A Study of Efinopegdutide (MK-6024) in Participants With Nonalcoholic Fatty Liver Disease (NAFLD) (MK-6024-001)

NCT04944992 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: 6024-001MK-6024-0012020-005136-30
• Study Type: interventional
• Target: 145
• Locations: 16 countries
• Sites: 69

Brief Summary

The principal goal of this study is to determine the efficacy of efinopegdutide in liver fat reduction in participants with NAFLD. The primary hypotheses are that efinopegdutide is superior to semaglutide, or that efinopegdutide is superior to semaglutide by at least 10% with respect to mean relative reduction from baseline in liver fat content (LFC) after 24 weeks.

Conditions

Nonalcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (3)

• Mean Relative Reduction From Baseline in Liver Fat Content (LFC) Measured by Magnetic Resonance Imaging-Estimated Proton Density Fat Fraction (MRI-PDFF), Evaluated by Blinded Independent Central Review (BICR) After 24 Weeks

  LFC was measured with liver images taken by MRI-PDFF and analyzed by BICR. Relative Reduction from Baseline to Week 24 = (Baseline - Week 24) / Baseline x 100%. Mean relative reduction from baseline in liver fat content is presented.

  Baseline and up to ~24 Weeks

• Percentage of Participants Who Experienced an Adverse Event (AE)

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced an adverse event is presented.

  Up to ~29 weeks

• Percentage of Participants Who Discontinued Study Intervention Due to an AE

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinued study intervention due to adverse event is presented.

  Up to ~24 weeks

Secondary Outcomes (8)

• Mean Absolute Reduction From Baseline in LFC Measured by MRI-PDFF (Evaluated by BICR) After 24 Weeks

  Baseline and up to ~24 Weeks

• Mean Percent Change From Baseline in Body Weight After 24 Weeks

  Baseline and up to ~24 weeks

• Mean Percent Change From Baseline in Total Cholesterol After 24 Weeks

  Baseline and up to ~24 weeks

• Mean Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) After 24 Weeks

  Baseline and up to ~24 weeks

• Mean Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) After 24 Weeks

  Baseline and up to ~24 weeks

Study Arms (2)

Efinopegdutide

EXPERIMENTAL

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.

Drug: Efinopegdutide 20 mg/mL

Semaglutide

ACTIVE COMPARATOR

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.

Drug: Semaglutide 1.34 mg/mL

Interventions

Efinopegdutide 20 mg/mL DRUG

Subcutaneous injection in a dose-escalation administration of 2.4 mg, 5.0 mg, and 10.0 mg

Also known as: MK-6024, HM12525A, JNJ-64565111

Efinopegdutide

Semaglutide 1.34 mg/mL DRUG

Subcutaneous injection in a dose-escalation administration of 0.25 mg, 0.5 mg, and 1.0 mg

Also known as: Ozempic®

Semaglutide

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• LFC ≥10% as assessed by MRI-PDFF at time of screening.
• 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).

You may not qualify if:

• History of Type 1 Diabetes Mellitus (T1DM), diabetic ketoacidosis, or diabetes secondary to pancreatitis or pancreatectomy.
• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (69)

Catalina Research Institute, LLC ( Site 1939)

Montclair, California, 91763, United States

Location

Sweet Hope Research Specialty, Inc ( Site 1902)

Hialeah, Florida, 33016, United States

Location

Floridian Clinical Research, LLC ( Site 1950)

Miami Lakes, Florida, 33016, United States

Location

Sensible Healthcare, LLC ( Site 1903)

Ocoee, Florida, 34761, United States

Location

Lucas Research, Inc ( Site 1930)

Morehead City, North Carolina, 28557, United States

Location

Texas Clinical Research Institute ( Site 1910)

Arlington, Texas, 76012, United States

Location

Baylor College of Medicine-Advanced Liver Therapies ( Site 1960)

Houston, Texas, 77030, United States

Location

American Research Corporation at Texas Liver Institute ( Site 1920)

