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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02026401

Enrollment

Registered

2014-01-03

Start date

2014-02-28

Completion date

2014-12-31

Last updated

2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Biliary Cirrhosis

Brief summary

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

Interventions

BIOLOGICALNGM282

BIOLOGICALPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Males or females, between 18 and 75 years of age, inclusive * PBC diagnosis consistent with AASLD and EASL guidelines * Stable dose of UDCA

Exclusion criteria

* Chronic liver disease of a non-PBC etiology * Evidence of clinically significant hepatic decompensation

Design outcomes

Primary

Measure	Time frame
Absolute change in plasma ALP from Baseline to Day 28	28 days

Secondary

Measure	Time frame
Absolute change in bilirubin from Baseline to Day 28	28 days

Countries

Australia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026