A Study of NGM282 in Patients With Primary Sclerosing Cho... | NCT02704364

ID	Type	Description	Link
2015-003392-30	EudraCT Number

Label	Type	Description	Intervention Names
NGM282 Dose 1	Experimental	NGM282 Dose 1	Biological: NGM282
NGM282 Dose 2	Experimental	NGM282 Dose 2	Biological: NGM282
Placebo	Active Comparator	Placebo	Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
NGM282	Biological		NGM282 Dose 1 NGM282 Dose 2
Placebo

Measure	Description	Time Frame
Mean Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis	Blood samples were collected to assess changes in alkaline phosphatase levels.	Baseline to Week 12

Measure	Description	Time Frame
Mean Percent Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis	Blood samples were collected to assess changes in alkaline phosphatase levels.	Baseline to Week 12
Mean Rate of Change in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis

Name	Affiliation	Role
Stephen J Rossi, PharmD	NGM Biopharmaceuticals, Inc	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
NGM Clinical Study Site 118		Sacramento	California		United States
NGM Clinical Study Site 112

PubMed Identifier	Type	Citation	Retractions
33898959	Derived	Sanyal AJ, Ling L, Beuers U, DePaoli AM, Lieu HD, Harrison SA, Hirschfield GM. Potent suppression of hydrophobic bile acids by aldafermin, an FGF19 analogue, across metabolic and cholestatic liver diseases. JHEP Rep. 2021 Feb 19;3(3):100255. doi: 10.1016/j.jhepr.2021.100255. eCollection 2021 Jun.

ID	Title	Description
FG000	NGM282 1.0 mg	Participants who were randomized to NGM282 1.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
FG001	NGM282 3.0 mg

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 27, 2016	Mar 3, 2025

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 Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis

Blood samples were collected to assess changes in alkaline phosphatase levels.

Mean change from baseline in ALP was assessed in participants with available data in the Full Analysis Set.

Posted

Mean

Standard Error

International units/Liter

Baseline to Week 12

ID	Title	Description
OG000	NGM282 1.0 mg	Participants who were randomized to NGM282 1.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
OG001	NGM282 3.0 mg	Participants who were randomized to NGM282 3.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
OG002	Placebo	Participants who were randomized to placebo self-administered placebo as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.

Units	Counts
Participants	OG00021 OG00120 OG00220

Title

Denominators

Categories

Title	Measurements
	OG00025.6± 100.3 OG001-9.8± 101.3 OG002-0.6± 79.5

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 OG002		Wilcoxon (Mann-Whitney)		0.434		Hodges-Lehmann estimate	-14.0	Standard Error of the Mean	21.4	2-Sided	95	-68.0	28.0					Superiority
OG001 OG002		Wilcoxon (Mann-Whitney)

Secondary

Mean Percent Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis

Blood samples were collected to assess changes in alkaline phosphatase levels.

Mean percent change from baseline in ALP was assessed in participants with available data in the Full Analysis Set.

Posted

Mean

Standard Error

percent change

Baseline to Week 12

ID	Title	Description
OG000	NGM282 1.0 mg	Participants who were randomized to NGM282 1.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
OG001	NGM282 3.0 mg	Participants who were randomized to NGM282 3.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
OG002	Placebo	Participants who were randomized to placebo self-administered placebo as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.

Secondary

Mean Rate of Change in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis

Blood samples were collected to assess rate of change in alkaline phosphatase levels. Serum levels of alkaline phosphatase was measured in a central laboratory using standard enzymatic method. The unit of measure is U/L.

Mean rate of change in ALP was assessed in participants with available data in the Full Analysis Set .

Posted

Mean

Standard Error

U/L/Week

Baseline to Week 12

ID	Title	Description
OG000	NGM282 1.0 mg	Participants who were randomized to NGM282 1.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
OG001	NGM282 3.0 mg	Participants who were randomized to NGM282 3.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.

Units	Counts
Participants

Secondary

Mean Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase in Patients With Primary Sclerosing Cholangitis

Blood samples were collected to assess changes in aspartate aminotransferase and alanine aminotransferase levels.

Mean changes from baseline in aspartate aminotransferase and alanine aminotransferase were assessed in participants with available data in the Full Analysis Set.

Posted

Mean

Standard Error

units/liter

Baseline to Week 12

ID	Title	Description
OG000	NGM282 1.0 mg	Participants who were randomized to NGM282 1.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
OG001	NGM282 3.0 mg	Participants who were randomized to NGM282 3.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
OG002	Placebo	Participants who were randomized to placebo self-administered placebo as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.

Secondary

Mean Percent Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase in Patients With Primary Sclerosing Cholangitis

Blood samples were collected to assess changes in aspartate aminotransferase and alanine aminotransferase levels.