San Antonio, Texas, 78215, United States

Location

Clinical Trials of Texas, Inc. ( Site 1906)

San Antonio, Texas, 78229, United States

Location

CIPREC-Laboratorio ( Site 0104)

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1119ACN, Argentina

Location

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0101)

Mar del Plata, Buenos Aires, B7600FZO, Argentina

Location

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0105)

Buenos Aires, Buenos Aires F.D., C1425AGC, Argentina

Location

IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0107)

Buenos Aires, C1012AAR, Argentina

Location

Westmead Hospital-Gastroenterology & Hepatology ( Site 0204)

Westmead, New South Wales, 2145, Australia

Location

Flinders Medical Centre-Hepatology and Liver Transplant Medicine ( Site 0201)

Bedford Park, South Australia, 5042, Australia

Location

Heritage Medical Research Clinic ( Site 0302)

Calgary, Alberta, T2N 4Z6, Canada

Location

Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital F-ENDOCRINOLOGY-DIABETOLOGY ( Site 0401)

Dijon, Cote-d Or, 21000, France

Location

centre hospitalier lyon sud-Endocrinologie, Diabète et Nutrition ( Site 0402)

Pierre-Bénite, Rhone, 69310, France

Location

Rambam Health Care Campus-Liver disease unit ( Site 0704)

Haifa, 3109601, Israel

Location

Carmel Hospital-Liver Unit ( Site 0705)

Haifa, 3436212, Israel

Location

Shaare Zedek Medical Center-Liver Unit ( Site 0703)

Jerusalem, 9778419, Israel

Location

Rabin Medical Center ( Site 0701)

Petah Tikva, 49100, Israel

Location

Sheba Medical Center-The Liver Diseases Center ( Site 0700)

Ramat Gan, 5262100, Israel

Location

Sourasky Medical Center-Gastroenterology and Liver Disease ( Site 0702)

Tel Aviv, 6423906, Israel

Location

Policlinico Umberto I ( Site 0801)

Rome, Lazio, 00161, Italy

Location

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0805)

Milan, Lombardy, 20122, Italy

Location

Humanitas-Medicina interna ed Epatologia ( Site 0800)

Rozzano, Lombardy, 20089, Italy

Location

Azienda Ospedaliero Universitaria ( Site 0803)

Modena, 41125, Italy

Location

Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma-Medicine ( Site 0804)

Verona, 37134, Italy

Location

Arké Estudios Clínicos S.A. de C.V.-Gastroenterology-Hepatology ( Site 0906)

Mexico City, Mexico City, 06700, Mexico

Location

Medica Sur-Clinica de Enfermedades Digestivas y Obesidad ( Site 0908)

Mexico City, Mexico City, 14050, Mexico

Location

Avix Investigación Clinica, S.C. ( Site 0907)

Monterrey, Nuevo León, 64710, Mexico

Location

Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan (

Mérida, Yucatán, 97130, Mexico

Location

Centro de Investigación y Gastroenterología ( Site 0902)

Cuauhtémoc, 06700, Mexico

Location

Christchurch Hospital-Gastroenterology Research ( Site 1002)

Christchurch, Canterbury, 8011, New Zealand

Location

Auckland City Hospital-Liver Research Unit ( Site 1003)

Auckland, 1023, New Zealand

Location

Middlemore Clinical Trials ( Site 1000)

Auckland, 2025, New Zealand

Location

Nasz Lekarz Przychodnie Medyczne ( Site 1105)

Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

Location

Centrum Medyczne Pratia Warszawa ( Site 1107)

Warsaw, Masovian Voivodeship, 01-868, Poland

Location

Clinical Medical Research ( Site 1101)

Katowice, Silesian Voivodeship, 40-156, Poland

Location

ID Clinic ( Site 1100)

Mysowice, Silesian Voivodeship, 41-400, Poland

Location

Center targetnoy therapy ( Site 1203)

Moscow, Moscow, 125008, Russia

Location

New Technologies of Medicine Clinic ( Site 1204)

