A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Boston Pharmaceuticals
Study ID
NCT06920043
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Efimosfermin — DRUG
    Efimosfermin will be administered as a subcutaneous injection.
  • Placebo — DRUG
    Placebo will be administered as a subcutaneous injection.

Study Details

The purpose of this study is to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of efimosfermin in participants with metabolic dysfunction associated steatohepatitis (MASH) and compensated cirrhosis consistent with stage F4 fibrosis.

Key Dates

Start date
Apr 9, 2025
Status verified
Dec 2025
Primary completion
Nov 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Efimosfermin (Dose 1)
    Participants will receive efimosfermin (Dose 1) once every 4 weeks (Q4W).
  • Experimental: Efimosfermin (Dose 2)
    Participants will receive efimosfermin (Dose 2) Q4W.
  • Placebo Comparator: Placebo
    Participants will receive placebo Q4W.

Primary Outcome Measure

Number of participants with treatment emergent adverse events (TEAEs) [ Time Frame: From Day 1 to 100 weeks ]

Central Contacts

Locations (35)

FacilityCityStateZIPSite coordinators
Arizona Liver Health - ChandlerChandlerArizona85224-
Arizona Liver Health - PeoriaPeoriaArizona85381-
The Institute for Liver Health II LLC dba Arizona Liver Health - TucsonTucsonArizona85712-
Fresno Clinical Research CenterFresnoCalifornia93720-
OM Research LLCLancasterCalifornia93534-
Knowledge Research CenterOrangeCalifornia92868-
California Liver Research InstitutePasadenaCalifornia91105-
Inland Empire Liver FoundationRialtoCalifornia92377-
Santa Maria Gastroenterology CenterSanta MariaCalifornia93458-
ClinCloud Research - MaitlandMaitlandFlorida32751-
ClinCloud Research - VieraMelbourneFlorida32940-
Advanced Clinical Research of MiamiMiamiFlorida33155-
Centricity Research - ColumbusColumbusGeorgia31904-
Gastrointestinal Specialists of Georgia PCMariettaGeorgia30060-
Mercy Medical Center - Baltimore, MarylandBaltimoreMaryland21202-
Gastrointestinal Associates and Endoscopy Center, PA - FlowoodFlowoodMississippi39232-
Kansas City Research InstituteKansas CityMissouri64131-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Coastal Research Institute, LLCFayettevilleNorth Carolina28304-
M3 Wake Research, IncRaleighNorth Carolina27612-
American Research Corporation - Austin, TXAustinTexas78757-
IMA Clinical Research - Austin, TXAustinTexas78745-
Pinnacle Clinical Research - Austin, TXAustinTexas78757-
The Liver Institute at Methodist Dallas Medical CenterDallasTexas75203-
Pinnacle Clinical Research - GeorgetownGeorgetownTexas78626-
Baylor College of MedicineHoustonTexas77030-
Houston Research InstituteHoustonTexas77079-
Houston Research Institute - Texas Medical CenterHoustonTexas77030-
LinQ Research, LLCKatyTexas77494-
Houston Research Institute - PasadenaPasadenaTexas77505-
American Research Corporation - San AntonioSan AntonioTexas78215-
Pinnacle Clinical Research - San AntonioSan AntonioTexas78229-
Velocity Clinical Research - WacoWacoTexas76710-
Richmond Institute for Veterans ResearchRichmondVirginia23249-
GI Alliance - Washington GastroenterologyTacomaWashington98405-

Find similar trials in Chandler, AZ

By research site
Arizona Liver Health - Chandler· Chandler, AZArizona Liver Health - Peoria· Peoria, AZThe Institute for Liver Health II LLC dba Arizona Liver Health - Tucson· Tucson, AZFresno Clinical Research Center· Fresno, CAOM Research LLC· Lancaster, CAKnowledge Research Center· Orange, CA

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