A Study of NGM282 in Patients With Primary Sclerosing Cholangitis
A Phase 2, Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Center Study to Evaluate the Safety, Tolerability, and Efficacy of NGM282 Administered for 12 Weeks in Patients With Primary Sclerosing Cholangitis
2 other identifiers
interventional
62
4 countries
38
Brief Summary
The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Sclerosing Cholangitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2016
Shorter than P25 for phase_2
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 29, 2016
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedFirst Posted
Study publicly available on registry
March 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedResults Posted
Study results publicly available
June 17, 2025
CompletedJune 17, 2025
March 1, 2025
1.3 years
February 29, 2016
March 5, 2025
June 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (17)
Mean Percent Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis
Baseline to Week 12
Mean Rate of Change in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis
Baseline to Week 12
Mean Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase in Patients With Primary Sclerosing Cholangitis
Baseline to Week 12
Mean Percent Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase in Patients With Primary Sclerosing Cholangitis
Baseline to Week 12
Mean Change From Baseline in Bilirubin (Direct and Total) in Patients With Primary Sclerosing Cholangitis
Baseline to Week 12
- +12 more secondary outcomes
Study Arms (3)
NGM282 Dose 1
EXPERIMENTALNGM282 Dose 1
NGM282 Dose 2
EXPERIMENTALNGM282 Dose 2
Placebo
ACTIVE COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of PSC
You may not qualify if:
- Clinically significant acute or chronic liver disease of an etiology other than PSC
- Secondary or IgG4 related sclerosing cholangitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
NGM Clinical Study Site 118
Sacramento, California, United States
NGM Clinical Study Site 112
San Clemente, California, United States
NGM Clinical Study Site 127
San Francisco, California, United States
NGM Clinical Study Site 106
Aurora, Colorado, United States
NGM Clinical Study Site 115
Washington D.C., District of Columbia, United States
NGM Clinical Study Site 110
Gainesville, Florida, United States
NGM Clinical Study Site 124
Lakewood Rch, Florida, United States
NGM Clinical Study Site 105
Miami, Florida, United States
NGM Clinical Study Site 109
Indianapolis, Indiana, United States
NGM Clinical Study Site 104
Detroit, Michigan, United States
NGM Clinical Study Site 102
Kansas City, Missouri, United States
NGM Clinical Study Site 107
St Louis, Missouri, United States
NGM Clinical Study Site 103
New York, New York, United States
NGM Clinical Study Site 116
Durham, North Carolina, United States
NGM Clinical Study Site 120
Cincinnati, Ohio, United States
NGM Clinical Study Site 114
Nashville, Tennessee, United States
NGM Clinical Study Site 113
Dallas, Texas, United States
NGM Clinical Study Site 117
Dallas, Texas, United States
NGM Clinical Study Site 119
Houston, Texas, United States
NGM Clinical Study Site 125
Southlake, Texas, United States
NGM Clinical Study Site 111
Charlottesville, Virginia, United States
NGM Clinical Study Site 122
Newport News, Virginia, United States
NGM Clinical Study Site 101
Norfolk, Virginia, United States
NGM Clinical Study Site 121
Richmond, Virginia, United States
NGM Clinical Study Site 108
Seattle, Washington, United States
NGM Clinical Study Site 126
Seattle, Washington, United States
NGM Clinical Study Site 301
Paris, France
NGM Clinical Study Site 402
Amsterdam, Netherlands
NGM Clinical Study Site 407
Amsterdam, Netherlands
NGM Clinical Study Site 406
Leiden, Netherlands
NGM Clinical Study Site 401
Nijmegen, Netherlands
NGM Clinical Study Site 404
Rotterdam, Netherlands
NGM Clinical Study Site 405
Utrecht, Netherlands
NGM Clinical Study Site 505
Birmingham, United Kingdom
NGM Clinical Study Site 504
Liverpool, United Kingdom
NGM Clinical Study Site 502
London, United Kingdom
NGM Clinical Study Site 501
Newcastle, United Kingdom
NGM Clinical Study Site 503
Norwich, United Kingdom
Related Publications (1)
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.
PMID: 33898959DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Information and Disclosure
- Organization
- NGM Biopharmaceuticals, Inc
Study Officials
- STUDY DIRECTOR
Stephen J Rossi, PharmD
NGM Biopharmaceuticals, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 29, 2016
First Posted
March 10, 2016
Study Start
March 1, 2016
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
June 17, 2025
Results First Posted
June 17, 2025
Record last verified: 2025-03