CTIS2023-507503-62-00招募中1 期
17 ß-Hydroxysteroid Dehydrogenase type 13 Minimization for the treatment of NASH (HORIZON): A Double-Blind, Placebo-Controlled Phase 2b Study to Evaluate the Efficacy and Safety of GSK4532990 in Adults with Nonalcoholic Steatohepatitis - 218672
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 258
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
- 18 至 64（—）
- 性别
- All
入选标准
- •Participant must be 18 to 75 years of age inclusive, at the time of screening., Body Mass Index (BMI) =25 kilogram per meter square (kg/m^2) (all ethnic origins) except for Asian participants who qualify for the study with BMI =23 kg/m2 at Screening., In the opinion of the investigator, there are features of metabolic syndrome and NAFLD is the most likely cause of liver disease. Metabolic syndrome may include type 2 diabetes mellitus (T2DM), obesity, dyslipidemia and hypertension., The liver biopsy must show a NAS =4 with at least 1 point each in steatosis, inflammation, and ballooning and Fibrosis 3 using NASH CRN Scoring System, confirmed by central scoring., Capable of giving signed informed consent prior to the performance of any study-specific procedures, Able and willing to comply with all study assessments., A female participant is eligible to participate, if she is not pregnant or breastfeeding and one of the following conditions applies: • Is a woman of nonchildbearing potential (WONCBP) as defined in Section 10.4 Contraception and Barrier Guidance OR • Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1%, as described in Section 10.4. Contraceptive measures must start from the time of negative serum pregnancy test at screening and at least 28 days before first administration of study intervention. Contraceptive measures should then continue during the study intervention period, and for at least 18 weeks after the last administration of study intervention. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated in relationship to the first dose of study intervention). o A WOCBP must have a negative highly sensitive pregnancy test (serum or urine as required by local regulations) within 24 hours before the first dose of study intervention, see Section 8.2.5 Pregnancy Testing.
排除标准
- •Current alcohol consumption =14 standard drinks (24 units, 196 g ethanol) per week for females or =21 standard drinks (37 units, 294g ethanol) per week for males. One standard drink is equivalent to: 12 US fluid ounces (oz) beer (5% alcohol); 5 oz of wine (12% alcohol), or 1.5 oz of 80 proof spirits (40% alcohol)., Weight reduction surgery (including gastric banding and intragastric balloon insertion) within 2 years of Screening 1., History of cancer within previous 2 years from Screening 1, except adequately
研究者
相似试验
招募中
2 期
A Double-Blind, Placebo-Controlled Phase 2b Study to Evaluate the Efficacy and Safety of GSK4532990 in Adults With Pre-Cirrhotic Non-Alcoholic SteatohepatitisCTRI/2023/03/051029GSK Research and Development Limite
已完成
1 期
A Study to Assess 11 Beta-hydroxysteroid Dehydrogenase Type 1 Inhibition in Adipose Tissue by SPI-62Type 2 Diabetes Mellitus in ObeseType2DiabetesObesityNCT05409027Sparrow Pharmaceuticals12
已完成
不适用
71A/G HSD17B5 SNP and Effects of Oral Contraceptive Pill in PCOS WomenPolycystic Ovary SyndromeNCT01372293Federal University of Rio Grande do Sul49
已完成
不适用
In vivo analysis of the 11-beta-hydroxysteroid dehydrogenase activity during critical illness using isotopically labeled cortisol and cortisoneISRCTN08083905Catholic University Leuven (Katholieke Universiteit Leuven) (Belgium)22
进行中（未招募）
1 期
[18F] Dihyro-testosterone(FDHT) PET/CT- A novel Imaging technique in Patients with Porgressive Prostate CancerEUCTR2014-005684-32-GBThe Royal Marsden NHS Foundation Trust105