Phase 2b Study of NGM282 Extended Treatment in Patients With Primary Biliary Cirrhosis

A Phase 2, Multi-Center Study to Evaluate Three Doses of NGM282 Administered for 24 Weeks in Patients With Primary Biliary Cirrhosis (PBC) Who Have Completed Study 13-0103

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02135536

Enrollment

Registered

2014-05-12

Start date

2014-05-31

Completion date

2016-02-29

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 extended treatment with NGM282 in patients with Primary Biliary Cirrhosis.

Interventions

BIOLOGICALNGM282

NGM282

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Completion of NGM 13-0103 * 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 Week 12	12 weeks

Secondary

Measure	Time frame
Percentage change in bilirubin, ALT, AST, and GGT from Baseline to Week 12 and Week 24	12 weeks and 24 weeks

Countries

Australia, New Zealand, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026