Study of Aldafermin (NGM282) in Subjects With Compensated Cirrhosis (ALPINE 4)

NGM Biopharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Compensated Cirrhosis; Nonalcoholic Steatohepatitis

Treatments: Biological: aldafermin; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04210245

282-CC-207

Details and patient eligibility

About

A multi-center evaluation of aldafermin in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis.

Full description

The study will compare multiple doses of aldafermin against placebo in a compensated NASH cirrhosis population for 48 weeks of treatment.

Enrollment: 160 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Liver biopsy consistent with NASH cirrhosis.
2. Compensated cirrhosis due to NASH.

Key Exclusion Criteria:

1. Other causes of liver disease including but not limited to alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders, primary biliary cirrhosis, drug-induced hepatotoxicity, Wilson's disease, hemochromatosis, and alpha-1-anti-trypsin definition based on medical history and/or centralized read of liver histology.
2. Evidence of drug induced steatohepatitis secondary to amiodarone, corticosteroids, estrogens, methotrexate, tetracycline, or other medications known to cause hepatic steatosis.
3. History of hepatic decompensation including variceal bleeding, ascites, or hepatic encephalopathy.
4. Model of end stage liver disease (MELD) score >12.

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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160 participants in 4 patient groups, including a placebo group

Daily 0.3 mg dose

Experimental group

Description:

Administered by subcutaneous injection

Treatment:

Biological: aldafermin

Daily 1 mg dose

Experimental group

Description:

Administered by subcutaneous injection

Treatment:

Biological: aldafermin

Daily 3 mg dose

Experimental group

Description:

Administered by subcutaneous injection

Treatment:

Biological: aldafermin

Placebo

Placebo Comparator group

Description:

Administered by subcutaneous injection

Treatment:

Other: Placebo