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
- Conditions
- onalcoholic Fatty Liver DiseaseMedDRA version: 22.0Level: PTClassification code 10082249Term: Nonalcoholic fatty liver diseaseSystem Organ Class: 10019805 - Hepatobiliary disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2020-005136-30-FR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 145
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
OR
? 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
Or
? 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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method