Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis

Phase 2CompletedNCT02026401

NGM Biopharmaceuticals, Inc45 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Primary Biliary Cirrhosis

Interventions

NGM282BIOLOGICAL

PlaceboBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (17)

NGM Clinical Study Site 103

Phoenix, Arizona, United States

NGM Clinical Study Site 108

Coronado, California, United States

Outcomes

Primary Outcomes

Absolute change in plasma ALP from Baseline to Day 28

Time frame: 28 days

Secondary Outcomes

Absolute change in bilirubin from Baseline to Day 28

Time frame: 28 days

Data from ClinicalTrials.gov

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