Trial Outcomes & Findings for A Study of NGM282 in Patients With Primary Sclerosing Cholangitis (NCT NCT02704364)
NCT ID: NCT02704364
Last Updated: 2025-06-17
Results Overview
Blood samples were collected to assess changes in alkaline phosphatase levels.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
62 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2025-06-17
Participant Flow
A total of 62 participants who met all inclusion criteria and no exclusion criteria were randomized to receive treatment over a 12-week treatment period at 24 clinic sites in the United States, 5 sites in the United Kingdom, 5 sites in the Netherlands, and 1 site in France.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
20
|
|
Overall Study
COMPLETED
|
19
|
18
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
|
Overall Study
Noncompliance with study drug
|
1
|
1
|
0
|
|
Overall Study
Other
|
0
|
1
|
1
|
Baseline Characteristics
A Study of NGM282 in Patients With Primary Sclerosing Cholangitis
Baseline characteristics by cohort
| Measure |
NGM282 1.0 mg
n=21 Participants
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.
|
NGM282 3.0 mg
n=21 Participants
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.
|
Placebo
n=20 Participants
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.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Age, Continuous
|
46.0 years
STANDARD_DEVIATION 15.9 • n=5 Participants
|
40.2 years
STANDARD_DEVIATION 13.0 • n=7 Participants
|
43.4 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
43.2 years
STANDARD_DEVIATION 13.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Mean change from baseline in ALP was assessed in participants with available data in the Full Analysis Set.
Blood samples were collected to assess changes in alkaline phosphatase levels.
Outcome measures
| Measure |
NGM282 1.0 mg
n=21 Participants
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.
|
NGM282 3.0 mg
n=20 Participants
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.
|
Placebo
n=20 Participants
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.
|
|---|---|---|---|
|
Mean Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis
|
25.6 International units/Liter
Standard Error 100.3
|
-9.8 International units/Liter
Standard Error 101.3
|
-0.6 International units/Liter
Standard Error 79.5
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Mean percent change from baseline in ALP was assessed in participants with available data in the Full Analysis Set.
Blood samples were collected to assess changes in alkaline phosphatase levels.
Outcome measures
| Measure |
NGM282 1.0 mg
n=21 Participants
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.
|
NGM282 3.0 mg
n=20 Participants
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.
|
Placebo
n=20 Participants
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.
|
|---|---|---|---|
|
Mean Percent Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis
|
7.1 percent change
Standard Error 5.8
|
-4.2 percent change
Standard Error 5.9
|
-3.4 percent change
Standard Error 6.0
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Mean rate of change in ALP was assessed in participants with available data in the Full Analysis Set .
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.
Outcome measures
| Measure |
NGM282 1.0 mg
n=21 Participants
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.
|
NGM282 3.0 mg
n=19 Participants
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.
|
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.
|
|---|---|---|---|
|
Mean Rate of Change in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis
Weeks 1 through 4
|
-17.7 U/L/Week
Standard Error 6.4
|
-2.2 U/L/Week
Standard Error 6.1
|
—
|
|
Mean Rate of Change in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis
Weeks 5 through 12
|
11.9 U/L/Week
Standard Error 4.5
|
-0.2 U/L/Week
Standard Error 2.2
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Mean changes from baseline in aspartate aminotransferase and alanine aminotransferase were assessed in participants with available data in the Full Analysis Set.
Blood samples were collected to assess changes in aspartate aminotransferase and alanine aminotransferase levels.
Outcome measures
| Measure |
NGM282 1.0 mg
n=21 Participants
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.
|
NGM282 3.0 mg
n=20 Participants
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.
|
Placebo
n=20 Participants
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.
|
|---|---|---|---|
|
Mean Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase in Patients With Primary Sclerosing Cholangitis
Aspartate aminotransferase
|
-0.2 units/liter
Standard Error 7.0
|
-30.9 units/liter
Standard Error 7.0
|
-13.3 units/liter
Standard Error 7.1
|
|
Mean Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase in Patients With Primary Sclerosing Cholangitis
Alanine aminotransferase
|
8.5 units/liter
Standard Error 10.2
|
-45.1 units/liter
Standard Error 10.4
|
-12.1 units/liter
Standard Error 10.5
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Mean percent changes from baseline in aspartate aminotransferase and alanine aminotransferase were assessed in participants with available data in the Full Analysis Set.
