Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis

NGM Biopharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Primary Biliary Cirrhosis

Treatments: Biological: Placebo; Biological: NGM282

Study type: Interventional

Funder types: Industry

Identifiers

NCT02026401

13-0103

Details and patient eligibility

About

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

Enrollment: 45 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

---

45 participants in 3 patient groups, including a placebo group

NGM282 Dose 1

Experimental group

Description:

NGM282 Dose 1

Treatment:

Biological: NGM282

NGM282 Dose 2

Experimental group

Description:

NGM282 Dose 2

Treatment:

Biological: NGM282

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Biological: Placebo