Clinical trial NCT05327127: Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis
Official title: Study to Evaluate the Efficacy and Safety of Combination Therapy of K-877-ER and CSG452 in Participants With Noncirrhotic Nonalcoholic Steatohepatitis (NASH) With Liver Fibrosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: NASH
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: A study to investigate the use of combination therapy with two investigational products for the treatment of adult patients with Nonalcoholic steatohepatitis (NASH).


Eligibility criteria: Inclusion Criteria:

* Able to understand and comply with study procedures and give written informed consent
* Age ≥18 years
* NAS ≥4 with a score of at least 1 in each component of the NAS (steatosis, lobular inflammation, and ballooning) at Visit 2 liver biopsy, or a historical liver biopsy performed within 24 weeks of randomization
* Fibrosis stage of 1 or greater and below 4 on NASH CRN (Clinical Research Network) fibrosis staging system at Visit 2 liver biopsy, or a historical liver biopsy performed within 24 weeks of randomization
* Meet all inclusion criteria outlined in clinical study protocol

Exclusion Criteria:

* Participation in another clinical trial involving an investigational agent within 30 days prior to signing the Informed Consent Form (ICF) for this study
* Ongoing or recent consumption of Greater than moderate amounts of alcohol as defined in clinical study protocol
* Evidence of other forms of chronic liver disease as defined in clinical study protocol
* Does not meet any other exclusion criteria outlined in clinical study protocol

