NCT05929079已完成3 期
A Master Protocol to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight: A Randomized Double-Blind, Placebo-Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,152
- 试验地点
- 186
- 主要终点
- Percent Change from Baseline in Body Weight
研究概览
简要总结
The purpose of this study is to is to evaluate the efficacy and safety of retatrutide in participants with type 2 diabetes in participants who have obesity or overweight (J1I-MC-GZBK master protocol) including a subset of participants who have obstructive sleep apnea (OSA) (J1I-MC-GSA2). The study will last about 89 weeks and will include up to 24 visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a body mass index (BMI) greater than or equal to 27.0 kilogram/square meter (kg/m ²)
- •Have Type 2 Diabetes (T2D)
- •Are on stable treatment for T2D for at least 90 days
- •Have a history of at least one unsuccessful dietary effort to lose body weight.
- •GSA2 Inclusion Criteria
- •Previously diagnosed with OSA
- •Have AHI ≥15 on polysomnography at screening (definition of moderate-to-severe OSA)
- •For participants not on positive airway pressure (PAP) therapy: unable or unwilling to use PAP therapy and have not used PAP for at least 4 weeks prior to screening.
- •If on PAP therapy, have been on PAP therapy for at least 3 consecutive months prior to screening, and willing to temporarily stop using PAP therapy for approximately 7 days prior to each of the sleep study (PSG) visits.
排除标准
- •Have a self-reported or documented change in body weight >5 kg (11 pounds) within 90 days.
- •Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
- •Have a prior or planned surgical treatment for obesity.
- •Have Type 1 diabetes
- •Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- •Have had pancreatitis
- •GSA2 Exclusion Criteria
- •Use stimulants (for example, modafinil, armodafinil, solriamfetol, pitolisant, amphetamine) less than 3 months prior to screening.
- •Use hypnotics, mirtazapine, opioids, trazodone, and zonisamide less than 3 months prior to screening.
- •Use a dental appliance or other device to treat OSA other than PAP therapy.
研究组 & 干预措施
Retatrutide Dose 1
Experimental
Participants will receive retatrutide subcutaneously (SC).
干预措施: Retatrutide (Drug)
Retatrutide Dose 2
Experimental
Participants will receive retatrutide SC.
干预措施: Retatrutide (Drug)
Placebo
Placebo Comparator
Participants will receive placebo.
干预措施: Placebo (Drug)
Retatrutide Dose 3
Experimental
Participants will receive retatrutide SC.
干预措施: Retatrutide (Drug)
结局指标
主要结局
Percent Change from Baseline in Body Weight
时间窗: Baseline, Week 80
Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset
时间窗: Baseline, Week 80
次要结局
- Change from Baseline in Hemoglobin (A1c) HbA1c %(Baseline, Week 80)
- Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score(Baseline, Week 80)
- Change from Baseline in Diastolic Blood Pressure (DBP)(Baseline, Week 80)
- Change from Baseline in Body Mass Index (BMI)(Baseline, Week 80)
- Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)(Baseline through Week 80)
- Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10 for GSA2 Subset(Week 80)
- Percent Change from Baseline in Total Cholesterol(Baseline, Week 80)
- Percent Change from Baseline in Triglycerides(Baseline, Week 80)
- Percent Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset(Baseline, Week 80)
- Percentage of Participants with ≥50% AHI Reduction from Baseline for GSA2 Subset(Baseline to Week 80)
- Change from Baseline in Waist Circumference(Baseline, Week 80)
- Change from Baseline in Systolic Blood Pressure (SBP)(Baseline, Week 80)
- Change from Baseline in Fasting Glucose(Baseline, Week 80)
- A Hierarchical Combination of Functional Outcomes of Sleep Questionnaire (FOSQ) 10 score, FOSQ Vigilance Domain Score, and FOSQ Activity Level Domain Score for GSA2 Subset(Baseline to Week 80)
研究者
研究点 (186)
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