Safety, Tolerability, Pharmacokinetics and Efficacy of EY... | NCT03812029

NCT03812029

ID	Type	Description	Link
2018-003119-22	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
Vonafexor 100 mg BID	Experimental	Oral dose twice daily for 12 weeks (84 days)	Drug: Vonafexor
Vonafexor 200 mg QD	Experimental	Oral dose once daily for 12 weeks (84 days)	Drug: Vonafexor
Vonafexor 400 mg QD	Experimental	Oral dose once daily for 12 weeks (84 days)	Drug: Vonafexor
Placebo	Placebo Comparator	Oral dose twice daily for 12 weeks (84 days)	Other: Placebo
Vonafexor 100 mg QD	Experimental	Oral dose once daily for 12 weeks (84 days)	Drug: Vonafexor

Name	Type	Description	Arm Group Labels	Other Names
Vonafexor	Drug	Oral tablets	Vonafexor 100 mg BID Vonafexor 100 mg QD Vonafexor 200 mg QD Vonafexor 400 mg QD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Analysis of Absolute Change From Baseline in Percentage of Fat in the Liver as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)	The liver fat percentage was assessed by MRI-PDFF, which is an established method that enables the quantification of fat content in the liver; the value of liver fat is expressed in percentage and ranges from 0 to 100% with higher values representing higher liver fat level.	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Analysis of Change From Baseline in Glomerular Filtration rate_Part B		12 weeks
Analysis of Percent Change (Relative) From Baseline in Percentage of Fat in the Liver as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)	The liver fat percentage was assessed by MRI-PDFF, which is an established method that enables the quantification of fat content in the liver; the value of liver fat is expressed in percentage and ranges from 0 to 100% with higher values representing higher liver fat level.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Harrison Stephen, MD	Pinnacle Clinical Research	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
ENYO PHARMA Investigative site 0424		North Little Rock	Arkansas	72117	United States
ENYO PHARMA Investigative site 0418

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36334688	Derived	Ratziu V, Harrison SA, Loustaud-Ratti V, Bureau C, Lawitz E, Abdelmalek M, Alkhouri N, Francque S, Girma H, Darteil R, Couchoux H, Wolf M, Sanyal A, Vonderscher J, Scalfaro P. Hepatic and renal improvements with FXR agonist vonafexor in individuals with suspected fibrotic NASH. J Hepatol. 2023 Mar;78(3):479-492. doi: 10.1016/j.jhep.2022.10.023. Epub 2022 Nov 9.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo Part A	Oral dose twice daily for 12 weeks (84 days) Placebo: Oral tablets
FG001	Vonafexor Pooled Part A	Oral dose once or twice a day according to treatment arm for 12 weeks (84 days) Vonafexor: Oral tablets

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

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 24, 2020	Dec 14, 2021

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

For Part A, data from the 3 vonafexor treatment groups were pooled and summarized. Due to the small number of subjects by treatment group in Part A, and as the Study EYP001 202 Part A PK results between groups were found to be nonlinear with similar exposure for the vonafexor 200 mg QD and vonafexor 400 mg QD groups, only the pooled vonafexor treatment group were compared with the placebo group.

Arm/Group Information

ID	Title	Description
BG000	Placebo Part A	Oral dose twice daily for 12 weeks (84 days) Placebo: Oral tablets
BG001	Vonafexor Pooled Part A	Oral dose once or twice a day according to treatment arms for 12 weeks (84 days) Vonafexor: Oral tablets
BG002	Placebo Part B	Oral dose once daily for 12 weeks (84 days) Placebo: Oral tablets
BG003	Vonafexor 100 mg QD Part B	Oral dose once daily for 12 weeks (84 days) Vonafexor: Oral tablets
BG004	Vonafexor 200 mg QD Part B	Oral dose once daily for 12 weeks (84 days) Vonafexor: Oral tablets
BG005	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

Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.

Mean

Standard Deviation

years

Title	Denominators	Categories
Age Part A	ParticipantsBG0007 ParticipantsBG00117 ParticipantsBG0020 ParticipantsBG003

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG0007 ParticipantsBG00117 ParticipantsBG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG0007 ParticipantsBG00117 ParticipantsBG002

Race (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG0007 ParticipantsBG00117 ParticipantsBG002

Height

Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.

Mean

Standard Deviation

Title	Denominators	Categories
Height Part A	ParticipantsBG0007 ParticipantsBG00117 ParticipantsBG002

Weight

Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.

Mean

Standard Deviation

Title	Denominators	Categories
Weight Part A	ParticipantsBG0007 ParticipantsBG00117 ParticipantsBG002

BMI

Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.

