KCT0012302进行中（未招募）2 期
A Phase 2 Dose-escalation and Adaptive Clinical Trial to Evaluate the Safety and Efficacy of PG-102 in Patients with Metabolic Dysfunction-Associated Steatotic Liver Disease and Steatohepatitis (MASLD/MASH) with Increased Intestinal Permeability: A Pilot Study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 19(Year) 至 No Limit（—）
- 性别
- All
入选标准
- •Adults aged 19 years or older.
- •Participants with hepatic fat content =5% as measured by MRI-proton density fat fraction (MRI-PDFF) at screening.
- •Participants with at least one of the following cardiometabolic risk factors at screening:
- •Body mass index (BMI) =23 kg/m² or waist circumference =90 cm (men) or =85 cm (women).
- •Fasting plasma glucose =100 mg/dL, or 2-hour plasma glucose =140 mg/dL, or HbA1c =5.7%, diagnosis of type 2 diabetes mellitus, or use of antidiabetic medication.
- •Blood pressure =130/85 mmHg or use of antihypertensive medication.
- •Triglycerides =150 mg/dL or receiving triglyceride-lowering medication.
- •High-density lipoprotein cholesterol (HDL-C) =40 mg/dL (men) or =50 mg/dL (women), or receiving lipid-modifying medication
- •Participants with increased intestinal permeability confirmed by a lipopolysaccharide-binding protein (LBP) level =10 µg/mL at screening.
- •Participants with a BMI <27 kg/m² and HbA1c <8.0% at screening.
- •Participants who have maintained a stable diet for at least 4 weeks before screening and who do not intend to make significant changes to their diet, exercise habits, or body weight during the study.
- •Participants who have received a full explanation of the study, understand the study procedures, voluntarily agree to participate, and provide written informed consent.
排除标准
- •Participants with any of the following medical histories or conditions:
- •History or current evidence of liver cirrhosis or related complications (e.g., esophageal varices, ascites, hepatic encephalopathy, or portal hypertension).
- •Severe inflammatory bowel disease, gastroparesis, or any other serious medical condition that may affect gastric emptying or interfere with the interpretation of safety or tolerability data, or a history of bariatric surgery for obesity (e.g., sleeve gastrectomy, biliopancreatic diversion, or jejunoileal bypass) within 1 year prior to screening.
- •Severe hypertension inadequately controlled despite appropriate medical treatment (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg).
- •Severe hypertriglyceridemia inadequately controlled despite appropriate medical treatment (triglycerides >500 mg/dL).
- •History of colorectal polyps considered untreatable by the investigator.
- •Participants with any of the following occurring within 6 months prior to screening or who are currently clinically unstable:
- •New York Heart Association (NYHA) Class III or IV heart failure, myocardial infarction, unstable angina, clinically significant coronary artery disease (e.g., Canadian Cardiovascular Society [CCS] Class III or IV angina), coronary artery bypass grafting (CABG), urgent percutaneous coronary intervention (PCI) (diagnostic coronary angiography and elective PCI are permitted), transient ischemic attack (TIA), cerebrovascular accident (stroke), or decompensated congestive heart failure. Participants may be enrolled if these events occurred more than 6 months before screening and are considered resolved or clinically stable by the investigator.
- •History of acute pancreatitis or pancreatic surgery.
- •History of malignancy within 5 years prior to screening, except adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, cervical carcinoma in situ, or prostate carcinoma in situ.
- •Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2).
- •Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen/antibody.
- •History of major depressive disorder or severe psychiatric illness (e.g., schizophrenia or bipolar disorder) within 2 years prior to screening.
- •Participants with any of the following medication or substance use histories:
- •Use of systemic corticosteroids within 90 days prior to screening (excluding short-term treatment of =10 days; topical, ophthalmic, inhaled, or intranasal corticosteroids are permitted).
- •Use of a GLP-1 receptor agonist within 90 days prior to screening.
- •Use of approved anti-obesity medications or hormonal therapy within 90 days prior to screening.
- •History of alcohol or substance abuse within 2 years prior to screening.
- •Participants meeting any of the following screening criteria:
- •Estimated glomerular filtration rate (eGFR; CKD-EPI) <60 mL/min/1.73 m².
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5 × the upper limit of normal (ULN).
- •Total bilirubin >2 × ULN.
- •Clinical evidence of liver cirrhosis or portal hypertension.
- •Clinically significant abnormalities on the 12-lead electrocardiogram (ECG) at screening that, in the investigator's judgment, would make the participant unsuitable for study participation.
- •Women of childbearing potential or fertile men (including those wi
研究者
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