PER-024-23招募中2 期
A Phase 2b Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Adults With Precirrhotic Nonalcoholic Steatohepatitis
Merck Sharp & Dohme LLC., (una subsidiaria de Merck & Co. Inc.)0 个研究点目标入组 0 人开始时间: 2024年4月2日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
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
- •Type of Participant and Disease Characteristics:
- •Has histologic confirmation of NASH based on a liver biopsy obtained =6 months before Visit 1a/Screening. If no acceptable biopsy performed =6 months before Visit 1a/Screening is available, a liver biopsy will be performed at Visit 1c/Liver Biopsy. Histologic criteria for study entry include: • NAS =4 with a score =1 point in each component (steatosis, ballooning, and lobular inflammation),
- •NASH CRN fibrosis score indicative of Stage 2 or 3.
- •Note: the liver biopsy will be read according to details provided in the Liver Biopsy Reading Charter.
- •Meets 1 of the following criteria:
- •Has no history of T2DM
- •Has a history of T2DM with an A1C =9% at Visit 1a/Screening AND the T2DM is controlled by diet or stable doses of AHAs (either as monotherapy or in combination) for at least 6 weeks before Visit 1a/Screening and through Randomization.
- •Has stable weight (based on self-reporting), defined as =5% gain or loss of body weight for at least 3 months before Visit 1a/Screening.
- •Demographics:
- •Is an individual of any sex/gender, from 18years to 80 years of age inclusive (in South Korea, from 19 years to 80 years [inclusive] [Appendix 7]), at the time of providing informed consent.
- •Female Participants:
- •A participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding, or planning to become pregnant, and at least one of the following conditions applies:
- •Is not a POCBP
- •Is a POCBP and:
- •-Uses a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency, or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), as described in Appendix 5, during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is:
- •? efinopegdutide/placebo: 5 weeks.
- •? semaglutide: 9 weeks.
- •-The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention. Contraceptive use by POCBPs should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions are more stringent than the requirements above, the local label requirements are to be followed.
- •-Has a negative highly sensitive pregnancy test (urine or serum, as required by local regulations) within 24 hours (for urine test) or 72 hours (for serum test) 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. Additional requirement
排除标准
- •Medical Conditions:
- •Has a history or evidence of chronic liver disease other than NAFLD or NASH, including but not limited to:
- •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
- •Note: For participants whose baseline liver biopsy was obtained before Visit 1a/Screening, HCV PCR must be negative =3 years before the liver biopsy and
- •through the screening period.
- •Drug-induced liver disease
- •Autoimmune liver disease
- •Primary biliary cirrhosis (cholangitis)
- •Primary sclerosing cholangitis
- •Reye syndrome
- •Wilson disease
- •Alpha-1-antitrypsin deficiency
- •Hemochromatosis or iron overload
- •Known bile duct obstruction
- •Has history or evidence of cirrhosis:
- •NASH CRN fibrosis score = 4 based on liver biopsy, obtained either =6 months before or at screening.
- •a liver stiffness score >14 kPa based on VCTE (FibroScan®) at screening.
- •Note (1): This VCTE-based criterion does not apply for participants with a qualifying historical liver biopsy.
- •Note (2): This VCTE-based criterion does not apply for participants with AIMD, who will not undergo VCTE.
- •Evidence of decompensated liver disease including, but not limited to ascites, esophageal or gastric variceal bleeding, hepatocellular carcinoma, hepatic encephalopathy, splenomegaly, or spontaneous bacterial peritonitis.
- •Has an ELF score <7.7.
- •Note: This criterion does not apply for participants with a qualifying historical liver biopsy.
- •Has a VCTE FAST score <0.35.
- •Note (1): This criterion does not apply for participants with a qualifying historical liver biopsy.
- •Note (2): This criterion does not apply for participants with AIMD, who will not undergo VCTE.
- •Has a history of pancreatitis.
- •Has a history of T1DM, diabetic ketoacidosis, or diabetes secondary to pancreatectomy.
- •Has symptomatic hyperglycemia that, in the investigator’s opinion, requires immediate initiation, adjustment, or addition of antihyperglycemic therapy.
- •Has a history of a bariatric surgical procedure =5 years before Visit 1a/Screening or a known clinically significant gastric emptying abnormality (eg, severe gastroparesis or gastric outlet obstruction).
- •Note: For participants whose baseline liver biopsy was obtained before Visit 1a/Screening, there must be no history of bariatric surgery =5 years before the liver biopsy and through Visit 2/Randomization.
- •Has a history of obesity with a known secondary cause.
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