EUCTR2019-003048-63-DE进行中（未招募）1 期
A Phase 2b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 328
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Has histological confirmation of NASH based on a liver biopsy obtained =6 months before Visit 1/Screening. If no acceptable biopsy performed =6 months before Visit 1/Screening is available, a liver biopsy will be performed at Visit 3/Liver Biopsy.
- •Histological criteria for study entry include:
- •- NAS =4 with a score =1 point in each component (steatosis, ballooning, and lobular inflammation),
- •- NASH CRN fibrosis score of Stage 2 or 3.
- •2. Has an MRI-PDFF =8% as assessed at Visit 2/MRI-PDFF.
- •3. Has a baseline MELD-Na score =12 at Visit 1/Screening.
- •4. Is a male or female aged 18 years to 80 years (in Japan and Taiwan, aged 20 to 80 years), at the time of signing the ICF.
- •5. Has a BMI =25 kg/m2 and =50 kg/m2 at the time of Visit 1/Screening.
- •6. Has stable weight (based on self-reporting) defined as =5% gain or loss of body weight for at least 3 months before Visit 1/Screening.
- •7. Meets one of the following criteria:
- •- Has no history of T2DM.
- •- Has a history of T2DM with an A1C =9.5% at Visit 1/Screening and controlled by diet or stable doses of AHAs.
- •8. Has a systolic blood pressure of =160 mm Hg and a diastolic blood
- •pressure =90 mm Hg (after at least a 10-minute seated rest) based on
- •the mean of 3 measurements at Visit 1/Screening OR blood pressure is
- •considered likely to be below these limits by Visit 5/Randomization (Day
- •1) with initiation or adjustment of antihypertensive medication.
- •9. Be willing and able to comply with scheduled visits, treatment plan,
- •laboratory tests,and/or other study procedures.
- •10. Contraceptive use by male participants should be consistent with
- •local regulations regarding the methods of contraception for those
- •participating in clinical studies.
- •11. A female participant is eligible to participate if she is not pregnant or
- •breastfeeding, and at least one of the following conditions applies:
- •Is not a WOCBP
- •Is a WOCBP and:
- •- Uses a contraceptive method that is highly effective.
- •- Has a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention.If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
- •- Abstains from breastfeeding during the study intervention period and at least 16 weeks after the last dose of study intervention.
- •-Medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- •12. The participant (or legally acceptable representative, if applicable)
- •has provided documented informed consent for the study. The
- •participant may also provide consent for FBR. However, the participant
- •may participate in the main study without participating in FBR.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 230
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 98
排除标准
- •1. Has presence of cirrhosis on liver biopsy.
- •2. Has Type 1 diabetes.
- •3. Has a history of malignancy, unless cancer free =5 years, or is under evaluation for active or suspected malignancy before signing the ICF except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
- •4. Has a history of bariatric surgery =5 years before Visit 1/Screening.
- •5. Has undergone a major surgical procedure =3 months before signing the ICF or has major surgery planned during the study.
- •6. Has a history or evidence of:
- •- Chronic liver disease other than NASH
- •- Hepatitis B as defined by the presence of HBsAg
- •- Hepatitis C as defined by the presence of HCV RNA or positive Hepatitis
- •C antibody (anti-HCV); participants with a history of HCV infection may
- •be included if HCV PCR is negative =3 years
- •- Drug-induced liver disease
- •- Ongoing autoimmune liver disease
- •- Decompensated liver disease
- •- Primary biliary cirrhosis (cholangitis)
- •- Primary sclerosing cholangitis
- •- Reye Syndrome
- •- Splenomegaly
- •- Wilson's disease
- •- Documented Cushing disease, Cushing syndrome, or any condition
- •associated with hypercortisolism
- •- Hyperthyroidism, and is currently being treated.
- •- Hypothyroidism, and is on thyroid hormone replacement therapy that
- •has not been at a stable dose for at least 12 weeks prior to Visit
- •1/Screening.
- •- Alpha-1-antitrypsin deficiency
- •- Hemochromatosis or iron overload
- •- Spontaneous bacterial peritonitis
- •- Known bile duct obstruction
- •- Hepatocellular carcinoma
- •- Untreated obstructive sleep apnea
- •- Hemostasis disorder
- •- Hematological disorder
- •7. Has significant systemic or major illnesses other than liver disease, including recent events (=6 months before Visit 1/Screening) of congestive heart failure, unstable coronary artery disease, arterial revascularization, pulmonary disease, renal failure, stroke, transient ischemic attack, or organ transplantation.
- •8. Has a known hypersensitivity to any of the ingredients or excipients of the IMP.
- •9. Has experienced any bone trauma, fracture, or bone surgery =2 months before Visit 1/Screening.
- •10. Has a history of osteoporosis or an indication that requires treatment with a bone-active pharmacological agent in the classes listed in exclusion criterion #18 at Visit 1/Screening.
- •11. Has current or history of significant alcohol consumption for a period of more than 3 consecutive months =24 months before Visit 1/Screening.
- •12. Has an inability to reliably quantify alcohol consumption.
- •13. Has a recent history of drug abuse (defined as =3 years) or is a current user of recreational or illicit drugs at the time of Visit 1/Screening.
- •14. Has a known psychiatric or any other cognitive disorder per the opinion of the investigator, that would interfere with the participant’s ability to cooperate with the requirements of the study.
- •15. Is at imminent risk of self-harm, based on clinical interview and responses on the C-SSRS, or of harm to others in the opinion of the investigator.
- •16. Has a total score >12 on the PHQ-9.
- •17. Is on treatment with or has been treated with the following agents:
- •Within =12 months before Visit 1/Screening:
- •-Thiazolidinediones (ie, pioglitazone, rosiglitazone)
- •-Investigational agents as defined in the protocol
- •Within =6 months before Visit 1/Screening:
- •-L-ornithine L-aspartate
- •18. Is on treatment with or has used bone-active agents in the classes listed in the protocol =24 months before Visit 1/Screening.
- 另有 1 项未显示
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