Study of Aldafermin (NGM282) in Subjects With Compensated Cirrhosis (ALPINE 4)
NCT ID: NCT04210245
Last Updated: 2025-03-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
160 participants
INTERVENTIONAL
2020-03-23
2023-02-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Daily 0.3 mg dose
Administered by subcutaneous injection
aldafermin
aldafermin
Daily 1 mg dose
Administered by subcutaneous injection
aldafermin
aldafermin
Daily 3 mg dose
Administered by subcutaneous injection
aldafermin
aldafermin
Placebo
Administered by subcutaneous injection
Placebo
Placebo for aldafermin
Interventions
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aldafermin
aldafermin
Placebo
Placebo for aldafermin
Eligibility Criteria
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Inclusion Criteria
2. Compensated cirrhosis due to NASH.
Exclusion Criteria
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.
18 Years
75 Years
ALL
No
Sponsors
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NGM Biopharmaceuticals, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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NGM Study Director
Role: STUDY_DIRECTOR
NGM Biopharmaceuticals
Locations
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NGM Clinical Study Site
Glendale, Arizona, United States
NGM Clinical Study Site 413
Tucson, Arizona, United States
NGM Clinical Study Site 415
Tucson, Arizona, United States
NGM Clinical Study Site
North Little Rock, Arkansas, United States
NGM Clinical Study Site
Fresno, California, United States
NGM Clinical Study Site
La Jolla, California, United States
NGM Clinical Study Site
Los Angeles, California, United States
NGM Clinical Study Site
Panorama City, California, United States
NGM Clinical Study Site
Rialto, California, United States
NGM Clinical Study Site
Boca Raton, Florida, United States
NGM Clinical Study Site
Miami, Florida, United States
NGM Clinical Study Site
Marietta, Georgia, United States
NGM Clinical Study Site
Chicago, Illinois, United States
NGM Clinical Study Site
Chicago, Illinois, United States
NGM Clinical Study Site
Baltimore, Maryland, United States
NGM Clinical Study Site
Boston, Massachusetts, United States
NGM Clinical Study Site
Boston, Massachusetts, United States
NGM Clinical Study Site
Flowood, Mississippi, United States
NGM Clinical Study Site 488
Jackson, Mississippi, United States
NGM Clinical Study Site
Kansas City, Missouri, United States
NGM Clinical Study Site
Durham, North Carolina, United States
NGM Clinical Study Site
Germantown, Tennessee, United States
NGM Clinical Study Site
Austin, Texas, United States
NGM Clinical Study Site
Edinburg, Texas, United States
NGM Clinical Study Site
Edinburg, Texas, United States
NGM Clinical Study Site 481
Houston, Texas, United States
NGM Clinical Study Site
San Antonio, Texas, United States
NGM Clinical Study Site
San Antonio, Texas, United States
NGM Clinical Study Site
Richmond, Virginia, United States
NGM Clinical Study Site
Richmond, Virginia, United States
NGM Clinical Study Site 482
Seattle, Washington, United States
NGM Clinical Study Site
Camperdown, New South Wales, Australia
NGM Clinical Study Site
Westmead, New South Wales, Australia
NGM Clinical Study Site
Adelaide, South Australia, Australia
NGM Clinical Study Site
Bedford Park, South Australia, Australia
NGM Clinical Study Site
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
Brussels, , Belgium
NGM Clinical Study Site
Paris, , France
NGM Clinical Study Site
Pessac, , France
NGM Clinical Study Site
Leipzig, , Germany
NGM Clinical Study Site
Leipzig, , Germany
NGM Clinical Study Site
Shatin, , Hong Kong
NGM Clinical Study Site 444
Wroclaw, , Poland
NGM Clinical Study Site 446
Wroclaw, , Poland
NGM Clinical Study Site
San Juan, , Puerto Rico
NGM Clinical Study Site 466
London, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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282-CC-207
Identifier Type: -
Identifier Source: org_study_id
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