JPRN-jRCT2031220200招募中1 期
A Single-Ascending and Repeated Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3849891 in Participants With Nonalcoholic Fatty Liver Disease Who Have the PNPLA3 I148M Genotype - J3W-MC-GZOA
Wakayama Naohiko0 个研究点目标入组 176 人开始时间: 2022年7月8日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 176
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 70age old（—）
- 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% 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%
- •-Male participants agree to use an effective method of contraception for the duration of the study
- •-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
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