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A Clinical Study of Efinopegdutide in Participants With Precirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-6024-013)

Primary Purpose

Non-alcoholic Fatty Liver Disease, Fatty Liver, Nonalcoholic, NAFLD

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Efinopegdutide
Semaglutide
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-alcoholic Fatty Liver Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histological confirmation of NASH, defined as NAFLD Activity Score (NAS) ≥4 with a score ≥1 point in each component (steatosis, ballooning, and lobular inflammation) AND NASH clinical research network (CRN) fibrosis score of Stage 2 or 3 No history of Type 2 diabetes mellitus (T2DM) OR a history of T2DM with an A1C ≤9% that is controlled by diet or stable doses of antihyperglycemic agents (AHAs) Participants in South Korea are eligible between the ages of 19 to 80 years of age (inclusive) Exclusion Criteria: History of liver disease other than NASH History or evidence of cirrhosis History of pancreatitis History of Type 1 diabetes mellitus (T1DM), diabetic ketoacidosis, or diabetes secondary to pancreatectomy History of a bariatric surgical procedure ≤5 years before study entry, or a known clinically significant gastric emptying abnormality Has significant systemic or major illnesses, including recent events (≤6 months before study entry) of congestive heart failure, unstable angina, myocardial infarction, arterial revascularization, stroke, or transient ischemic attack

