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New shot shows promise for fatty liver disease in early trial

NCT ID NCT04880031

Disease control Sponsor: GlaxoSmithKline 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 09, 2026 · Updated 3 times

Summary

This study tested a drug called BOS-580 (efimosfermin) in 231 obese adults with or at risk for NASH, a serious fatty liver disease. Participants received either the drug or a placebo as a shot under the skin. The main goal was to check safety and side effects. The trial is now complete, and results will help decide if further testing is warranted.

What this could mean

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

Active substance
Efimosfermin (also called BOS-580), a drug given as a shot under the skin
What this could lead to
If successful, this could point toward a new treatment option for NASH, a liver disease with no approved therapies.
What could go wrong
This is an early Phase 2a trial focused on safety, not proof of effectiveness. The results may not lead to a working treatment, and side effects are still being studied.

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

231 people

The number who actually took part.

Started

Sep 2021

Finished

Oct 2025

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 (Part A and Part B): * Participant is either male or female and 18 to 75 years of age inclusive, at the time of signing the informed consent * Obese participants with body mass index (BMI) of ≥ 27 kg/m\^2 * Hepatic fat fraction (HFF) measured by magnetic resonance imaging derived proton density fat fraction (MRI-PDFF) ≥8% * Liver fibrosis assessment based on a vibration controlled transient elastography (VCTE) liver stiffness measurement (LSM) score of 7.0 to 9.9 kPa (Part A only) inclusive or 7.0 to 20.0 kPa (Part B only) inclusive and Liver injury assessment measured by aspartate aminotransferase (AST) \>25U/L. A qualifying historical biopsy (confirmed eligibility based on the central pathology read) supersedes the LSM, controlled attenuation parameter (CAP) score criteria and AST criteria. * Histopathologically confirmed F2 or F3 stage NASH on a diagnostic liver biopsy performed during Screening or within 6 months prior to the first day of dosing for historical biopsies (Part B only). * History or presence of at least 2 of 4 components of metabolic syndrome: obesity/overweight, dyslipidemia (high triglycerides and/or low high density lipoprotein \[HDL\]), type 2 diabetes with elevated glycated hemoglobin (HbA1c), and hypertension. Inclusion Criteria (Part C): * Participant must have completed the Part B of the study. * Participant willing to undergo liver biopsy at Week 56 * NASH F stage \<F4 at 24 week assessment in Part B Inclusion Criteria (Part D): * BMI of ≥ 25 kg/m\^2 * Liver fibrosis based on assessments taken during screening visit * Participant should be willing and able to undergo liver biopsy during Screening (if a historical biopsy within 12 months prior to Screening is not available) and per protocol as judged by the Investigator. * Other inclusion criteria may apply Exclusion Criteria (Part A and Part B): * Documented clinical, laboratory or radiologic evidence of cirrhosis (compensated or decompensated) * Triglycerides ≥ 500 mg/dL * Change in body weight (more than 5% self-reported OR 5 kg self-reported change during the previous 3 months from Screening, whichever is smaller) * History of type 1 diabetes, diabetic ketoacidosis, or positive glutamic acid decarboxylase (GAD) auto-antibodies (latent autoimmune diabetes in adults) * Hemoglobin A1c \> 9.5% * Participants with a condition that requires substantial anticoagulant medication may not be eligible for the study enrollment (e.g., deep vein thrombosis). Exclusion Criteria (Part C): • Participants that received their 24 week dose in Part B \> 10 weeks prior to enrollment into Part C Exclusion Criteria (Part D): * Other causes of chronic liver disease * Documented evidence or history of decompensated liver cirrhosis. * History of type 1 diabetes or poorly controlled type 2 diabetes. * History of malignancy. * Use of other investigational drugs. * Other exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

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.

Nonalcoholic steatohepatitis (NASH)

Contacts and locations

Locations

  • Accelemed Research

    Austin, Texas, 78745, United States

  • Admed Research

    Miami, Florida, 33173, United States

  • Advanced Clinical Research

    Miami, Florida, 33156, United States

  • Alliance Research Institute

    Canoga Park, California, 91304, United States

  • American Research Corporation at Texas Liver Institute

    San Antonio, Texas, 78215, United States

  • Apex Mobile Clinical Research

    Bellaire, Texas, 77401, United States

  • Arizona Liver Health

    Chandler, Arizona, 85224, United States

  • Arizona Liver Health

    Peoria, Arizona, 85381, United States

  • Arizona Liver Health

    Tucson, Arizona, 85712, United States

  • Ark Clinical Research

    Fountain Valley, California, 92708, United States

  • Catalina Research Institute

    Montclair, California, 91763, United States

  • Central Research Associates

    Birmingham, Alabama, 35205, United States

  • Century Research

    Miami, Florida, 33173, United States

  • Charter Research

    Orlando, Florida, 32803, United States

  • Coastal Research Institute, LLC

    Fayetteville, North Carolina, 28304, United States

  • Covenant Metabolic Specialists - Fort Myers

    Fort Myers, Florida, 33912, United States

  • Covenant Metabolic Specialists - Sarasota

    Sarasota, Florida, 34240, United States

  • Entrust Clinical Research Center

    Kendall, Florida, 33176, United States

  • Evolution Clinical Trials

    Hialeah Gardens, Florida, 33016, United States

  • FOMAT Medical Research

    Oxnard, California, 93030, United States

  • Fresno Clinical Research Center

    Fresno, California, 92720, United States

  • G+C Research Group

    Miami, Florida, 33126, United States

  • Galenus Group

    Lehigh Acres, Florida, 33976, United States

  • Houston Research Institute

    Houston, Texas, 77079, United States

  • Inland Empire Clinical Trials

    Rialto, California, 92377, United States

  • Kansas City Research Institute

    Kansas City, Missouri, 64131, United States

  • Knowledge Research Center

    Orange, California, 92868, United States

  • Lillestol Research LLC

    Fargo, North Dakota, 58104, United States

  • LinQ Research, LLC

    Pearland, Texas, 77584, United States

  • Liver Institute NorthWest

    Seattle, Washington, 98105, United States

  • Liver Institute PPLC

    Tucson, Arizona, 85712, United States

  • Miami Clinical Research

    Miami, Florida, 33155, United States

  • Olympus Family Medicine

    Salt Lake City, Utah, 84117, United States

  • Panex Clinical Research

    Miami Lakes, Florida, 33014, United States

  • Pinnacle Clinical Research - Austin

    Austin, Texas, 78757, United States

  • Pinnacle Clinical Research - Georgetown

    Georgetown, Texas, 78626, United States

  • Pinnacle Clinical Research - San Antonio

    San Antonio, Texas, 78229, United States

  • Progressive Medical Research

    Port Orange, Florida, 32127, United States

  • QLMC

    Tucson, Arizona, 85712, United States

  • Quality Research, Inc

    San Antonio, Texas, 78209, United States

  • South Ogden Family Medicine

    South Ogden, Utah, 84405, United States

  • South Texas Research Institute-Brownsville

    Brownsville, Texas, 78520, United States

  • South Texas Research Institute-Edinburg

    Edinburg, Texas, 75839, United States

  • Southwest General Healthcare Center

    Fort Myers, Florida, 33907, United States

  • Tandem Clinical Research

    Marrero, Louisiana, 70072, United States

  • Texas Liver Institute - Austin

    Austin, Texas, 78757, United States

  • Velocity Clinical Research

    East Greenwich, Rhode Island, 02818, United States

  • Velocity Clinical Research - Waco

    Waco, Texas, 76710, United States

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