A Study of Efinopegdutide (MK-6024) in Participants With... | NCT04944992

NCT04944992

ID	Type	Description	Link
MK-6024-001	Other Identifier	Merck
2020-005136-30	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Efinopegdutide	Experimental	Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.	Drug: Efinopegdutide 20 mg/mL
Semaglutide	Active Comparator	Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.	Drug: Semaglutide 1.34 mg/mL

Name	Type	Description	Arm Group Labels	Other Names
Efinopegdutide 20 mg/mL	Drug	Subcutaneous injection in a dose-escalation administration of 2.4 mg, 5.0 mg, and 10.0 mg	Efinopegdutide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Relative Reduction From Baseline in Liver Fat Content (LFC) Measured by Magnetic Resonance Imaging-Estimated Proton Density Fat Fraction (MRI-PDFF), Evaluated by Blinded Independent Central Review (BICR) After 24 Weeks	LFC was measured with liver images taken by MRI-PDFF and analyzed by BICR. Relative Reduction from Baseline to Week 24 = (Baseline - Week 24) / Baseline x 100%. Mean relative reduction from baseline in liver fat content is presented.	Baseline and up to ~24 Weeks
Percentage of Participants Who Experienced an Adverse Event (AE)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced an adverse event is presented.	Up to ~29 weeks
Percentage of Participants Who Discontinued Study Intervention Due to an AE	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinued study intervention due to adverse event is presented.	Up to ~24 weeks

Secondary Outcomes

Measure	Description	Time Frame
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.	Baseline and up to ~24 Weeks

Eligibility Module

Eligibility Criteria

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).

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.

Contacts/Locations Module

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Catalina Research Institute, LLC ( Site 1939)		Montclair	California	91763	United States
Sweet Hope Research Specialty, Inc ( Site 1902)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37355043	Result	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.

Label	URL
Merck Clinical Trials Information	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.
FG001	Semaglutide

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Aug 26, 2021

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Masking Info

MK-6024
HM12525A
JNJ-64565111

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.

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00048.0± 11.0 BG00150.7± 10.9 BG00249.4± 11.0

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00039 BG00141 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00025 BG00126 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0003 BG0012 BG002

Body Mass Index (BMI)

Mean

Standard Deviation

Kg/M^2

Title

Denominators

Categories

Title	Measurements
	BG00035.2± 5.7 BG00133.5± 5.0 BG002

Weight

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG000100.2± 18.9 BG00194.4± 18.9 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

All randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment.

Posted

Least Squares Mean

90% Confidence Interval

Percent Reduction

Baseline and up to ~24 Weeks

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG00072 OG00173

Title

Denominators

Categories

Title	Measurements
	OG00072.7(66.8 to 78.7) OG00142.3(36.5 to 48.1)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Mixed Models Analysis		<0.0001		Difference in least squared means	30.4			2-Sided	90	22.1	38.7					Superiority

Primary

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.

All randomized participants who received at least 1 injection (including only partial) of study intervention.

Posted

Number

Percentage of Participants

Up to ~29 weeks

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts

Primary

Percentage of Participants Who Discontinued Study Intervention Due to an AE

All randomized participants who received at least 1 injection (including only partial) of study intervention.

Posted

Number

Percentage of Participants

Up to ~24 weeks

ID	Title	Description
OG000	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.
OG001	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.

Units

Secondary

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.

All randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment.

Posted

Least Squares Mean

90% Confidence Interval

Percentage of liver fat

Baseline and up to ~24 Weeks

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

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.

All randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment.

Posted

Least Squares Mean

90% Confidence Interval

Percent Change

Baseline and up to ~24 weeks

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

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.

All randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment.

Posted

Least Squares Mean

90% Confidence Interval

Percent Change

Baseline and up to ~24 weeks

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

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.

All randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment.

Posted

Least Squares Mean

90% Confidence Interval

Percent Change

Baseline and up to ~24 weeks

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

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.

All randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment.

Posted

Least Squares Mean

90% Confidence Interval

Percent Change

Baseline and up to ~24 weeks

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

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.

All randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment.

Posted

Least Squares Mean

90% Confidence Interval

Percent Change

Baseline and up to ~24 weeks

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

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.

All randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment.

Posted

Least Squares Mean

90% Confidence Interval

Percent Change

Baseline and up to ~24 weeks

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

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.

All randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment.

Posted

Least Squares Mean

90% Confidence Interval

Percent Change

Baseline and up to ~24 weeks

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	0	72	1	72	57	72
EG001	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.	0	73	1	73	44	73

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 25.1	Systematic Assessment		EG0000 events0 affected72 at risk EG0011 events1 affected73 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 25.1	Systematic Assessment		EG0001 events1 affected72 at risk EG0010 events0 affected73 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal distension	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0004 events4 affected72 at risk EG0014 events3 affected73 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG00015 events9 affected72 at risk EG0014 events2 affected73 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG00010 events7 affected72 at risk EG0011 events1 affected73 at risk
Constipation	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG00016 events12 affected72 at risk EG0014 events4 affected73 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG00032 events12 affected72 at risk EG00129 events13 affected73 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0006 events6 affected72 at risk EG0015 events5 affected73 at risk
Flatulence	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0004 events4 affected72 at risk EG0011 events1 affected73 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG0006 events6 affected72 at risk EG0016 events5 affected73 at risk
Nausea	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG00038 events20 affected72 at risk EG00136 events23 affected73 at risk
Vomiting	Gastrointestinal disorders	MedDRA 25.1	Systematic Assessment	EG00023 events12 affected72 at risk EG00112 events11 affected73 at risk
Fatigue	General disorders	MedDRA 25.1	Systematic Assessment	EG0001 events1 affected72 at risk EG0016 events6 affected73 at risk
COVID-19	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0008 events8 affected72 at risk EG00110 events10 affected73 at risk
Urinary tract infection	Infections and infestations	MedDRA 25.1	Systematic Assessment	EG0004 events4 affected72 at risk EG0012 events2 affected73 at risk
Alanine aminotransferase increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0004 events4 affected72 at risk EG0010 events0 affected73 at risk
Lipase increased	Investigations	MedDRA 25.1	Systematic Assessment	EG0005 events4 affected72 at risk EG0013 events3 affected73 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 25.1	Systematic Assessment	EG00012 events12 affected72 at risk EG00113 events11 affected73 at risk
Dizziness	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0007 events4 affected72 at risk EG0012 events2 affected73 at risk
Headache	Nervous system disorders	MedDRA 25.1	Systematic Assessment	EG0005 events5 affected72 at risk EG0018 events5 affected73 at risk

First MCP Posted Date

ID	Term
D065626	Non-alcoholic Fatty Liver Disease

ID	Term
C000591245	semaglutide

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases