Trial · NCT02704364

A Study of NGM282 in Patients With Primary Sclerosing Cholangitis

NCT02704364, Phase 2, Completed, NGM Biopharmaceuticals, Inc; results first posted 2025-06-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of NGM282 in Patients With Primary Sclerosing Cholangitis. Trials, record NCT02704364. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02704364

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of NGM282 in Patients With Primary Sclerosing Cholangitis
NCT number: NCT02704364
Status: Completed
Phases: Phase 2
Enrollment: 62 participants, actual
Lead sponsor: NGM Biopharmaceuticals, Inc
Conditions: Primary Sclerosing Cholangitis
Interventions: NGM282, Placebo
First posted: 2016-03-10
Last updated: 2025-06-17
Other registries' IDs: eudract:2015-003392-30
Results first posted: 2025-06-17

Source ClinicalTrials.gov

Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis	Baseline to Week 12	Blood samples were collected to assess changes in alkaline phosphatase levels.
Secondary	Mean Percent Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis	Baseline to Week 12	Blood samples were collected to assess changes in alkaline phosphatase levels.
Secondary	Mean Rate of Change in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis	Baseline to Week 12	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.
Secondary	Mean Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase in Patients With Primary Sclerosing Cholangitis	Baseline to Week 12	Blood samples were collected to assess changes in aspartate aminotransferase and alanine aminotransferase levels.
Secondary	Mean Percent Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase in Patients With Primary Sclerosing Cholangitis	Baseline to Week 12	Blood samples were collected to assess changes in aspartate aminotransferase and alanine aminotransferase levels.
Secondary	Mean Change From Baseline in Bilirubin (Direct and Total) in Patients With Primary Sclerosing Cholangitis	Baseline to Week 12	Blood samples were collected to assess changes in bilirubin (direct and total) levels.
Secondary	Mean Percent Change From Baseline in Bilirubin (Direct and Total) in Patients With Primary Sclerosing Cholangitis	Baseline to Week 12	Blood samples were collected to assess changes in bilirubin (direct and total) levels.
Secondary	Mean Change From Baseline in Gamma Glutamyl Transferase in Patients With Primary Sclerosing Cholangitis	Baseline to Week 12	Blood samples were collected to assess changes in gamma glutamyl transferase levels.
Secondary	Mean Percent Change From Baseline in Gamma Glutamyl Transferase in Patients With Primary Sclerosing Cholangitis	Baseline to Week 12	Blood samples were collected to assess changes in gamma glutamyl transferase levels.
Secondary	Mean Change From Baseline in Cholesterol Levels in Patients With Primary Sclerosing Cholangitis	Baseline to Week 12	Blood samples were collected to assess changes in cholesterol levels.

1 to 10 of 18Source ClinicalTrials.gov

See all 18 registered outcomes

Outcomes18

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis	Baseline to Week 12	Mean change from baseline in ALP was assessed in participants with available data in the Full Analysis Set.	International units/Liter	MEAN
SECONDARY	Mean Percent Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis	Baseline to Week 12	Mean percent change from baseline in ALP was assessed in participants with available data in the Full Analysis Set.	percent change	MEAN
SECONDARY	Mean Rate of Change in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis	Baseline to Week 12	Mean rate of change in ALP was assessed in participants with available data in the Full Analysis Set .	U/L/Week	MEAN
SECONDARY	Mean Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase in Patients With Primary Sclerosing Cholangitis	Baseline to Week 12	Mean changes from baseline in aspartate aminotransferase and alanine aminotransferase were assessed in participants with available data in the Full Analysis Set.	units/liter	MEAN
SECONDARY	Mean Percent Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase in Patients With Primary Sclerosing Cholangitis	Baseline to Week 12	Mean percent changes from baseline in aspartate aminotransferase and alanine aminotransferase were assessed in participants with available data in the Full Analysis Set.	percent change	MEAN
SECONDARY	Mean Change From Baseline in Bilirubin (Direct and Total) in Patients With Primary Sclerosing Cholangitis	Baseline to Week 12	Mean change from baseline in bilirubin (total and direct) was assessed in participants with available data in the Full Analysis Set.	micromole/liter	MEAN
SECONDARY	Mean Percent Change From Baseline in Bilirubin (Direct and Total) in Patients With Primary Sclerosing Cholangitis	Baseline to Week 12	Mean percent changes from baseline in bilirubin (total and direct) were assessed in participants with available data in the Full Analysis Set.	percent change	MEAN
SECONDARY	Mean Change From Baseline in Gamma Glutamyl Transferase in Patients With Primary Sclerosing Cholangitis	Baseline to Week 12	Mean change from baseline in gamma glutamyl transferase was assessed in participants with available data in the Full Analysis Set.	units/liter	MEAN
SECONDARY	Mean Percent Change From Baseline in Gamma Glutamyl Transferase in Patients With Primary Sclerosing Cholangitis	Baseline to Week 12	Mean percent change from baseline in gamma glutamyl transferase was assessed in participants with available data in the Full Analysis Set.	percent change	MEAN
SECONDARY	Mean Change From Baseline in Cholesterol Levels in Patients With Primary Sclerosing Cholangitis	Baseline to Week 12	Mean change from baseline in cholesterol levels were assessed in participants with available data in the Full Analysis Set.	millimole/liter	MEAN

