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

Primary Purpose

Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Efinopegdutide 20 mg/mL
Semaglutide 1.34 mg/mL
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonalcoholic Fatty Liver Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Liver Fat Content (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 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:

  • History of 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.
  • 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.

Sites / Locations

  • Catalina Research Institute, LLC ( Site 1939)
  • Sweet Hope Research Specialty, Inc ( Site 1902)
  • Floridian Clinical Research, LLC ( Site 1950)
  • Sensible Healthcare, LLC ( Site 1903)
  • Lucas Research, Inc ( Site 1930)
  • Texas Clinical Research Institute ( Site 1910)
  • Baylor College of Medicine-Advanced Liver Therapies ( Site 1960)
  • American Research Corporation at Texas Liver Institute ( Site 1920)
  • Clinical Trials of Texas, Inc. ( Site 1906)
  • CIPREC-Laboratorio ( Site 0104)
  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0101)
  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0105)
  • IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0107)
  • Westmead Hospital-Gastroenterology & Hepatology ( Site 0204)
  • Flinders Medical Centre-Hepatology and Liver Transplant Medicine ( Site 0201)
  • Heritage Medical Research Clinic ( Site 0302)
  • Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital F-ENDOCRINOLOGY-DIABETOLOGY ( Site 0401)
  • centre hospitalier lyon sud-Endocrinologie, Diabète et Nutrition ( Site 0402)
  • Rambam Health Care Campus-Liver disease unit ( Site 0704)
  • Carmel Hospital-Liver Unit ( Site 0705)
  • Shaare Zedek Medical Center-Liver Unit ( Site 0703)
  • Rabin Medical Center ( Site 0701)
  • Sheba Medical Center-The Liver Diseases Center ( Site 0700)
  • Sourasky Medical Center-Gastroenterology and Liver Disease ( Site 0702)
  • Policlinico Umberto I ( Site 0801)
  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0805)
  • Humanitas-Medicina interna ed Epatologia ( Site 0800)
  • Azienda Ospedaliero Universitaria ( Site 0803)
  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma-Medicine ( Site 0804)
  • Soon Chun Hyang University Bucheon Hospital ( Site 1304)
  • Inha University Hospital-Gastroenterolgy/Hepatology ( Site 1303)
  • Severance Hospital, Yonsei University Health System ( Site 1305)
  • Samsung Medical Center-Gastroenterology/Internal Medicine ( Site 1302)
  • Korea University Guro Hospital ( Site 1300)
  • Medica Sur-Clinica de Enfermedades Digestivas y Obesidad ( Site 0908)
  • Arké Estudios Clínicos S.A. de C.V.-Gastroenterology-Hepatology ( Site 0906)
  • Avix Investigación Clinica, S.C. ( Site 0907)
  • Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan (
  • Centro de Investigación y Gastroenterología ( Site 0902)
  • Christchurch Hospital-Gastroenterology Research ( Site 1002)
  • Auckland City Hospital-Liver Research Unit ( Site 1003)
  • Middlemore Clinical Trials ( Site 1000)
  • Nasz Lekarz Przychodnie Medyczne ( Site 1105)
  • Centrum Medyczne Pratia Warszawa ( Site 1107)
  • Clinical Medical Research ( Site 1101)
  • ID Clinic ( Site 1100)
  • New Technologies of Medicine Clinic ( Site 1204)
  • Center targetnoy therapy ( Site 1203)
  • Saint Petersburg City Polyclinic 117-endocrinology department ( Site 1201)
  • Astarta Clinic ( Site 1202)
  • Hospital Universitario Virgen de la Victoria-UGC Endocrinologia y nutricion ( Site 1405)
  • CHUS - Hospital Clinico Universitario ( Site 1403)
  • Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 1400)
  • HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA-Gastroenterologia y Hepatologia ( Site 1402)
  • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Unidad de Ensayos Clínicos de Aparato Digestivo ( Site 1404)
  • NATIONAL CHENG-KUNG UNI. HOSP.-Liver Research team of National Cheng Kung University Hospital ( Site
  • National Taiwan University Hospital ( Site 1501)
  • Chang Gung Medical Foundation-Linkou Branch-Division of hepatology, department of gastroenterology (
  • Dokuz Eylül Üniversitesi-Endocrinology and Met. ( Site 1610)
  • Ankara University Department of Hematology, Clinical Research Unit ( Site 1603)
  • Hacettepe Universitesi-internal diseases ( Site 1602)
  • Gazi Universitesi-gastroenterology ( Site 1605)
  • Bezmialem Vakf Üniversitesi-Gastroenterology ( Site 1606)
  • Istanbul University Capa Campus-Gastroenterology ( Site 1604)
  • Ukrainian Research Institute of Therapy ( Site 1704)
  • L.T. Mala National Institute of Therapy of NAMS of Ukraine-Department of Aging Studies and Prevent
  • Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho ( Site 1710)
  • Communal Non-profit Enterprise "City Hospital #6" of Zaporizhzhia City Council-Therapy department (
  • Adonis Plus-Outpatient department ( Site 1701)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Efinopegdutide

