A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
A legfontosabb adatok
- Hol
- Amarillo, Atlanta, Aurora, Austin, Baltimore, Bastrop, Bellaire, Birmingham, Bradenton, Brandon, Brownsville, Buffalo, Chandler, Chapel Hill, Charleston, Charlotte, Chattanooga, Chicago, Chula Vista, Clarksville, Colorado Springs, Columbia, Columbus, Conway, Coronado, Corpus Christi, Covington, Dallas, Dayton, Denison, Doral, Dothan, Durham, Edinburg, Englewood, Escondido, Falls Church, Fayetteville, Flagstaff, Florham Park, Flowood, Folsom, Forney, Fort Myers, Fort Worth, Gainesville, Glen Burnie, Greenbelt, Hammond, Hermitage, Hershey, Hialeah Gardens, Houma, Houston, Indianapolis, Inglewood, Inverness, Jackson, Jacksonville, Jonesboro, Kansas City, La Mesa, Lady Lake, Lakewood Rch, Lancaster, Largo, Las Vegas, Lehigh Acres, Lewisville, Little Rock, Long Beach, Los Angeles, Louisville, Madison, Maitland, Manhasset, Margate, Marietta, Marrero, McAllen, Metairie, Miami, Miami Gardens, Miami Lakes, Morehead City, Naples, Nashville, New Bedford, New Bern, New Haven, New Orleans, New Port Richey, New York, Newport Beach, Newport News, Norfolk, North Little Rock, Novi, Ocala, Ogden, Orange, Orlando, Palm Springs, Pasadena, Pembroke Pines, Peoria, Philadelphia, Pittsburgh, Port Orange, Raleigh, Redwood City, Reno, Richmond, Ridgewood, Riverview, Roanoke, Rochester, Sacramento, Salt Lake City, San Antonio, San Diego, San Francisco, San Marcos, Sandy City, Santa Fe, Santa Maria, Sarasota, Seattle, Shreveport, Somers Point, South Bend, South Ogden, Southfield, Sparta, Spokane, Springboro, St Louis, Statesville, Suffolk, Summerville, Temple Terrace, Topeka, Tucson, Venice, Viera, Waco, Washington D.C., Webster, West Des Moines, West Monroe, West Palm Beach, Westlake, Weston, Wichita, Wichita Falls, Winter Park, Wyoming, Ypsilanti és Zephyrhills (Egyesült Államok)Mind a 159 helyszín megnézése
- Fázis
- 3. fázis
AI-kivonat: kiket keres a vizsgálat
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
A vizsgálat olyan felnőtteket keres, akiknek NASH/MASH betegségük (zsírmájbetegség májgyulladással) és 2-es vagy 3-as stádiumú májfibrózisuk (hegesedés) van, de nincs cirrhosisuk, és ezt friss májbiopszia igazolja.
- Életkor
- 18 és 80 év között
- Nem
- Férfiak és nők. A nők nem lehetnek terhesek vagy szoptatók.
- A betegség stádiuma
- NASH/MASH 2-es vagy 3-as stádiumú fibrózissal, cirrhosis nélkül. 1. kohorsz: 2-es vagy 3-as fibrózis és legalább 4-es NAS pontszám. 2. kohorsz: 3-as fibrózis, a NAS pontszám lehet 4-nél kisebb.
- Biomarker vagy leletérték
- A szűrés előtt legfeljebb 180 nappal készült májbiopszia, amely NASH/MASH-t vagy fibrózist mutat. Az 1. kohorszban a steatosis, a ballonosodás és a lobuláris gyulladás pontszáma is legalább 1 kell legyen.
A részvétel fő kizáró okai
- A májbetegség más oka
- Cirrhosis a májbiopsziában (4-es stádiumú fibrózis)
- 1-es típusú cukorbetegség
- Nem kontrollált 2-es típusú cukorbetegség
- Terhes vagy szoptató nők
Gépi kiolvasás: 2026. november 12.
Neked szólhat?
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 18 és 80 év között vagy?
