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Nonalcoholic Steatohepatitis (NASH)Phase 2NCT04880031

A Study of BOS-580 in Obese Subjects at Risk for, or With Biopsy-confirmed, Nonalcoholic Steatohepatitis (NASH) With an Extension

A Phase 2 study testing Efimosfermin in people with Nonalcoholic Steatohepatitis (NASH), run by GlaxoSmithKline at 48 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a randomized, blinded, placebo-controlled study of Efimosfermin in obese participants at risk for, or with biopsy-confirmed, nonalcoholic steatohepatitis (NASH), with a single arm open-label extension. It includes Parts A, B, C and D. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Nonalcoholic Steatohepatitis (NASH)
What is being tested?
Efimosfermin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
231 participants
Where
48 sitesUnited States
Study dates
30 Sep 2021to 27 Oct 2025
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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
  • 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

Who cannot join

  • 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).
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  • Participants that received their 24 week dose in Part B > 10 weeks prior to enrollment into Part C
  • 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

Trial locations and contacts

48 sites in 1 country.

48 sites in 1 country

United States48 sites

  • Accelemed Research

    Austin, Texas, 78745

  • Pinnacle Clinical Research - Austin

    Austin, Texas, 78757

  • Texas Liver Institute - Austin

    Austin, Texas, 78757

  • Apex Mobile Clinical Research

    Bellaire, Texas, 77401

  • Central Research Associates

    Birmingham, Alabama, 35205

  • South Texas Research Institute-Brownsville

    Brownsville, Texas, 78520

  • Alliance Research Institute

    Canoga Park, California, 91304

  • Arizona Liver Health

    Chandler, Arizona, 85224

  • Velocity Clinical Research

    East Greenwich, Rhode Island, 02818

  • South Texas Research Institute-Edinburg

    Edinburg, Texas, 75839

  • Lillestol Research LLC

    Fargo, North Dakota, 58104

  • Coastal Research Institute, LLC

    Fayetteville, North Carolina, 28304

  • Southwest General Healthcare Center

    Fort Myers, Florida, 33907

  • Covenant Metabolic Specialists - Fort Myers

    Fort Myers, Florida, 33912

  • Ark Clinical Research

    Fountain Valley, California, 92708

  • Fresno Clinical Research Center

    Fresno, California, 92720

  • Pinnacle Clinical Research - Georgetown

    Georgetown, Texas, 78626

  • Evolution Clinical Trials

    Hialeah Gardens, Florida, 33016

  • Houston Research Institute

    Houston, Texas, 77079

  • Kansas City Research Institute

    Kansas City, Missouri, 64131

  • Entrust Clinical Research Center

    Kendall, Florida, 33176

  • Galenus Group

    Lehigh Acres, Florida, 33976

  • Tandem Clinical Research

    Marrero, Louisiana, 70072

  • G+C Research Group

    Miami, Florida, 33126

  • Miami Clinical Research

    Miami, Florida, 33155

  • Advanced Clinical Research

    Miami, Florida, 33156

  • Admed Research

    Miami, Florida, 33173

  • Century Research

    Miami, Florida, 33173

  • Panex Clinical Research

    Miami Lakes, Florida, 33014

  • Catalina Research Institute

    Montclair, California, 91763

  • Knowledge Research Center

    Orange, California, 92868

  • Charter Research

    Orlando, Florida, 32803

  • FOMAT Medical Research

    Oxnard, California, 93030

  • LinQ Research, LLC

    Pearland, Texas, 77584

  • Arizona Liver Health

    Peoria, Arizona, 85381

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Inland Empire Clinical Trials

    Rialto, California, 92377

  • Olympus Family Medicine

    Salt Lake City, Utah, 84117

  • Quality Research, Inc

    San Antonio, Texas, 78209

  • American Research Corporation at Texas Liver Institute

    San Antonio, Texas, 78215

  • Pinnacle Clinical Research - San Antonio

    San Antonio, Texas, 78229

  • Covenant Metabolic Specialists - Sarasota

    Sarasota, Florida, 34240

  • Liver Institute NorthWest

    Seattle, Washington, 98105

  • South Ogden Family Medicine

    South Ogden, Utah, 84405

  • Arizona Liver Health

    Tucson, Arizona, 85712

  • Liver Institute PPLC

    Tucson, Arizona, 85712

  • QLMC

    Tucson, Arizona, 85712

  • Velocity Clinical Research - Waco

    Waco, Texas, 76710

Other trials in United States

About this study

Official title: A Phase 2a, Randomized, Blinded, Placebo-controlled Study of BOS-580 in Obese Subjects at Risk for, or With Biopsy-confirmed, Nonalcoholic Steatohepatitis (NASH) With a Single Arm Open-label Extension

This is a randomized, blinded, placebo-controlled study of Efimosfermin in obese participants at risk for, or with biopsy-confirmed, nonalcoholic steatohepatitis (NASH), with a single arm open-label extension. It includes Parts A, B, C and D.