Sites / Locations

  • Del Sol Research Management, LLC ( Site 3211)Recruiting
  • Velocity Clinical Research, Gardena ( Site 3225)Recruiting
  • Velocity Clinical Research, Huntington Park ( Site 3217)Recruiting
  • Velocity Clinical Research, San Diego ( Site 3226)Recruiting
  • Velocity Clinical Research, Westlake ( Site 3216)Recruiting
  • Velocity Clinical Research, Panorama City ( Site 3214)Recruiting
  • California Liver Research Institute ( Site 3232)Recruiting
  • Clinical Trials Research ( Site 3230)Recruiting
  • Top Medical Research ( Site 3209)Recruiting
  • Covenant Metabolic Specialists, LLC ( Site 3231)Recruiting
  • Velocity Clinical Research, Hallandale Beach ( Site 3241)Recruiting
  • Indago Research & Health Center, Inc ( Site 3207)Recruiting
  • Sweet Hope Research Specialty, Inc-Research ( Site 3200)Recruiting
  • Floridian Clinical Research, LLC ( Site 3203)Recruiting
  • Genoma Research Group ( Site 3242)Recruiting
  • Eagle Clinical Research ( Site 3233)Recruiting
  • University of Iowa ( Site 3213)Recruiting
  • Velocity Clinical Research, Syracuse ( Site 3227)Recruiting
  • New York Gastroenterology Associates ( Site 3252)Recruiting
  • Velocity Clinical Research, Cincinnati ( Site 3237)Recruiting
  • Velocity Clinical Research, Providence ( Site 3222)Recruiting
  • Velocity Clinical Research, Dallas ( Site 3220)Recruiting
  • American Research Corporation ( Site 3202)Recruiting
  • Velocity Clinical Research, Salt Lake City ( Site 3223)Recruiting
  • Enroll SpA ( Site 0501)Recruiting
  • CECIM ( Site 0500)Recruiting
  • centre hospitalier lyon sud-Endocrinologie, Diabète et Nutrition ( Site 0906)Recruiting
  • Prince of Wales Hospital ( Site 1000)Recruiting
  • Rambam Health Care Campus ( Site 1304)Recruiting
  • Carmel Hospital ( Site 1305)Recruiting
  • Rabin Medical Center ( Site 1301)Recruiting
  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 1403)Recruiting
  • Ehime University Hospital ( Site 1509)Recruiting
  • Kurume University Hospital ( Site 1504)Recruiting
  • Ogaki Municipal Hospital ( Site 1511)Recruiting
  • Sapporo Kosei General Hospital ( Site 1521)Recruiting
  • Kagawa Prefectural Central Hospital ( Site 1514)Recruiting
  • Shinyurigaoka General Hospital ( Site 1518)Recruiting
  • St. Marianna University Hospital ( Site 1516)Recruiting
  • Yokohama City University Hospital ( Site 1505)Recruiting
  • Shinshu University Hospital ( Site 1512)Recruiting
  • Nara Medical University Hospital ( Site 1513)Recruiting
  • Osaka Saiseikai Suita Hospital ( Site 1503)Recruiting
  • Fukuiken Saiseikai Hospital ( Site 1507)Recruiting
  • Gifu Municipal Hospital ( Site 1506)Recruiting
  • University Hospital,Kyoto Prefectural University of Medicine ( Site 1519)Recruiting
  • Kawasaki Medical School General Medical Center ( Site 1508)Recruiting
  • Osaka Metropolitan University Hospital ( Site 1520)Recruiting
  • Saga University Hospital ( Site 1510)Recruiting
  • Japanese Red Cross Musashino Hospital ( Site 1517)Recruiting
  • Boramae Medical Center-Internal Medicine ( Site 2403)Recruiting
  • Inha University Hospital-Gastroenterolgy/Hepatology ( Site 2402)Recruiting
  • Severance Hospital, Yonsei University Health System ( Site 2401)Recruiting
  • Samsung Medical Center-Gastroenterology/Internal Medicine ( Site 2400)Recruiting
  • ISIS CLINICAL RESEARCH CENTER ( Site 2006)Recruiting
  • Pan American Center for Oncology Trials ( Site 2000)Recruiting
  • Klinical Investigations Group-Clinical Research ( Site 2001)Recruiting
  • Latin Clinical Trial Center ( Site 2004)Recruiting
  • Hospital Universitario Marqués de Valdecilla-Gastroenterology and Hepatology ( Site 2505)Recruiting
  • Hospital General de Tomelloso-Aparato Digestivo ( Site 2514)Recruiting
  • CHUAC-Complejo Hospitalario Universitario A Coruña-Endocrinología ( Site 2511)Recruiting
  • Hospital Universitario Ramón y Cajal ( Site 2508)Recruiting
  • Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 2507)Recruiting
  • Hospital Universitario La Paz-HEPATOLOGIA ( Site 2509)Recruiting
  • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Unidad de Ensayos Clínicos de Aparato Digestivo ( Site 2504)Recruiting
  • Changhua Christian Hospital-Endocrinology and metabolism ( Site 2704)Recruiting
  • Chiayi Christian Hospital ( Site 2707)Recruiting
  • Taichung Veterans General Hospital ( Site 2703)Recruiting
  • National Cheng Kung University Hospital-Liver Research team of National Cheng Kung University HospiRecruiting
  • National Taiwan University Hospital-Internal Medicine ( Site 2700)Recruiting
  • Taipei Veterans General Hospital-Division of Gastroenterology & Hepatology, Department of Medicine (Recruiting
  • Chang Gung Medical Foundation-Linkou Branch ( Site 2702)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

Efinopegdutide 4mg

Efinopegdutide 7mg

Efinopegdutide 10mg

Placebo

Semaglutide 2.4 mg

Arm Description

Efinopegdutide administered by subcutaneous (SC) injection once weekly for 52 weeks in a dose-escalation regimen of 2 mg for 4 weeks and 4mg for 48 weeks.

Efinopegdutide administered by SC injection once weekly for 52 weeks in a dose-escalation regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, and 7 mg for 44 weeks.

Efinopegdutide administered by SC injection once weekly for 52 weeks in a dose-escalation regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for 40 weeks.

Placebo administered by SC injection once weekly for 52 weeks

Semaglutide administered by SC injection once weekly for 52 weeks in a dose-escalation regimen of 0.25 mg for 4 weeks, 0.5 mg for 4 weeks, 1.0 mg for 4 weeks, 1.7 mg for 4 weeks, and 2.4 mg for 36 weeks.

