Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis

Phase 2

Completed

• Conditions: Primary Biliary Cirrhosis
• Interventions: Biological: Placebo; Biological: NGM282

• Registration Number: NCT02026401
• Lead Sponsor: NGM Biopharmaceuticals, Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-30
• Study First Submitted QC: 2014-01-02
• Study First Posted: 2014-01-03
• Study Start: 2014-02
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2017-03
• Disposition First Submitted: 2017-03-27
• Disposition First Submitted QC: 2017-03-27
• Last Update Submitted: 2017-03-27
• Disposition First Posted: 2017-03-28
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
NGM282 Dose 1	NGM282	NGM282 Dose 1
NGM282 Dose 2	NGM282	NGM282 Dose 2

Primary Outcome Measures

Name	Time	Method
Absolute change in plasma ALP from Baseline to Day 28	28 days

Secondary Outcome Measures

Name	Time	Method
Absolute change in bilirubin from Baseline to Day 28	28 days

Trial Locations

Locations (17)

NGM Clinical Study Site 108; 🇺🇸 Coronado, California, United States

NGM Clinical Study Site 104; 🇺🇸 Richmond, Virginia, United States

NGM Clinical Study Site 614; 🇦🇺 Brisbane, Queensland, Australia

NGM Clinical Study Site 601; 🇦🇺 Melbourne, Victoria, Australia

NGM Clinical Study Site 604; 🇦🇺 Melbourne, Victoria, Australia

NGM Clinical Study Site 613; 🇦🇺 Melbourne, Victoria, Australia

NGM Clinical Study Site 102; 🇺🇸 Dallas, Texas, United States

NGM Clinical Study Site 607; 🇦🇺 Adelaide, South Australia, Australia

NGM Clinical Study Site 602; 🇦🇺 Sydney, New South Wales, Australia

NGM Clinical Study Site 606; 🇦🇺 Sydney, New South Wales, Australia

NGM Clinical Study Site 609; 🇦🇺 Sydney, New South Wales, Australia

NGM Clinical Study Site 611; 🇦🇺 Sydney, New South Wales, Australia

NGM Clinical Study Site 608; 🇦🇺 Adelaide, South Australia, Australia

NGM Clinical Study Site 103; 🇺🇸 Phoenix, Arizona, United States

NGM Clinical Study Site 105; 🇺🇸 Durham, North Carolina, United States

NGM Clinical Study Site 101; 🇺🇸 Detroit, Michigan, United States

NGM Clinical Study Site 113; 🇺🇸 San Antonio, Texas, United States