施: Matching Placebo-Garetosmab (Drug)

Arm 1

Experimental

Part C Sema and SC placebo Randomized 1:2:2

干预措施: Semaglutide (Drug)

Arm C0

Experimental

Part B Sema, high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1

干预措施: Semaglutide (Drug)

Arm A0

Experimental

Part B Semaglutide (sema) and subcutaneous (SC) placebo and intravenous (IV) placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1

干预措施: Semaglutide (Drug)

Arm C1

Experimental

Part B Sema, high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1

干预措施: Matching Placebo-Garetosmab (Drug)

Arm D0

Experimental

Part B Sema, high dose trevo, and garetosmab (gareto) followed by SC placebo Randomized 1:1:1:1:1:1:1:1

干预措施: Trevogrumab-Part B and Part C (Drug)

Arm D1

Experimental

Part B Sema, high dose trevo, and gareto followed by high dose trevo Randomized 1:1:1:1:1:1:1:1

干预措施: Garetosmab (Drug)

Arm C0

Experimental

Part B Sema, high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1

干预措施: Matching Placebo-Trevogrumab (Drug)

Arm C0

Experimental

Part B Sema, high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1

干预措施: Matching Placebo-Garetosmab (Drug)

Arm C1

Experimental

Part B Sema, high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1

干预措施: Trevogrumab-Part B and Part C (Drug)

Arm C0

Experimental

Part B Sema, high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1

干预措施: Trevogrumab-Part B and Part C (Drug)

Arm B1

Experimental

Part B Sema, moderate-high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1

干预措施: Trevogrumab-Part B and Part C (Drug)

Arm B1

Experimental

Part B Sema, moderate-high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1

干预措施: Matching Placebo-Garetosmab (Drug)

Arm C1

Experimental

Part B Sema, high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1

干预措施: Semaglutide (Drug)

Arm B1

Experimental

Part B Sema, moderate-high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1

干预措施: Semaglutide (Drug)

Arm A1

Experimental

Part B Sema and SC placebo and IV placebo followed by high dose trevogrumab (trevo) Randomized 1:1:1:1:1:1:1:1

干预措施: Semaglutide (Drug)

结局指标

主要结局

Percent change in total fat mass

时间窗: Baseline to week 26

Part B

Incidence of treatment-emergent adverse events (TEAEs)

时间窗: Baseline to week 7

Part A

Severity of TEAEs

时间窗: Baseline to week 7

Part A

Percent change in total fat mass

时间窗: Baseline to week 52

Part C

Percent change in total lean mass

时间窗: Baseline to week 52

Part C

Percent change in body weight

时间窗: Baseline to week 52

Part C

次要结局

  • Change in waist circumference (cm)(Baseline to week 52)
  • Percent change in fasting serum triglycerides(Baseline to week 26)
  • Percent change in total cholesterol(Baseline to week 26)
  • Percent change in Apolipoprotein B (Apo B)(Baseline to week 26)
  • Percent change in Low-Density Lipoprotein Cholesterol (LDL-C)(Baseline to week 26)
  • Concentrations of garetosmab in serum over time(Up to 75 weeks)
  • Incidence of anti-drug antibodies (ADA) to trevogrumab after repeated doses over time(Up to 75 weeks)
  • Magnitude of ADAs to trevogrumab over time(Up to 75 weeks)
  • Incidence of ADAs to garetosmab after repeated doses over time(Up to 75 weeks)
  • Magnitude of ADAs to garetosmab over time(Up to 75 weeks)
  • Percent change in total fat mass(Baseline to week 52)
  • Percent change in total lean mass(Baseline to week 52)
  • Change in waist circumference (cm)(Baseline to week 26)
  • Percent change in body weight(Baseline to week 52)
  • Concentrations of trevogrumab in serum over time(Up to 75 weeks)
  • Percent change in total fat mass(Baseline to week 26)
  • Percent change in total lean mass(Baseline to week 26)
  • Percent change in body weight(Baseline to week 26)
  • Concentrations of trevogrumab in serum over time(Up to 75 weeks)
  • Percent change in total fat mass(Baseline to week 26)
  • Percent change in total lean mass(Baseline to week 26)
  • Percent change in body weight(Baseline to week 26)
  • Change in waist circumference (cm)(Baseline to week 52)
  • Percent change in fasting serum triglycerides(Baseline to week 26)
  • Percent change in total cholesterol(Baseline to week 26)
  • Percent change in Apolipoprotein B (Apo B)(Baseline to week 26)
  • Percent change in Low-Density Lipoprotein Cholesterol (LDL-C)(Baseline to week 26)
  • Concentrations of garetosmab in serum over time(Up to 75 weeks)
  • Incidence of anti-drug antibodies (ADA) to trevogrumab after repeated doses over time(Up to 75 weeks)
  • Magnitude of ADAs to trevogrumab over time(Up to 75 weeks)
  • Incidence of ADAs to garetosmab after repeated doses over time(Up to 75 weeks)
  • Magnitude of ADAs to garetosmab over time(Up to 75 weeks)
  • Incidence of TEAEs(Up to 75 weeks)
  • Severity of TEAEs(Up to 75 weeks)
  • Concentration of total Growth Differentiation Factor (GDF) 8 in serum over time(Up to 75 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (120)

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