Mean percent changes from baseline in aspartate aminotransferase and alanine aminotransferase were assessed in participants with available data in the Full Analysis Set.

Posted

Mean

Standard Error

percent change

Baseline to Week 12

ID	Title	Description
OG000	NGM282 1.0 mg	Participants who were randomized to NGM282 1.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
OG001	NGM282 3.0 mg	Participants who were randomized to NGM282 3.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
OG002	Placebo	Participants who were randomized to placebo self-administered placebo as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.

Secondary

Mean Change From Baseline in Bilirubin (Direct and Total) in Patients With Primary Sclerosing Cholangitis

Blood samples were collected to assess changes in bilirubin (direct and total) levels.

Mean change from baseline in bilirubin (total and direct) was assessed in participants with available data in the Full Analysis Set.

Posted

Mean

Standard Error

micromole/liter

Baseline to Week 12

ID	Title	Description
OG000	NGM282 1.0 mg	Participants who were randomized to NGM282 1.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
OG001	NGM282 3.0 mg	Participants who were randomized to NGM282 3.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
OG002	Placebo	Participants who were randomized to placebo self-administered placebo as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.

Secondary

Mean Percent Change From Baseline in Bilirubin (Direct and Total) in Patients With Primary Sclerosing Cholangitis

Blood samples were collected to assess changes in bilirubin (direct and total) levels.

Mean percent changes from baseline in bilirubin (total and direct) were assessed in participants with available data in the Full Analysis Set.

Posted

Mean

Standard Error

percent change

Baseline to Week 12

ID	Title	Description
OG000	NGM282 1.0 mg	Participants who were randomized to NGM282 1.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
OG001	NGM282 3.0 mg	Participants who were randomized to NGM282 3.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
OG002	Placebo	Participants who were randomized to placebo self-administered placebo as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.

Secondary

Mean Change From Baseline in Gamma Glutamyl Transferase in Patients With Primary Sclerosing Cholangitis

Blood samples were collected to assess changes in gamma glutamyl transferase levels.

Mean change from baseline in gamma glutamyl transferase was assessed in participants with available data in the Full Analysis Set.

Posted

Mean

Standard Error

units/liter

Baseline to Week 12

ID	Title	Description
OG000	NGM282 1.0 mg	Participants who were randomized to NGM282 1.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
OG001	NGM282 3.0 mg	Participants who were randomized to NGM282 3.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
OG002	Placebo	Participants who were randomized to placebo self-administered placebo as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.

Secondary

Mean Percent Change From Baseline in Gamma Glutamyl Transferase in Patients With Primary Sclerosing Cholangitis

Blood samples were collected to assess changes in gamma glutamyl transferase levels.

Mean percent change from baseline in gamma glutamyl transferase was assessed in participants with available data in the Full Analysis Set.

Posted

Mean

Standard Error

percent change

Baseline to Week 12

ID	Title	Description
OG000	NGM282 1.0 mg	Participants who were randomized to NGM282 1.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
OG001	NGM282 3.0 mg	Participants who were randomized to NGM282 3.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
OG002	Placebo	Participants who were randomized to placebo self-administered placebo as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.

Secondary

Mean Change From Baseline in Cholesterol Levels in Patients With Primary Sclerosing Cholangitis

Blood samples were collected to assess changes in cholesterol levels.

Mean change from baseline in cholesterol levels were assessed in participants with available data in the Full Analysis Set.

Posted

Mean

Standard Deviation

millimole/liter

Baseline to Week 12

ID	Title	Description
OG000	NGM282 1.0 mg	Participants who were randomized to NGM282 1.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
OG001	NGM282 3.0 mg	Participants who were randomized to NGM282 3.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
OG002	Placebo	Participants who were randomized to placebo self-administered placebo as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.

Secondary

Mean Percent Change From Baseline in Cholesterol Levels in Patients With Primary Sclerosing Cholangitis

Blood samples were collected to assess changes in cholesterol levels.

Mean percent change from baseline in cholesterol levels were assessed in the Full Analysis Set.

Posted

Mean

Standard Deviation

percent change

Baseline to Week 12

ID	Title	Description
OG000	NGM282 1.0 mg	Participants who were randomized to NGM282 1.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
OG001	NGM282 3.0 mg	Participants who were randomized to NGM282 3.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
OG002	Placebo	Participants who were randomized to placebo self-administered placebo as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.

Secondary

Mean Change From Baseline in 25-Hydroxyvitamin D in Patients With Primary Sclerosing Cholangitis

Blood samples were collected to assess changes in 25-Hydroxyvitamin D levels.

Mean change from baseline in 25-Hydroxyvitamin D was assessed in the Full Analysis Set.