Dzerzhinskiy, Moscow Oblast, 140091, Russia

Location

Saint Petersburg City Polyclinic 117-endocrinology department ( Site 1201)

Saint Petersburg, Sankt-Peterburg, 194358, Russia

Location

Astarta Clinic ( Site 1202)

Saint Petersburg, Sankt-Peterburg, 199226, Russia

Location

Soon Chun Hyang University Bucheon Hospital ( Site 1304)

Bucheon-si, Kyonggi-do, 14584, South Korea

Location

Inha University Hospital-Gastroenterolgy/Hepatology ( Site 1303)

Incheon, 22332, South Korea

Location

Severance Hospital, Yonsei University Health System ( Site 1305)

Seoul, 03722, South Korea

Location

Samsung Medical Center-Gastroenterology/Internal Medicine ( Site 1302)

Seoul, 06351, South Korea

Location

Korea University Guro Hospital ( Site 1300)

Seoul, 08308, South Korea

Location

Hospital Universitario Virgen de la Victoria-UGC Endocrinologia y nutricion ( Site 1405)

Málaga, Andalusia, 29010, Spain

Location

CHUS - Hospital Clinico Universitario ( Site 1403)

Santiago de Compostela, La Coruna, 15706, Spain

Location

Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 1400)

Barcelona, 08035, Spain

Location

HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA-Gastroenterologia y Hepatologia ( Site 1402)

Madrid, 28222, Spain

Location

HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Unidad de Ensayos Clínicos de Aparato Digestivo ( Site 1404)

Seville, 41013, Spain

Location

NATIONAL CHENG-KUNG UNI. HOSP.-Liver Research team of National Cheng Kung University Hospital ( Site

Tainan, 704, Taiwan

Location

National Taiwan University Hospital ( Site 1501)

Taipei, 10002, Taiwan

Location

Chang Gung Medical Foundation-Linkou Branch-Division of hepatology, department of gastroenterology (

Taoyuan District, 333, Taiwan

Location

Dokuz Eylül Üniversitesi-Endocrinology and Met. ( Site 1610)

Balçova, İzmir, 35330, Turkey (Türkiye)

Location

Ankara University Department of Hematology, Clinical Research Unit ( Site 1603)

Ankara, 06100, Turkey (Türkiye)

Location

Hacettepe Universitesi-internal diseases ( Site 1602)

Ankara, 06230, Turkey (Türkiye)

Location

Gazi Universitesi-gastroenterology ( Site 1605)

Ankara, 06560, Turkey (Türkiye)

Location

Bezmialem Vakf Üniversitesi-Gastroenterology ( Site 1606)

Istanbul, 34093, Turkey (Türkiye)

Location

Istanbul University Capa Campus-Gastroenterology ( Site 1604)

Istanbul, 34093, Turkey (Türkiye)

Location

Ukrainian Research Institute of Therapy ( Site 1704)

Kharkiv, Kharkivs’ka Oblast’, 310039, Ukraine

Location

L.T. Mala National Institute of Therapy of NAMS of Ukraine-Department of Aging Studies and Prevent

Kharkiv, Kharkivs’ka Oblast’, 61039, Ukraine

Location

Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho ( Site 1710)

Poltava, Poltava Oblast, 36011, Ukraine

Location

Communal Non-profit Enterprise "City Hospital #6" of Zaporizhzhia City Council-Therapy department (

Zaporizhia, Zaporizhzhia Oblast, 69035, Ukraine

Location

Adonis Plus-Outpatient department ( Site 1701)

Kyiv, 02002, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 37355043 RESULT

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: June 30, 2021
• Study Start: August 4, 2021
• Primary Completion: October 19, 2022
• Study Completion: October 19, 2022
• Last Updated: November 15, 2023
• Results First Posted: November 15, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

AU (2); FR (2); IT (5); TW (3); RU (4); IL (6); ME (5); ES (5); NZ (3); US (9); PL (4); KR (5); TU (6); UA (5); CA (1); AR (4)