Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)

NGM Biopharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Nonalcoholic Steatohepatitis (NASH)

Treatments: Other: Placebo; Biological: NGM282

Study type: Interventional

Funder types: Industry

Identifiers

NCT02443116

15-0105

Details and patient eligibility

About

The purpose of this study is to determine the safety, tolerability, and efficacy of NGM282 in patients with nonalcoholic steatohepatitis.

Enrollment: 254 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
• Histologically confirmed NASH diagnosis

Exclusion criteria

• Clinically significant acute or chronic liver disease
• Prior liver transplantation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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254 participants in 9 patient groups, including a placebo group

Cohort 1 - Placebo

Placebo Comparator group

Description:

Cohort 1 - Placebo

Treatment:

Other: Placebo

Cohort 1 - NGM282 3mg

Experimental group

Description:

Cohort 1 - NGM282 3mg

Treatment:

Biological: NGM282

Cohort 1 - NGM282 6mg

Experimental group

Description:

Cohort 1 - NGM282 6mg

Treatment:

Biological: NGM282

Cohort 2 - NGM282 0.3mg

Experimental group

Description:

Cohort 2 - NGM282 0.3mg

Treatment:

Biological: NGM282

Cohort 2 - NGM282 1mg

Placebo Comparator group

Description:

Cohort 2 - NGM282 1mg

Treatment:

Biological: NGM282

Cohort 2 - NGM282 3mg

Experimental group

Description:

Cohort 2 - NGM282 3mg

Treatment:

Biological: NGM282

Cohort 3 - NGM282 1mg

Experimental group

Description:

Cohort 3 - NGM282 1mg

Treatment:

Biological: NGM282

Cohort 4 - Placebo

Placebo Comparator group

Description:

Cohort 4 - Placebo

Treatment:

Other: Placebo

Cohort 4 - NGM282 1mg

Experimental group

Description:

Cohort 4 - NGM282 1mg

Treatment:

Biological: NGM282