EUCTR2020-000217-32-FR进行中（未招募）1 期
VK2809 A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY, SAFETY, AND TOLERABILITY OF VK2809 ADMINISTERED FOR 52 WEEKS FOLLOWED BY A 4-WEEK OFF-DRUG PHASE IN SUBJECTS WITH BIOPSY PROVEN NON-ALCOHOLIC STEATOHEPATITIS WITH FIBROSIS - VOYAGE
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 337
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
- 性别
- All
入选标准
- •1. Provide a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study and is willing and able to participate;
- •2. Have a histologically-confirmed diagnosis of NASH on a liver biopsy performed during screening or within 6 months before screening; for this study, confirmation requires: (a) NASH Clinical Research Network (CRN) fibrosis stage 1 to stage 3 and (b) NASH activity score (NAS) of =4 with at least a score of 1 in each of the following NAS components: ballooning degeneration (score = 0-2), lobular inflammation (score = 0-3) and steatosis (score = 0-3); (c) F1 subjects must have at least one of these risk factors: type 2 diabetes, body mass index of = 30 mg/ m2, and/ or alanine aminotransferase > 1.5 x ULN
- •3. Have a screening MRI-PDFF with = 8% liver fat fraction;
- •4. Male and females be 18 to 75 years of age, inclusive, at screening;
- •5. Be able to comply with contraception restrictions:
- •Female subjects of non-childbearing potential must: (a) have documentation of surgical intervention (i.e., bilateral oophorectomy, hysterectomy, or tubal ligation) or (b) be naturally sterile (i.e., reliable history of >12 consecutive months without menses). Female subjects of childbearing potential must: (c) have a negative serum pregnancy (beta human chorionic gonadotropin) test at screening, (d) have a negative urine pregnancy test documented within the 24-hour period prior to the first dose of investigational product, (e) agree to use two effective methods of contraception from the date of screening until 28 days after the last dose of investigational product; acceptable effective methods of contraception include hormonal contraception intrauterine devices including hormone-containing devices and barrier methods, (f) abstinence is allowed if documented in medical record to be reliable and ongoing for at least 12 months or more and considered appropriate by the investigator. For purposes of the trial, abstinence is defined as a long-term habitual practice if it has been practiced for twelve months or more. Abstinence should be verified by being included in the medical history and the subject must continue abstinence until 28 days after study completion, (g) not be breastfeeding, and (h) not plan to become pregnant during the study; Male subjects who are sexually active with female partners of reproductive potential must: (i) use barrier contraception and their female partners must use a second effective birth control method (see Inclusion Criteria 5 (e) for acceptable, effective contraception methods) during the study and for at least 28 days after the last dose of investigational product; OR (j) have had a vasectomy and use barrier contraception (e.g. condom with spermicide) or their female partners must use an effective birth control method during the study and for at least 28 days after the last dose of investigational product;
- •6. Subjects with type 2 diabetes must have stable glycemic control defined as screening Hemoglobin A1C < 9%. The following oral agents are permitted as long as treatment has been stable for at least 3 months prior to the qualifying liver biopsy until randomization: (a) biguanides (example: metformin) (b) sulfonylureas (c) DPP4 inhibitors (d) meglitinides (e) a-Glucosidase inhibitors (example: acarbose) (f) bromocriptine (g) SLGT2 inhibitors are permitted as long as treatment has been
排除标准
- •Please refer to the protocol for the full exclusion criteria
- •1. Are unwilling to undergo the required liver biopsy procedures or have any condition that would prevent obtaining a liver biopsy as part of this clinical protocol;
- •2. Have evidence of current or history of excessive alcohol consumption of more than 20 g per day for women and 30 g per day for men, on average, within 6 months before the qualifying liver biopsy and up to randomization, or are unable to provide a reliable estimate of alcohol consumption during this period;
- •3. Have evidence (positive drug and alcohol test) of or acknowledge use of illicit drugs and excessive alcohol consumption within 6 months prior to screening with the exception of: (a) use of medical marijuana (b) recreational use of marijuana, if in the opinion of the Investigator it will have no adverse impact on the compliance and safety of the subject in the study;
- •4. Have had weight change > 5% within 6 months prior to the qualifying liver biopsy and up to randomization;
- •5. Treatment with medications for the purpose of weight loss within 6 months prior to qualifying liver biopsy, unless approved after consultation with the medical monitor. These include drugs approved for weight loss (e.g. orlistat, bupropion/naltrexone, phentermine-topiramate, phentermine, lorcaserin), as well as drugs used off-label, herbal preparations and dietary supplements marketed for control of body weight or appetite;
- •6. History of eating disorders;
- •7. Active involvement in a structured weight loss program (including programs such as Weight Watchers, Jenny Craig, etc.) within 6 months prior to qualifying liver biopsy, unless approved after consultation with the medical monitor;
- •8. Have a history of: (a) Type 1 diabetes or Latent autoimmune diabetes in adults (LADA) (b) uncontrolled Type 2 diabetes (Hemoglobin A1c =9% at Screening);
- •9. Have a history of: (a) solid organ or bone marrow transplantation, (b) active thyroid disease including hyperthyroidism, (c) hepatic decompensation (example: including history of esophageal varices, ascites, hepatic encephalopathy, etc.) (d) immunologically-mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, severe psoriasis, rheumatoid arthritis), or (e) osteoporosis;
- •10. Have a history of effective bariatric surgery prior to qualifying for the study (subjects with ineffective surgery may be able to participate after consultation with the medical monitor),
- •11. Have a diagnosis (or current evidence) of other chronic liver diseases, including: (a) Hepatitis B (HBV) infection, as defined by presence of hepatitis B surface antigen (HBsAg) (b) HCV, as defined by positive antibody and detectable HCV RNA NOTE: Hep C RNA testing instead of initial screening for HCV antibody positivity must be done in all subjects with prior history of Hep C infection. Subjects with detectable HCV RNA levels within 6 months prior to the qualifying liver biopsy and up to screening will not be eligible to participate; (c) Hepatitis E (HEV) infection NOTE: Hep E testing instead of initial screening for HEV infection positivity must be done in all subjects with prior history of Hep E infection. Subjects with detectable HEV RNA levels within 6 months prior to the qualifying liver biopsy and up to screening will not be eligible to participate; (d) Acute Hepatitis A HAV IgM antibodies in serum (e) cirrhosis (f) he
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