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Nonalcoholic Fatty Liver DiseasePhase 2NCT04944992

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

A Phase 2 study testing Efinopegdutide 20 mg/mL and Semaglutide 1.34 mg/mL in people with Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis, run by Merck Sharp & Dohme LLC at 69 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Efinopegdutide 20 mg/mL and Semaglutide 1.34 mg/mL
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
145 participants
Where
69 sitesin 16 countries
Study dates
4 Aug 2021to 19 Oct 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 22Show fewer
  • 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.

Trial locations and contacts

69 sites in 16 countries.

69 sites in 16 countries

United States9 sites

  • Texas Clinical Research Institute ( Site 1910)

    Arlington, Texas, 76012

  • Sweet Hope Research Specialty, Inc ( Site 1902)

    Hialeah, Florida, 33016

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

    Houston, Texas, 77030

  • Floridian Clinical Research, LLC ( Site 1950)

    Miami Lakes, Florida, 33016

  • Catalina Research Institute, LLC ( Site 1939)

    Montclair, California, 91763

  • Lucas Research, Inc ( Site 1930)

    Morehead City, North Carolina, 28557

  • Sensible Healthcare, LLC ( Site 1903)

    Ocoee, Florida, 34761

  • American Research Corporation at Texas Liver Institute ( Site 1920)

    San Antonio, Texas, 78215

  • Clinical Trials of Texas, Inc. ( Site 1906)

    San Antonio, Texas, 78229

Other trials in United States

Israel6 sites

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

    Haifa, 3109601

  • Carmel Hospital-Liver Unit ( Site 0705)

    Haifa, 3436212

  • Shaare Zedek Medical Center-Liver Unit ( Site 0703)

    Jerusalem, 9778419

  • Rabin Medical Center ( Site 0701)

    Petah Tikva, 49100

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

    Ramat Gan, 5262100

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

    Tel Aviv, 6423906

Other trials in Israel

Turkey (Türkiye)6 sites

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

    Ankara, 06100

  • Hacettepe Universitesi-internal diseases ( Site 1602)

    Ankara, 06230

  • Gazi Universitesi-gastroenterology ( Site 1605)

    Ankara, 06560

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

    Balçova, İzmir, 35330

  • Bezmialem Vakf Üniversitesi-Gastroenterology ( Site 1606)

    Istanbul, 34093

  • Istanbul University Capa Campus-Gastroenterology ( Site 1604)

    Istanbul, 34093

Other trials in Turkey (Türkiye)

Italy5 sites

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0805)

    Milan, Lombardy, 20122

  • Azienda Ospedaliero Universitaria ( Site 0803)

    Modena, 41125

  • Policlinico Umberto I ( Site 0801)

    Rome, Lazio, 00161

  • Humanitas-Medicina interna ed Epatologia ( Site 0800)

    Rozzano, Lombardy, 20089

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

    Verona, 37134

Other trials in Italy

Mexico5 sites

  • Centro de Investigación y Gastroenterología ( Site 0902)

    Cuauhtémoc, 06700

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

    Mérida, Yucatán, 97130

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

    Mexico City, Mexico City, 06700

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

    Mexico City, Mexico City, 14050

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

    Monterrey, Nuevo León, 64710

Other trials in Mexico

South Korea5 sites

  • Soon Chun Hyang University Bucheon Hospital ( Site 1304)

    Bucheon-si, Kyonggi-do, 14584

  • Inha University Hospital-Gastroenterolgy/Hepatology ( Site 1303)

    Incheon, 22332

  • Severance Hospital, Yonsei University Health System ( Site 1305)

    Seoul, 03722

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

    Seoul, 06351

  • Korea University Guro Hospital ( Site 1300)

    Seoul, 08308

Other trials in South Korea

Spain5 sites

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

    Barcelona, 08035

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

    Madrid, 28222

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

    Málaga, Andalusia, 29010

  • CHUS - Hospital Clinico Universitario ( Site 1403)

    Santiago de Compostela, La Coruna, 15706

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

    Seville, 41013

Other trials in Spain

Ukraine5 sites

  • Ukrainian Research Institute of Therapy ( Site 1704)

    Kharkiv, Kharkiv Oblast, 310039

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

    Kharkiv, Kharkiv Oblast, 61039

  • Adonis Plus-Outpatient department ( Site 1701)

    Kyiv, 02002

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

    Poltava, Poltava Oblast, 36011

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

    Zaporizhia, Zaporizhzhia Oblast, 69035

Other trials in Ukraine

Argentina4 sites

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

    Buenos Aires, Buenos Aires F.D., C1425AGC

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

    Buenos Aires, C1012AAR

  • CIPREC-Laboratorio ( Site 0104)

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1119ACN

  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0101)

    Mar del Plata, Buenos Aires, B7600FZO

Other trials in Argentina

Poland4 sites

  • Clinical Medical Research ( Site 1101)