Mean

Standard Deviation

kg/m^2

Title	Denominators	Categories
BMI Part A	ParticipantsBG0007 ParticipantsBG00117 ParticipantsBG002

Waist circumference

Part A + Part B were analysed fully separately as per SAP and Study Protocol v5.0 with study populations slightly different between the 2 study parts.

Mean

Standard Deviation

Title	Denominators	Categories
Waist circumference Part A	ParticipantsBG0007 ParticipantsBG00117 ParticipantsBG002

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

Analysis of Absolute Change From Baseline in Percentage of Fat in the Liver as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)

The liver fat percentage was assessed by MRI-PDFF, which is an established method that enables the quantification of fat content in the liver; the value of liver fat is expressed in percentage and ranges from 0 to 100% with higher values representing higher liver fat level.

For Part A, as per ICH, analysis were performed as defined in the SAP: data from the 3 vonafexor treatment groups were pooled and compared with the placebo group.

The modified ITT (mITT) Population which was defined as patients from the ITT Population who have valid baseline and Week 12/Early Termination (ET) MRI-PDFF measurements of Liver Fat Content (LFC) has been used to analyse this endpoint.

Posted

Least Squares Mean

95% Confidence Interval

Percentage of liver fat change

12 weeks

ID	Title	Description
OG000	Placebo Part B	Oral dose once daily for 12 weeks (84 days) Placebo: Oral tablets
OG001	Vonafexor 100 mg QD Part B	Oral dose once daily for 12 weeks (84 days) Vonafexor: Oral tablets
OG002	Vonafexor 200 mg QD Part B	Oral dose once daily for 12 weeks (84 days) Vonafexor: Oral tablets
OG003	Placebo Part A	Oral dose twice daily for 12 weeks (84 days) Placebo: Oral tablets
OG004	Vonafexor Pooled Part A	Oral dose once or twice a day according to treatment arms for 12 weeks (84 days) Vonafexor: Oral tablets

Units	Counts
Participants	OG00032 OG00128 OG00228 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-2.3(-4.0 to -0.6) OG001-6.3(-8.1 to -4.5) OG002-5.4(-7.2 to -3.6) OG003

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		ANCOVA		0.0015	a priori threshold for statistical significance : <0.05.													Superiority
OG000 OG002		ANCOVA		0.0121

Secondary

Analysis of Change From Baseline in Glomerular Filtration rate_Part B

The Intent-to-Treat (ITT) Population, which was defined as all patients who were randomized and administered at least 1 dose of study drug was used to analyse this endpoint.

Posted

Least Squares Mean

95% Confidence Interval

mL/min/1.73m2

12 weeks

ID	Title	Description
OG000	Placebo Part B	Oral dose once daily for 12 weeks (84 days) Placebo: Oral tablets
OG001	Vonafexor 100 mg QD Part B	Oral dose once daily for 12 weeks (84 days) Vonafexor: Oral tablets
OG002	Vonafexor 200 mg QD Part B	Oral dose once daily for 12 weeks (84 days) Vonafexor: Oral tablets

Units	Counts
Participants	OG000

Secondary

Analysis of Percent Change (Relative) From Baseline in Percentage of Fat in the Liver as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)

For Part A, as per ICH, analysis were performed as defined in the SAP: data from the 3 vonafexor treatment groups were pooled and compared with the placebo group.

The modified ITT (mITT) Population which was defined as patients from the ITT Population who have valid baseline and Week 12/ET MRI-PDFF measurements of LFC has been used to analyse this endpoint.

Posted

Least Squares Mean

95% Confidence Interval

Percent change

12 weeks

ID	Title	Description
OG000	Placebo Part B	Oral dose once daily for 12 weeks (84 days) Placebo: Oral tablets
OG001	Vonafexor 100 mg QD Part B	Oral dose once daily for 12 weeks (84 days) Vonafexor: Oral tablets
OG002	Vonafexor 200 mg QD Part B	Oral dose once daily for 12 weeks (84 days) Vonafexor: Oral tablets

Secondary

Analysis of Change From Baseline in Corrected T1 (CT1)

For Part A, as per ICH, analysis were performed as defined in the SAP: data from the 3 vonafexor treatment groups were pooled and compared with the placebo group.

The modified ITT (mITT) Population which was defined as patients from the ITT Population who have valid baseline and Week 12/ET MRI-PDFF measurements of LFC has been used to analyse this endpoint.

Posted

Least Squares Mean

95% Confidence Interval

msec

12 weeks

ID	Title	Description
OG000	Placebo Part B	Oral dose once daily for 12 weeks (84 days) Placebo: Oral tablets
OG001	Vonafexor 100 mg QD Part B	Oral dose once daily for 12 weeks (84 days) Vonafexor: Oral tablets
OG002	Vonafexor 200 mg QD Part B	Oral dose once daily for 12 weeks (84 days) Vonafexor: Oral tablets
OG003	Placebo Part A	Oral dose twice daily for 12 weeks (84 days) Placebo: Oral tablets
OG004

Secondary

Analysis of Change From Baseline in Alanine Aminotransferase (ALT)

For Part A, as per ICH, analysis were performed as defined in the SAP: data from the 3 vonafexor treatment groups were pooled and compared with the placebo group.

