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

Primary Purpose

Compensated Cirrhosis, Nonalcoholic Steatohepatitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
aldafermin
Placebo
Sponsored by
NGM Biopharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Compensated Cirrhosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site
  • NGM Clinical Study Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Daily 0.3 mg dose

Daily 1 mg dose

Daily 3 mg dose

Placebo

Arm Description

Administered by subcutaneous injection

Administered by subcutaneous injection

Administered by subcutaneous injection

Administered by subcutaneous injection

Outcomes

Primary Outcome Measures

Improvement in Enhanced Liver Fibrosis (ELF) score.
Safety assessed by reported and observed adverse events.

Secondary Outcome Measures

Full Information

First Posted
December 16, 2019
Last Updated
June 9, 2023
Sponsor
NGM Biopharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT04210245
Brief Title
Study of Aldafermin (NGM282) in Subjects With Compensated Cirrhosis (ALPINE 4)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 23, 2020 (Actual)
Primary Completion Date
January 4, 2023 (Actual)
Study Completion Date
February 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NGM Biopharmaceuticals, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Compensated Cirrhosis, Nonalcoholic Steatohepatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Daily 0.3 mg dose
Arm Type
Experimental
Arm Description
Administered by subcutaneous injection
Arm Title
Daily 1 mg dose
Arm Type
Experimental
Arm Description
Administered by subcutaneous injection
Arm Title
Daily 3 mg dose
Arm Type
Experimental
Arm Description
Administered by subcutaneous injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administered by subcutaneous injection
Intervention Type
Biological
Intervention Name(s)
aldafermin
Intervention Description
aldafermin
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo for aldafermin
Primary Outcome Measure Information:
Title
Improvement in Enhanced Liver Fibrosis (ELF) score.
Time Frame
48 weeks
Title
Safety assessed by reported and observed adverse events.
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Liver biopsy consistent with NASH cirrhosis. Compensated cirrhosis due to NASH. Key Exclusion Criteria: 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. Other protocol-defined inclusion/exclusion criteria could apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
NGM Study Director
Organizational Affiliation
NGM Biopharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
NGM Clinical Study Site
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
NGM Clinical Study Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
NGM Clinical Study Site
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
NGM Clinical Study Site
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
NGM Clinical Study Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
NGM Clinical Study Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
NGM Clinical Study Site
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
NGM Clinical Study Site
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Facility Name
NGM Clinical Study Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33434
Country
United States
Facility Name
NGM Clinical Study Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
NGM Clinical Study Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
NGM Clinical Study Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
NGM Clinical Study Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
NGM Clinical Study Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
NGM Clinical Study Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
NGM Clinical Study Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
NGM Clinical Study Site
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
NGM Clinical Study Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
NGM Clinical Study Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
NGM Clinical Study Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
NGM Clinical Study Site
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
NGM Clinical Study Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78746
Country
United States
Facility Name
NGM Clinical Study Site
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
NGM Clinical Study Site
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Facility Name
NGM Clinical Study Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
NGM Clinical Study Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
NGM Clinical Study Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
NGM Clinical Study Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
NGM Clinical Study Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
NGM Clinical Study Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
NGM Clinical Study Site
City
Camperdown
State/Province
New South Wales
Country
Australia
Facility Name
NGM Clinical Study Site
City
Westmead
State/Province
New South Wales
Country
Australia
Facility Name
NGM Clinical Study Site
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
NGM Clinical Study Site
City
Bedford Park
State/Province
South Australia
Country
Australia
Facility Name
NGM Clinical Study Site
City
Clayton
State/Province
Victoria
Country
Australia
Facility Name
NGM Clinical Study Site
City
Fitzroy
State/Province
Victoria
Country
Australia
Facility Name
NGM Clinical Study Site
City
Heidelberg
State/Province
Victoria
Country
Australia
Facility Name
NGM Clinical Study Site
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
NGM Clinical Study Site
City
Brussels
Country
Belgium
Facility Name
NGM Clinical Study Site
City
Paris
Country
France
Facility Name
NGM Clinical Study Site
City
Pessac Cedex
ZIP/Postal Code
33604
Country
France
Facility Name
NGM Clinical Study Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
NGM Clinical Study Site
City
Leipzig
Country
Germany
Facility Name
NGM Clinical Study Site
City
Shatin
Country
Hong Kong
Facility Name
NGM Clinical Study Site
City
Wroclaw
Country
Poland
Facility Name
NGM Clinical Study Site
City
San Juan
ZIP/Postal Code
00927-4807
Country
Puerto Rico
Facility Name
NGM Clinical Study Site
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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

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