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Evaluation of Efficacy, Safety and Tolerability of Aldafermin in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study In Subjects With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis (ALPINE 2/3)

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ClinicalTrials.gov Identifier: NCT03912532
Recruitment Status : Active, not recruiting
First Posted : April 11, 2019
Last Update Posted : November 23, 2020
Sponsor:
Information provided by (Responsible Party):
NGM Biopharmaceuticals, Inc

Study Description
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Brief Summary:
This is a multi-center evaluation of NGM282 in a randomized, double-blind, placebo-controlled study administered for 24 weeks in participants with histologically confirmed NASH and F2/F3 Fibrosis.

Condition or disease Intervention/treatment Phase
NASH - Nonalcoholic Steatohepatitis Biological: NGM282 Other: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy, Safety, and Tolerability of Three Doses of NGM282 Administered for 24 Weeks for the Treatment of Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : September 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: NGM282 Dose 1
Administered by subcutaneous injection
 Biological: NGM282
NGM282
Experimental: NGM282 Dose 2
Administered by subcutaneous injection
 Biological: NGM282
NGM282
Experimental: NGM282 Dose 3
Administered by subcutaneous injection
 Biological: NGM282
NGM282
Placebo Comparator: Placebo
Administered by subcutaneous injection
 Other: Placebo
Placebo for NGM282


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of participants achieving a histologic treatment effect (histologic response) as determined by the NASH CRN criteria after 24 weeks of NGM282 or matched placebo. [ Time Frame: 24 weeks ]
  2. Evaluate safety and tolerability of NGM282 in participants with NASH as a function of dose level after up to 24 weeks of treatment with NGM282. [ Time Frame: 24 weeks ]

Eligibility Criteria
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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

Inclusion Criteria:

  1. Histologically confirmed NASH diagnosis as defined by the NASH CRN
  2. Total liver fat content of ≥ 8% as measured by MRI-PDFF

Exclusion Criteria:

  1. Clinically significant acute or chronic liver disease of an etiology other than NASH
  2. Evidence of drug-induced steatohepatitis secondary to amiodarone, corticosteroids, estrogens, methotrexate, tetracycline, or other medications known to cause hepatic steatosis
  3. History or presence of cirrhosis (compensated or decompensated) as determined by histology and/or relevant medical complications and/or laboratory parameters
  4. Prior or pending liver transplantation

Other protocol-defined inclusion/exclusion criteria could apply.

Contacts and Locations
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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): NCT03912532


Locations
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United States, Arizona
NGM Clinical Study Site
Chandler, Arizona, United States, 85224
NGM Clinical Study Site
Tucson, Arizona, United States, 85712
United States, Arkansas
NGM Clinical Study Site
North Little Rock, Arkansas, United States, 72117
United States, California
NGM Clinical Study Site
Fresno, California, United States, 93720
NGM Clinical Study Site
La Jolla, California, United States, 92093
NGM Clinical Study Site
Los Angeles, California, United States, 90036
NGM Clinical Study Site
Los Angeles, California, United States, 90057
NGM Clinical Study Site
Poway, California, United States, 92064
NGM Clinical Study Site
Rialto, California, United States, 92377
United States, Florida
NGM Clinical Study Site
Boca Raton, Florida, United States, 33434
NGM Clinical Study Site
Lakewood Ranch, Florida, United States, 34211
NGM Clinical Study Site
Port Orange, Florida, United States, 32127
NGM Clinical Study Site
Sarasota, Florida, United States, 34240
NGM Clinical Study Site
The Villages, Florida, United States, 32162
United States, Illinois
NGM Clinical Study Site
Chicago, Illinois, United States, 60611
United States, Louisiana
NGM Clinical Study Site
Baton Rouge, Louisiana, United States, 70809
United States, Maryland
NGM Clinical Study Site
Baltimore, Maryland, United States, 21202
United States, Michigan
NGM Clinical Study Site
Ann Arbor, Michigan, United States, 48109
United States, Mississippi
NGM Clinical Study Site
Flowood, Mississippi, United States, 39232
NGM Clinical Study Site
Jackson, Mississippi, United States, 39216
United States, Missouri
NGM Clinical Study Site
Kansas City, Missouri, United States, 64131
NGM Clinical Study Site
Saint Louis, Missouri, United States, 63104
United States, New York
NGM Clinical Study Site
New York, New York, United States, 10029
United States, North Carolina
NGM Clinical Study Site
Durham, North Carolina, United States, 27708
NGM Clinical Study Site
Fayetteville, North Carolina, United States, 28304
United States, Tennessee
NGM Clinical Study Site
Germantown, Tennessee, United States, 38138
NGM Clinical Study Site
Hermitage, Tennessee, United States, 37076
United States, Texas
NGM Clinical Study Site
Austin, Texas, United States, 78757
NGM Clinical Study Site
Edinburg, Texas, United States, 78539
NGM Clinical Study Site
Houston, Texas, United States, 77030
NGM Clinical Study Site
San Antonio, Texas, United States, 78229
NGM Clinical Study Site
San Antonio, Texas, United States, 78233
United States, Virginia
NGM Clinical Study Site
Richmond, Virginia, United States, 23226
NGM Clinical Study Site
Richmond, Virginia, United States, 23298
Puerto Rico
NGM Clinical Study Site
San Juan, Puerto Rico
Sponsors and Collaborators
NGM Biopharmaceuticals, Inc
Investigators
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Study Director: NGM Study Director NGM Biopharmaceuticals
More Information
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Responsible Party: NGM Biopharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT03912532    
Other Study ID Numbers: 18-0108
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: November 23, 2020
Last Verified: November 2020
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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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases