NASHPhase 2NCT05327127
Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis
A Phase 2 study testing K-877-ER and CSG452 in people with NASH, run by Kowa Research Institute, Inc. at 77 sites in 6 countries.
Trial summary
A study to investigate the use of combination therapy with two investigational products for the treatment of adult patients with Nonalcoholic steatohepatitis (NASH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NASH
- What is being tested?
- K-877-ER and CSG452
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 77 sitesin 6 countries
- Study dates
- 14 Nov 2022to 3 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
77 sites in 6 countries.
77 sites in 6 countries
United States37 sites
University of Michigan
Ann Arbor, Michigan, 48109
Boston Medical Center Boston University Chobanian & Avedisian School of Medicine
Boston, Massachusetts, 02118
GI Alliance Research
Cedar Park, Texas, 78613
Iowa Digestive Disease Center
Clive, Iowa, 50325
GI Associates Research, LLC
Columbia, Missouri, 65201
Centricity Research
Columbus, Georgia, 31904
GI Alliance Research
Dallas, Texas, 75246
DSI Research Northridge, LLC
Dayton, Ohio, 45414
GI Alliance Research
Flowood, Mississippi, 39232
GI Alliance Research
Garland, Texas, 75044
Mid-Atlantic GI Research, LLC
Greenbelt, Maryland, 20770
Penn State Health/Penn State College of Medicine
Hershey, Pennsylvania, 17033
Nature Coast Clinical Research, LLC
Inverness, Florida, 34452
ENCORE Borland Groover Clinical Research
Jacksonville, Florida, 32256
Jefferson City Medical Group
Jefferson City, Missouri, 65109
Clinical Trials Research
Lincoln, California, 95648
Arcare Center for Clinical Research
Little Rock, Arkansas, 72205
United Clinical Research Institute
Los Alamitos, California, 90720
Velocity Clinical Research
Los Angeles, California, 90057
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, 30060
Tandem Clinical Research, LLC
Marrero, Louisiana, 70072
Miami Clinical Research
Miami, Florida, 33155
Lucas Research, Inc.
Morehead City, North Carolina, 28557
Ocala GI Research
Ocala, Florida, 34471
Sensible Healthcare Clinical Research, LLC
Ocoee, Florida, 34761
GLRI McAllen Research
Pharr, Texas, 78577
Alliance Clinical Research
Poway, California, 92064
North Richmond Health Research
Richmond, Virginia, 23229
GI Select Health Research
Richmond, Virginia, 23236
Northeast Clinical Rsearch of San Antonio
San Antonio, Texas, 78233
Endeavor Clinical Trials
San Antonio, Texas, 78240
Liver Institute Northwest
Seattle, Washington, 98105
Centricity
Suffolk, Virginia, 23435
Adobe Clinical Research, LLC
Tucson, Arizona, 85712
Arizona Liver Health
Tucson, Arizona, 85712
Impact Research Institute
Waco, Texas, 76710
Digestive Health Research of Central Texas, LLC
Waco, Texas, 76712
Japan23 sites
Asahikawa Medical University Hospital
Asahikawa, Hokkaido, 078-8510
Nippon Medical School Hospital
Bunkyō City, Toyko, 113-8603
Fukui-ken Saiseikai Hospital
Fukui-shi, Fukui, 918-8503
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Hiroshima, Hiroshima, 730-8619
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641
SHIN-YURIGAOKA General Hospital
Kawasaki, Kanagawa, 215-0026
St. Marianna University School of Medicine
Kawasaki, Kanagawa, 216-8511
NHO Kure Medical Center and Chugoku Cancer Center
Kure Shi, Hiroshima, 737-0023
Shinshu University Hospital
Matsumoto Shi, Nagano, 390-8621
Japanese Red Cross Musashino Hospital
Musashino, Tokyo, 180-8610
Nagano municipal Hospital
Nagano, Nagano, 381-0006
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560
Saiseikai Niigata Hospital
Niigata, Niigata, 950-1104
Ogaki Municipal Hospital
Ōgaki, Gifu, 503-8502
Oita Cardiovascular Hospital
Ōita, 870-0837
Kawasaki Medical School General Medical Center
Okayama, Okayama-ken, 700-8505
Saga University Hospital
Saga, Saga-ken, 849-8501
JCHO Hokkaido Hospital
Sapporo, Hokkaido, 062-8618
Tohoku Rosai Hospital
Sendai, Miyagi, 981-8563
NHO Takasaki General Medical Center
Takasaki Shi, Gumna, 370-0829
Ehime University Hospital
Tōon, Ehime, 791-0295
Fujita Health University Hospital
Toyoake, Aichi-ken, 470-1192
Yokohama City University Hospital
Yokohama, Kanagawa, 236-0004
Argentina6 sites
Hospital Italiano de Buenos Aires
Ciudad Autónoma de Buenos Aires, Buenos Aires, 1199
CINME - Centro De Investigaciones Metabolicas
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1056ABJ
Hospital Italiano de La Plata
La Plata, Buenos Aires, 1900
Instituto de Investigaciones Clinicas de Mar del Plata
Mar del Plata, Buenos Aires, B7600FZN
Hospital Universitario Austra
