A Study of Efinopegdutide (MK-6024) in Participants With Nonalcoholic Fatty Liver Disease (NAFLD) (MK-6024-001)
NCT ID: NCT04944992
Last Updated: 2023-11-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
145 participants
INTERVENTIONAL
2021-08-04
2022-10-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Efinopegdutide
Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.
Efinopegdutide 20 mg/mL
Subcutaneous injection in a dose-escalation administration of 2.4 mg, 5.0 mg, and 10.0 mg
Semaglutide
Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.
Semaglutide 1.34 mg/mL
Subcutaneous injection in a dose-escalation administration of 0.25 mg, 0.5 mg, and 1.0 mg
Interventions
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Efinopegdutide 20 mg/mL
Subcutaneous injection in a dose-escalation administration of 2.4 mg, 5.0 mg, and 10.0 mg
Semaglutide 1.34 mg/mL
Subcutaneous injection in a dose-escalation administration of 0.25 mg, 0.5 mg, and 1.0 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI) ≥25 kg/m² and ≤50 kg/m² at time of screening.
* Stable weight (based on self-reporting) defined as ≤5% gain or loss of body weight for at least 3 months before screening visit.
* No history of Type 2 Diabetes Mellitus (T2DM) OR history of T2DM with an Glycated Hemoglobin (A1C) ≤8.5% at screening AND controlled by diet or a stable dose of metformin for the 3 months before screening.
* A female participant is eligible to participate if she is not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP), or is a WOCBP and agrees to follow contraceptive guidance during the study intervention period and for at least 5 weeks after the last dose of study intervention.
* Participants in Taiwan are eligible between the ages of 20 to 70 years of age (inclusive).
* Participants in South Korea are eligible between the ages of 19 to 70 years of age (inclusive).
Exclusion Criteria
* Ongoing, inadequately controlled hypothyroidism or hyperthyroidism.
* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasm type-2 syndrome.
* Recent event (within 6 months prior to screening) of congestive heart failure, unstable angina, myocardial infarction, arterial revascularization, stroke, or transient ischemic attack.
* History or evidence of chronic liver disease other than NAFLD or Non-Alcoholic SteatoHepatitis (NASH).
* Known history of cirrhosis.
* History of acute or chronic pancreatitis.
* History of a bariatric surgical procedure or a known clinically significant gastric emptying abnormality.
* History of malignancy ≤5 years prior to screening, except for skin cancer or cervical cancer.
* Clinically active hematologic disorder.
* Diagnosis of human immunodeficiency virus (HIV).
* Surgery requiring general anesthesia within 3 months before screening visit.
* History of organ transplantation, except for corneal transplant.
* Active diabetic proliferative retinopathy or a history of maculopathy.
* Untreated obstructive sleep apnea.
* History of treatment with any glucagon-like peptide-1 (GLP-1) receptor agonist within 6 months before screening.
* History of treatment with thiazolidinediones (ie, pioglitazone, rosiglitazone) within 6 months before screening.
* Previous use (within 3 months before screening) or current use of prescription weight-management medications or over-the-counter weight-loss medications or therapies.
* Treatment with systemic corticosteroid medication within 3 months before screening.
* Current treatment with anticoagulants (eg, warfarin, heparin).
* Inability to have an MRI-PDFF performed due to either severe claustrophobia, metallic implant that prevents MRI-PDFF examination, or any other contraindication to MRI-PDFF examination.
* Previous or current history of significant alcohol consumption (average of 7 standard drinks per week in females or 14 standard drinks per week in males) for a period of more than 3 consecutive months in the 24 months before screening.
18 Years
70 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Catalina Research Institute, LLC ( Site 1939)
Montclair, California, United States
Sweet Hope Research Specialty, Inc ( Site 1902)
Hialeah, Florida, United States
Floridian Clinical Research, LLC ( Site 1950)
Miami Lakes, Florida, United States
Sensible Healthcare, LLC ( Site 1903)
Ocoee, Florida, United States
Lucas Research, Inc ( Site 1930)
Morehead City, North Carolina, United States
Texas Clinical Research Institute ( Site 1910)
Arlington, Texas, United States
Baylor College of Medicine-Advanced Liver Therapies ( Site 1960)
Houston, Texas, United States
American Research Corporation at Texas Liver Institute ( Site 1920)
San Antonio, Texas, United States
Clinical Trials of Texas, Inc. ( Site 1906)
San Antonio, Texas, United States
CIPREC-Laboratorio ( Site 0104)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0101)
Mar del Plata, Buenos Aires, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0105)
Buenos Aires, Buenos Aires F.D., Argentina
IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0107)
Buenos Aires, , Argentina
Westmead Hospital-Gastroenterology & Hepatology ( Site 0204)
Westmead, New South Wales, Australia
Flinders Medical Centre-Hepatology and Liver Transplant Medicine ( Site 0201)
Bedford Park, South Australia, Australia
Heritage Medical Research Clinic ( Site 0302)
Calgary, Alberta, Canada
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital F-ENDOCRINOLOGY-DIABETOLOGY ( Site 0401)
