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

NGM Biopharmaceuticals, Inc36 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Primary Biliary Cirrhosis

Interventions

NGM282BIOLOGICAL

NGM282

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

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 Week 12

Time frame: 12 weeks

Secondary Outcomes

Percentage change in bilirubin, ALT, AST, and GGT from Baseline to Week 12 and Week 24

Time frame: 12 weeks and 24 weeks

Data from ClinicalTrials.gov

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