Clinical trial NCT03912532: 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)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: NASH - Nonalcoholic Steatohepatitis
Lead sponsor: NGM Biopharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2019-04-11
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 24 weeks
measure: 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.
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: NGM Clinical Study Site
state: Arizona
city: Tucson
country: United States
facility: NGM Clinical Study Site
state: Arizona
city: North Little Rock
country: United States
facility: NGM Clinical Study Site
state: Arkansas
city: Fresno
country: United States
facility: NGM Clinical Study Site
state: California
city: La Jolla
country: United States
facility: NGM Clinical Study Site
state: California
city: Los Angeles
country: United States
facility: NGM Clinical Study Site
state: California
city: Los Angeles
country: United States
facility: NGM Clinical Study Site
state: California
city: Poway
country: United States
facility: NGM Clinical Study Site
state: California
city: Rialto
country: United States
facility: NGM Clinical Study Site
state: California
city: Boca Raton
country: United States
facility: NGM Clinical Study Site
state: Florida
city: Lakewood Ranch
country: United States
facility: NGM Clinical Study Site
state: Florida
city: Port Orange
country: United States
facility: NGM Clinical Study Site
state: Florida
city: Sarasota
country: United States
facility: NGM Clinical Study Site
state: Florida
city: The Villages
country: United States
facility: NGM Clinical Study Site
state: Florida
city: Chicago
country: United States
facility: NGM Clinical Study Site
state: Illinois
city: Baton Rouge
country: United States
facility: NGM Clinical Study Site
state: Louisiana
city: Baltimore
country: United States
facility: NGM Clinical Study Site
state: Maryland
city: Ann Arbor
country: United States
facility: NGM Clinical Study Site
state: Michigan
city: Flowood
country: United States
facility: NGM Clinical Study Site
state: Mississippi
city: Jackson
country: United States
facility: NGM Clinical Study Site
state: Mississippi
city: Kansas City
country: United States
facility: NGM Clinical Study Site
state: Missouri
city: Saint Louis
country: United States
facility: NGM Clinical Study Site
state: Missouri
city: New York
country: United States
facility: NGM Clinical Study Site
state: New York
city: Durham
country: United States
facility: NGM Clinical Study Site
state: North Carolina
city: Fayetteville
country: United States
facility: NGM Clinical Study Site
state: North Carolina
city: Germantown
country: United States
facility: NGM Clinical Study Site
state: Tennessee
city: Hermitage
country: United States
facility: NGM Clinical Study Site
state: Tennessee
city: Austin
country: United States
facility: NGM Clinical Study Site
state: Texas
city: Edinburg
country: United States
facility: NGM Clinical Study Site
state: Texas
city: Houston
country: United States
facility: NGM Clinical Study Site
state: Texas
city: San Antonio
country: United States
facility: NGM Clinical Study Site
state: Texas
city: San Antonio
country: United States
facility: NGM Clinical Study Site
state: Texas
city: Richmond
country: United States
facility: NGM Clinical Study Site
state: Virginia
city: Richmond
country: United States
facility: NGM Clinical Study Site
state: Virginia
city: San Juan
country: Puerto Rico
facility: NGM Clinical Study Site
Study officials:
affiliation: NGM Biopharmaceuticals
name: NGM Study Director
role: STUDY_DIRECTOR
References:
citation: Harrison SA, Abdelmalek MF, Neff G, Gunn N, Guy CD, Alkhouri N, Bashir MR, Freilich B, Kohli A, Khazanchi A, Sheikh MY, Leibowitz M, Rinella ME, Siddiqui MS, Kipnes M, Moussa SE, Younes ZH, Bansal M, Baum SJ, Borg B, Ruane PJ, Thuluvath PJ, Gottwald M, Khan M, Chen C, Melchor-Khan L, Chang W, DePaoli AM, Ling L, Lieu HD. Aldafermin in patients with non-alcoholic steatohepatitis (ALPINE 2/3): a randomised, double-blind, placebo-controlled, phase 2b trial. Lancet Gastroenterol Hepatol. 2022 Jul;7(7):603-616. doi: 10.1016/S2468-1253(22)00017-6. Epub 2022 Mar 21.