Outcomes

Primary Outcome Measures

Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis At Week 52
The NASH Clinical Research Network (CRN) scoring system evaluated by Blinded Independent Central Review (BICR) is used to assess treatment response. The NASH CRN scoring scales are: lobular inflammation score (0-3); hepatocyte ballooning score (0-2); steatosis score (0-3); and fibrosis score (0-4). NASH resolution is defined as a score of 0-1 for inflammation, 0 for ballooning, and any grade of steatosis.
Percentage of Participants Who Experienced an Adverse Event (AE)
An adverse event (AE) is a health problem that happens or worsens during a study.
Percentage of Participants Discontinuing Study Medication Due to an AE
An adverse event (AE) is a health problem that happens or worsens during a study.

Secondary Outcome Measures

Percentage of Participants With ≥1 Stage Improvement in Fibrosis Without Worsening of Steatohepatitis At Week 52
Participants will be assessed using the NASH CRN scoring system evaluated by BICR for ≥1-stage improvement in fibrosis without worsening of steatohepatitis. Fibrosis is scored from stage 0 to 4 where 0 = None, 1=Perisinusoidal OR periportal, 2=Perisinusoidal AND portal/periportal, 3= Bridging fibrosis, 4=Cirrhosis. No worsening of steatohepatitis is defined as no increase in the ballooning, inflammation, or steatosis scores.
Change from Baseline in Body Weight At Week 52
Body weight (kg) will be measured using a standardized, digital scale. The percent change from baseline in body weight after 52 weeks will be reported.

Full Information

First Posted
May 17, 2023
Last Updated
October 19, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05877547
Brief Title
A Clinical Study of Efinopegdutide in Participants With Precirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-6024-013)
Official Title
A Phase 2b Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Adults With Precirrhotic Nonalcoholic Steatohepatitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2023 (Actual)
Primary Completion Date
December 5, 2025 (Anticipated)
Study Completion Date
December 5, 2025 (Anticipated)