1 to 10 of 18Source ClinicalTrials.gov

See all 18 outcomes

Results by group94

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Mean Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis	NGM282 1.0 mg		25.6	Standard Error 100.3	International units/Liter
Mean Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis	NGM282 3.0 mg		-9.8	Standard Error 101.3	International units/Liter
Mean Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis	Placebo		-0.6	Standard Error 79.5	International units/Liter
Mean Percent Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis	NGM282 1.0 mg		7.1	Standard Error 5.8	percent change
Mean Percent Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis	NGM282 3.0 mg		-4.2	Standard Error 5.9	percent change
Mean Percent Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis	Placebo		-3.4	Standard Error 6.0	percent change
Mean Rate of Change in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis	NGM282 1.0 mg	Weeks 1 through 4	-17.7	Standard Error 6.4	U/L/Week
Mean Rate of Change in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis	NGM282 3.0 mg	Weeks 1 through 4	-2.2	Standard Error 6.1	U/L/Week
Mean Rate of Change in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis	NGM282 1.0 mg	Weeks 5 through 12	11.9	Standard Error 4.5	U/L/Week
Mean Rate of Change in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis	NGM282 3.0 mg	Weeks 5 through 12	-0.2	Standard Error 2.2	U/L/Week

1 to 10 of 94Source ClinicalTrials.gov

See all 94 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	NGM282 1.0 mg	21
Overall Study	STARTED	NGM282 3.0 mg	21
Overall Study	STARTED	Placebo	20
Overall Study	COMPLETED	NGM282 1.0 mg	19
Overall Study	COMPLETED	NGM282 3.0 mg	18
Overall Study	COMPLETED	Placebo	19
Overall Study	NOT COMPLETED	NGM282 1.0 mg	2
Overall Study	NOT COMPLETED	NGM282 3.0 mg	3
Overall Study	NOT COMPLETED	Placebo	1

Source ClinicalTrials.gov

Adverse events135

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal cramps	Gastrointestinal disorders	NGM282 1.0 mg	1	21
other	Abdominal cramps	Gastrointestinal disorders	NGM282 3.0 mg	0	21
other	Abdominal cramps	Gastrointestinal disorders	Placebo	2	20
other	Abdominal distension	Gastrointestinal disorders	NGM282 1.0 mg	0	21
other	Abdominal distension	Gastrointestinal disorders	NGM282 3.0 mg	0	21
other	Abdominal distension	Gastrointestinal disorders	Placebo	1	20
other	Diarrhea	Gastrointestinal disorders	NGM282 1.0 mg	5	21
other	Diarrhea	Gastrointestinal disorders	NGM282 3.0 mg	4	21
other	Diarrhea	Gastrointestinal disorders	Placebo	0	20
other	Dry mouth	Gastrointestinal disorders	NGM282 1.0 mg	0	21

1 to 10 of 135Source ClinicalTrials.gov

See all 135 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	NGM282 1.0 mg	0	21
Total, all-cause mortality	NGM282 3.0 mg	0	21
Total, all-cause mortality	Placebo	0	20
Total, other adverse events	NGM282 1.0 mg	17	21
Total, other adverse events	NGM282 3.0 mg	20	21
Total, other adverse events	Placebo	18	20
Total, serious adverse events	NGM282 1.0 mg	1	21
Total, serious adverse events	NGM282 3.0 mg	2	21
Total, serious adverse events	Placebo	0	20

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33898959	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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