Phase 2 N=62 Randomized Double-blind Treatment

A Study of NGM282 in Patients With Primary Sclerosing Cholangitis

Primary Sclerosing Cholangitis

Bottom Line

View on ClinicalTrials.gov: NCT02704364 ↗

Enrolled (actual)

Serious AEs

4.8%

Results posted

Jun 2025

Primary outcome: Primary: Mean Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis — 25.6; -9.8; -0.6 International units/Liter — p=0.434

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: NGM282 (Biological); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: NGM Biopharmaceuticals, Inc
Primary completion: Jun 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis	25.6; -9.8; -0.6	0.434
SECONDARY Mean Percent Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis	7.1; -4.2; -3.4	—
SECONDARY Mean Rate of Change in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis	-17.7; -2.2; 11.9; -0.2	—
SECONDARY Mean Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase in Patients With Primary Sclerosing Cholangitis	-0.2; -30.9; -13.3; 8.5; -45.1; -12.1	—
SECONDARY Mean Percent Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase in Patients With Primary Sclerosing Cholangitis	2.6; -25.5; -7.2; 7.2; -29.2; -6.1	—
SECONDARY Mean Change From Baseline in Bilirubin (Direct and Total) in Patients With Primary Sclerosing Cholangitis	9.14; 0.54; 0.55; 9.78; 0.04; 0.83	—
SECONDARY Mean Percent Change From Baseline in Bilirubin (Direct and Total) in Patients With Primary Sclerosing Cholangitis	36.5; 5.7; 9.2; 27.2; -3.6; 6.8	—
SECONDARY Mean Change From Baseline in Gamma Glutamyl Transferase in Patients With Primary Sclerosing Cholangitis	156.6; -20.3; 4.6	—
SECONDARY Mean Percent Change From Baseline in Gamma Glutamyl Transferase in Patients With Primary Sclerosing Cholangitis	20.9; 6.6; 7.5	—
SECONDARY Mean Change From Baseline in Cholesterol Levels in Patients With Primary Sclerosing Cholangitis	0.14; 0.26; 0.15; 0.04; -0.05; -0.06	—
SECONDARY Mean Percent Change From Baseline in Cholesterol Levels in Patients With Primary Sclerosing Cholangitis	1.81; 5.67; 3.89; 0.47; -0.36; -3.09	—
SECONDARY Mean Change From Baseline in 25-Hydroxyvitamin D in Patients With Primary Sclerosing Cholangitis	6.4; 1.1; 0.7	—
SECONDARY Mean Percent Change From Baseline in 25-Hydroxyvitamin D in Patients With Primary Sclerosing Cholangitis	30.5; 17.0; 4.4	—
SECONDARY Mean Change From Baseline in Prothrombin International Normalized Ratio in Patients With Primary Sclerosing Cholangitis	0.03; 0.01; 0.00	—
SECONDARY Mean Percent Change From Baseline in Prothrombin International Normalized Ratio in Patients With Primary Sclerosing Cholangitis	3.39; 0.65; 0.47	—
SECONDARY Mean Change From Baseline in Calprotectin in Patients With Primary Sclerosing Cholangitis	353.4; 211.8; -10.3	—
SECONDARY Mean Change From Baseline in Enhanced Liver Fibrosis Score in Patients With Primary Sclerosing Cholangitis	-0.22; -0.26; 0.05	—
SECONDARY Severity of Inflammatory Bowel Disease-Associated Intestinal Symptoms in Patients With Primary Sclerosing Cholangitis	12; 13; 17; 8; 8; 3	—

Summary

The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Sclerosing Cholangitis.

Eligibility Criteria

Inclusion Criteria

Confirmed diagnosis of PSC

Exclusion Criteria

Clinically significant acute or chronic liver disease of an etiology other than PSC
Secondary or IgG4 related sclerosing cholangitis

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02704364). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.