Blood samples were collected to assess changes in aspartate aminotransferase and alanine aminotransferase levels.
Outcome measures
| Measure |
NGM282 1.0 mg
n=21 Participants
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.
|
NGM282 3.0 mg
n=20 Participants
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.
|
Placebo
n=20 Participants
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.
|
|---|---|---|---|
|
Mean Percent Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase in Patients With Primary Sclerosing Cholangitis
Aspartate aminotransferase
|
2.6 percent change
Standard Error 7.8
|
-25.5 percent change
Standard Error 7.9
|
-7.2 percent change
Standard Error 8.0
|
|
Mean Percent Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase in Patients With Primary Sclerosing Cholangitis
Alanine aminotransferase
|
7.2 percent change
Standard Error 8.1
|
-29.2 percent change
Standard Error 8.2
|
-6.1 percent change
Standard Error 8.3
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Mean change from baseline in bilirubin (total and direct) was assessed in participants with available data in the Full Analysis Set.
Blood samples were collected to assess changes in bilirubin (direct and total) levels.
Outcome measures
| Measure |
NGM282 1.0 mg
n=21 Participants
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.
|
NGM282 3.0 mg
n=20 Participants
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.
|
Placebo
n=20 Participants
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.
|
|---|---|---|---|
|
Mean Change From Baseline in Bilirubin (Direct and Total) in Patients With Primary Sclerosing Cholangitis
Direct bilirubin
|
9.14 micromole/liter
Standard Error 5.19
|
0.54 micromole/liter
Standard Error 5.30
|
0.55 micromole/liter
Standard Error 5.2
|
|
Mean Change From Baseline in Bilirubin (Direct and Total) in Patients With Primary Sclerosing Cholangitis
Total bilirubin
|
9.78 micromole/liter
Standard Error 5.88
|
0.04 micromole/liter
Standard Error 6.01
|
0.83 micromole/liter
Standard Error 6.02
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Mean percent changes from baseline in bilirubin (total and direct) were assessed in participants with available data in the Full Analysis Set.
Blood samples were collected to assess changes in bilirubin (direct and total) levels.
Outcome measures
| Measure |
NGM282 1.0 mg
n=21 Participants
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.
|
NGM282 3.0 mg
n=20 Participants
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.
|
Placebo
n=20 Participants
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.
|
|---|---|---|---|
|
Mean Percent Change From Baseline in Bilirubin (Direct and Total) in Patients With Primary Sclerosing Cholangitis
Direct bilirubin
|
36.5 percent change
Standard Error 16.7
|
5.7 percent change
Standard Error 17.1
|
9.2 percent change
Standard Error 17.1
|
|
Mean Percent Change From Baseline in Bilirubin (Direct and Total) in Patients With Primary Sclerosing Cholangitis
Total bilirubin
|
27.2 percent change
Standard Error 17.9
|
-3.6 percent change
Standard Error 18.2
|
6.8 percent change
Standard Error 18.2
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Mean change from baseline in gamma glutamyl transferase was assessed in participants with available data in the Full Analysis Set.
Blood samples were collected to assess changes in gamma glutamyl transferase levels.
Outcome measures
| Measure |
NGM282 1.0 mg
n=21 Participants
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.
|
NGM282 3.0 mg
n=20 Participants
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.
|
Placebo
n=20 Participants
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.
|
|---|---|---|---|
|
Mean Change From Baseline in Gamma Glutamyl Transferase in Patients With Primary Sclerosing Cholangitis
|
156.6 units/liter
Standard Error 45.7
|
-20.3 units/liter
Standard Error 46.3
|
4.6 units/liter
Standard Error 46.5
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Mean percent change from baseline in gamma glutamyl transferase was assessed in participants with available data in the Full Analysis Set.
Blood samples were collected to assess changes in gamma glutamyl transferase levels.
