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

NGM Biopharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Primary Biliary Cirrhosis

Treatments: Biological: NGM282

Study type: Interventional

Funder types: Industry

Identifiers

NCT02135536

14-0104

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 3 patient groups

NGM282 Dose 1

Experimental group

Description:

NGM282 Dose 1

Treatment:

Biological: NGM282

NGM282 Dose 2

Experimental group

Description:

NGM282 Dose 2

Treatment:

Biological: NGM282

NGM282 Dose 3

Experimental group

Description:

NGM282 Dose 3

Treatment:

Biological: NGM282