Forrás: NCT06215716: ki vehet részt
Helyszínek itt: Egyesült Államok
- Amarillo, TexasHospital not named in the registryContact: Akero Site 0104Résztvevőt keres
- Atlanta, GeorgiaHospital not named in the registryContact: Akero Site 0230Résztvevőt keres
- Aurora, ColoradoHospital not named in the registryContact: Akero Site 0217Résztvevőt keres
- Austin, TexasHospital not named in the registryContact: Akero Site 0131Résztvevőt keres
- Baltimore, MarylandHospital not named in the registryContact: Akero Site 0108Résztvevőt keres
- Bastrop, LouisianaHospital not named in the registryContact: Akero Site 9220Résztvevőt keres
- Bellaire, TexasHospital not named in the registryContact: Akero Site 0165Résztvevőt keres
- Birmingham, AlabamaHospital not named in the registryContact: Akero Site 0129Résztvevőt keres
- Bradenton, FloridaHospital not named in the registryContact: Akero Site 0153Résztvevőt keres
- Brandon, FloridaHospital not named in the registryContact: Akero Site 0222Résztvevőt keres
- Brownsville, TexasHospital not named in the registryContact: Akero Site 0154Résztvevőt keres
- Buffalo, New YorkHospital not named in the registryContact: Akero Site 0241Résztvevőt keres
- Chandler, ArizonaHospital not named in the registryContact: Akero Site 9106Résztvevőt keres
- Chapel Hill, North CarolinaHospital not named in the registryContact: Akero Site 0192Résztvevőt keres
- Charleston, South CarolinaHospital not named in the registryContact: Akero Site 0246Résztvevőt keres
- Charlotte, North CarolinaHospital not named in the registryContact: Akero Site 9147Résztvevőt keres
- Chattanooga, TennesseeHospital not named in the registryContact: Akero Site 0175Résztvevőt keres
- Chicago, IllinoisHospital not named in the registryContact: Akero Site 9245Résztvevőt keres
- Chula Vista, CaliforniaHospital not named in the registryContact: Akero Study DirectorNo longer taking part
- Clarksville, TennesseeHospital not named in the registryContact: Akero Site 0144Résztvevőt keres
- Colorado Springs, ColoradoHospital not named in the registryContact: Akero Site 0260Résztvevőt keres
- Columbia, MissouriHospital not named in the registryContact: Akero Site 0141Résztvevőt keres
- Columbus, GeorgiaHospital not named in the registryContact: Akero Study DirectorNo longer taking part
- Conway, ArkansasHospital not named in the registryContact: Akero Study DirectorNo longer taking part
- Coronado, CaliforniaHospital not named in the registryContact: Akero Site 0132Résztvevőt keres
- Corpus Christi, TexasHospital not named in the registryContact: Akero Site 0223Résztvevőt keres
- Covington, LouisianaHospital not named in the registryContact: Akero Site 0195Résztvevőt keres
- Dallas, TexasHospital not named in the registryContact: Akero Site 0126Résztvevőt keres
- Dayton, OhioHospital not named in the registryContact: Akero Site 0127Résztvevőt keres
- Denison, TexasHospital not named in the registryContact: Akero Site 0244Résztvevőt keres
- Doral, FloridaHospital not named in the registryContact: Akero Site 0267Résztvevőt keres
- Dothan, AlabamaHospital not named in the registryContact: Akero Site 0233Résztvevőt keres
- Durham, North CarolinaHospital not named in the registryContact: Akero Site 0224Résztvevőt keres
- Edinburg, TexasHospital not named in the registryContact: Akero Site 9117Résztvevőt keres
- Englewood, ColoradoHospital not named in the registryContact: Akero Site 9243Résztvevőt keres
- Escondido, CaliforniaHospital not named in the registryContact: Akero Site 0266Résztvevőt keres
- Falls Church, VirginiaHospital not named in the registryContact: Akero Study DirectorNo longer taking part
- Fayetteville, North CarolinaHospital not named in the registryContact: Akero Site 9227Résztvevőt keres
- Flagstaff, ArizonaHospital not named in the registryContact: Akero Study DirectorNo longer taking part
- Florham Park, New JerseyHospital not named in the registryContact: Akero Study DirectorNo longer taking part
- Flowood, MississippiHospital not named in the registryContact: Akero Site 0277Résztvevőt keres
- Folsom, CaliforniaHospital not named in the registryContact: Akero Site 0263Résztvevőt keres
- Forney, TexasHospital not named in the registryContact: Akero Site 0286Résztvevőt keres
