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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04944992




Registration number
NCT04944992
Ethics application status
Date submitted
28/06/2021
Date registered
30/06/2021

Titles & IDs
Public title
A Study of Efinopegdutide (MK-6024) in Participants With Nonalcoholic Fatty Liver Disease (NAFLD) (MK-6024-001)
Scientific 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
Secondary ID [1] 0 0
MK-6024-001
Secondary ID [2] 0 0
6024-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nonalcoholic Fatty Liver Disease 0 0
Nonalcoholic Steatohepatitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Liver
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Efinopegdutide 20 mg/mL
Treatment: Drugs - Semaglutide 1.34 mg/mL

Experimental: Efinopegdutide - Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.

Active comparator: Semaglutide - Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.


Treatment: Drugs: Efinopegdutide 20 mg/mL
Subcutaneous injection in a dose-escalation administration of 2.4 mg, 5.0 mg, and 10.0 mg

Treatment: Drugs: Semaglutide 1.34 mg/mL
Subcutaneous injection in a dose-escalation administration of 0.25 mg, 0.5 mg, and 1.0 mg
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Baseline and up to ~24 Weeks
Primary outcome [2] 0 0
Percentage of Participants Who Experienced an Adverse Event (AE)
Timepoint [2] 0 0
Up to ~29 weeks
Primary outcome [3] 0 0
Percentage of Participants Who Discontinued Study Intervention Due to an AE
Timepoint [3] 0 0
Up to ~24 weeks
Secondary outcome [1] 0 0
Mean Absolute Reduction From Baseline in LFC Measured by MRI-PDFF (Evaluated by BICR) After 24 Weeks
Timepoint [1] 0 0
Baseline and up to ~24 Weeks
Secondary outcome [2] 0 0
Mean Percent Change From Baseline in Body Weight After 24 Weeks
Timepoint [2] 0 0
Baseline and up to ~24 weeks
Secondary outcome [3] 0 0
Mean Percent Change From Baseline in Total Cholesterol After 24 Weeks
Timepoint [3] 0 0
Baseline and up to ~24 weeks
Secondary outcome [4] 0 0
Mean Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) After 24 Weeks
Timepoint [4] 0 0
Baseline and up to ~24 weeks
Secondary outcome [5] 0 0
Mean Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) After 24 Weeks
Timepoint [5] 0 0
Baseline and up to ~24 weeks
Secondary outcome [6] 0 0
Mean Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) After 24 Weeks
Timepoint [6] 0 0
Baseline and up to ~24 weeks
Secondary outcome [7] 0 0
Mean Percent Change From Baseline in Triglycerides (TG) After 24 Weeks
Timepoint [7] 0 0
Baseline and up to ~24 weeks
Secondary outcome [8] 0 0
Mean Percent Change From Baseline in Apolipoprotein B (apoB) After 24 Weeks
Timepoint [8] 0 0
Baseline and up to ~24 weeks