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
Yes

5. Study Description

Brief Summary
The purpose of this study is to learn how well efinopegdutide works compared to placebo in people who have non-alcoholic steatohepatitis (NASH). Researchers will also learn about the safety and benefit of efinopegdutide and how well people tolerate the medicine. The main goal of the study is to compare how many people taking efinopegdutide or placebo stop showing evidence of NASH without liver scarring getting worse.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Efinopegdutide 4mg
Arm Type
Experimental
Arm Description
Efinopegdutide administered by subcutaneous (SC) injection once weekly for 52 weeks in a dose-escalation regimen of 2 mg for 4 weeks and 4mg for 48 weeks.
Arm Title
Efinopegdutide 7mg
Arm Type
Experimental
Arm Description
Efinopegdutide administered by SC injection once weekly for 52 weeks in a dose-escalation regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, and 7 mg for 44 weeks.
Arm Title
Efinopegdutide 10mg
Arm Type
Experimental
Arm Description
Efinopegdutide administered by SC injection once weekly for 52 weeks in a dose-escalation regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for 40 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered by SC injection once weekly for 52 weeks
Arm Title
Semaglutide 2.4 mg
Arm Type
Active Comparator
Arm Description
Semaglutide administered by SC injection once weekly for 52 weeks in a dose-escalation regimen of 0.25 mg for 4 weeks, 0.5 mg for 4 weeks, 1.0 mg for 4 weeks, 1.7 mg for 4 weeks, and 2.4 mg for 36 weeks.
Intervention Type
Drug
Intervention Name(s)
Efinopegdutide
Other Intervention Name(s)
MK-6024, HM12525A, JNJ-64565111
Intervention Description
Subcutaneous (SC) injection in dose-escalation regimens potentially including doses of 2 mg, 4 mg, 7 mg, and 10 mg
Intervention Type
Drug
Intervention Name(s)
Semaglutide
Other Intervention Name(s)
Wegovy
Intervention Description
SC injection in a dose-escalation regimen of 0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
SC injection of matching placebo
Primary Outcome Measure Information:
Title
Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis At Week 52
Description
The NASH Clinical Research Network (CRN) scoring system evaluated by Blinded Independent Central Review (BICR) is used to assess treatment response. The NASH CRN scoring scales are: lobular inflammation score (0-3); hepatocyte ballooning score (0-2); steatosis score (0-3); and fibrosis score (0-4). NASH resolution is defined as a score of 0-1 for inflammation, 0 for ballooning, and any grade of steatosis.
Time Frame
Week 52
Title
Percentage of Participants Who Experienced an Adverse Event (AE)
Description
An adverse event (AE) is a health problem that happens or worsens during a study.
Time Frame
Up to 60 weeks
Title
Percentage of Participants Discontinuing Study Medication Due to an AE
Description
An adverse event (AE) is a health problem that happens or worsens during a study.
Time Frame
Up to 52 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With ≥1 Stage Improvement in Fibrosis Without Worsening of Steatohepatitis At Week 52
Description
Participants will be assessed using the NASH CRN scoring system evaluated by BICR for ≥1-stage improvement in fibrosis without worsening of steatohepatitis. Fibrosis is scored from stage 0 to 4 where 0 = None, 1=Perisinusoidal OR periportal, 2=Perisinusoidal AND portal/periportal, 3= Bridging fibrosis, 4=Cirrhosis. No worsening of steatohepatitis is defined as no increase in the ballooning, inflammation, or steatosis scores.
Time Frame
Week 52
Title
Change from Baseline in Body Weight At Week 52
Description
Body weight (kg) will be measured using a standardized, digital scale. The percent change from baseline in body weight after 52 weeks will be reported.
Time Frame
Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histological confirmation of NASH, defined as NAFLD Activity Score (NAS) ≥4 with a score ≥1 point in each component (steatosis, ballooning, and lobular inflammation) AND NASH clinical research network (CRN) fibrosis score of Stage 2 or 3 No history of Type 2 diabetes mellitus (T2DM) OR a history of T2DM with an A1C ≤9% that is controlled by diet or stable doses of antihyperglycemic agents (AHAs) Participants in South Korea are eligible between the ages of 19 to 80 years of age (inclusive) Exclusion Criteria: History of liver disease other than NASH History or evidence of cirrhosis History of pancreatitis History of Type 1 diabetes mellitus (T1DM), diabetic ketoacidosis, or diabetes secondary to pancreatectomy History of a bariatric surgical procedure ≤5 years before study entry, or a known clinically significant gastric emptying abnormality Has significant systemic or major illnesses, including recent events (≤6 months before study entry) of congestive heart failure, unstable angina, myocardial infarction, arterial revascularization, stroke, or transient ischemic attack
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
1-888-577-8839
Email
Trialsites@merck.com
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
Del Sol Research Management, LLC ( Site 3211)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
520-257-3881
Facility Name
Velocity Clinical Research, Gardena ( Site 3225)
City
Gardena
State/Province
California
ZIP/Postal Code
90247
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
310-351-1368
Facility Name
Velocity Clinical Research, Huntington Park ( Site 3217)