Outcome measures
| Measure |
NGM282 1.0 mg
n=21 Participants
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.
|
NGM282 3.0 mg
n=20 Participants
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.
|
Placebo
n=20 Participants
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.
|
|---|---|---|---|
|
Mean Percent Change From Baseline in Gamma Glutamyl Transferase in Patients With Primary Sclerosing Cholangitis
|
20.9 percent change
Standard Error 10.5
|
6.6 percent change
Standard Error 10.6
|
7.5 percent change
Standard Error 10.6
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Mean change from baseline in cholesterol levels were assessed in participants with available data in the Full Analysis Set.
Blood samples were collected to assess changes in cholesterol levels.
Outcome measures
| Measure |
NGM282 1.0 mg
n=21 Participants
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.
|
NGM282 3.0 mg
n=21 Participants
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.
|
Placebo
n=20 Participants
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.
|
|---|---|---|---|
|
Mean Change From Baseline in Cholesterol Levels in Patients With Primary Sclerosing Cholangitis
Total cholesterol
|
0.14 millimole/liter
Standard Deviation 1.01
|
0.26 millimole/liter
Standard Deviation 1.10
|
0.15 millimole/liter
Standard Deviation 0.69
|
|
Mean Change From Baseline in Cholesterol Levels in Patients With Primary Sclerosing Cholangitis
High-density lipoprotein
|
0.04 millimole/liter
Standard Deviation 0.46
|
-0.05 millimole/liter
Standard Deviation 0.50
|
-0.06 millimole/liter
Standard Deviation 0.19
|
|
Mean Change From Baseline in Cholesterol Levels in Patients With Primary Sclerosing Cholangitis
Low-density lipoprotein
|
0.07 millimole/liter
Standard Deviation 0.85
|
0.30 millimole/liter
Standard Deviation 0.71
|
0.12 millimole/liter
Standard Deviation 0.54
|
|
Mean Change From Baseline in Cholesterol Levels in Patients With Primary Sclerosing Cholangitis
Triglycerides
|
0.01 millimole/liter
Standard Deviation 0.59
|
-0.08 millimole/liter
Standard Deviation 0.37
|
0.10 millimole/liter
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Mean percent change from baseline in cholesterol levels were assessed in the Full Analysis Set.
Blood samples were collected to assess changes in cholesterol levels.
Outcome measures
| Measure |
NGM282 1.0 mg
n=21 Participants
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.
|
NGM282 3.0 mg
n=21 Participants
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.
|
Placebo
n=20 Participants
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.
|
|---|---|---|---|
|
Mean Percent Change From Baseline in Cholesterol Levels in Patients With Primary Sclerosing Cholangitis
Total cholesterol
|
1.81 percent change
Standard Deviation 16.45
|
5.67 percent change
Standard Deviation 16.31
|
3.89 percent change
Standard Deviation 12.17
|
|
Mean Percent Change From Baseline in Cholesterol Levels in Patients With Primary Sclerosing Cholangitis
High-density lipoprotein
|
0.47 percent change
Standard Deviation 28.94
|
-0.36 percent change
Standard Deviation 23.87
|
-3.09 percent change
Standard Deviation 10.42
|
|
Mean Percent Change From Baseline in Cholesterol Levels in Patients With Primary Sclerosing Cholangitis
Low-density lipoprotein
|
1.36 percent change
Standard Deviation 27.56
|
10.63 percent change
Standard Deviation 19.62
|
6.18 percent change
Standard Deviation 19.15
|
|
Mean Percent Change From Baseline in Cholesterol Levels in Patients With Primary Sclerosing Cholangitis
Triglycerides
|
3.47 percent change
Standard Deviation 45.71
|
-5.81 percent change
Standard Deviation 27.22
|
11.61 percent change
Standard Deviation 33.32
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Mean change from baseline in 25-Hydroxyvitamin D was assessed in the Full Analysis Set.
Blood samples were collected to assess changes in 25-Hydroxyvitamin D levels.