Semaglutide

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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 will be measured with liver images taken by MRI-PDFF and analyzed by BICR. The mean relative reduction (%) from baseline in LFC after 24 weeks of treatment will be reported.
Number of Participants Who Experience an Adverse Event
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.
Number of Participants Who Discontinue Study Intervention Due to an Adverse Event
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.

Secondary Outcome Measures

Mean Absolute Reduction from Baseline in LFC Measured by MRI-PDFF (evaluated by BICR) After 24 Weeks
LFC will be measured by liver images taken by MRI-PDFF and analyzed by BICR. The mean absolute reduction from baseline in LFC after 24 weeks of treatment will be reported.
Mean Percent Change from Baseline in Body Weight After 24 weeks
Body weight (kg) will be measured using a standardized, digital scale. The mean percent change from baseline in body weight after 24 weeks will be reported.
Mean Change from Baseline in Total Cholesterol After 24 Weeks
Fasting blood samples will be collected at baseline and after 24 weeks of treatment to assess mean change in total cholesterol.
Mean Change from Baseline in Non-High Density Lipoprotein-Cholesterol (non-HDL-C) After 24 Weeks
Fasting blood samples will be collected at baseline and after 24 weeks of treatment to assess mean change in non-HDL-C.
Mean Change from Baseline in High Density Lipoprotein-Cholesterol (HDL-C) After 24 Weeks
Fasting blood samples will be collected at baseline and after 24 weeks of treatment to assess mean change in HDL-C.
Mean Change from Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) After 24 weeks
Fasting blood samples will be collected at baseline and after 24 weeks of treatment to assess mean change in LDL-C.
Mean Change from Baseline in Triglycerides (TG) After 24 Weeks
Fasting blood samples will be collected at baseline and after 24 weeks of treatment to assess mean change in triglycerides.
Mean Change from Baseline in Apolipoprotein B (apoB) After 24 Weeks
Fasting blood samples will be collected at baseline and after 24 weeks of treatment to assess mean change in apoB.