- Fort Myers, FloridaHospital not named in the registryContact: Akero Site 9134Résztvevőt keres
- Fort Worth, TexasHospital not named in the registryContact: Akero Site 9211Résztvevőt keres
- Gainesville, FloridaHospital not named in the registryContact: Akero Site 0114Résztvevőt keres
- Glen Burnie, MarylandHospital not named in the registryContact: Akero Study DirectorNo longer taking part
- Greenbelt, MarylandHospital not named in the registryContact: Akero Study DirectorNo longer taking part
- Hammond, IndianaHospital not named in the registryContact: Akero Site 0254Résztvevőt keres
- Hermitage, TennesseeHospital not named in the registryContact: Akero Site 9123Résztvevőt keres
- Hershey, PennsylvaniaHospital not named in the registryContact: Akero Site 0264Résztvevőt keres
- Hialeah Gardens, FloridaHospital not named in the registryContact: Akero Site 9242Résztvevőt keres
- Houma, LouisianaHospital not named in the registryContact: Akero Site 0112Résztvevőt keres
- Houston, TexasHospital not named in the registryContact: Akero Site 0293Résztvevőt keres
- Indianapolis, IndianaHospital not named in the registryContact: Akero Site 0290Résztvevőt keres
- Inglewood, CaliforniaHospital not named in the registryContact: Akero Study DirectorNo longer taking part
- Inverness, FloridaHospital not named in the registryContact: Akero Site 9135Résztvevőt keres
- Jackson, New JerseyHospital not named in the registryContact: Akero Site 0105Résztvevőt keres
- Jacksonville, FloridaHospital not named in the registryContact: Akero Site 0118Résztvevőt keres
- Jonesboro, ArkansasHospital not named in the registryContact: Akero Study DirectorNo longer taking part
- Kansas City, MissouriHospital not named in the registryContact: Akero Site 9208Résztvevőt keres
- La Mesa, CaliforniaHospital not named in the registryContact: Akero Study DirectorNo longer taking part
- Lady Lake, FloridaHospital not named in the registryContact: Akero Study DirectorNo longer taking part
- Lakewood Rch, FloridaHospital not named in the registryContact: Akero Site 9203Résztvevőt keres
- Lancaster, CaliforniaHospital not named in the registryContact: Akero Study DirectorNo longer taking part
- Largo, FloridaHospital not named in the registryContact: Akero Site 9248Résztvevőt keres
- Las Vegas, NevadaHospital not named in the registryContact: Akero Site 9142Résztvevőt keres
- Lehigh Acres, FloridaHospital not named in the registryContact: Akero Site 0271Résztvevőt keres
- Lewisville, TexasHospital not named in the registryContact: Akero Study DirectorNo longer taking part
- Little Rock, ArkansasHospital not named in the registryContact: Akero Site 0106Résztvevőt keres
- Long Beach, CaliforniaHospital not named in the registryContact: Akero Site 0188Résztvevőt keres
- Los Angeles, CaliforniaHospital not named in the registryContact: Akero Study DirectorNo longer taking part
- Louisville, KentuckyHospital not named in the registryContact: Akero Site 0203Résztvevőt keres
- Madison, WisconsinHospital not named in the registryContact: Akero Site 0259Résztvevőt keres
- Maitland, FloridaHospital not named in the registryContact: Akero Study DirectorNo longer taking part
- Manhasset, New YorkHospital not named in the registryContact: Akero Site 0208Résztvevőt keres
- Margate, FloridaHospital not named in the registryContact: Akero Site 0248Résztvevőt keres
- Marietta, GeorgiaHospital not named in the registryContact: Akero Site 9111Résztvevőt keres
- Marrero, LouisianaHospital not named in the registryContact: Akero Site 9102Résztvevőt keres
- McAllen, TexasHospital not named in the registryContact: Akero Study DirectorNo longer taking part
- Metairie, LouisianaHospital not named in the registryContact: Akero Site 0109Résztvevőt keres
- Miami, FloridaHospital not named in the registryContact: Akero Site 0137Résztvevőt keres
- Miami Gardens, FloridaHospital not named in the registryContact: Akero Site 0243Résztvevőt keres
- Miami Lakes, FloridaHospital not named in the registryContact: Akero Site 9138Résztvevőt keres
- Morehead City, North CarolinaHospital not named in the registryContact: Akero Site 9128Résztvevőt keres
- Naples, FloridaHospital not named in the registryContact: Akero Site 0138Résztvevőt keres