Pilar, Buenos Aires, B1629ODT
Hospital Provincial del Centenario
Santa Fe, Rosario, S2002KDS
Brazil4 sites
Hospital Universitário João de Barros Barreto
Belém, Pará, 66073-000
Clínica de Endocrinologia e Metabologia Ltda
Brasília, Brasilia DF, 71625-009
Hospital de Clinicas de Porto Alegre
Porto Alegre, Porto Alegre RS, 90035-903
Hospital Alianca Rede D 'Or
Salvador, Estado de Bahia, 41920-900
Spain4 sites
Complejo Hospitalario Universitario A Coruna
A Coruña, 15001
Hospital General Universitario Gregorio Maranon
Madrid, 28007
Hospital Universitario Puerta De Hierro
Madrid, 28222
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008
Canada3 sites
University of Calgary
Calgary, Alberta, T2N 4Z6
Ecogene-21
Chicoutimi, Quebec, G7H 7K9
McGill University Health Centre
Montreal, Quebec, H4A 3J1
About this study
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
A study to investigate the use of combination therapy with two investigational products for the treatment of adult patients with Nonalcoholic steatohepatitis (NASH).
- Conditions
- NASH
- Being tested
- K-877-ER, CSG452, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K-877-ERDrug
K-877-ER tablet
CSG452Drug
CSG452 tablet
PlaceboDrug
Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| K-001 | Experimental | K-877-ER and CSG452 Once daily (QD) Receives: Drug: K-877-ER; Drug: CSG452 |
| K-877-ER | Experimental | K-877-ER and CSG452 Placebo QD Receives: Drug: K-877-ER; Drug: Placebo |
| CSG452 | Experimental | CSG452 and K-877-ER Placebo QD Receives: Drug: CSG452; Drug: Placebo |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in disease activity and no worsening of liver fibrosis (Yes/No)
The improvement in disease activity is defined as decrease in NAFLD Activity Score (NAS) ≥2 points. The worsening of fibrosis is defined as any numerical increase in the stage.
Measured: Baseline to Week 48
Secondary outcomes (1)
Number of Participants With Treatment-Related Adverse Events (AE)
Time frame is 52 weeks unless an unresolved AE is still being followed
Measured: 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start14 Nov 2022
- Primary completion20 May 2026
- Study completion3 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASHStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kowa Research Institute, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shona Pendse, MD, MMSc, Study chair, Kowa Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327127
- Sponsor's protocol ID
- K-001-201
- Status last verified
- Jun 2026
- First submitted
- 2 Mar 2022
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05327127
- Acronym / sponsor ID
- K-001-201
- Conditions
- NASH
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Kowa Research Institute, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 20 May 2026 (actual)
- Study completion
- 3 Jun 2026 (actual)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to investigate the use of combination therapy with two investigational products for the treatment of adult patients with Nonalcoholic steatohepatitis (NASH).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| K-001 | Experimental | Drug: K-877-ER, Drug: CSG452K-877-ER and CSG452 Once daily (QD) |
| K-877-ER | Experimental | Drug: K-877-ER, Drug: PlaceboK-877-ER and CSG452 Placebo QD |
| CSG452 | Experimental | Drug: CSG452, Drug: PlaceboCSG452 and K-877-ER Placebo QD |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| K-877-ERK-877-ER tablet | Drug | K-001, K-877-ER |
| CSG452CSG452 tablet | Drug | CSG452, K-001 |
| PlaceboPlacebo tablet | Drug | CSG452, K-877-ER, Placebo |
Primary outcome
Improvement in disease activity and no worsening of liver fibrosis (Yes/No)
Time frame: Baseline to Week 48
The improvement in disease activity is defined as decrease in NAFLD Activity Score (NAS) ≥2 points. The worsening of fibrosis is defined as any numerical increase in the stage.
1 secondary outcome
Number of Participants With Treatment-Related Adverse Events (AE)
Time frame: 52 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shona Pendse, MD, MMSc study chair
Kowa Research Institute, Inc.
77 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing K-877-ER and CSG452 in people with NASH, run by Kowa Research Institute, Inc. at 77 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 77 sites in United States, Japan, Argentina, Brazil, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in disease activity and no worsening of liver fibrosis (Yes/No) (time frame: Baseline to Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.