Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02026401
• Date of registration: 30/12/2013
• Prospective Registration: Yes
• Primary sponsor: NGM Biopharmaceuticals, Inc
• Public title: Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis
• Scientific title: 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
• Date of first enrolment: February 2014
• Target sample size: 45
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02026401
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Australia, United States

Contacts

• Name: Stephen J Rossi, PharmD
• Affiliation: NGM Biopharmaceuticals, Inc

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Primary Biliary Cirrhosis

Intervention(s)

Biological: NGM282

Biological: Placebo

Primary Outcome(s)

Absolute change in plasma ALP from Baseline to Day 28 [Time Frame: 28 days]

Secondary Outcome(s)

Absolute change in bilirubin from Baseline to Day 28 [Time Frame: 28 days]

Secondary ID(s)

13-0103

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

NGM Biopharmaceuticals Australia Pty Ltd