Posted

Mean

Standard Error

nmol/Liter

Baseline to Week 12

ID	Title	Description
OG000	NGM282 1.0 mg	Participants who were randomized to NGM282 1.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
OG001	NGM282 3.0 mg	Participants who were randomized to NGM282 3.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
OG002	Placebo	Participants who were randomized to placebo self-administered placebo as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.

Secondary

Mean Percent Change From Baseline in 25-Hydroxyvitamin D in Patients With Primary Sclerosing Cholangitis

Blood samples were collected to assess changes in 25-Hydroxyvitamin D levels.

Mean percent change from baseline in 25-Hydroxyvitamin D was assessed in the Full Analysis Set.

Posted

Mean

Standard Error

percent change

Baseline to Week 12

ID	Title	Description
OG000	NGM282 1.0 mg	Participants who were randomized to NGM282 1.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
OG001	NGM282 3.0 mg	Participants who were randomized to NGM282 3.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
OG002	Placebo	Participants who were randomized to placebo self-administered placebo as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.

Secondary

Mean Change From Baseline in Prothrombin International Normalized Ratio in Patients With Primary Sclerosing Cholangitis

Blood samples were collected to assess changes in Prothrombin levels.

Mean change from baseline in Prothrombin was assessed in participants with available data in the Full Analysis Set.

Posted

Mean

Standard Deviation

International normalized ratio

Baseline to Week 12

ID	Title	Description
OG000	NGM282 1.0 mg	Participants who were randomized to NGM282 1.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
OG001	NGM282 3.0 mg	Participants who were randomized to NGM282 3.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
OG002	Placebo	Participants who were randomized to placebo self-administered placebo as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.

Secondary

Mean Percent Change From Baseline in Prothrombin International Normalized Ratio in Patients With Primary Sclerosing Cholangitis

Blood samples were collected to assess changes in Prothrombin levels.

Mean percent change from baseline in Prothrombin was assessed in participants with available data in the Full Analysis Set.

Posted

Mean

Standard Deviation

percent change

Baseline to Week 12

ID	Title	Description
OG000	NGM282 1.0 mg	Participants who were randomized to NGM282 1.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
OG001	NGM282 3.0 mg	Participants who were randomized to NGM282 3.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
OG002	Placebo	Participants who were randomized to placebo self-administered placebo as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.

Secondary

Mean Change From Baseline in Calprotectin in Patients With Primary Sclerosing Cholangitis

Blood samples were collected to assess changes in Calprotectin levels.

Mean change from baseline in Calprotectin was assessed in participants with available data in the Full Analysis Set.

Posted

Mean

Standard Deviation

microgram/gram

Baseline to Week 12

ID	Title	Description
OG000	NGM282 1.0 mg	Participants who were randomized to NGM282 1.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
OG001	NGM282 3.0 mg	Participants who were randomized to NGM282 3.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
OG002	Placebo	Participants who were randomized to placebo self-administered placebo as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.

Secondary

Mean Change From Baseline in Enhanced Liver Fibrosis Score in Patients With Primary Sclerosing Cholangitis

Enhanced Liver Fibrosis (ELF) score is a non-invasive blood test derived from the measurement of hyaluronic acid (HA), amino terminal propeptide of type III procollagen (PIIINP), and tissue inhibitor of metalloprotease 1 (TIMP1) using a proprietary algorithm (Siemens). ELF score is a laboratory test, is unitless, and is used as a continuous variable. The minimal ELF score is zero, the maximal ELF score is unknown. The higher the ELF score, the worse the disease outcome.

ELF is a score on a scale of severity assessment against biopsy-proven fibrosis. A score of <7.7 is none to mild, > 7.7-9.8 is moderate, > 9.8 is severe.

Mean change from baseline in Enhanced Liver Fibrosis Score was assessed in the Full Analysis Set.

Posted

Mean

Standard Deviation

units on a scale

Baseline to Week 12

ID	Title	Description
OG000	NGM282 1.0 mg	Participants who were randomized to NGM282 1.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
OG001	NGM282 3.0 mg	Participants who were randomized to NGM282 3.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.

Secondary

Severity of Inflammatory Bowel Disease-Associated Intestinal Symptoms in Patients With Primary Sclerosing Cholangitis

Severity of inflammatory bowel disease (IBD)-associated symptoms and acute cholangitis are summarized with number and percentage. The partial Mayo IBD scale assesses stool frequency, rectal bleeding, and there is a Physician's global assessment. Each section is summed and remission is defined as a total score of 0-1, mild disease 2-4, moderate disease 5-6, and severe disease 7-9. Higher total scores indicate more severe disease. The number of participants are being presented based on the severity of their IBD symptoms.

