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

NCT04210245 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-03-26

Study results available
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Summary

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

Conditions

Interventions

BIOLOGICAL

aldafermin

aldafermin

OTHER

Placebo

Placebo for aldafermin

Sponsors & Collaborators

  • NGM Biopharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • NGM Study Director · NGM Biopharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-23
Primary Completion
2023-01-04
Completion
2023-02-23
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • France
  • Germany
  • Hong Kong
  • Poland
  • Puerto Rico
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04210245 on ClinicalTrials.gov