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
323-588-1968
Facility Name
Velocity Clinical Research, San Diego ( Site 3226)
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
619-567-1550
Facility Name
Velocity Clinical Research, Westlake ( Site 3216)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
213-483-1800
Facility Name
Velocity Clinical Research, Panorama City ( Site 3214)
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
818-532-6880
Facility Name
California Liver Research Institute ( Site 3232)
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
626-795-5769
Facility Name
Clinical Trials Research ( Site 3230)
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
001-916-434-8230
Facility Name
Top Medical Research ( Site 3209)
City
Cutler Bay
State/Province
Florida
ZIP/Postal Code
33189
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
305-971-6883
Facility Name
Covenant Metabolic Specialists, LLC ( Site 3231)
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
941-894-2014
Facility Name
Velocity Clinical Research, Hallandale Beach ( Site 3241)
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
954-455-5757
Facility Name
Indago Research & Health Center, Inc ( Site 3207)
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
305-825-6588
Facility Name
Sweet Hope Research Specialty, Inc-Research ( Site 3200)
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
786-560-5794
Facility Name
Floridian Clinical Research, LLC ( Site 3203)
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
954-439-0531
Facility Name
Genoma Research Group ( Site 3242)
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
305-392-1264
Facility Name
Eagle Clinical Research ( Site 3233)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60621
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
708-646-1080
Facility Name
University of Iowa ( Site 3213)
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
319-335-6707
Facility Name
Velocity Clinical Research, Syracuse ( Site 3227)
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
315-760-5905
Facility Name
New York Gastroenterology Associates ( Site 3252)
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
347-248-8719
Facility Name
Velocity Clinical Research, Cincinnati ( Site 3237)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
813-263-8991
Facility Name
Velocity Clinical Research, Providence ( Site 3222)
City
East Greenwich
State/Province
Rhode Island
ZIP/Postal Code
02818
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
401-739-9350
Facility Name
Velocity Clinical Research, Dallas ( Site 3220)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
972-566-7799
Facility Name
American Research Corporation ( Site 3202)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
210-253-3426
Facility Name
Velocity Clinical Research, Salt Lake City ( Site 3223)
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
801-542-8190
Facility Name
Enroll SpA ( Site 0501)
City
Providencia
State/Province
Region M. De Santiago
ZIP/Postal Code
7500587
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
964790949
Facility Name
CECIM ( Site 0500)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8320000
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56968352630
Facility Name
centre hospitalier lyon sud-Endocrinologie, Diabète et Nutrition ( Site 0906)
City
Pierre-Bénite
State/Province
Rhone-Alpes
ZIP/Postal Code
69494 Cédex
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33478861489
Facility Name
Prince of Wales Hospital ( Site 1000)
City
Shatin
ZIP/Postal Code
NT
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
852-92176788
Facility Name
Rambam Health Care Campus ( Site 1304)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+972 54 4746115
Facility Name
Carmel Hospital ( Site 1305)
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
97248250053
Facility Name
Rabin Medical Center ( Site 1301)
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
97239377252
Facility Name
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 1403)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+39 02 55033301
Facility Name
Ehime University Hospital ( Site 1509)
City
Toon
State/Province
Ehime
ZIP/Postal Code
7910295
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-89-964-5111
Facility Name
Kurume University Hospital ( Site 1504)
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-942-35-3311
Facility Name
Ogaki Municipal Hospital ( Site 1511)
City
Ogaki
State/Province
Gifu
ZIP/Postal Code
503-0864
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-5-8481-3341
Facility Name
Sapporo Kosei General Hospital ( Site 1521)
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0033
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-11-261-5331
Facility Name
Kagawa Prefectural Central Hospital ( Site 1514)
City
Takamatsu
State/Province
Kagawa
ZIP/Postal Code
760-8557
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-87-811-3333
Facility Name
Shinyurigaoka General Hospital ( Site 1518)
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
215-0026
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-44-322-9991
Facility Name
St. Marianna University Hospital ( Site 1516)
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-44-977-8111
Facility Name
Yokohama City University Hospital ( Site 1505)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
2360004
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-4-5787-2800
Facility Name
Shinshu University Hospital ( Site 1512)