Severity of inflammatory bowel disease-associated intestinal symptoms were assessed in the Full Analysis Set.

Posted

Count of Participants

Participants

Baseline to Week 12

ID	Title	Description
OG000	NGM282 1.0 mg	Participants who were randomized to NGM282 1.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
OG001	NGM282 3.0 mg	Participants who were randomized to NGM282 3.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
OG002

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal cramps	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected21 at risk EG0022 affected20 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected21 at risk EG0021 affected20 at risk
Diarrhea	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0005 affected21 at risk EG0014 affected21 at risk EG0020 affected20 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected21 at risk EG0021 affected20 at risk
Dyspepsia aggravated	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected21 at risk EG0021 affected20 at risk
Frequent bowel movements	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected21 at risk EG0010 affected21 at risk EG0020 affected20 at risk
Increased stool frequency	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected21 at risk EG0013 affected21 at risk EG0020 affected20 at risk
Loose stools	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0004 affected21 at risk EG0012 affected21 at risk EG0021 affected20 at risk
Nausea	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected21 at risk EG0012 affected21 at risk EG0023 affected20 at risk
Nausea aggravated	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected21 at risk EG0021 affected20 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected21 at risk EG0021 affected20 at risk
Vomiting	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected21 at risk EG0011 affected21 at risk EG0021 affected20 at risk
Chest pain	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected21 at risk EG0021 affected20 at risk
Fatigue	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected21 at risk EG0013 affected21 at risk EG0023 affected20 at risk
Injection site erythema	General disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected21 at risk EG00111 affected21 at risk EG0021 affected20 at risk
Injection site pain	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected21 at risk EG0011 affected21 at risk EG0022 affected20 at risk
Malaise	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected21 at risk EG0021 affected20 at risk
Pyrexia	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected21 at risk EG0021 affected20 at risk
Influenza	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected21 at risk EG0021 affected20 at risk
Nasopharyngitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected21 at risk EG0012 affected21 at risk EG0024 affected20 at risk
Rhinitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected21 at risk EG0021 affected20 at risk
Urinary tract infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected21 at risk EG0012 affected21 at risk EG0020 affected20 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected21 at risk EG0011 affected21 at risk EG0022 affected20 at risk
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected21 at risk EG0012 affected21 at risk EG0022 affected20 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected21 at risk EG0021 affected20 at risk
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected21 at risk EG0021 affected20 at risk
Burning sensation	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected21 at risk EG0021 affected20 at risk
Dizziness	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected21 at risk EG0022 affected20 at risk
Headache	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected21 at risk EG0014 affected21 at risk EG0023 affected20 at risk
Paraesthesia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected21 at risk EG0021 affected20 at risk
Increased appetite	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0004 affected21 at risk EG0011 affected21 at risk EG0020 affected20 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0003 affected21 at risk EG0011 affected21 at risk EG0021 affected20 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected21 at risk EG0012 affected21 at risk EG0020 affected20 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected21 at risk EG0021 affected20 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected21 at risk EG0022 affected20 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected21 at risk EG0011 affected21 at risk EG0022 affected20 at risk
Insomnia	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected21 at risk EG0021 affected20 at risk
Irritability	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected21 at risk EG0021 affected20 at risk
Angina pectoris	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected21 at risk EG0021 affected20 at risk
Dry eye	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected21 at risk EG0021 affected20 at risk
Sarcoidosis	Immune system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected21 at risk EG0010 affected21 at risk EG0021 affected20 at risk

ID	Term
D002761	Cholangitis
D001649	Bile Duct Diseases
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases

ID	Title	Description
BG000	NGM282 1.0 mg	Participants who were randomized to NGM282 1.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
BG001	NGM282 3.0 mg	Participants who were randomized to NGM282 3.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
BG002	Placebo	Participants who were randomized to placebo self-administered placebo as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	NGM282 1.0 mg	Participants who were randomized to NGM282 1.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.	21	1	21	17	21
EG001	NGM282 3.0 mg	Participants who were randomized to NGM282 3.0 mg self-administered NGM282 as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.	21	2	21	20	21
EG002	Placebo	Participants who were randomized to placebo self-administered placebo as an subcutaneous (SC) injection to the abdomen daily, at approximately the same time each morning, over the 12-week treatment period.	20	0	20	18	20

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bowel obstruction	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected21 at risk EG0020 affected20 at risk
Cholangitis sclerosing	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected21 at risk EG0020 affected20 at risk
Intervertebral discitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected21 at risk EG0011 affected21 at risk EG0020 affected20 at risk
Blood bilirubin increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 affected21 at risk EG0010 affected21 at risk EG0020 affected20 at risk