A Study of BOS-580 in Obese Subjects at Risk for, or With Biopsy-confirmed, Nonalcoholic Steatohepatitis (NASH) With an Extension
NCT ID: NCT04880031
Last Updated: 2025-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
231 participants
INTERVENTIONAL
2021-09-30
2025-10-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
NCT06920043
A Study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH)
NCT02413372
Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)
NCT02443116
A Clinical Study of Efinopegdutide in Participants With Precirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-6024-013)
NCT05877547
Phase IIb Study to Evaluate the Efficacy and Safety of GFT505 Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH)
NCT01694849
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort A1: Efimosfermin Dose 1 or placebo (PBO)
Efimosfermin
Efimosfermin will be administered by subcutaneous injection
Placebo
Placebo will be administered by subcutaneous injection
Cohort A2: Efimosfermin Dose 2 or PBO
Efimosfermin
Efimosfermin will be administered by subcutaneous injection
Placebo
Placebo will be administered by subcutaneous injection
Cohort A3: Efimosfermin Dose 3 or PBO
Efimosfermin
Efimosfermin will be administered by subcutaneous injection
Placebo
Placebo will be administered by subcutaneous injection
Cohort A4: Efimosfermin Dose 4 or PBO
Efimosfermin
Efimosfermin will be administered by subcutaneous injection
Placebo
Placebo will be administered by subcutaneous injection
Cohort A5: Efimosfermin Dose 5 or PBO
Efimosfermin
Efimosfermin will be administered by subcutaneous injection
Placebo
Placebo will be administered by subcutaneous injection
Part B: Efimosfermin Dose 1 or PBO
Efimosfermin
Efimosfermin will be administered by subcutaneous injection
Placebo
Placebo will be administered by subcutaneous injection
Part C: Efimosfermin Dose 1
Efimosfermin
Efimosfermin will be administered by subcutaneous injection
Part D: Efimosfermin Dose 6 or PBO
Efimosfermin
Efimosfermin will be administered by subcutaneous injection
Placebo
Placebo will be administered by subcutaneous injection
Part D: Efimosfermin Dose 1 or PBO
Efimosfermin
Efimosfermin will be administered by subcutaneous injection
Placebo
Placebo will be administered by subcutaneous injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Efimosfermin
Efimosfermin will be administered by subcutaneous injection
Placebo
Placebo will be administered by subcutaneous injection
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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).
• 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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GSK Research and Development Limited
UNKNOWN
Boston Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Central Research Associates
Birmingham, Alabama, United States
Arizona Liver Health
Chandler, Arizona, United States
Arizona Liver Health
Peoria, Arizona, United States
Arizona Liver Health
Tucson, Arizona, United States
Liver Institute PPLC
Tucson, Arizona, United States
QLMC
Tucson, Arizona, United States
Alliance Research Institute
Canoga Park, California, United States
Ark Clinical Research
Fountain Valley, California, United States
Fresno Clinical Research Center
Fresno, California, United States
Catalina Research Institute
Montclair, California, United States
Knowledge Research Center
Orange, California, United States
FOMAT Medical Research
Oxnard, California, United States
Inland Empire Clinical Trials
Rialto, California, United States
Southwest General Healthcare Center
Fort Myers, Florida, United States
Covenant Metabolic Specialists - Fort Myers
Fort Myers, Florida, United States
Evolution Clinical Trials
Hialeah Gardens, Florida, United States
Entrust Clinical Research Center
Kendall, Florida, United States
Galenus Group
Lehigh Acres, Florida, United States
G+C Research Group
Miami, Florida, United States
Miami Clinical Research
Miami, Florida, United States
Advanced Clinical Research
Miami, Florida, United States
Admed Research
Miami, Florida, United States
Century Research
Miami, Florida, United States
Panex Clinical Research
Miami Lakes, Florida, United States
Charter Research
Orlando, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Covenant Metabolic Specialists - Sarasota
Sarasota, Florida, United States
Tandem Clinical Research
Marrero, Louisiana, United States
Kansas City Research Institute
Kansas City, Missouri, United States
Coastal Research Institute, LLC
Fayetteville, North Carolina, United States
Lillestol Research LLC
Fargo, North Dakota, United States
Velocity Clinical Research
East Greenwich, Rhode Island, United States
Accelemed Research
Austin, Texas, United States
Pinnacle Clinical Research - Austin
Austin, Texas, United States
Texas Liver Institute - Austin
Austin, Texas, United States
Apex Mobile Clinical Research
Bellaire, Texas, United States
South Texas Research Institute-Brownsville
Brownsville, Texas, United States
South Texas Research Institute-Edinburg
Edinburg, Texas, United States
Pinnacle Clinical Research - Georgetown
Georgetown, Texas, United States
Houston Research Institute
Houston, Texas, United States
LinQ Research, LLC
Pearland, Texas, United States
Quality Research, Inc
San Antonio, Texas, United States
American Research Corporation at Texas Liver Institute
San Antonio, Texas, United States
Pinnacle Clinical Research - San Antonio
San Antonio, Texas, United States
Velocity Clinical Research - Waco
Waco, Texas, United States
Olympus Family Medicine
Salt Lake City, Utah, United States
South Ogden Family Medicine
South Ogden, Utah, United States
Liver Institute NorthWest
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
301182 (BOS-580-201)
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.