The ITT Population, defined as all patients who were randomized and administered at least 1 dose of study drug was used to analyse this endpoint but for this endpoint 1 patient in Vonafexor 200 mg QD part B arm was excluded because he experienced a serious transaminase increase due to previously undiagnosed auto-immune hepatitis.

Posted

Least Squares Mean

95% Confidence Interval

U/L

12 weeks

ID	Title	Description
OG000	Placebo Part B	Oral dose once daily for 12 weeks (84 days) Placebo: Oral tablets
OG001	Vonafexor 100 mg QD Part B	Oral dose once daily for 12 weeks (84 days) Vonafexor: Oral tablets
OG002	Vonafexor 200 mg QD Part B	Oral dose once daily for 12 weeks (84 days) Vonafexor: Oral tablets
OG003	Placebo Part A	Oral dose twice daily for 12 weeks (84 days) Placebo: Oral tablets

Secondary

Analysis of Change From Baseline in Gamma Glutamyltranspeptidase (GT)

For Part A, as per ICH, analysis were performed as defined in the SAP: data from the 3 vonafexor treatment groups were pooled and compared with the placebo group.

The Intent-to-Treat (ITT) Population, which was defined as all patients who were randomized and administered at least 1 dose of study drug was used to analyse this endpoint.

Posted

Least Squares Mean

95% Confidence Interval

U/L

12 weeks

ID	Title	Description
OG000	Placebo Part B	Oral dose once daily for 12 weeks (84 days) Placebo: Oral tablets
OG001	Vonafexor 100 mg QD Part B	Oral dose once daily for 12 weeks (84 days) Vonafexor: Oral tablets
OG002	Vonafexor 200 mg QD Part B	Oral dose once daily for 12 weeks (84 days) Vonafexor: Oral tablets
OG003	Placebo Part A	Oral dose twice daily for 12 weeks (84 days) Placebo: Oral tablets
OG004

Secondary

Analysis of Change From Baseline in Body Weight

For Part A, as per ICH, analysis were performed as defined in the SAP: data from the 3 vonafexor treatment groups were pooled and compared with the placebo group.

The Intent-to-Treat (ITT) Population, which was defined as all patients who were randomized and administered at least 1 dose of study drug was used to analyse this endpoint.

Posted

Least Squares Mean

95% Confidence Interval

12 weeks

ID	Title	Description
OG000	Placebo Part B	Oral dose once daily for 12 weeks (84 days) Placebo: Oral tablets
OG001	Vonafexor 100 mg QD Part B	Oral dose once daily for 12 weeks (84 days) Vonafexor: Oral tablets
OG002	Vonafexor 200 mg QD Part B	Oral dose once daily for 12 weeks (84 days) Vonafexor: Oral tablets
OG003	Placebo Part A	Oral dose twice daily for 12 weeks (84 days) Placebo: Oral tablets
OG004

Secondary

Analysis of Change From Baseline in Waist Circumference

For Part A, as per ICH, analysis were performed as defined in the SAP: data from the 3 vonafexor treatment groups were pooled and compared with the placebo group.

The Intent-to-Treat (ITT) Population, which was defined as all patients who were randomized and administered at least 1 dose of study drug was used to analyse this endpoint.

Posted

Least Squares Mean

95% Confidence Interval

12 weeks

ID	Title	Description
OG000	Placebo Part B	Oral dose once daily for 12 weeks (84 days) Placebo: Oral tablets
OG001	Vonafexor 100 mg QD Part B	Oral dose once daily for 12 weeks (84 days) Vonafexor: Oral tablets
OG002	Vonafexor 200 mg QD Part B	Oral dose once daily for 12 weeks (84 days) Vonafexor: Oral tablets
OG003	Placebo Part A	Oral dose twice daily for 12 weeks (84 days) Placebo: Oral tablets
OG004

Secondary

Analysis of Change From Baseline in Waist to Hip ratio_Part B

The Intent-to-Treat (ITT) Population, which was defined as all patients who were randomized and administered at least 1 dose of study drug was used to analyse this endpoint.

