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

NCT04210245 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 282-CC-207
• Study Type: interventional
• Target: 160
• Locations: 9 countries
• Sites: 49

Brief Summary

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

Conditions

Compensated Cirrhosis; Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Enhanced Liver Fibrosis Score at Week 48

  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

Study Arms (4)

Daily 0.3 mg dose

EXPERIMENTAL

Administered by subcutaneous injection

Biological: aldafermin

Daily 1 mg dose

EXPERIMENTAL

Administered by subcutaneous injection

Biological: aldafermin

Daily 3 mg dose

EXPERIMENTAL

Administered by subcutaneous injection

Biological: aldafermin

Placebo

PLACEBO COMPARATOR

Administered by subcutaneous injection

Other: Placebo

Interventions

aldafermin BIOLOGICAL

aldafermin

Daily 0.3 mg dose; Daily 1 mg dose; Daily 3 mg dose

Placebo OTHER

Placebo for aldafermin

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Liver biopsy consistent with NASH cirrhosis.
• Compensated cirrhosis due to NASH.

You may not qualify if:

• 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.
• Evidence of drug induced steatohepatitis secondary to amiodarone, corticosteroids, estrogens, methotrexate, tetracycline, or other medications known to cause hepatic steatosis.
• History of hepatic decompensation including variceal bleeding, ascites, or hepatic encephalopathy.
• Model of end stage liver disease (MELD) score \>12.

Sponsors & Collaborators

• NGM Biopharmaceuticals, Inc: lead

Study Sites (49)

NGM Clinical Study Site

Glendale, Arizona, 85306, United States

Location

NGM Clinical Study Site 413

Tucson, Arizona, 85711, United States

Location

NGM Clinical Study Site 415

Tucson, Arizona, 85711, United States

Location

NGM Clinical Study Site

North Little Rock, Arkansas, 72117, United States

Location

NGM Clinical Study Site

Fresno, California, 93720, United States

Location

NGM Clinical Study Site

La Jolla, California, 92037, United States

Location

NGM Clinical Study Site

Los Angeles, California, 90057, United States

Location

NGM Clinical Study Site

Panorama City, California, 91402, United States

Location

NGM Clinical Study Site

Rialto, California, 92377, United States

Location

NGM Clinical Study Site

Boca Raton, Florida, 33434, United States

Location

NGM Clinical Study Site

Miami, Florida, 33136, United States

Location

NGM Clinical Study Site

Marietta, Georgia, 30060, United States

Location

NGM Clinical Study Site

Chicago, Illinois, 60611, United States

Location

NGM Clinical Study Site

Chicago, Illinois, 60637, United States

Location

NGM Clinical Study Site

Baltimore, Maryland, 21202, United States

Location

NGM Clinical Study Site

Boston, Massachusetts, 02111, United States

Location

NGM Clinical Study Site

Boston, Massachusetts, 02114, United States

Location

NGM Clinical Study Site

Flowood, Mississippi, 39232, United States

Location

NGM Clinical Study Site 488

Jackson, Mississippi, 39216, United States

Location

NGM Clinical Study Site

Kansas City, Missouri, 64131, United States

Location

NGM Clinical Study Site

Durham, North Carolina, 27710, United States

Location

NGM Clinical Study Site

Germantown, Tennessee, 38138, United States

Location

NGM Clinical Study Site

Austin, Texas, 78746, United States

Location

NGM Clinical Study Site

Edinburg, Texas, 78229, United States

Location

NGM Clinical Study Site

Edinburg, Texas, 78539, United States

Location

NGM Clinical Study Site 481

Houston, Texas, 77030, United States

Location

NGM Clinical Study Site

San Antonio, Texas, 78215, United States

Location

NGM Clinical Study Site

San Antonio, Texas, 78229, United States

Location

NGM Clinical Study Site

Richmond, Virginia, 23249, United States

Location

NGM Clinical Study Site

Richmond, Virginia, 23298, United States

Location

NGM Clinical Study Site 482

Seattle, Washington, 98104, United States

Location

NGM Clinical Study Site

Camperdown, New South Wales, Australia

Location

NGM Clinical Study Site

Westmead, New South Wales, Australia

Location

NGM Clinical Study Site

Adelaide, South Australia, Australia

Location

NGM Clinical Study Site

Bedford Park, South Australia, Australia

Location

NGM Clinical Study Site

Clayton, Victoria, Australia

Location

NGM Clinical Study Site

Fitzroy, Victoria, Australia

Location

NGM Clinical Study Site

Heidelberg, Victoria, Australia

Location

NGM Clinical Study Site

Melbourne, Victoria, Australia

Location

NGM Clinical Study Site

Brussels, Belgium

Location

NGM Clinical Study Site

Paris, France

Location

NGM Clinical Study Site

Pessac, 33604, France

Location

NGM Clinical Study Site

Leipzig, 04103, Germany

Location

NGM Clinical Study Site

Leipzig, Germany

Location

NGM Clinical Study Site

Shatin, Hong Kong

Location

NGM Clinical Study Site 444

Wroclaw, Poland

Location

NGM Clinical Study Site 446

Wroclaw, Poland

Location

NGM Clinical Study Site

San Juan, 00927-4807, Puerto Rico

Location

NGM Clinical Study Site 466

London, United Kingdom

Location

Related Publications (1)

• Rinella ME, Lieu HD, Kowdley KV, Goodman ZD, Alkhouri N, Lawitz E, Ratziu V, Abdelmalek MF, Wong VW, Younes ZH, Sheikh AM, Brannan D, Freilich B, Membreno F, Sinclair M, Melchor-Khan L, Sanyal AJ, Ling L, Harrison SA. A randomized, double-blind, placebo-controlled trial of aldafermin in patients with NASH and compensated cirrhosis. Hepatology. 2024 Mar 1;79(3):674-689. doi: 10.1097/HEP.0000000000000607. Epub 2023 Sep 21.

  PMID: 37732990 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

aldafermin

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: VP, Clinical Operations
• Organization: NGM Biopharmaceuticals

ngm282@ngmbio.com

(650) 243-5555

Study Officials

• NGM Study Director

  NGM Biopharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 24, 2019
• Study Start: March 23, 2020
• Primary Completion: January 4, 2023
• Study Completion: February 23, 2023
• Last Updated: March 26, 2025
• Results First Posted: March 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1); PL (2); HK (1); AU (8); BE (1); GB (1); US (31); FR (2); DE (2)