Eligibility
Key inclusion criteria
* 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).
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of Type 1 Diabetes Mellitus (T1DM), diabetic ketoacidosis, or diabetes secondary to pancreatitis or pancreatectomy.
* Ongoing, inadequately controlled hypothyroidism or hyperthyroidism.
* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasm type-2 syndrome.
* Recent event (within 6 months prior to screening) of congestive heart failure, unstable angina, myocardial infarction, arterial revascularization, stroke, or transient ischemic attack.
* History or evidence of chronic liver disease other than NAFLD or Non-Alcoholic SteatoHepatitis (NASH).
* Known history of cirrhosis.
* History of acute or chronic pancreatitis.
* History of a bariatric surgical procedure or a known clinically significant gastric emptying abnormality.
* History of malignancy =5 years prior to screening, except for skin cancer or cervical cancer.
* Clinically active hematologic disorder.
* Diagnosis of human immunodeficiency virus (HIV).
* Surgery requiring general anesthesia within 3 months before screening visit.
* History of organ transplantation, except for corneal transplant.
* Active diabetic proliferative retinopathy or a history of maculopathy.
* Untreated obstructive sleep apnea.
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/10/2022
Sample size
Target
Accrual to date
Final
145
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Westmead Hospital-Gastroenterology & Hepatology ( Site 0204) - Westmead
Recruitment hospital [2] 0 0
Flinders Medical Centre-Hepatology and Liver Transplant Medicine ( Site 0201) - Bedford Park
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Argentina
State/province [5] 0 0
Buenos Aires
Country [6] 0 0
Argentina
State/province [6] 0 0
Caba
Country [7] 0 0
Canada
State/province [7] 0 0
Alberta
Country [8] 0 0
France
State/province [8] 0 0
Cote-d Or
Country [9] 0 0
France
State/province [9] 0 0
Rhone
Country [10] 0 0
Israel
State/province [10] 0 0
Haifa
Country [11] 0 0
Israel
State/province [11] 0 0
Jerusalem
Country [12] 0 0
Israel
State/province [12] 0 0
Petah-Tikva
Country [13] 0 0
Israel
State/province [13] 0 0
Ramat Gan
Country [14] 0 0
Israel
State/province [14] 0 0
Tel Aviv
Country [15] 0 0
Italy
State/province [15] 0 0
Lazio
Country [16] 0 0
Italy
State/province [16] 0 0
Lombardia
Country [17] 0 0
Italy
State/province [17] 0 0
Modena
Country [18] 0 0
Italy
State/province [18] 0 0
Verona
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Kyonggi-do
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Incheon
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Seoul
Country [22] 0 0
Mexico
State/province [22] 0 0
Distrito Federal
Country [23] 0 0
Mexico
State/province [23] 0 0
Nuevo Leon
Country [24] 0 0
Mexico
State/province [24] 0 0
Yucatan
Country [25] 0 0
Mexico
State/province [25] 0 0
Cuauhtémoc
Country [26] 0 0
New Zealand
State/province [26] 0 0
Canterbury
Country [27] 0 0
New Zealand
State/province [27] 0 0
Auckland
Country [28] 0 0
Poland
State/province [28] 0 0
Kujawsko-pomorskie
Country [29] 0 0
Poland
State/province [29] 0 0
Mazowieckie
Country [30] 0 0
Poland
State/province [30] 0 0
Slaskie
Country [31] 0 0
Russian Federation
State/province [31] 0 0
Moskovskaya Oblast
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Moskva
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Sankt-Peterburg
Country [34] 0 0
Spain
State/province [34] 0 0
Andalucia
Country [35] 0 0
Spain
State/province [35] 0 0
La Coruna
Country [36] 0 0
Spain
State/province [36] 0 0
Barcelona
Country [37] 0 0
Spain
State/province [37] 0 0
Madrid
Country [38] 0 0
Spain
State/province [38] 0 0
Sevilla
Country [39] 0 0
Taiwan
State/province [39] 0 0
Tainan
Country [40] 0 0
Taiwan
State/province [40] 0 0
Taipei
Country [41] 0 0
Taiwan
State/province [41] 0 0
Taoyuan
Country [42] 0 0
Turkey
State/province [42] 0 0
Izmir
Country [43] 0 0
Turkey
State/province [43] 0 0
Ankara
Country [44] 0 0
Turkey
State/province [44] 0 0
Istanbul
Country [45] 0 0
Ukraine
State/province [45] 0 0
Kharkivska Oblast
Country [46] 0 0
Ukraine
State/province [46] 0 0
Poltavska Oblast
Country [47] 0 0
Ukraine
State/province [47] 0 0
Zaporizka Oblast
Country [48] 0 0
Ukraine
State/province [48] 0 0
Kyiv

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations or Other Details
Journal Romero-Gomez M, Lawitz E, Shankar RR, Chaudhri E, ... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT04944992