Full Information

First Posted
June 28, 2021
Last Updated
July 26, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04944992
Brief Title
A Study of Efinopegdutide (MK-6024) in Participants With Nonalcoholic Fatty Liver Disease (NAFLD) (MK-6024-001)
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
August 4, 2021 (Actual)
Primary Completion Date
October 19, 2022 (Actual)
Study Completion Date
October 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Efinopegdutide
Arm Type
Experimental
Arm Description
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.
Arm Title
Semaglutide
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Efinopegdutide 20 mg/mL
Other Intervention Name(s)
MK-6024, HM12525A, JNJ-64565111
Intervention Description
Subcutaneous injection in a dose-escalation administration of 2.4 mg, 5.0 mg, and 10.0 mg
Intervention Type
Drug
Intervention Name(s)
Semaglutide 1.34 mg/mL
Other Intervention Name(s)
Ozempic®
Intervention Description
Subcutaneous injection in a dose-escalation administration of 0.25 mg, 0.5 mg, and 1.0 mg
Primary Outcome Measure Information:
Title
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
Description
LFC will be measured with liver images taken by MRI-PDFF and analyzed by BICR. The mean relative reduction (%) from baseline in LFC after 24 weeks of treatment will be reported.
Time Frame
At Baseline and 24 weeks
Title
Number of Participants Who Experience an Adverse Event
Description
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.
Time Frame
Up to Approximately 28 weeks
Title
Number of Participants Who Discontinue Study Intervention Due to an Adverse Event
Description
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.
Time Frame
Up to approximately 24 weeks
Secondary Outcome Measure Information:
Title
Mean Absolute Reduction from Baseline in LFC Measured by MRI-PDFF (evaluated by BICR) After 24 Weeks
Description
LFC will be measured by liver images taken by MRI-PDFF and analyzed by BICR. The mean absolute reduction from baseline in LFC after 24 weeks of treatment will be reported.
Time Frame
At Baseline and 24 weeks
Title
Mean Percent Change from Baseline in Body Weight After 24 weeks
Description
Body weight (kg) will be measured using a standardized, digital scale. The mean percent change from baseline in body weight after 24 weeks will be reported.
Time Frame
At Baseline and 24 Weeks
Title
Mean Change from Baseline in Total Cholesterol After 24 Weeks
Description
Fasting blood samples will be collected at baseline and after 24 weeks of treatment to assess mean change in total cholesterol.
Time Frame
At Baseline and 24 Weeks
Title
Mean Change from Baseline in Non-High Density Lipoprotein-Cholesterol (non-HDL-C) After 24 Weeks
Description
Fasting blood samples will be collected at baseline and after 24 weeks of treatment to assess mean change in non-HDL-C.
Time Frame
At Baseline and 24 Weeks
Title
Mean Change from Baseline in High Density Lipoprotein-Cholesterol (HDL-C) After 24 Weeks
Description
Fasting blood samples will be collected at baseline and after 24 weeks of treatment to assess mean change in HDL-C.
Time Frame
At Baseline and 24 Weeks
Title
Mean Change from Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) After 24 weeks
Description
Fasting blood samples will be collected at baseline and after 24 weeks of treatment to assess mean change in LDL-C.
Time Frame
At Baseline and 24 Weeks
Title
Mean Change from Baseline in Triglycerides (TG) After 24 Weeks
Description
Fasting blood samples will be collected at baseline and after 24 weeks of treatment to assess mean change in triglycerides.
Time Frame
At Baseline and 24 Weeks
Title
Mean Change from Baseline in Apolipoprotein B (apoB) After 24 Weeks
Description
Fasting blood samples will be collected at baseline and after 24 weeks of treatment to assess mean change in apoB.
Time Frame
At Baseline and 24 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Liver Fat Content (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 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: History of 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Catalina Research Institute, LLC ( Site 1939)
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Facility Name
Sweet Hope Research Specialty, Inc ( Site 1902)
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Floridian Clinical Research, LLC ( Site 1950)
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Sensible Healthcare, LLC ( Site 1903)
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Lucas Research, Inc ( Site 1930)
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Texas Clinical Research Institute ( Site 1910)
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Baylor College of Medicine-Advanced Liver Therapies ( Site 1960)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
American Research Corporation at Texas Liver Institute ( Site 1920)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Clinical Trials of Texas, Inc. ( Site 1906)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
CIPREC-Laboratorio ( Site 0104)
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1119ACN
Country
Argentina
Facility Name
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0101)
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
B7600FZO
Country
Argentina
Facility Name
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0105)
City
Ciudad Autonoma de Buenos Aires
State/Province
Caba
ZIP/Postal Code
C1425AGC
Country
Argentina
Facility Name
IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0107)
City
Buenos Aires
ZIP/Postal Code
C1012AAR
Country
Argentina
Facility Name
Westmead Hospital-Gastroenterology & Hepatology ( Site 0204)
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Flinders Medical Centre-Hepatology and Liver Transplant Medicine ( Site 0201)
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Heritage Medical Research Clinic ( Site 0302)
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital F-ENDOCRINOLOGY-DIABETOLOGY ( Site 0401)
City
Dijon
State/Province
Cote-d Or
ZIP/Postal Code
21000
Country
France
Facility Name
centre hospitalier lyon sud-Endocrinologie, Diabète et Nutrition ( Site 0402)
City
Pierre-Bénite
State/Province
Rhone
ZIP/Postal Code
69310
Country
France
Facility Name
Rambam Health Care Campus-Liver disease unit ( Site 0704)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Carmel Hospital-Liver Unit ( Site 0705)
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Facility Name