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
390-8621
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-263-37-3389
Facility Name
Nara Medical University Hospital ( Site 1513)
City
Kashihara
State/Province
Nara
ZIP/Postal Code
634-8522
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-744-22-3051
Facility Name
Osaka Saiseikai Suita Hospital ( Site 1503)
City
Suita
State/Province
Osaka
ZIP/Postal Code
564-0013
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-6-6382-1521
Facility Name
Fukuiken Saiseikai Hospital ( Site 1507)
City
Fukui
ZIP/Postal Code
918-8503
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-776-23-1111
Facility Name
Gifu Municipal Hospital ( Site 1506)
City
Gifu
ZIP/Postal Code
500-8513
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-952-34-3010
Facility Name
University Hospital,Kyoto Prefectural University of Medicine ( Site 1519)
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-75-251-5111
Facility Name
Kawasaki Medical School General Medical Center ( Site 1508)
City
Okayama
ZIP/Postal Code
700-8505
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-8-6225-2111
Facility Name
Osaka Metropolitan University Hospital ( Site 1520)
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-6-6645-2121
Facility Name
Saga University Hospital ( Site 1510)
City
Saga
ZIP/Postal Code
849-8501
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-952-34-3010
Facility Name
Japanese Red Cross Musashino Hospital ( Site 1517)
City
Tokyo
ZIP/Postal Code
180-8610
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-422-32-3111
Facility Name
Boramae Medical Center-Internal Medicine ( Site 2403)
City
Dongjak-gu
State/Province
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Inha University Hospital-Gastroenterolgy/Hepatology ( Site 2402)
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82328902548
Facility Name
Severance Hospital, Yonsei University Health System ( Site 2401)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82222281988
Facility Name
Samsung Medical Center-Gastroenterology/Internal Medicine ( Site 2400)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82234103878
Facility Name
ISIS CLINICAL RESEARCH CENTER ( Site 2006)
City
Guaynabo
ZIP/Postal Code
00970
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
7874045252
Facility Name
Pan American Center for Oncology Trials ( Site 2000)
City
Rio Piedras
ZIP/Postal Code
00935
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
787-362-9625
Facility Name
Klinical Investigations Group-Clinical Research ( Site 2001)
City
San Juan
ZIP/Postal Code
00907
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
7879197865
Facility Name
Latin Clinical Trial Center ( Site 2004)
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
7879859911
Facility Name
Hospital Universitario Marqués de Valdecilla-Gastroenterology and Hepatology ( Site 2505)
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39005
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
942204073
Facility Name
Hospital General de Tomelloso-Aparato Digestivo ( Site 2514)
City
Tomelloso
State/Province
Ciudad Real
ZIP/Postal Code
13700
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0034926525927
Facility Name
CHUAC-Complejo Hospitalario Universitario A Coruña-Endocrinología ( Site 2511)
City
A Coruña
State/Province
La Coruna
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
34655624017
Facility Name
Hospital Universitario Ramón y Cajal ( Site 2508)
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
34913368589
Facility Name
Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 2507)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
34-666630248
Facility Name
Hospital Universitario La Paz-HEPATOLOGIA ( Site 2509)
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
34912071876
Facility Name
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Unidad de Ensayos Clínicos de Aparato Digestivo ( Site 2504)
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
955012065
Facility Name
Changhua Christian Hospital-Endocrinology and metabolism ( Site 2704)
City
Changhua County
State/Province
Changhua
ZIP/Postal Code
50006
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
886-7238595-3239
Facility Name
Chiayi Christian Hospital ( Site 2707)
City
Chiayi City
State/Province
Chiayi
ZIP/Postal Code
600
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+886 971-000-208
Facility Name
Taichung Veterans General Hospital ( Site 2703)
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
8864235925253309
Facility Name
National Cheng Kung University Hospital-Liver Research team of National Cheng Kung University Hospi
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+886 6 235 3535
Facility Name
National Taiwan University Hospital-Internal Medicine ( Site 2700)
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+886972651071
Facility Name
Taipei Veterans General Hospital-Division of Gastroenterology & Hepatology, Department of Medicine (
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+886938590872
Facility Name
Chang Gung Medical Foundation-Linkou Branch ( Site 2702)
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
886975366077

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
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=6024-013&&kw=6024-013
Description
Plain Language Summary

Learn more about this trial

A Clinical Study of Efinopegdutide in Participants With Precirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-6024-013)

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