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

March 24, 2025 updated by: NGM Biopharmaceuticals, Inc

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia
        • NGM Clinical Study Site
      • Westmead, New South Wales, Australia
        • NGM Clinical Study Site
    • South Australia
      • Adelaide, South Australia, Australia
        • NGM Clinical Study Site
      • Bedford Park, South Australia, Australia
        • NGM Clinical Study Site
    • Victoria
      • Clayton, Victoria, Australia
        • NGM Clinical Study Site
      • Fitzroy, Victoria, Australia
        • NGM Clinical Study Site
      • Heidelberg, Victoria, Australia
        • NGM Clinical Study Site
      • Melbourne, Victoria, Australia
        • NGM Clinical Study Site
  • Belgium
      • Brussels, Belgium
        • NGM Clinical Study Site
  • France
      • Paris, France
        • NGM Clinical Study Site
      • Pessac Cedex, France, 33604
        • NGM Clinical Study Site
  • Germany
      • Leipzig, Germany, 04103
        • NGM Clinical Study Site
      • Leipzig, Germany
        • NGM Clinical Study Site
  • Hong Kong
      • Shatin, Hong Kong
        • NGM Clinical Study Site
  • Poland
      • Wroclaw, Poland
        • NGM Clinical Study Site 444
      • Wroclaw, Poland
        • NGM Clinical Study Site 446
  • Puerto Rico
      • San Juan, Puerto Rico, 00927-4807
        • NGM Clinical Study Site
  • United Kingdom
      • London, United Kingdom
        • NGM Clinical Study Site 466
  • United States
    • Arizona
      • Glendale, Arizona, United States, 85306
        • NGM Clinical Study Site
      • Tucson, Arizona, United States, 85711
        • NGM Clinical Study Site 413
      • Tucson, Arizona, United States, 85711
        • NGM Clinical Study Site 415
    • Arkansas
      • North Little Rock, Arkansas, United States, 72117
        • NGM Clinical Study Site
    • California
      • Fresno, California, United States, 93720
        • NGM Clinical Study Site
      • La Jolla, California, United States, 92037
        • NGM Clinical Study Site
      • Los Angeles, California, United States, 90057
        • NGM Clinical Study Site
      • Panorama City, California, United States, 91402
        • NGM Clinical Study Site
      • Rialto, California, United States, 92377
        • NGM Clinical Study Site
    • Florida
      • Boca Raton, Florida, United States, 33434
        • NGM Clinical Study Site
      • Miami, Florida, United States, 33136
        • NGM Clinical Study Site
    • Georgia
      • Marietta, Georgia, United States, 30060
        • NGM Clinical Study Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • NGM Clinical Study Site
      • Chicago, Illinois, United States, 60637
        • NGM Clinical Study Site
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • NGM Clinical Study Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • NGM Clinical Study Site
      • Boston, Massachusetts, United States, 02114
        • NGM Clinical Study Site
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • NGM Clinical Study Site
      • Jackson, Mississippi, United States, 39216
        • NGM Clinical Study Site 488
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • NGM Clinical Study Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • NGM Clinical Study Site
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • NGM Clinical Study Site
    • Texas
      • Austin, Texas, United States, 78746
        • NGM Clinical Study Site
      • Edinburg, Texas, United States, 78229
        • NGM Clinical Study Site
      • Edinburg, Texas, United States, 78539
        • NGM Clinical Study Site
      • Houston, Texas, United States, 77030
        • NGM Clinical Study Site 481
      • San Antonio, Texas, United States, 78215
        • NGM Clinical Study Site
      • San Antonio, Texas, United States, 78229
        • NGM Clinical Study Site
    • Virginia
      • Richmond, Virginia, United States, 23249
        • NGM Clinical Study Site
      • Richmond, Virginia, United States, 23298
        • NGM Clinical Study Site
    • Washington
      • Seattle, Washington, United States, 98104
        • NGM Clinical Study Site 482

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Administered by subcutaneous injection
Other: Placebo
Placebo for aldafermin
Experimental: Daily 0.3 mg dose
Administered by subcutaneous injection
Biological: aldafermin
aldafermin
Experimental: Daily 1 mg dose
Administered by subcutaneous injection
Biological: aldafermin
aldafermin
Experimental: Daily 3 mg dose
Administered by subcutaneous injection
Biological: aldafermin
aldafermin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Enhanced Liver Fibrosis Score at Week 48
Time Frame: 48 weeks

Enhanced Liver Fibrosis (ELF) score is a non-invasive blood test derived from the measurement of hyaluronic acid (HA), amino terminal propeptide of type III procollagen (PIIINP), and tissue inhibitor of metalloprotease 1 (TIMP1) using a proprietary algorithm (Siemens). ELF score is a laboratory test, is unitless, and is used as a continuous variable. The minimal ELF score is zero, the maximal ELF score is unknown. The higher the ELF score, the worse the disease outcome.

ELF is a score on a scale of severity assessment against biopsy-proven fibrosis. A score of <7.7 is none to mild, > 7.7-9.8 is moderate, > 9.8 is severe.
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NGM Biopharmaceuticals, Inc

Investigators

  • Study Director: NGM Study Director, NGM Biopharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2020

Primary Completion (Actual)

January 4, 2023

Study Completion (Actual)

February 23, 2023

Study Registration Dates

First Submitted

December 16, 2019

First Submitted That Met QC Criteria

December 20, 2019

First Posted (Actual)

December 24, 2019

Study Record Updates

Last Update Posted (Actual)

March 26, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 282-CC-207

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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