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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 : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
NGM Biopharmaceuticals, Inc

Tracking Information
First Submitted Date  ICMJE December 16, 2019
First Posted Date  ICMJE December 24, 2019
Last Update Posted Date April 1, 2021
Actual Study Start Date  ICMJE March 23, 2020
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2019)
  • Improvement in liver fibrosis of greater or equal to one stage with no worsening of NASH. [ Time Frame: 48 weeks ]
  • Safety assessed by reported and observed adverse events. [ Time Frame: 48 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Aldafermin (NGM282) in Subjects With Compensated Cirrhosis (ALPINE 4)
Official Title  ICMJE 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Compensated Cirrhosis
  • Nonalcoholic Steatohepatitis
Intervention  ICMJE
  • Biological: aldafermin
    aldafermin
  • Other: Placebo
    Placebo for aldafermin
Study Arms  ICMJE
  • Experimental: Daily 0.3 mg dose
    Administered by subcutaneous injection
    Intervention: Biological: aldafermin
  • Experimental: Daily 1 mg dose
    Administered by subcutaneous injection
    Intervention: Biological: aldafermin
  • Experimental: Daily 3 mg dose
    Administered by subcutaneous injection
    Intervention: Biological: aldafermin
  • Placebo Comparator: Placebo
    Administered by subcutaneous injection
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 20, 2019)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: NGM Study Director (650) 243-5555 ngm282@ngmbio.com
Listed Location Countries  ICMJE Australia,   Belgium,   France,   Germany,   Hong Kong,   Poland,   Puerto Rico,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04210245
Other Study ID Numbers  ICMJE 282-CC-207
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party NGM Biopharmaceuticals, Inc
Study Sponsor  ICMJE NGM Biopharmaceuticals, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: NGM Study Director NGM Biopharmaceuticals
PRS Account NGM Biopharmaceuticals, Inc
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP