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New drug combo targets fatty liver in major trial

NCT ID NCT07288138

Disease control Sponsor: Eccogene Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Updated 8 times

Summary

This study tests two experimental drugs, ECC4703 and ECC0509, alone or together, in 160 adults with MASH (a type of fatty liver disease). The goal is to see if they can safely reduce liver fat over 12 weeks. Participants will be randomly assigned to receive the drugs or a placebo.

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

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Sep 2027

An estimate. End dates often move.

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 to 75 years

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: 1. Adults between 18 and 75 years of age, inclusive, who can provide written informed consent and comply with study procedures. 2. Diagnosis of presumed MASH based on: liver biopsy within 180 days prior to screening showing an NAFLD activity score (NAS) of ≥3 and a fibrosis score (F) of F1-3 OR FibroScan® CAP \>280 dB/m at screening with presence of metabolic risk factors. 3. Evidence of hepatic steatosis confirmed by FibroScan® LSM \> 7 kPa and \< 20 kPa and MRI-PDFF \>8% at screening. 4. BMI \>25 kg/m\^2 to \<50 kg/m\^2 (non-Asian); BMI ≥23.0 to \<50.0 kg/m\^2 (Asian). 5. ALT ≥60 U/L at the first screening visit and stability of ALT and AST levels during the screening period. 6. Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73m\^2 (Chronic Kidney Disease Epidemiology Collaboration, \[CKD-EPI\]). 7. Stable body weight (no \>5% change) for at least 6 months prior to screening. 8. Willing to comply with contraception requirements (as applicable to males and females of childbearing potential). 9. In the opinion of the investigator, able to participate safely and complete required MRI/biomarker assessments. Exclusion Criteria: 1. Chronic liver disease other than metabolic dysfunction-associated steatotic liver disease (MASLD)/MASH, including alcoholic liver disease, autoimmune hepatitis, cholestatic disease, genetic liver diseases, or drug-induced liver injury. 2. Presence of cirrhosis on liver histology according to the assessment of the central reader, and/or cross-sectional imaging evidence consistent with cirrhosis and/or portal hypertension (e.g, nodular liver contour; portosystemic collaterals, ascites, splenomegaly; known presence or history of esophageal varices; and/or elastography evidence consistent with cirrhosis). 3. ALT and/or AST \>5× Upper Limit of Normal (ULN) or ALP \>2×ULN at screening. 4. Clinically significant thyroid or adrenal dysfunction, including uncontrolled hypothyroidism, hyperthyroidism, or adrenal disorders. 5. Type 1 diabetes, HbA1c \>9.5%, or unstable type 2 diabetes requiring medication changes within 90 days. 6. Use of medications that affect liver fat or fibrosis (e.g., Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs) not on a stable dose, pioglitazone, obeticholic acid, high-dose vitamin E, hepatotoxic drugs) within protocol-specified washout periods. 7. Significant alcohol use within 1 year prior to screening. 8. Recent cardiovascular events, including myocardial infraction (MI), stroke, unstable angina, heart failure (New York heart association \[NYHA III-IV\]), or uncontrolled arrhythmia. 9. Current or recent serious psychiatric illness, including psychosis, active suicidal ideation, or suicide attempt within 5 years. 10. Pregnancy, breastfeeding, or conditions that increase risk or interfere with study procedures, including MRI contraindications or other investigator-determined safety concerns.

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Conditions

The condition(s) this trial relates to.

liver disorder metabolic dysfunction-associated steatohepatitis metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

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

Metabolic dysfunction-associated steatohepatitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    63 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • ARK Clinical Research - Fountain Valley