Outcome measures
| Measure |
NGM282 1.0 mg
n=21 Participants
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.
|
NGM282 3.0 mg
n=21 Participants
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.
|
Placebo
n=20 Participants
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.
|
|---|---|---|---|
|
Mean Change From Baseline in 25-Hydroxyvitamin D in Patients With Primary Sclerosing Cholangitis
|
6.4 nmol/Liter
Standard Error 33.9
|
1.1 nmol/Liter
Standard Error 30.6
|
0.7 nmol/Liter
Standard Error 21.7
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Mean percent change from baseline in 25-Hydroxyvitamin D was assessed in the Full Analysis Set.
Blood samples were collected to assess changes in 25-Hydroxyvitamin D levels.
Outcome measures
| Measure |
NGM282 1.0 mg
n=21 Participants
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.
|
NGM282 3.0 mg
n=21 Participants
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.
|
Placebo
n=20 Participants
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.
|
|---|---|---|---|
|
Mean Percent Change From Baseline in 25-Hydroxyvitamin D in Patients With Primary Sclerosing Cholangitis
|
30.5 percent change
Standard Error 97.3
|
17.0 percent change
Standard Error 64.8
|
4.4 percent change
Standard Error 41.6
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Mean change from baseline in Prothrombin was assessed in participants with available data in the Full Analysis Set.
Blood samples were collected to assess changes in Prothrombin levels.
Outcome measures
| Measure |
NGM282 1.0 mg
n=21 Participants
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.
|
NGM282 3.0 mg
n=20 Participants
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.
|
Placebo
n=19 Participants
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.
|
|---|---|---|---|
|
Mean Change From Baseline in Prothrombin International Normalized Ratio in Patients With Primary Sclerosing Cholangitis
|
0.03 International normalized ratio
Standard Deviation 0.09
|
0.01 International normalized ratio
Standard Deviation 0.07
|
0.00 International normalized ratio
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Mean percent change from baseline in Prothrombin was assessed in participants with available data in the Full Analysis Set.
Blood samples were collected to assess changes in Prothrombin levels.
Outcome measures
| Measure |
NGM282 1.0 mg
n=21 Participants
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.
|
NGM282 3.0 mg
n=20 Participants
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.
|
Placebo
n=19 Participants
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.
|
|---|---|---|---|
|
Mean Percent Change From Baseline in Prothrombin International Normalized Ratio in Patients With Primary Sclerosing Cholangitis
|
3.39 percent change
Standard Deviation 8.02
|
0.65 percent change
Standard Deviation 6.67
|
0.47 percent change
Standard Deviation 6.75
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Mean change from baseline in Calprotectin was assessed in participants with available data in the Full Analysis Set.
Blood samples were collected to assess changes in Calprotectin levels.
Outcome measures
| Measure |
NGM282 1.0 mg
n=14 Participants
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.
|
NGM282 3.0 mg
n=9 Participants
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.
|
Placebo
n=16 Participants
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.
|
|---|---|---|---|
|
Mean Change From Baseline in Calprotectin in Patients With Primary Sclerosing Cholangitis
|
353.4 microgram/gram
Standard Deviation 839.8
|
211.8 microgram/gram
Standard Deviation 585.8
|
-10.3 microgram/gram
Standard Deviation 457.9
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Mean change from baseline in Enhanced Liver Fibrosis Score was assessed in the Full Analysis Set.
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.
Outcome measures
| Measure |
NGM282 1.0 mg
n=21 Participants
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.
|
NGM282 3.0 mg
n=21 Participants
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.
|
Placebo
n=20 Participants
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.
|
|---|---|---|---|
|
Mean Change From Baseline in Enhanced Liver Fibrosis Score in Patients With Primary Sclerosing Cholangitis
|
-0.22 units on a scale
Standard Deviation 0.64
|
-0.26 units on a scale
Standard Deviation 0.66
|
0.05 units on a scale
Standard Deviation 0.52
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Severity of inflammatory bowel disease-associated intestinal symptoms were assessed in the Full Analysis Set.
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.