Shaare Zedek Medical Center-Liver Unit ( Site 0703)
City
Jerusalem
ZIP/Postal Code
9778419
Country
Israel
Facility Name
Rabin Medical Center ( Site 0701)
City
Petah-Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Sheba Medical Center-The Liver Diseases Center ( Site 0700)
City
Ramat Gan
ZIP/Postal Code
5262100
Country
Israel
Facility Name
Sourasky Medical Center-Gastroenterology and Liver Disease ( Site 0702)
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Policlinico Umberto I ( Site 0801)
City
Roma
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
Facility Name
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0805)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Facility Name
Humanitas-Medicina interna ed Epatologia ( Site 0800)
City
Rozzano
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria ( Site 0803)
City
Modena
ZIP/Postal Code
41125
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma-Medicine ( Site 0804)
City
Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
Soon Chun Hyang University Bucheon Hospital ( Site 1304)
City
Bucheon
State/Province
Kyonggi-do
ZIP/Postal Code
14584
Country
Korea, Republic of
Facility Name
Inha University Hospital-Gastroenterolgy/Hepatology ( Site 1303)
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System ( Site 1305)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Samsung Medical Center-Gastroenterology/Internal Medicine ( Site 1302)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital ( Site 1300)
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Medica Sur-Clinica de Enfermedades Digestivas y Obesidad ( Site 0908)
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
14050
Country
Mexico
Facility Name
Arké Estudios Clínicos S.A. de C.V.-Gastroenterology-Hepatology ( Site 0906)
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Avix Investigación Clinica, S.C. ( Site 0907)
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64710
Country
Mexico
Facility Name
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan (
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97130
Country
Mexico
Facility Name
Centro de Investigación y Gastroenterología ( Site 0902)
City
Cuauhtémoc
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Christchurch Hospital-Gastroenterology Research ( Site 1002)
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Auckland City Hospital-Liver Research Unit ( Site 1003)
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Middlemore Clinical Trials ( Site 1000)
City
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
Nasz Lekarz Przychodnie Medyczne ( Site 1105)
City
Torun
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Centrum Medyczne Pratia Warszawa ( Site 1107)
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
01-868
Country
Poland
Facility Name
Clinical Medical Research ( Site 1101)
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-156
Country
Poland
Facility Name
ID Clinic ( Site 1100)
City
Mysowice
State/Province
Slaskie
ZIP/Postal Code
41-400
Country
Poland
Facility Name
New Technologies of Medicine Clinic ( Site 1204)
City
Dzerzhinskiy
State/Province
Moskovskaya Oblast
ZIP/Postal Code
140091
Country
Russian Federation
Facility Name
Center targetnoy therapy ( Site 1203)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
125008
Country
Russian Federation
Facility Name
Saint Petersburg City Polyclinic 117-endocrinology department ( Site 1201)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
194358
Country
Russian Federation
Facility Name
Astarta Clinic ( Site 1202)
City
Saint-Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
199226
Country
Russian Federation
Facility Name
Hospital Universitario Virgen de la Victoria-UGC Endocrinologia y nutricion ( Site 1405)
City
Malaga
State/Province
Andalucia
ZIP/Postal Code
29010
Country
Spain
Facility Name
CHUS - Hospital Clinico Universitario ( Site 1403)
City
Santiago de Compostela
State/Province
La Coruna
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 1400)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA-Gastroenterologia y Hepatologia ( Site 1402)
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Unidad de Ensayos Clínicos de Aparato Digestivo ( Site 1404)
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
NATIONAL CHENG-KUNG UNI. HOSP.-Liver Research team of National Cheng Kung University Hospital ( Site
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital ( Site 1501)
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Chang Gung Medical Foundation-Linkou Branch-Division of hepatology, department of gastroenterology (
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Dokuz Eylül Üniversitesi-Endocrinology and Met. ( Site 1610)
City
Balçova
State/Province
Izmir
ZIP/Postal Code
35330
Country
Turkey
Facility Name
Ankara University Department of Hematology, Clinical Research Unit ( Site 1603)
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Hacettepe Universitesi-internal diseases ( Site 1602)
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Gazi Universitesi-gastroenterology ( Site 1605)
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
Facility Name
Bezmialem Vakf Üniversitesi-Gastroenterology ( Site 1606)
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Istanbul University Capa Campus-Gastroenterology ( Site 1604)
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Ukrainian Research Institute of Therapy ( Site 1704)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
310039
Country
Ukraine
Facility Name
L.T. Mala National Institute of Therapy of NAMS of Ukraine-Department of Aging Studies and Prevent
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61039
Country
Ukraine
Facility Name
Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho ( Site 1710)
City
Poltava
State/Province
Poltavska Oblast
ZIP/Postal Code
36011
Country
Ukraine
Facility Name
Communal Non-profit Enterprise "City Hospital #6" of Zaporizhzhia City Council-Therapy department (
City
Zaporizhia
State/Province
Zaporizka Oblast
ZIP/Postal Code
69035
Country
Ukraine
Facility Name
Adonis Plus-Outpatient department ( Site 1701)
City
Kyiv
ZIP/Postal Code
02002
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
37355043
Citation
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.
Results Reference
result
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information

Learn more about this trial

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

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