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

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ClinicalTrials.gov Identifier: NCT04210245
Recruitment Status : Recruiting
First Posted : December 24, 2019
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
NGM Biopharmaceuticals, Inc

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

Condition or disease Intervention/treatment Phase
Compensated Cirrhosis Nonalcoholic Steatohepatitis Biological: aldafermin Other: Placebo Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 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 : June 2022
Estimated Study Completion Date : September 2022


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




Primary Outcome Measures :
  1. Improvement in liver fibrosis of greater or equal to one stage with no worsening of NASH. [ Time Frame: 48 weeks ]
  2. Safety assessed by reported and observed adverse events. [ Time Frame: 48 weeks ]


Information from the National Library of Medicine

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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
Criteria

Key Inclusion Criteria:

  1. Liver biopsy consistent with fibrosis stage 4 (F4) cirrhosis.
  2. Compensated cirrhosis due to NASH.
  3. Total liver fat content of ≥ 8% as measured by MRI-PDFF.

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.


Information from the National Library of Medicine

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


Contacts
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Contact: NGM Study Director (650) 243-5555 ngm282@ngmbio.com

Locations
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Sponsors and Collaborators
NGM Biopharmaceuticals, Inc
Investigators
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Study Director: NGM Study Director NGM Biopharmaceuticals
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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: February 10, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Cirrhosis
Fatty Liver
Non-alcoholic Fatty Liver Disease
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases