jRCT2031220200招募中不适用
A Single-Ascending and Repeated Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3849891 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) Who Have the PNPLA3 I148M Genotype (J3W-MC-GZOA)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 176
- 主要终点
- Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 70age old under（—）
- 性别
- All
入选标准
- •Participants must have a body mass index (BMI) within the range greater than or equal to (>=) 25 and less than (<) 50 kilogram per square meter (kg/m2) inclusive
- •Participants must have liver fat content >=10% in Part A and >=8% for Part B as determined by MRI-PDFF
- •Participants must be carriers of the PNPLA3 I148M allele
- •Participants with or without type 2 diabetes mellitus (T2DM)
- •For participants with T2DM, hemoglobin A1c (HbA1c) <8%% in Part A and <9% in Part B
- •Male participants agree to use an effective method of contraception for the duration of the study and for 90 days after the last dose of study intervention
- •Women not of childbearing potential may participate and include those who are: infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as Mullerian agenesis; or those who are postmenopausal
排除标准
- •Participants must not have known or suspected alcohol abuse (>14 units/week for women and >21 units/week for men) or active substance abuse
- •Participants must not have evidence of cirrhosis or other forms of liver disease
- •Participants must not have heart attack, stroke, or hospitalization for congestive heart failure in the past 3 months
- •Participants must not have active cancer within the last 5 years
- •Participants must not have uncontrolled high blood pressure
- •Participants must not have renal impairment with estimated glomerular filtration rate (eGFR) <60 milliters/minute/1.73m2
- •Participants must not have a diagnosis of type 1 diabetes
- •Participants must not have a contraindication to MRI examinations, such as persons with cardiac pacemaker and implants made out of metal (for example, cochlear implant, nerve stimulators, magnetic vascular clips, and metallic heart valve) or other contraindications for MRI
结局指标
主要结局
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Predose up to 26 weeks post dose
A summary of TEAEs and AEs, regardless of causality, will be reported in the Reported Adverse Events module
Pharmacodynamics (PD): Mean change from baseline on liver inflammation and fibrosis measured by magnetic resonance imaging (MRI)
时间窗: Baseline through 24 weeks
PD:Mean change from baseline on liver inflammation and fibrosis content measured by MRI
次要结局
未报告次要终点
研究者
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