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Clinical Trials/NCT02026401
NCT02026401
Completed
Phase 2

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

NGM Biopharmaceuticals, Inc17 sites in 2 countries45 target enrollmentFebruary 2014
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ConditionsPrimary Biliary Cirrhosis

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Primary Biliary Cirrhosis
Sponsor
NGM Biopharmaceuticals, Inc
Enrollment
45
Locations
17
Primary Endpoint
Absolute change in plasma ALP from Baseline to Day 28
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
February 2014
End Date
December 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Sponsor
NGM Biopharmaceuticals, Inc
Responsible Party
Sponsor

Eligibility Criteria

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

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(28 days)

Study Sites (17)

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