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New combo pill aims to halt liver scarring in NASH patients

NCT ID NCT05327127

Disease control Sponsor: Kowa Research Institute, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed Phase 2 study tested whether a combination of two experimental drugs, K-877-ER and CSG452, can improve liver health in adults with nonalcoholic steatohepatitis (NASH) and liver fibrosis. The 228 participants received either the combination or a placebo. The main goal was to see if the treatment reduced liver disease activity without worsening scarring.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
K-877-ER and CSG452 tablets
What this could lead to
If successful, this combination could offer a new treatment option to reduce liver damage and slow fibrosis progression in people with NASH.
What could go wrong
This is an early Phase 2 trial with a moderate number of participants. The results may not confirm benefit, and side effects are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

228 people

The number who actually took part.

Started

Nov 2022

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

metabolic dysfunction-associated steatohepatitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

NASH

Contacts and locations

Locations

  • Adobe Clinical Research, LLC

    Tucson, Arizona, 85712, United States

  • Alliance Clinical Research

    Poway, California, 92064, United States

  • Arcare Center for Clinical Research

    Little Rock, Arkansas, 72205, United States

  • Arizona Liver Health

    Tucson, Arizona, 85712, United States

  • Asahikawa Medical University Hospital

    Asahikawa, Hokkaido, 078-8510, Japan

  • Boston Medical Center Boston University Chobanian & Avedisian School of Medicine

    Boston, Massachusetts, 02118, United States

  • CINME - Centro De Investigaciones Metabolicas

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1056ABJ, Argentina

  • Centricity

    Suffolk, Virginia, 23435, United States

  • Centricity Research

    Columbus, Georgia, 31904, United States

  • Clinical Trials Research

    Lincoln, California, 95648, United States

  • Clínica de Endocrinologia e Metabologia Ltda

    Brasília, Brasilia DF, 71625-009, Brazil

  • Complejo Hospitalario Universitario A Coruna

    A Coruña, 15001, Spain

  • DSI Research Northridge, LLC

    Dayton, Ohio, 45414, United States

  • Digestive Health Research of Central Texas, LLC

    Waco, Texas, 76712, United States

  • ENCORE Borland Groover Clinical Research

    Jacksonville, Florida, 32256, United States

  • Ecogene-21

    Chicoutimi, Quebec, G7H 7K9, Canada

  • Ehime University Hospital

    Tōon, Ehime, 791-0295, Japan

  • Endeavor Clinical Trials

    San Antonio, Texas, 78240, United States

  • Fujita Health University Hospital

    Toyoake, Aichi-ken, 470-1192, Japan

  • Fukui-ken Saiseikai Hospital

    Fukui-shi, Fukui, 918-8503, Japan

  • GI Alliance Research

    Flowood, Mississippi, 39232, United States

  • GI Alliance Research

    Cedar Park, Texas, 78613, United States

  • GI Alliance Research

    Dallas, Texas, 75246, United States

  • GI Alliance Research

    Garland, Texas, 75044, United States

  • GI Associates Research, LLC

    Columbia, Missouri, 65201, United States

  • GI Select Health Research

    Richmond, Virginia, 23236, United States

  • GLRI McAllen Research

    Pharr, Texas, 78577, United States

  • Gastrointestinal Specialists of Georgia, PC

    Marietta, Georgia, 30060, United States

  • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

    Hiroshima, Hiroshima, 730-8619, Japan

  • Hospital Alianca Rede D 'Or

    Salvador, Estado de Bahia, 41920-900, Brazil

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007, Spain

  • Hospital Italiano de Buenos Aires

    Ciudad Autónoma de Buenos Aires, Buenos Aires, 1199, Argentina

  • Hospital Italiano de La Plata

    La Plata, Buenos Aires, 1900, Argentina

  • Hospital Provincial del Centenario

    Santa Fe, Rosario, S2002KDS, Argentina

  • Hospital Universitario Austra

    Pilar, Buenos Aires, B1629ODT, Argentina

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Puerta De Hierro

    Madrid, 28222, Spain

  • Hospital Universitário João de Barros Barreto

    Belém, Pará, 66073-000, Brazil

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Porto Alegre RS, 90035-903, Brazil

  • Impact Research Institute

    Waco, Texas, 76710, United States

  • Instituto de Investigaciones Clinicas de Mar del Plata

    Mar del Plata, Buenos Aires, B7600FZN, Argentina

  • Iowa Digestive Disease Center

    Clive, Iowa, 50325, United States

  • JCHO Hokkaido Hospital

    Sapporo, Hokkaido, 062-8618, Japan

  • Japanese Red Cross Musashino Hospital

    Musashino, Tokyo, 180-8610, Japan

  • Jefferson City Medical Group

    Jefferson City, Missouri, 65109, United States

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641, Japan

  • Kawasaki Medical School General Medical Center

    Okayama, Okayama-ken, 700-8505, Japan

  • Liver Institute Northwest

    Seattle, Washington, 98105, United States

  • Lucas Research, Inc.

    Morehead City, North Carolina, 28557, United States

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1, Canada

  • Miami Clinical Research

    Miami, Florida, 33155, United States

  • Mid-Atlantic GI Research, LLC

    Greenbelt, Maryland, 20770, United States

  • NHO Kure Medical Center and Chugoku Cancer Center

    Kure Shi, Hiroshima, 737-0023, Japan

  • NHO Takasaki General Medical Center

    Takasaki Shi, Gumna, 370-0829, Japan

  • Nagano municipal Hospital

    Nagano, Nagano, 381-0006, Japan

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560, Japan

  • Nature Coast Clinical Research, LLC

    Inverness, Florida, 34452, United States

  • Nippon Medical School Hospital

    Bunkyō City, Toyko, 113-8603, Japan

  • North Richmond Health Research

    Richmond, Virginia, 23229, United States

  • Northeast Clinical Rsearch of San Antonio

    San Antonio, Texas, 78233, United States

  • Ocala GI Research

    Ocala, Florida, 34471, United States

  • Ogaki Municipal Hospital

    Ōgaki, Gifu, 503-8502, Japan

  • Oita Cardiovascular Hospital

    Ōita, 870-0837, Japan

  • Penn State Health/Penn State College of Medicine

    Hershey, Pennsylvania, 17033, United States

  • SHIN-YURIGAOKA General Hospital

    Kawasaki, Kanagawa, 215-0026, Japan

  • Saga University Hospital

    Saga, Saga-ken, 849-8501, Japan

  • Saiseikai Niigata Hospital

    Niigata, Niigata, 950-1104, Japan

  • Sensible Healthcare Clinical Research, LLC

    Ocoee, Florida, 34761, United States

  • Shinshu University Hospital

    Matsumoto Shi, Nagano, 390-8621, Japan

  • St. Marianna University School of Medicine

    Kawasaki, Kanagawa, 216-8511, Japan

  • Tandem Clinical Research, LLC

    Marrero, Louisiana, 70072, United States

  • Tohoku Rosai Hospital

    Sendai, Miyagi, 981-8563, Japan

  • United Clinical Research Institute

    Los Alamitos, California, 90720, United States

  • University of Calgary

    Calgary, Alberta, T2N 4Z6, Canada

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • Velocity Clinical Research

    Los Angeles, California, 90057, United States

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 236-0004, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.