Outcome measures
| Measure |
NGM282 1.0 mg
n=21 Participants
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.
|
NGM282 3.0 mg
n=21 Participants
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.
|
Placebo
n=20 Participants
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.
|
|---|---|---|---|
|
Severity of Inflammatory Bowel Disease-Associated Intestinal Symptoms in Patients With Primary Sclerosing Cholangitis
Remission
|
12 Participants
|
13 Participants
|
17 Participants
|
|
Severity of Inflammatory Bowel Disease-Associated Intestinal Symptoms in Patients With Primary Sclerosing Cholangitis
Mild disease
|
8 Participants
|
8 Participants
|
3 Participants
|
|
Severity of Inflammatory Bowel Disease-Associated Intestinal Symptoms in Patients With Primary Sclerosing Cholangitis
Moderate disease
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Severity of Inflammatory Bowel Disease-Associated Intestinal Symptoms in Patients With Primary Sclerosing Cholangitis
Severe disease
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
NGM282 1.0 mg
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
NGM282 3.0 mg
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NGM282 1.0 mg
n=21 participants at risk
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.
|
NGM282 3.0 mg
n=21 participants at risk
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.
|
Placebo
n=20 participants at risk
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.
|
|---|---|---|---|
|
Gastrointestinal disorders
Bowel obstruction
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
0.00%
0/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Hepatobiliary disorders
Cholangitis sclerosing
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
0.00%
0/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
0.00%
0/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Investigations
Blood bilirubin increased
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
0.00%
0/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
Other adverse events
| Measure |
NGM282 1.0 mg
n=21 participants at risk
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.
|
NGM282 3.0 mg
n=21 participants at risk
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.
|
Placebo
n=20 participants at risk
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.
|
|---|---|---|---|
|
Nervous system disorders
Burning sensation
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
5.0%
1/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Infections and infestations
Nasopharyngitis
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
9.5%
2/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
20.0%
4/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
5.0%
1/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
9.5%
2/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
0.00%
0/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
10.0%
2/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
9.5%
2/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
9.5%
2/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
10.0%
2/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
5.0%
1/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
5.0%
1/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Gastrointestinal disorders
Abdominal cramps
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
10.0%
2/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
5.0%
1/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Gastrointestinal disorders
Diarrhea
|
23.8%
5/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
19.0%
4/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
0.00%
0/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
5.0%
1/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Gastrointestinal disorders
Dyspepsia aggravated
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
5.0%
1/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
9.5%
2/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
0.00%
0/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Gastrointestinal disorders
Increased stool frequency
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
14.3%
3/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
0.00%
0/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Gastrointestinal disorders
Loose stools
|
19.0%
4/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
9.5%
2/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
5.0%
1/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Gastrointestinal disorders
Nausea
|
9.5%
2/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
9.5%
2/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
15.0%
3/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Gastrointestinal disorders
Nausea aggravated
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
5.0%
1/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
5.0%
1/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
5.0%
1/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
General disorders
Chest pain
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
5.0%
1/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
General disorders
Fatigue
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
14.3%
3/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
15.0%
3/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
General disorders
Injection site erythema
|
9.5%
2/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
52.4%
11/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
5.0%
1/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
General disorders
Injection site pain
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
10.0%
2/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
General disorders
Malaise
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
5.0%
1/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
General disorders
Pyrexia
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
5.0%
1/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Infections and infestations
Influenza
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
5.0%
1/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
10.0%
2/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Nervous system disorders
Headache
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
19.0%
4/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
15.0%
3/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
5.0%
1/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Metabolism and nutrition disorders
Increased appetite
|
19.0%
4/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
0.00%
0/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
14.3%
3/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
5.0%
1/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
9.5%
2/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
0.00%
0/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
5.0%
1/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
10.0%
2/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
4.8%
1/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
10.0%
2/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
5.0%
1/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
5.0%
1/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
5.0%
1/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Eye disorders
Dry eye
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
5.0%
1/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
0.00%
0/21 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
5.0%
1/20 • Treatment-emergent adverse events were collected from Day 1 up to Week 16.
|
Additional Information
Clinical Trial Information and Disclosure
NGM Biopharmaceuticals, Inc
Phone: 650-243-5555
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place