- Nashville, TennesseeHospital not named in the registryContact: Akero Site 9130Résztvevőt keres
- New Bedford, MassachusettsHospital not named in the registryContact: Akero Site 0181Résztvevőt keres
- New Bern, North CarolinaHospital not named in the registryContact: Akero Site 0166Résztvevőt keres
- New Haven, ConnecticutHospital not named in the registryContact: Akero Site 0213Résztvevőt keres
- New Orleans, LouisianaHospital not named in the registryContact: Akero Site 0196Résztvevőt keres
- New Port Richey, FloridaHospital not named in the registryContact: Akero Study DirectorNo longer taking part
- New YorkHospital not named in the registryContact: Akero Site 0198Résztvevőt keres
- Newport Beach, CaliforniaHospital not named in the registryContact: Akero Site 0206Résztvevőt keres
- Newport News, VirginiaHospital not named in the registryContact: Akero Study DirectorNo longer taking part
- Norfolk, VirginiaHospital not named in the registryContact: Akero Site 0143Résztvevőt keres
- North Little Rock, ArkansasHospital not named in the registryContact: Akero Site 9214Résztvevőt keres
- Novi, MichiganHospital not named in the registryContact: Akero Site 0204Résztvevőt keres
- Ocala, FloridaHospital not named in the registryContact: Akero Site 9127Résztvevőt keres
- Ogden, UtahHospital not named in the registryContact: Akero Study DirectorNo longer taking part
- Orange, CaliforniaHospital not named in the registryContact: Akero Site 0261Résztvevőt keres
- Orlando, FloridaHospital not named in the registryContact: Akero Site 0250Résztvevőt keres
- Palm Springs, CaliforniaHospital not named in the registryContact: Akero Study DirectorNo longer taking part
- Pasadena, CaliforniaHospital not named in the registryContact: Akero Site 9250Résztvevőt keres
- Pembroke Pines, FloridaHospital not named in the registryContact: Akero Site 0239Résztvevőt keres
- Peoria, ArizonaHospital not named in the registryContact: Akero Site 9104Résztvevőt keres
- Philadelphia, PennsylvaniaHospital not named in the registryContact: Akero Site 0207Résztvevőt keres
- Pittsburgh, PennsylvaniaHospital not named in the registryContact: Akero Site 0102Résztvevőt keres
- Port Orange, FloridaHospital not named in the registryContact: Akero Site 9105Résztvevőt keres
- Raleigh, North CarolinaHospital not named in the registryContact: Akero Site 0169Résztvevőt keres
- Redwood City, CaliforniaHospital not named in the registryContact: Akero Site 0191Résztvevőt keres
- Reno, NevadaHospital not named in the registryContact: Akero Site 9240Résztvevőt keres
- Richmond, VirginiaHospital not named in the registryContact: Akero Site 0212Résztvevőt keres
- Ridgewood, New JerseyHospital not named in the registryContact: Akero Site 0287Résztvevőt keres
- Riverview, FloridaHospital not named in the registryContact: Akero Site 0295Résztvevőt keres
- Roanoke, VirginiaHospital not named in the registryContact: Akero Site 0139Résztvevőt keres
- Rochester, New YorkHospital not named in the registryContact: Akero Site 0240Résztvevőt keres
- Sacramento, CaliforniaHospital not named in the registryContact: Akero Site 0274Résztvevőt keres
- Salt Lake City, UtahHospital not named in the registryContact: Akero Study DirectorNo longer taking part
- San Antonio, TexasHospital not named in the registryContact: Akero Site 9116Résztvevőt keres
- San Diego, CaliforniaHospital not named in the registryContact: Akero Study DirectorNo longer taking part
- San Francisco, CaliforniaHospital not named in the registryContact: Akero Site 0147Résztvevőt keres
- San Marcos, TexasHospital not named in the registryContact: Akero Study DirectorNo longer taking part
- Sandy City, UtahHospital not named in the registryContact: Akero Site 9241Résztvevőt keres
- Santa Fe, New MexicoHospital not named in the registryContact: Akero Study DirectorNo longer taking part
- Santa Maria, CaliforniaHospital not named in the registryContact: Akero Site 0205Résztvevőt keres
- Sarasota, FloridaHospital not named in the registryContact: Akero Site 9218Résztvevőt keres
- Seattle, WashingtonHospital not named in the registryContact: Akero Site 0119Résztvevőt keres
- Shreveport, LouisianaHospital not named in the registryContact: Akero Site 9145Résztvevőt keres
