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)

Completed · Phase 2 · Has a placebo group

Conditions studied: NASH - Nonalcoholic Steatohepatitis

In brief

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.

Key facts

Study ID

NCT03912532

Run by

NGM Biopharmaceuticals, Inc

People needed

171

Starts

2019-05-16

Expected to finish

2021-03-29

Last updated by the study team

2025-07-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• NGM Clinical Study Site — Chandler, Arizona, United States
• NGM Clinical Study Site 814 — Tucson, Arizona, United States
• NGM Clinical Study Site 816 — Tucson, Arizona, United States
• NGM Clinical Study Site — North Little Rock, Arkansas, United States
• NGM Clinical Study Site — Fresno, California, United States
• NGM Clinical Study Site — La Jolla, California, United States
• NGM Clinical Study Site — Los Angeles, California, United States
• NGM Clinical Study Site — Los Angeles, California, United States
• NGM Clinical Study Site — Poway, California, United States
• NGM Clinical Study Site — Rialto, California, United States
• NGM Clinical Study Site — Boca Raton, Florida, United States
• NGM Clinical Study Site — Lakewood Rch, Florida, United States
• NGM Clinical Study Site — Port Orange, Florida, United States
• NGM Clinical Study Site — Sarasota, Florida, United States
• NGM Clinical Study Site — The Villages, Florida, United States
• NGM Clinical Study Site — Chicago, Illinois, United States
• NGM Clinical Study Site — Baton Rouge, Louisiana, United States
• NGM Clinical Study Site — Baltimore, Maryland, United States
• NGM Clinical Study Site — Ann Arbor, Michigan, United States
• NGM Clinical Study Site — Flowood, Mississippi, United States
• NGM Clinical Study Site — Jackson, Mississippi, United States
• NGM Clinical Study Site — Kansas City, Missouri, United States
• NGM Clinical Study Site — St Louis, Missouri, United States
• NGM Clinical Study Site — New York, New York, United States
• NGM Clinical Study Site — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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