    RECRUITING

    Fountain Valley, California, 92708, United States

  • ARcare Center for Clinical Research

    RECRUITING

    Little Rock, Arkansas, 77205, United States

  • Adobe Clinical Research, LLC

    RECRUITING

    Tucson, Arizona, 85712, United States

  • Akron Gastro Research

    RECRUITING

    Akron, Ohio, 44333, United States

  • Arizona Liver Health

    RECRUITING

    Chandler, Arizona, 85224, United States

  • Arizona Liver Health - Peoria

    RECRUITING

    Peoria, Arizona, 85381, United States

  • Arizona Liver Health - Tucson

    RECRUITING

    Tucson, Arizona, 85712, United States

  • Ark Clinical Research

    RECRUITING

    Long Beach, California, 90815, United States

  • Arkansas Gastroenterology, P.A

    RECRUITING

    Little Rock, Arkansas, 71913, United States

  • Bellaire Clinical Research

    RECRUITING

    Bellaire, Texas, 77401, United States

  • Care United Research

    RECRUITING

    Forney, Texas, 75126, United States

  • CenExel - iResearch

    RECRUITING

    Decatur, Georgia, 30030, United States

  • ClinCloud, LLC

    RECRUITING

    Viera, Florida, 32940, United States

  • Clinical Research Institute of Ohio (CRIOH), LLC

    RECRUITING

    Westlake, Ohio, 44145, United States

  • Clinical Research Integrity (CRI) Lifetree, LLC

    RECRUITING

    Marlton, New Jersey, 08053, United States

  • Coastal Research Institute

    RECRUITING

    Fayetteville, North Carolina, 28304, United States

  • Columbia Gastroenterology Associates, Llc

    RECRUITING

    Columbia, South Carolina, 29204, United States

  • DSI Research

    RECRUITING

    Springboro, Ohio, 45066, United States

  • Dallas Research Institute, LLC

    RECRUITING

    Farmers Branch, Texas, 75234, United States

  • Delta Research Partners

    RECRUITING

    Monroe, Louisiana, 71201, United States

  • Delta Research Partners, LLC

    RECRUITING

    West Monroe, Louisiana, 71291, United States

  • Digestive Health Research of North Texas, LLC

    RECRUITING

    Wichita Falls, Texas, 76301, United States

  • Digestive Research Alliance of Michiana

    RECRUITING

    South Bend, Indiana, 46635, United States

  • Digestive Research of Central Texas

    COMPLETED

    Waco, Texas, 76712, United States

  • Digestive Specialists

    RECRUITING

    Dayton, Ohio, 45414, United States

  • Evidentis Clinical Research

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • Evolution Clinical Trials

    RECRUITING

    Miami, Florida, 33122, United States

  • Floridian Clinical Research, LLC

    RECRUITING

    Miami Lakes, Florida, 33016, United States

  • GI Alliance Richmond

    RECRUITING

    Richmond, Virginia, 23229, United States

  • GI Select Health Research

    RECRUITING

    Richmond, Virginia, 23236, United States

  • Gastrointestinal Associates

    RECRUITING

    Columbia, Missouri, 65201, United States

  • Gastrointestinal Specialists of Georgia, PC

    RECRUITING

    Marietta, Georgia, 30060, United States

  • Gateway GI Research, LLC

    RECRUITING

    St Louis, Missouri, 63141, United States

  • Health Awareness, Inc.

    RECRUITING

    Jupiter, Florida, 33458, United States

  • Houston Research Institute

    RECRUITING

    Houston, Texas, 77079, United States

  • Houston Research Institute - Medical Center

    RECRUITING

    Houston, Texas, 770004, United States

  • Houston Research Institute - Pasadena

    RECRUITING

    Pasadena, Texas, 77505, United States

  • Jubilee Clinical Research, Inc

    RECRUITING

    Las Vegas, Nevada, 89106, United States

  • Knowledge Research Center

    RECRUITING

    Orange, California, 92868, United States

  • Louisiana Research Center, LLC

    RECRUITING

    Shreveport, Louisiana, 71105, United States

  • Metabolic Research Institute

    RECRUITING

    West Palm Beach, Florida, 33401, United States

  • Mid-Atlantic GI Research

    RECRUITING

    Greenbelt, Maryland, 20770, United States

  • Ocala GI Research

    RECRUITING

    Ocala, Florida, 34471, United States

  • Om Research

    RECRUITING

    Apple Valley, California, 92307, United States

  • Om Research

    RECRUITING

    Lancaster, California, 93534, United States

  • Om Research

    RECRUITING

    Victorville, California, 92395, United States

  • Pinnacle Clinical Research

    RECRUITING

    Austin, Texas, 78757, United States

  • Pinnacle Clinical Research

    RECRUITING

    Corpus Christi, Texas, 78404, United States

  • Pinnacle Clinical Research

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Pinnacle Clinical Research - Georgetown

    RECRUITING

    Georgetown, Texas, 78626, United States

  • Pinnacle Clinical Research - South San Antonio

    RECRUITING

    San Antonio, Texas, 78222, United States

  • Premier Health Research

    RECRUITING

    Sparta, New Jersey, 07871, United States

  • Progressive Medical Research

    RECRUITING

    Port Orange, Florida, 32127, United States

  • Quality Research, Inc.

    RECRUITING

    San Antonio, Texas, 78209, United States

  • South Texas Research Institute (STRI)

    RECRUITING

    Edinburg, Texas, 78539, United States

  • South Texas Research Institute (STRI) - Brownsville

    RECRUITING

    Brownsville, Texas, 78520, United States

  • Sugarland Medical Associates (Sma)

    RECRUITING

    Sugar Land, Texas, 77478, United States

  • Synergy Healthcare

    RECRUITING

    Bradenton, Florida, 33511, United States

  • Synergy Healthcare

    RECRUITING

    Bradenton, Florida, 34209, United States

  • Tandem Clinical Research

    RECRUITING

    Covington, Louisiana, 70433, United States

  • Tandem Clinical Research

    RECRUITING

    Houma, Louisiana, 70360, United States

  • Tandem Clinical Research

    RECRUITING

    Metairie, Louisiana, 70006, United States

  • Tandem Clinical Research GI, LLC

    RECRUITING

    Marrero, Louisiana, 70072, United States

  • UCSD Medical Center

    RECRUITING

    La Jolla, California, 92037, United States

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