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NCT03912532 Clinical Trial

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)

NASH - Nonalcoholic Steatohepatitis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03912532
Other study ID # 18-0108
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 16, 2019
Est. completion date March 29, 2021

Study information
Verified date January 2022
Source NGM Biopharmaceuticals, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 171
Est. completion date March 29, 2021
Est. primary completion date March 4, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

  • Fatty Liver
  • NASH - Nonalcoholic Steatohepatitis
  • Non-alcoholic Fatty Liver Disease

Intervention

Biological:
• NGM282
NGM282
Other:
• Placebo
Placebo for NGM282

Locations
Country Name City State
Puerto Rico NGM Clinical Study Site San Juan
United States NGM Clinical Study Site Ann Arbor Michigan
United States NGM Clinical Study Site Austin Texas
United States NGM Clinical Study Site Baltimore Maryland
United States NGM Clinical Study Site Baton Rouge Louisiana
United States NGM Clinical Study Site Boca Raton Florida
United States NGM Clinical Study Site Chandler Arizona
United States NGM Clinical Study Site Chicago Illinois
United States NGM Clinical Study Site Durham North Carolina
United States NGM Clinical Study Site Edinburg Texas
United States NGM Clinical Study Site Fayetteville North Carolina
United States NGM Clinical Study Site Flowood Mississippi
United States NGM Clinical Study Site Fresno California
United States NGM Clinical Study Site Germantown Tennessee
United States NGM Clinical Study Site Hermitage Tennessee
United States NGM Clinical Study Site Houston Texas
United States NGM Clinical Study Site Jackson Mississippi
United States NGM Clinical Study Site Kansas City Missouri
United States NGM Clinical Study Site La Jolla California
United States NGM Clinical Study Site Lakewood Ranch Florida
United States NGM Clinical Study Site Los Angeles California
United States NGM Clinical Study Site Los Angeles California
United States NGM Clinical Study Site New York New York
United States NGM Clinical Study Site North Little Rock Arkansas
United States NGM Clinical Study Site Port Orange Florida
United States NGM Clinical Study Site Poway California
United States NGM Clinical Study Site Rialto California
United States NGM Clinical Study Site Richmond Virginia
United States NGM Clinical Study Site Richmond Virginia
United States NGM Clinical Study Site Saint Louis Missouri
United States NGM Clinical Study Site San Antonio Texas
United States NGM Clinical Study Site San Antonio Texas
United States NGM Clinical Study Site Sarasota Florida
United States NGM Clinical Study Site The Villages Florida
United States NGM Clinical Study Site Tucson Arizona

Sponsors (1)
Lead Sponsor Collaborator
NGM Biopharmaceuticals, Inc

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 24 weeks
Primary 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. 24 weeks
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