A Phase 2, Parallel-Group, Double-Blind, Placebo-Controlled Study to Investigate Weight Management With LY3841136 and Tirzepatide, Alone or in Combination, in Adult Participants With Obesity or Overweight With Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 367
- 试验地点
- 103
- 主要终点
- Percent Change from Baseline in Body Weight
研究概览
简要总结
The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to investigate the safety and efficacy of LY3841136 for chronic weight management alone or in combination with Tirzepatide across a wide dose range in participants with Type 2 Diabetes. Participation in the study will last about 64 weeks.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •W8M-MC-LAA2
- •Have a Body Mass Index (BMI) of ≥27 kilograms per square meter (kg/m²)
- •Have Type 2 Diabetes
- •Have a HbA1c ≥7.0 % (53 millimoles/mole (mmol/mol)) to ≤10.5% (91 mmol/mol) and treated with diet and exercise alone or with a stable dose of metformin (and not more than the locally approved dose) with or without a sodium-glucose cotransporter 2 (SGLT2) inhibitor for at least 3 months prior to screening
- •W8M-MC-CWMM:
- •Have had a stable body weight for the 3 months prior to randomization (<5% body weight gain and/or loss)
排除标准
- •W8M-MC-LAA2
- •Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening
- •Have an on-going or history of bradyarrhythmia and/or sinus bradycardia
- •Have an elevated resting pulse rate (mean >100 beats per minute (bpm)) or reduced resting pulse rate (mean <60 bpm) at screening
- •Have any of the following cardiovascular conditions within 6 months prior to screening:
- •acute myocardial infarction
- •cerebrovascular accident (stroke)
- •unstable angina, or
- •hospitalization due to congestive heart failure
- •Have renal impairment measured as estimated glomerular filtration rate (eGFR) <45 milliliters per minute (mL/min)/1.73 m2
- •Have a history of acute or chronic pancreatitis
- •Have fasting triglycerides >500 milligrams per deciliter (mg/dL) (5.7 mmol/L) at screening
- •All concomitant medications should be at a stable dose for at least 3 months prior to screening
- •W8M-MC-CWMM
- •Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed >1 year prior to screening.
- •Have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of ketoacidosis or hyperosmolar coma.
- •Have poorly controlled hypertension.
- •Have a history of symptomatic gallbladder disease within the past 2 years
- •Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease.
- •Have a lifetime history of suicide attempts.
研究组 & 干预措施
LY3841136 Dose 2 + Tirzepatide Dose 1
Participants will receive LY3841136 SC and Tirzepatide SC
干预措施: LY3841136 (Drug)
LY3841136 Dose 1
Participants will receive LY3841136 subcutaneously (SC)
干预措施: LY3841136 (Drug)
LY3841136 Dose 2
Participants will receive LY3841136 SC
干预措施: LY3841136 (Drug)
LY3841136 Dose 3
Participants will receive LY3841136 SC
干预措施: LY3841136 (Drug)
LY3841136 Dose 1 + Tirzepatide Dose 1
Participants will receive LY3841136 SC and Tirzepatide SC
干预措施: LY3841136 (Drug)
LY3841136 Dose 1 + Tirzepatide Dose 1
Participants will receive LY3841136 SC and Tirzepatide SC
干预措施: Tirzepatide (Drug)
LY3841136 Dose 2 + Tirzepatide Dose 1
Participants will receive LY3841136 SC and Tirzepatide SC
干预措施: Tirzepatide (Drug)
LY3841136 Dose 2 + Tirzepatide Dose 2
Participants will receive LY3841136 SC and Tirzepatide SC
干预措施: LY3841136 (Drug)
LY3841136 Dose 2 + Tirzepatide Dose 2
Participants will receive LY3841136 SC and Tirzepatide SC
干预措施: Tirzepatide (Drug)
LY3841136 Dose 3 + Tirzepatide Dose 3
Participants will receive LY3841136 SC and Tirzepatide SC
干预措施: LY3841136 (Drug)
LY3841136 Dose 3 + Tirzepatide Dose 3
Participants will receive LY3841136 SC and Tirzepatide SC
干预措施: Tirzepatide (Drug)
Tirzepatide Dose 3
Participants will receive Tirzepatide SC
干预措施: Tirzepatide (Drug)
LY3841136 Dose 2 + Tirzepatide Dose 3
Participants will receive LY3841136 SC and Tirzepatide SC
干预措施: LY3841136 (Drug)
LY3841136 Dose 2 + Tirzepatide Dose 3
Participants will receive LY3841136 SC and Tirzepatide SC
干预措施: Tirzepatide (Drug)
Placebo
Participants will receive placebo administered SC.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change from Baseline in Body Weight
时间窗: Baseline, Week 48
次要结局
- Change from Baseline in Body Weight(Baseline, Week 48)
- Percentage of Participants Who Achieve ≥5% Body Weight Reduction(Week 48)
- Percentage of Participants Who Achieve ≥10% Body Weight Reduction(Week 48)
- Change from baseline in Hemoglobin A1c (HbA1c)(Baseline, Week 48)
- Pharmacokinetics (PK): Area Under the Curve (AUC) of LY3841136(Baseline, Week 48)
- PK: Maximum Concentration (Cmax) of LY3841136(Baseline, Week 48)