Being tested
Efimosfermin, Placebo
Keywords
BOS-580, Safety, Tolerability, Pharmacokinetics, Efimosfermin
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EfimosferminDrug

    Also called BOS-580

    Efimosfermin will be administered by subcutaneous injection

  • PlaceboDrug

    Placebo will be administered by subcutaneous injection

Study groups in NCT04880031
Study groupRoleWhat they receive
Cohort A1: Efimosfermin Dose 1 or placebo (PBO)ExperimentalNot described
Receives: Drug: Efimosfermin; Drug: Placebo
Cohort A2: Efimosfermin Dose 2 or PBOExperimentalNot described
Receives: Drug: Efimosfermin; Drug: Placebo
Cohort A3: Efimosfermin Dose 3 or PBOExperimentalNot described
Receives: Drug: Efimosfermin; Drug: Placebo
Cohort A4: Efimosfermin Dose 4 or PBOExperimentalNot described
Receives: Drug: Efimosfermin; Drug: Placebo
Cohort A5: Efimosfermin Dose 5 or PBOExperimentalNot described
Receives: Drug: Efimosfermin; Drug: Placebo
Part B: Efimosfermin Dose 1 or PBOExperimentalNot described
Receives: Drug: Efimosfermin; Drug: Placebo
Part C: Efimosfermin Dose 1ExperimentalNot described
Receives: Drug: Efimosfermin
Part D: Efimosfermin Dose 6 or PBOExperimentalNot described
Receives: Drug: Efimosfermin; Drug: Placebo
Part D: Efimosfermin Dose 1 or PBOExperimentalNot described
Receives: Drug: Efimosfermin; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A, Part B, Part C, and Part D: Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)

    The effects of Efimosfermin on safety and tolerability will be assessed.

    Measured: Until End of study/Early Termination (Day 393)

  2. Part A, Part B, Part C, and Part D: Changes from Baseline in systolic and diastolic blood pressure (BP)

    The effects of Efimosfermin on safety and tolerability will be assessed.

    Measured: Baseline, Week 12 (Day 85, Part A), Week 24 (Day 169, Part B), Week 56 (Day 393, Part C), and Weeks 36 (Day 253), and 48 (Day 337) (Part D)

  3. Part A, Part B, Part C, and Part D: Changes from Baseline in heart rate

    The effects of Efimosfermin on safety and tolerability will be assessed.

    Measured: Baseline, Week 12 (Day 85, Part A), Week 24 (Day 169, Part B), Week 56 (Day 393, Part C), and Weeks 36 (Day 253), and 48 (Day 337) (Part D)

  4. Part A, Part B, Part C, and Part D: Number of participants with Grade 3 and Grade 4 laboratory abnormalities

    The effects of Efimosfermin on safety and tolerability will be assessed.

    Measured: Baseline, Week 12 (Day 85, Part A), Week 24 (Day 169, Part B), Week 56 (Day 393, Part C), and Weeks 36 (Day 253), and 48 (Day 337) (Part D)

Secondary outcomes (5)

  1. Part A only: Efimosfermin serum concentration on Day 8 of the first dose

    The pharmacokinetics (PK) of Efimosfermin will be assessed.

    Measured: Day 8

  2. Part A only: Efimosfermin serum concentration at the end of the dosing interval (Ctrough)

    The PK of Efimosfermin will be assessed.

    Measured: Pre-dose at Days 15, 29, 43, 57, 71, 85 and 113 (End of study/Early termination) for bi-weekly schedule; pre-dose on Days 29, 57, 85 and 113 (End of study/Early termination) for the monthly schedule

  3. Part B only: Efimosfermin serum concentration on Day 7

    The PK of Efimosfermin will be assessed.

    Measured: Day 7

  4. Part B and Part C: Efimosfermin serum concentration at the end of the dosing interval (Ctrough)

    The PK of Efimosfermin will be assessed.

    Measured: Pre-dose at Days 29, 57, 85, 113, 141, 169, 225, 253, 281, 309, 316, 323, 330, 337, 365 and at Day 393 (End of study/Early Termination)

  5. Part B and Part C: Area under the serum concentration-time curve (AUC) for Efimosfermin for one dosing interval at steady state

    The PK of Efimosfermin will be assessed.

    Measured: At Days 121, 127, 134, 316, 323, 330 and pre-dose at Days 141 and 337

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2021
  2. Study start30 Sep 2021
  3. Primary completion27 Oct 2025
  4. Study completion27 Oct 2025

Resources

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
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
231 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04880031
Sponsor's protocol ID
301182
Status last verified
Jul 2026
First submitted
5 May 2021
Last updated
8 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Noureddin M, Kowdley KV, Odrljin T, Bain G, Zhao J, Jeglinski B, Koziel MJ, Loomba R. Efimosfermin alfa (BOS-580) once per month in people with metabolic dysfunction-associated steatohepatitis with F2 or F3 fibrosis: results from a 24-week, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2026 Feb 21;407(10530):794-804. doi: 10.1016/S0140-6736(25)02276-7. Epub 2026 Feb 5.

    PubMed 41655584

  • Loomba R, Kowdley KV, Rodriguez J, Kim NJ, Alvarez AM, Morrow L, Jeglinski B, Clawson A, Chowdhury S, Bain G, Odrljin T. Efimosfermin alfa (BOS-580), a long-acting FGF21 analogue, in participants with phenotypic metabolic dysfunction-associated steatohepatitis: a multicentre, randomised, double-blind, placebo-controlled, phase 2a trial. Lancet Gastroenterol Hepatol. 2025 Aug;10(8):734-745. doi: 10.1016/S2468-1253(25)00067-6. Epub 2025 Jun 6.

    PubMed 40484014

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Efimosfermin in people with Nonalcoholic Steatohepatitis (NASH), run by GlaxoSmithKline at 48 sites in United States.

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 13 inclusion and 13 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 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States. 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. 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?

Part A, Part B, Part C, and Part D: Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) (time frame: Until End of study/Early Termination (Day 393)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04880031, which also lists 2 linked publications.

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 8 Jul 2026.

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