    Katowice, Silesian Voivodeship, 40-156

  • ID Clinic ( Site 1100)

    Mysowice, Silesian Voivodeship, 41-400

  • Nasz Lekarz Przychodnie Medyczne ( Site 1105)

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • Centrum Medyczne Pratia Warszawa ( Site 1107)

    Warsaw, Masovian Voivodeship, 01-868

Other trials in Poland

Russia4 sites

  • New Technologies of Medicine Clinic ( Site 1204)

    Dzerzhinskiy, Moscow Oblast, 140091

  • Center targetnoy therapy ( Site 1203)

    Moscow, Moscow, 125008

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

    Saint Petersburg, Sankt-Peterburg, 194358

  • Astarta Clinic ( Site 1202)

    Saint Petersburg, Sankt-Peterburg, 199226

Other trials in Russia

New Zealand3 sites

  • Auckland City Hospital-Liver Research Unit ( Site 1003)

    Auckland, 1023

  • Middlemore Clinical Trials ( Site 1000)

    Auckland, 2025

  • Christchurch Hospital-Gastroenterology Research ( Site 1002)

    Christchurch, Canterbury, 8011

Other trials in New Zealand

Taiwan3 sites

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

    Tainan, 704

  • National Taiwan University Hospital ( Site 1501)

    Taipei, 10002

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

    Taoyuan, 333

Other trials in Taiwan

Australia2 sites

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

    Bedford Park, South Australia, 5042

  • Westmead Hospital-Gastroenterology & Hepatology ( Site 0204)

    Westmead, New South Wales, 2145

Other trials in Australia

France2 sites

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

    Dijon, Cote-d Or, 21000

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

    Pierre-Bénite, Rhone, 69310

Other trials in France

Canada1 site

  • Heritage Medical Research Clinic ( Site 0302)

    Calgary, Alberta, T2N 4Z6

Other trials in Canada

About this study

Official title: 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

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.

Being tested
Efinopegdutide 20 mg/mL, Semaglutide 1.34 mg/mL
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Efinopegdutide 20 mg/mLDrug

    Also called MK-6024, HM12525A, JNJ-64565111

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

  • Semaglutide 1.34 mg/mLDrug

    Also called Ozempic®

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

Study groups in NCT04944992
Study groupRoleWhat they receive
EfinopegdutideExperimentalEfinopegdutide 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.
Receives: Drug: Efinopegdutide 20 mg/mL
SemaglutideActive comparatorSemaglutide 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.
Receives: Drug: Semaglutide 1.34 mg/mL

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and up to ~24 Weeks

  2. 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.

    Measured: Up to ~29 weeks

  3. 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.

    Measured: Up to ~24 weeks

Secondary outcomes (8)

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

    LFC was measured by liver images taken by MRI-PDFF and analyzed by BICR. The absolute reduction from baseline to Week 24 = Baseline - Week 24. The mean absolute reduction from baseline in LFC after 24 weeks of treatment is presented.

    Measured: Baseline and up to ~24 Weeks

  2. Mean Percent Change From Baseline in Body Weight After 24 Weeks

    Body weight in kilograms was measured using a standardized, digital scale. The mean percent change from baseline in body weight after 24 weeks is presented.

    Measured: Baseline and up to ~24 weeks

  3. Mean Percent Change From Baseline in Total Cholesterol After 24 Weeks

    Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in total cholesterol. The mean percent change in total cholesterol is presented.

    Measured: Baseline and up to ~24 weeks

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

    Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in non-HDL-C. The mean percent change in non-HDL-C is presented.

    Measured: Baseline and up to ~24 weeks

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

    Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in HDL-C. Mean percent change in HDL-C is presented.

    Measured: Baseline and up to ~24 weeks

  6. Mean Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) After 24 Weeks

    Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in LDL-C. The mean percent change in LDL-C is presented.

    Measured: Baseline and up to ~24 weeks

  7. Mean Percent Change From Baseline in Triglycerides (TG) After 24 Weeks

    Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in triglycerides. The mean percent change in triglycerides is presented.

    Measured: Baseline and up to ~24 weeks

  8. Mean Percent Change From Baseline in Apolipoprotein B (apoB) After 24 Weeks

    Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in apoB. The mean percent change in apoB is presented.

    Measured: Baseline and up to ~24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2021
  2. Study start4 Aug 2021
  3. Primary completion19 Oct 2022
  4. Study completion19 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
145 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04944992
Sponsor's protocol ID
6024-001
Other IDs
MK-6024-001, 2020-005136-30
Status last verified
Oct 2023
First submitted
28 Jun 2021
Last updated
15 Nov 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • 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.

    PubMed 37355043

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Efinopegdutide 20 mg/mL and Semaglutide 1.34 mg/mL in people with Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis, run by Merck Sharp & Dohme LLC at 69 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in United States, Israel, Turkey (Türkiye), Italy, Mexico and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Baseline and up to ~24 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04944992, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.

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