Study of Aldafermin (NGM282) in Subjects With Compensated Cirrhosis (ALPINE 4)
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ClinicalTrials.gov Identifier: NCT04210245 |
Recruitment Status :
Active, not recruiting
First Posted : December 24, 2019
Last Update Posted : March 18, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Compensated Cirrhosis Nonalcoholic Steatohepatitis | Biological: aldafermin Other: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 160 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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) |
Actual Study Start Date : | March 23, 2020 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | March 2023 |

Arm | Intervention/treatment |
---|---|
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 |
Placebo Comparator: Placebo
Administered by subcutaneous injection
|
Other: Placebo
Placebo for aldafermin |
- Improvement in Enhanced Liver Fibrosis (ELF) score. [ Time Frame: 48 weeks ]
- Safety assessed by reported and observed adverse events. [ Time Frame: 48 weeks ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04210245

Study Director: | NGM Study Director | NGM Biopharmaceuticals |
Responsible Party: | NGM Biopharmaceuticals, Inc |
ClinicalTrials.gov Identifier: | NCT04210245 |
Other Study ID Numbers: |
282-CC-207 |
First Posted: | December 24, 2019 Key Record Dates |
Last Update Posted: | March 18, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Liver Cirrhosis Fatty Liver Non-alcoholic Fatty Liver Disease Fibrosis |
Pathologic Processes Liver Diseases Digestive System Diseases |