Primary outcomes:
measure: Improvement in disease activity and no worsening of liver fibrosis (Yes/No)
timeFrame: Baseline to Week 48
Secondary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events (AE)
timeFrame: 52 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Digestive Health Research, Inc.
state: Alabama
city: Tucson
country: United States
facility: Adobe Clinical Research, LLC
state: Arizona
city: Tucson
country: United States
facility: Arizona Liver Health
state: Arizona
city: Conway
country: United States
facility: Arcare Center for Clinical Research
state: Arkansas
city: Little Rock
country: United States
facility: Arcare Center for Clinical Research
state: Arkansas
city: Huntington Park
country: United States
facility: Velocity Clinical Research
state: California
city: La Jolla
country: United States
facility: UCSD NAFLD Research Center
state: California
city: Lincoln
country: United States
facility: Clinical Trials Research
state: California
city: Los Alamitos
country: United States
facility: United Clinical Research Institute
state: California
city: Los Angeles
country: United States
facility: Velocity Clinical Research
state: California
city: Oxnard
country: United States
facility: FOMAT Medical Research
state: California
city: Poway
country: United States
facility: Alliance Clinical Research
state: California
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates
state: Colorado
city: Inverness
country: United States
facility: Nature Coast Clinical Research, LLC
state: Florida
city: Jacksonville
country: United States
facility: ENCORE Borland Groover Clinical Research
state: Florida
city: Miami
country: United States
facility: Miami Clinical Research
state: Florida
city: Ocala
country: United States
facility: Ocala GI Research
state: Florida
city: Ocoee
country: United States
facility: Sensible Healthcare Clinical Research, LLC
state: Florida
city: Pensacola
country: United States
facility: Pensacola GI Research Center, LLC
state: Florida
city: Tampa
country: United States
facility: Tampa General Medical Group
state: Florida
city: Columbus
country: United States
facility: Centricity Research
state: Georgia
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia, PC
state: Georgia
city: New Albany
country: United States
facility: GHP Research
state: Indiana
city: Clive
country: United States
facility: Iowa Digestive Disease Center
state: Iowa
city: Marrero
country: United States
facility: Tandem Clinical Research, LLC
state: Louisiana
city: Greenbelt
country: United States
facility: Mid-Atlantic GI Research, LLC
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center Boston University Chobanian & Avedisian School of Medicine
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Flowood
country: United States
facility: GI Alliance Research
state: Mississippi
city: Jackson
country: United States
facility: Southern Therapy and Advanced Research, LLC
state: Mississippi
city: Columbia
country: United States
facility: GI Associates Research, LLC
state: Missouri
city: Jefferson City
country: United States
facility: Jefferson City Medical Group
state: Missouri
city: Charlotte
country: United States
facility: Javara
state: North Carolina
city: Morehead City
country: United States
facility: Lucas Research, Inc.
state: North Carolina
city: Dayton
country: United States
facility: DSI Research Northridge, LLC
state: Ohio
city: Hershey
country: United States
facility: Penn State Health/Penn State College of Medicine
state: Pennsylvania
city: Cedar Park
country: United States
facility: GI Alliance Research
state: Texas
city: Dallas
country: United States
facility: GI Alliance Research
state: Texas
city: Garland
country: United States
facility: GI Alliance Research
state: Texas
city: Pharr
country: United States
facility: GLRI McAllen Research
state: Texas
city: San Antonio
country: United States
facility: Diabetes & Glandular Disease Research Associates, Inc.
state: Texas
city: San Antonio
country: United States
facility: Northeast Clinical Rsearch of San Antonio
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Trials
state: Texas
city: San Marcos
country: United States
facility: GI Alliance Research
state: Texas
city: Waco
country: United States
facility: Impact Research Institute
state: Texas
city: Waco
country: United States
facility: Digestive Health Research of Central Texas, LLC
state: Texas
city: Salt Lake City
country: United States
facility: Velocity Clinical Research
state: Utah
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
city: Richmond
country: United States
facility: North Richmond Health Research
state: Virginia
city: Richmond
country: United States
facility: GI Select Health Research
state: Virginia
city: Suffolk
country: United States
facility: Centricity
state: Virginia
city: Seattle
country: United States
facility: Liver Institute Northwest
state: Washington
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: CIPREC
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: CINME - Centro De Investigaciones Metabolicas
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Glenny Corp. S.A.
state: Buenos Aires
city: La Plata
country: Argentina
facility: Hospital Italiano de La Plata
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Centro de Investigaciones Medicas Mar del Plata
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clinicas de Mar del Plata
state: Buenos Aires
city: Pilar
country: Argentina
facility: Hospital Universitario Austra
state: Buenos Aires
city: Santa Fe
country: Argentina
facility: Hospital Provincial del Centenario
state: Rosario
city: Salvador
country: Brazil
facility: Hospital Alianca Rede D 'Or
state: Bahia
city: Brasília
country: Brazil
facility: Clínica de Endocrinologia e Metabologia Ltda
state: Brasilia DF
city: Belem
country: Brazil
facility: Hospital Universitário João de Barros Barreto
state: Para
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Porto Alegre RS
city: São Paulo
country: Brazil
facility: CPCLIN - Centro de Pesquisas Clínicas Ltda.
state: Sao Paulo SP
city: Ribeirao Preto
country: Brazil
facility: Hospital das Clinicas FMRP-USP
state: Sao Paulo
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Tokuda Hospital Ead
state: Sofia City
city: Sofia
country: Bulgaria
facility: Diagnostic - Advisory Centre Alexandrovska Ltd.
state: Sofia City
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Cancer Center
state: Sofia City
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Chicoutimi
country: Canada
facility: Ecogene-21
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Quebec City
country: Canada
facility: Diex Recherche Quebec Inc.
state: Quebec
city: Nagoya
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Toyoake
country: Japan
facility: Fujita Health University Hospital
state: Aichi
city: Toon
country: Japan
facility: Ehime University Hospital
state: Ehime
city: Fukui City
country: Japan
facility: Fukui-ken Saiseikai Hospital
state: Fukui
city: Kurume
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Ogaki City
country: Japan
facility: Ogaki Municipal Hospital
state: Gifu
city: Takasaki Shi
country: Japan
facility: NHO Takasaki General Medical Center
state: Gumna
city: Hiroshima City
country: Japan
facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
state: Hiroshima
city: Kure Shi
country: Japan
facility: NHO Kure Medical Center and Chugoku Cancer Center
state: Hiroshima
city: Asahikawa
country: Japan
facility: Asahikawa Medical University Hospital
state: Hokkaido
city: Sapporo City
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Sapporo City
country: Japan
facility: JCHO Hokkaido Hospital
state: Hokkaido
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Kawasaki
country: Japan
facility: SHIN-YURIGAOKA General Hospital
state: Kanagawa
city: Kawasaki
country: Japan
facility: St. Marianna University School of Medicine
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City University Hospital
state: Kanagawa
city: Sendai City
country: Japan
facility: Tohoku Rosai Hospital
state: Miyagi
city: Matsumoto Shi
country: Japan
facility: Shinshu University Hospital
state: Nagano
city: Nagano Shi
country: Japan
facility: Nagano municipal Hospital
state: Nagano
city: Niigata City
country: Japan
facility: Saiseikai Niigata Hospital
state: Niigata
city: Niigata City
country: Japan
facility: Niigata University Medical and Dental Hospital
state: Niigata
city: Okayama City
country: Japan
facility: Kawasaki Medical School General Medical Center
state: Okayama
city: Saga City
country: Japan
facility: Saga University Hospital
state: Saga
city: Musashino City
country: Japan
facility: Japanese Red Cross Musashino Hospital
state: Tokyo
city: Bunkyo ku
country: Japan
facility: Nippon Medical School Hospital
state: Toyko
city: Oita
country: Japan
facility: Oita Cardiovascular Hospital
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Zaragoza
country: Spain
facility: Complejo Hospital Miguel Servet
state: Zargoza
city: A Coruna
country: Spain
facility: Complejo Hospitalario Universitario A Coruna
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Universitario Puerta De Hierro
city: Malaga
country: Spain
facility: Hospital Clinico Universitario Virgen de la Victoria
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
Study officials:
affiliation: Kowa Research Institute, Inc.
name: Shona Pendse, MD, MMSc
role: STUDY_CHAIR
References: