EUCTR2020-005136-30-ES进行中（未招募）1 期
A Phase 2a, Randomized, Active-Comparator-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Individuals With Nonalcoholic Fatty Liver Disease - Phase 2a Study of Efinopegdutide (MK-6024) in Individuals With NAFLD
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 130
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 an LFC =10% as assessed by MRI-PDFF at V2/MRI-PDFF
- •2. Has a BMI =25 kg/m2 and =50 kg/m2 at the time of V1/Screening
- •3. Has stable weight defined as =5% gain or loss of body weight for at least 3 months before V1/Screening
- •4. Meets one of the following criteria:
- •? Has no history of T2DM
- •? Has a history of T2DM with an A1C =8.5% at V1/Screening AND controlled by diet or a stable dose of metformin for the 3 months before V1/Screening
- •5. Is male or female, from 18 years to 70 years of age (inclusive) (in Taiwan, from 20 years to 70 years of age [inclusive]), at the time of signing the informed consent
- •6. 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 using a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least 5 weeks after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention
- •? A WOCBP must have 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
- •? The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy
- •? Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- •7. The participant (or legally acceptable representative) has provided documented informed consent for the study. The participant may also provide consent for FBR and/or the PK substudy. However, the participant may participate in the main study without participating in FBR and/or the PK substudy
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. History of T1DM, diabetic ketoacidosis, or diabetes secondary to pancreatitis or pancreatectomy
- •2. History of obesity with a known secondary cause
- •3. Ongoing, inadequately controlled hypothyroidism or hyperthyroidism
- •4. History of glucagonoma
- •5. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasm type-2 syndrome
- •6. Calcitonin value of =50 pg/mL (=50 ng/L) at V1/Screening
- •7. Symptomatic hyperglycemia that, in the investigator’s opinion, requires immediate initiation, adjustment, or addition of antihyperglycemic therapy
- •8. Significant systemic or major illnesses including recent events of congestive heart failure, unstable angina, myocardial infarction, arterial revascularization, stroke, or transient ischemic attack
- •9. History of pathologic, symptomatic, or sustained tachyarrhythmia
- •10. History of Wolff-Parkinson-White syndrome or congenital long QT syndrome
- •11. Average triplicate seated BP reading of SBP =160 mm Hg and/or DBP =100 mm Hg at V1/Screening
- •12. Average triplicate seated HR reading of <50 bpm or >100 bpm
- •13. History or evidence of chronic liver disease other than NAFLD or NASH
- •14. Known history of cirrhosis
- •15. History of acute or chronic pancreatitis
- •16. History of a bariatric surgical procedure or a known clinically significant gastric emptying abnormality
- •17. Previous or current history of a clinically significant eating disorder
- •18. History of severe psychiatric disorders, major depressive disorder, or any lifetime history of suicide attempt
- •19. History of malignancy =5 years before providing documented informed consent for the study except for squamous or basal cell carcinomas of the skin and carcinomas in situ of the cervix
- •20. Clinically active hematologic disorder and/or hemostasis disorder
- •21. HIV as assessed by medical history or current use of antiretroviral therapy
- •22. Undergone a major surgery within 3 mo before providing documented informed consent for the study, or has not fully recovered from surgery, or has major surgery planned during the participation of the current study
- •23. History of organ transplantation, except for corneal transplant
- •24. Received blood products =2 mo before V1/Scr, and/or donated blood products =1 month before V1/Scr, and/or plans to donate blood products throughout the duration of the study
- •25. Active diabetic proliferative retinopathy or a history of maculopathy
- •26. Untreated obstructive sleep apnea
- •27. Known allergies, hypersensitivity, contraindication, or intolerance to the active ingredients and/or excipients of efinopegdutide or semaglutide
- •28. Treated with any GLP-1 receptor agonist or investigational GLP-1/GCGR co-agonist within the 6 mo before V1/Scr
- •29. Been treated with thiazolidinediones within the 6 mo before V1/Scr
- •30. Previous or current use of prescription weight-management medications, or over-the-counter weight-loss medications or therapies within the 3 mo before V1/Scr
- •31. Been treated with systemic corticosteroid medication within the 3 mo before V1/Scr or is likely to require treatment with systemic corticosteroid medication during the study treatment period
- •32. Been treated with any of the following medications within the 3 mo before V1/Scr or is likely to require treatment with the following medications during the study treatment period:
- •? Antipsychotic drugs
- •? Anticonvulsants
- •? Tricyclic antidepressants, lithium, levodopa, and dopamine receptor agonists
- •33. On treatment with selective serotonin reuptake inhibitors and/or
研究者
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