- Somers Point, New JerseyHospital not named in the registryContact: Akero Site 0116Résztvevőt keres
- South Bend, IndianaHospital not named in the registryContact: Akero Site 9235Résztvevőt keres
- South Ogden, UtahHospital not named in the registryContact: Akero Study DirectorNo longer taking part
- Southfield, MichiganHospital not named in the registryContact: Akero Study DirectorNo longer taking part
- Sparta, New JerseyHospital not named in the registryContact: Akero Site 0117Résztvevőt keres
- Spokane, WashingtonHospital not named in the registryContact: Akero Site 0155Résztvevőt keres
- Springboro, OhioHospital not named in the registryContact: Akero Site 9233Résztvevőt keres
- St Louis, MissouriHospital not named in the registryContact: Akero Site 0296Résztvevőt keres
- Statesville, North CarolinaHospital not named in the registryContact: Akero Site 0142Résztvevőt keres
- Suffolk, VirginiaHospital not named in the registryContact: Akero Study DirectorNo longer taking part
- Summerville, South CarolinaHospital not named in the registryContact: Akero Site 9238Résztvevőt keres
- Temple Terrace, FloridaHospital not named in the registryContact: Akero Site 0242Résztvevőt keres
- Topeka, KansasHospital not named in the registryContact: Akero Site 9136Résztvevőt keres
- Tucson, ArizonaHospital not named in the registryContact: Akero Site 9210Résztvevőt keres
- Venice, FloridaHospital not named in the registryContact: Akero Study DirectorNo longer taking part
- Viera, FloridaHospital not named in the registryContact: Akero Study DirectorNo longer taking part
- Waco, TexasHospital not named in the registryContact: Akero Site 9246Résztvevőt keres
- Washington D.C., District of ColumbiaHospital not named in the registryContact: Akero Study DirectorNo longer taking part
- Webster, TexasHospital not named in the registryContact: Akero Site 9204Résztvevőt keres
- West Des Moines, IowaHospital not named in the registryContact: Akero Site 0146Résztvevőt keres
- West Monroe, LouisianaHospital not named in the registryContact: Akero Site 0283Résztvevőt keres
- West Palm Beach, FloridaHospital not named in the registryContact: Akero Study DirectorNo longer taking part
- Westlake, OhioHospital not named in the registryContact: Akero Site 9226Résztvevőt keres
- Weston, FloridaHospital not named in the registryContact: Akero Site 0270Résztvevőt keres
- Wichita, KansasHospital not named in the registryContact: Akero Study DirectorNo longer taking part
- Wichita Falls, TexasHospital not named in the registryContact: Akero Site 9247Résztvevőt keres
- Winter Park, FloridaHospital not named in the registryContact: Akero Site 0157Résztvevőt keres
- Wyoming, MichiganHospital not named in the registryContact: Akero Site 0107Résztvevőt keres
- Ypsilanti, MichiganHospital not named in the registryContact: Akero Study DirectorNo longer taking part
- Zephyrhills, FloridaHospital not named in the registryContact: Akero Site 0235Résztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Akero Therapeutics, Inc
- Azonosító
- NCT06215716
- A regiszteradat frissítve
- 2026. november 6.
- Eredeti leírás
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3).A teljes eredeti leírásKevesebb
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3).
The study will enroll subjects in two cohorts for a total samples size of 1650 subjects.
Bevonási feltételek: Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive, based on the date of the screening visit; Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes; Cohort 1: Biopsy-proven NASH/MASH. Must have had a liver biopsy obtained ≤ 180 days prior to screening with fibrosis stage 2 or 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:; Steatosis (scored 0 to 3),; Ballooning degeneration (scored 0 to 2), and; Lobular inflammation (scored 0 to 3); Cohort 2: Biopsy-proven fibrosis stage 3. Must have had a liver biopsy obtained ≤ 180 days prior to screening. Subjects with NAS <4 may be enrolled and are not required to meet 1 point in each of the components of NAS.
Kizáró feltételek: Type 1 or uncontrolled Type 2 diabetes; Other inclusion and exclusion criteria may apply; Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results; Presence of cirrhosis on liver biopsy (fibrosis stage 4).