Evaluation of Efficacy, Safety and Tolerability of Aldafermin in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study In Subjects With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis (ALPINE 2/3)

NGM Biopharmaceuticals

Status and phase: Completed; Phase 2

Conditions: NASH - Nonalcoholic Steatohepatitis

Treatments: Biological: NGM282; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03912532

18-0108

Details and patient eligibility

About

This is a multi-center evaluation of NGM282 in a randomized, double-blind, placebo-controlled study administered for 24 weeks in participants with histologically confirmed NASH and F2/F3 Fibrosis.

Enrollment: 171 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically confirmed NASH diagnosis as defined by the NASH CRN
2. Total liver fat content of ≥ 8% as measured by MRI-PDFF

Exclusion criteria

1. Clinically significant acute or chronic liver disease of an etiology other than NASH
2. Evidence of drug-induced steatohepatitis secondary to amiodarone, corticosteroids, estrogens, methotrexate, tetracycline, or other medications known to cause hepatic steatosis
3. History or presence of cirrhosis (compensated or decompensated) as determined by histology and/or relevant medical complications and/or laboratory parameters
4. Prior or pending liver transplantation

Other protocol-defined inclusion/exclusion criteria could apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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171 participants in 4 patient groups, including a placebo group

NGM282 Dose 1

Experimental group

Description:

Administered by subcutaneous injection

Treatment:

Biological: NGM282

NGM282 Dose 2

Experimental group

Description:

Administered by subcutaneous injection

Treatment:

Biological: NGM282

NGM282 Dose 3

Experimental group

Description:

Administered by subcutaneous injection

Treatment:

Biological: NGM282

Placebo

Placebo Comparator group

Description:

Administered by subcutaneous injection

Treatment:

Other: Placebo