NCT04210245

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

Evaluation of Efficacy, Safety and Tolerability of NGM282 (Aldafermin) in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (ALPINE 4)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: NGM Biopharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Compensated Cirrhosis
• Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
BIOLOGICAL	aldafermin	aldafermin
OTHER	Placebo	Placebo for aldafermin

Timeline

• Start date: 2020-03-23
• Primary completion: 2023-01-04
• Completion: 2023-02-23
• First posted: 2019-12-24
• Last updated: 2025-03-26
• Results posted: 2025-03-26

Locations

49 sites across 9 countries: United States, Australia, Belgium, France, Germany, Hong Kong, Poland, Puerto Rico, United Kingdom

Regulatory

• FDA-regulated drug study