Dijon, Cote-d Or, France
centre hospitalier lyon sud-Endocrinologie, Diabète et Nutrition ( Site 0402)
Pierre-Bénite, Rhone, France
Rambam Health Care Campus-Liver disease unit ( Site 0704)
Haifa, , Israel
Carmel Hospital-Liver Unit ( Site 0705)
Haifa, , Israel
Shaare Zedek Medical Center-Liver Unit ( Site 0703)
Jerusalem, , Israel
Rabin Medical Center ( Site 0701)
Petah Tikva, , Israel
Sheba Medical Center-The Liver Diseases Center ( Site 0700)
Ramat Gan, , Israel
Sourasky Medical Center-Gastroenterology and Liver Disease ( Site 0702)
Tel Aviv, , Israel
Policlinico Umberto I ( Site 0801)
Rome, Lazio, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0805)
Milan, Lombardy, Italy
Humanitas-Medicina interna ed Epatologia ( Site 0800)
Rozzano, Lombardy, Italy
Azienda Ospedaliero Universitaria ( Site 0803)
Modena, , Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma-Medicine ( Site 0804)
Verona, , Italy
Arké Estudios Clínicos S.A. de C.V.-Gastroenterology-Hepatology ( Site 0906)
Mexico City, Mexico City, Mexico
Medica Sur-Clinica de Enfermedades Digestivas y Obesidad ( Site 0908)
Mexico City, Mexico City, Mexico
Avix Investigación Clinica, S.C. ( Site 0907)
Monterrey, Nuevo León, Mexico
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan (
Mérida, Yucatán, Mexico
Centro de Investigación y Gastroenterología ( Site 0902)
Cuauhtémoc, , Mexico
Christchurch Hospital-Gastroenterology Research ( Site 1002)
Christchurch, Canterbury, New Zealand
Auckland City Hospital-Liver Research Unit ( Site 1003)
Auckland, , New Zealand
Middlemore Clinical Trials ( Site 1000)
Auckland, , New Zealand
Nasz Lekarz Przychodnie Medyczne ( Site 1105)
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Centrum Medyczne Pratia Warszawa ( Site 1107)
Warsaw, Masovian Voivodeship, Poland
Clinical Medical Research ( Site 1101)
Katowice, Silesian Voivodeship, Poland
ID Clinic ( Site 1100)
Mysowice, Silesian Voivodeship, Poland
Center targetnoy therapy ( Site 1203)
Moscow, Moscow, Russia
New Technologies of Medicine Clinic ( Site 1204)
Dzerzhinskiy, Moscow Oblast, Russia
Saint Petersburg City Polyclinic 117-endocrinology department ( Site 1201)
Saint Petersburg, Sankt-Peterburg, Russia
Astarta Clinic ( Site 1202)
Saint Petersburg, Sankt-Peterburg, Russia
Soon Chun Hyang University Bucheon Hospital ( Site 1304)
Bucheon-si, Kyonggi-do, South Korea
Inha University Hospital-Gastroenterolgy/Hepatology ( Site 1303)
Incheon, , South Korea
Severance Hospital, Yonsei University Health System ( Site 1305)
Seoul, , South Korea
Samsung Medical Center-Gastroenterology/Internal Medicine ( Site 1302)
Seoul, , South Korea
Korea University Guro Hospital ( Site 1300)
Seoul, , South Korea
Hospital Universitario Virgen de la Victoria-UGC Endocrinologia y nutricion ( Site 1405)
Málaga, Andalusia, Spain
CHUS - Hospital Clinico Universitario ( Site 1403)
Santiago de Compostela, La Coruna, Spain
Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 1400)
Barcelona, , Spain
HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA-Gastroenterologia y Hepatologia ( Site 1402)
Madrid, , Spain
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Unidad de Ensayos Clínicos de Aparato Digestivo ( Site 1404)
Seville, , Spain
NATIONAL CHENG-KUNG UNI. HOSP.-Liver Research team of National Cheng Kung University Hospital ( Site
Tainan City, , Taiwan
National Taiwan University Hospital ( Site 1501)
Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch-Division of hepatology, department of gastroenterology (
Taoyuan District, , Taiwan
Dokuz Eylül Üniversitesi-Endocrinology and Met. ( Site 1610)
Balçova, İzmir, Turkey (Türkiye)
Ankara University Department of Hematology, Clinical Research Unit ( Site 1603)
Ankara, , Turkey (Türkiye)
Hacettepe Universitesi-internal diseases ( Site 1602)
Ankara, , Turkey (Türkiye)
Gazi Universitesi-gastroenterology ( Site 1605)
Ankara, , Turkey (Türkiye)
Bezmialem Vakf Üniversitesi-Gastroenterology ( Site 1606)
Istanbul, , Turkey (Türkiye)
Istanbul University Capa Campus-Gastroenterology ( Site 1604)
Istanbul, , Turkey (Türkiye)
Ukrainian Research Institute of Therapy ( Site 1704)
Kharkiv, Kharkivs’ka Oblast’, Ukraine
L.T. Mala National Institute of Therapy of NAMS of Ukraine-Department of Aging Studies and Prevent
Kharkiv, Kharkivs’ka Oblast’, Ukraine
Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho ( Site 1710)
Poltava, Poltava Oblast, Ukraine
Communal Non-profit Enterprise "City Hospital #6" of Zaporizhzhia City Council-Therapy department (
Zaporizhia, Zaporizhzhia Oblast, Ukraine
Adonis Plus-Outpatient department ( Site 1701)
Kyiv, , Ukraine
Countries
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References
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Romero-Gomez M, Lawitz E, Shankar RR, Chaudhri E, Liu J, Lam RLH, Kaufman KD, Engel SS; MK-6024 P001 Study Group. A phase IIa active-comparator-controlled study to evaluate the efficacy and safety of efinopegdutide in patients with non-alcoholic fatty liver disease. J Hepatol. 2023 Oct;79(4):888-897. doi: 10.1016/j.jhep.2023.05.013. Epub 2023 Jun 22.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-6024-001
Identifier Type: OTHER
Identifier Source: secondary_id
2020-005136-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
6024-001
Identifier Type: -
Identifier Source: org_study_id
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