Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis
A Phase 2, Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Center Study to Evaluate the Safety, Tolerability, and Pharmacodynamic Activity of NGM282 in Combination With Ursodeoxycholic Acid (UDCA) Administered for 28 Days in Patients With Primary Biliary Cirrhosis
1 other identifier
interventional
45
2 countries
17
Brief Summary
The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Biliary Cirrhosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2014
Shorter than P25 for phase_2
17 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
December 30, 2013
CompletedFirst Posted
Study publicly available on registry
January 3, 2014
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMarch 28, 2017
March 1, 2017
10 months
December 30, 2013
March 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Absolute change in plasma ALP from Baseline to Day 28
28 days
Secondary Outcomes (1)
Absolute change in bilirubin from Baseline to Day 28
28 days
Study Arms (3)
NGM282 Dose 1
EXPERIMENTALNGM282 Dose 1
NGM282 Dose 2
EXPERIMENTALNGM282 Dose 2
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Males or females, between 18 and 75 years of age, inclusive
- PBC diagnosis consistent with AASLD and EASL guidelines
- Stable dose of UDCA
You may not qualify if:
- Chronic liver disease of a non-PBC etiology
- Evidence of clinically significant hepatic decompensation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
NGM Clinical Study Site 103
Phoenix, Arizona, United States
NGM Clinical Study Site 108
Coronado, California, United States
NGM Clinical Study Site 101
Detroit, Michigan, United States
NGM Clinical Study Site 105
Durham, North Carolina, United States
NGM Clinical Study Site 102
Dallas, Texas, United States
NGM Clinical Study Site 113
San Antonio, Texas, United States
NGM Clinical Study Site 104
Richmond, Virginia, United States
NGM Clinical Study Site 602
Sydney, New South Wales, Australia
NGM Clinical Study Site 606
Sydney, New South Wales, Australia
NGM Clinical Study Site 609
Sydney, New South Wales, Australia
NGM Clinical Study Site 611
Sydney, New South Wales, Australia
NGM Clinical Study Site 614
Brisbane, Queensland, Australia
NGM Clinical Study Site 607
Adelaide, South Australia, Australia
NGM Clinical Study Site 608
Adelaide, South Australia, Australia
NGM Clinical Study Site 601
Melbourne, Victoria, Australia
NGM Clinical Study Site 604
Melbourne, Victoria, Australia
NGM Clinical Study Site 613
Melbourne, Victoria, Australia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Stephen J Rossi, PharmD
NGM Biopharmaceuticals, Inc
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2013
First Posted
January 3, 2014
Study Start
February 1, 2014
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
March 28, 2017
Record last verified: 2017-03