Posted

Median

95% Confidence Interval

ratio

12 weeks

ID	Title	Description
OG000	Placebo Part B	Oral dose once daily for 12 weeks (84 days) Placebo: Oral tablets
OG001	Vonafexor 100 mg QD Part B	Oral dose once daily for 12 weeks (84 days) Vonafexor: Oral tablets
OG002	Vonafexor 200 mg QD Part B	Oral dose once daily for 12 weeks (84 days) Vonafexor: Oral tablets

Units	Counts
Participants	OG000

Secondary

Analysis of Change From Baseline in Glomerular Filtration rate_Part A

For Part A, as per ICH, analysis were performed as defined in the SAP: data from the 3 vonafexor treatment groups were pooled and compared with the placebo group.

Posted

Geometric Mean

Standard Deviation

mL/min/1.73m^2

12 weeks

ID	Title	Description
OG000	Placebo Part A	Oral dose twice daily for 12 weeks (84 days) Placebo: Oral tablets
OG001	Vonafexor Pooled Part A	Oral dose once or twice a day according to treatment arms for 12 weeks (84 days) Vonafexor: Oral tablets

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo Part A	Oral dose twice daily for 12 weeks (84 days) Placebo: Oral tablets	7	0	7	4	7
EG001	Vonafexor 100 mg BID Part A	Oral dose twice daily for 12 weeks (84 days) Vonafexor: Oral tablets	6	0	6	6	6
EG002	Vonafexor 200 mg QD Part A	Oral dose once daily for 12 weeks (84 days) Vonafexor: Oral tablets	5	0	5	4	5
EG003	Vonafexor 400 mg QD Part A	Oral dose once daily for 12 weeks (84 days) Vonafexor: Oral tablets	6	0	6	6	6
EG004	Placebo Part B	Oral dose once daily for 12 weeks (84 days) Placebo: Oral tablets	32	1	32	22	32
EG005	Vonafexor 100 mg QD Part B	Oral dose once daily for 12 weeks (84 days) Vonafexor: Oral tablets	31	1	31	25	31
EG006	Vonafexor 200 mg QD Part B	Oral dose once daily for 12 weeks (84 days) Vonafexor: Oral tablets	33	2	33	30	33

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina instable	Cardiac disorders	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected5 at risk EG0030 events0 affected6 at risk EG0040 events0 affected32 at risk EG0051 events1 affected31 at risk EG0060 events0 affected33 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected5 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected5 at risk EG003
Transaminases increased	Investigations	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected5 at risk EG003
COVID-19	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected5 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hypertension	Vascular disorders	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected5 at risk EG0030 events0 affected6 at risk EG0042 events2 affected32 at risk EG0051 events1 affected31 at risk EG0061 events1 affected33 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected6 at risk EG0021 events1 affected5 at risk EG003
Fatigue	General disorders	MedDRA (22.0)	Systematic Assessment	EG0001 events1 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected5 at risk EG003
Adverse drug reaction	General disorders	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected6 at risk EG0021 events1 affected5 at risk EG003
Pain	General disorders	MedDRA (22.0)	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected5 at risk EG003
Agitation	Psychiatric disorders	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected5 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected6 at risk EG0021 events1 affected5 at risk EG003
Depression	Psychiatric disorders	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected5 at risk EG003
Insomnia	Psychiatric disorders	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected5 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA (22.0)	Systematic Assessment	EG0001 events1 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected5 at risk EG003
Electric shock	Injury, poisoning and procedural complications	MedDRA (22.0)	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected5 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected5 at risk EG003
Post-traumatic pain	Injury, poisoning and procedural complications	MedDRA (22.0)	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected5 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected5 at risk EG003
Low density lipoprotein increased	Investigations	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected5 at risk EG003
Transaminases increased	Investigations	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected5 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected5 at risk EG003
Palpitations	Cardiac disorders	MedDRA (22.0)	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected5 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected5 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected5 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected5 at risk EG003
Headache	Nervous system disorders	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected5 at risk EG003
Vision blurred	Eye disorders	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected5 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected5 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected5 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected6 at risk EG0021 events1 affected5 at risk EG003
Abdominal rigidity	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected6 at risk EG0021 events1 affected5 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected5 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected5 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected5 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected5 at risk EG003
Renal cyst	Renal and urinary disorders	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected5 at risk EG003
Hepatic cyst	Hepatobiliary disorders	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected5 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0017 events5 affected6 at risk EG0025 events4 affected5 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected6 at risk EG0021 events1 affected5 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected5 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected5 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected5 at risk EG003
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (22.0)	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected5 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected5 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected5 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected5 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected5 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected6 at risk EG0020 events0 affected5 at risk EG003
COVID-19	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected6 at risk EG0020 events0 affected5 at risk EG003

First MCP Posted Date

ID	Term
D065626	Non-alcoholic Fatty Liver Disease
D008107	Liver Diseases

ParticipantsBG005120

OG004-4.7(-8.5 to 0.9)