Saroglitazar Magnesium for behandling av ikke-alkoholisk Steatohepatitt med Fibrose (NASH)
En fase 2b, prospektiv, multisenter, randomisert, dobbeltblind, placebokontrollert studie for å evaluere effektiviteten og sikkerheten til Saroglitazar Magnesium hos personer med ikke-alkoholisk Steatohepatitt og Fibrose
Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
A Phase 2b, Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Saroglitazar Magnesium in Subjects with Nonalcoholic Steatohepatitis and Fibrosis.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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Buenos Aires, Argentina, B1629ODT
- Zydus AR004
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CABA, Argentina, C1056ABJ
- Zydus AR001
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CABA, Argentina, C1180AAX
- Zydus AR013
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CABA, Argentina, C1199ABB
- Zydus AR007
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CABA, Argentina, C1221ADC
- Zydus AR006
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CABA, Argentina, C1264AAA
- Zydus AR005
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CABA, Argentina, C1425AGC
- Zydus AR008
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CABA, Argentina, C1426ABP
- Zydus AR012
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CABA, Argentina, CP143CKE
- Zydus AR003
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Mar del Plata, Argentina, B7600
- Zydus AR009
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Mar del Plata, Argentina
- Zydus AR011
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Ramos Mejía, Argentina
- Zydus AR002
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Rosario, Argentina, S2002KDS
- Zydus AR010
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Alabama
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Birmingham, Alabama, Forente stater, 35294
- Zydus US032
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Homewood, Alabama, Forente stater, 35209
- Zydus US079
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Arizona
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Phoenix, Arizona, Forente stater, 85013
- Zydus US047
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Tucson, Arizona, Forente stater, 85712
- Zydus US025
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Tucson, Arizona, Forente stater, 85712
- Zydus US087
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Tucson, Arizona, Forente stater, 85724
- Zydus US029
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California
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Chula Vista, California, Forente stater, 91911
- Zydus US118
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Fresno, California, Forente stater, 93720
- Zydus US041
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Gardena, California, Forente stater, 90247
- Zydus US111
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Huntington Park, California, Forente stater, 90255
- Zydus US013
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La Jolla, California, Forente stater, 92037
- Zydus US065
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Lancaster, California, Forente stater, 93534
- Zydus US094
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Long Beach, California, Forente stater, 90808
- Zydus US080
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Long Beach, California, Forente stater, 90815
- Zydus US090
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Los Angeles, California, Forente stater, 90027
- Zydus US022
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Los Angeles, California, Forente stater, 90033
- Zydus US062
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Murrieta, California, Forente stater, 92563
- Zydus US023
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Orange, California, Forente stater, 92868
- Zydus US052
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Panorama City, California, Forente stater, 91402
- Zydus US012
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Colorado
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Aurora, Colorado, Forente stater, 80045
- Zydus US039
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Florida
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Clearwater, Florida, Forente stater, 33761
- Zydus US122
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Fort Myers, Florida, Forente stater, 33907
- Zydus US057
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Hallandale, Florida, Forente stater, 33009
- Zydus US108
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Hialeah Gardens, Florida, Forente stater, 33016
- Zydus US096
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Lakeland, Florida, Forente stater, 33803
- Zydus US003
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Lakewood Rch, Florida, Forente stater, 34211
- Zydus US016
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Largo, Florida, Forente stater, 33777
- Zydus US125
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Maitland, Florida, Forente stater, 32751
- Zydus US001
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Maitland, Florida, Forente stater, 32751
- Zydus US124
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Miami, Florida, Forente stater, 33014
- Zydus US007
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Miami, Florida, Forente stater, 33135
- Zydus US024
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Miami, Florida, Forente stater, 33136
- Zydus US034
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Miami, Florida, Forente stater, 33136
- Zydus US038
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Miami, Florida, Forente stater, 33155
- Zydus US121
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Miami, Florida, Forente stater, 33173
- Zydus US054
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Miami Lakes, Florida, Forente stater, 33016
- Zydus US098
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Naples, Florida, Forente stater, 34102
- Zydus US099
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Ocala, Florida, Forente stater, 34471
- Zydus US081
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Orlando, Florida, Forente stater, 32806
- Zydus US085
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Port Orange, Florida, Forente stater, 32127
- Zydus US104
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Winter Park, Florida, Forente stater, 32789
- Zydus US004
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Georgia
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Dalton, Georgia, Forente stater, 30720
- Zydus US107
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Gainesville, Georgia, Forente stater, 30501
- Zydus US113
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Marietta, Georgia, Forente stater, 30060
- Zydus US114
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Savannah, Georgia, Forente stater, 31406
- Zydus US119
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Indiana
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Indianapolis, Indiana, Forente stater, 46202
- Zydus US020
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Iowa
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West Des Moines, Iowa, Forente stater, 50652
- Zydus US100
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Kansas
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Kansas City, Kansas, Forente stater, 66160
- Zydus US049
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Louisiana
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Houma, Louisiana, Forente stater, 70363
- Zydus US071
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Marrero, Louisiana, Forente stater, 70072
- Zydus US014
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West Monroe, Louisiana, Forente stater, 71291
- Zydus US123
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Massachusetts
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Boston, Massachusetts, Forente stater, 02215
- Zydus US017
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Michigan
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Chesterfield, Michigan, Forente stater, 48047
- Zydus US092
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Wyoming, Michigan, Forente stater, 49519
- Zydus US019
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Minnesota
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Saint Paul, Minnesota, Forente stater, 55101
- Zydus US115
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Missouri
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Columbia, Missouri, Forente stater, 65201
- Zydus US074
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Kansas City, Missouri, Forente stater, 64131
- Zydus US120
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Nevada
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Reno, Nevada, Forente stater, 89511
- Zydus US116
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New Jersey
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Sparta, New Jersey, Forente stater, 07871
- Zydus US077
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New York
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Manhasset, New York, Forente stater, 11030
- Zydus US069
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New York, New York, Forente stater, 10033
- Zydus US066
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North Carolina
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Asheville, North Carolina, Forente stater, 28801
- Zydus US018
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Charlotte, North Carolina, Forente stater, 28204
- Zydus US027
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Ohio
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Cincinnati, Ohio, Forente stater, 45044
- Zydus US010
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Cincinnati, Ohio, Forente stater, 45267-0595
- Zydus US009
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Cleveland, Ohio, Forente stater, 44109
- Zydus US035
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Springboro, Ohio, Forente stater, 45066
- Zydus US072
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Pennsylvania
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Hershey, Pennsylvania, Forente stater, 17033
- Zydus US060
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Philadelphia, Pennsylvania, Forente stater, 19141
- Zydus US053
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South Carolina
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Charleston, South Carolina, Forente stater, 29401
- Zydus US015
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Charleston, South Carolina, Forente stater, 29425
- Zydus US030
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Columbia, South Carolina, Forente stater, 29204
- Zydus US073
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Greenwood, South Carolina, Forente stater, 29646
- Zydus US075
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Summerville, South Carolina, Forente stater, 29485
- Zydus US112
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Tennessee
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Hermitage, Tennessee, Forente stater, 37067
- Zydus US011
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Nashville, Tennessee, Forente stater, 37232
- Zydus US028
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Texas
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Arlington, Texas, Forente stater, 76012
- Zydus US002
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Austin, Texas, Forente stater, 78745
- Zydus US051
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Austin, Texas, Forente stater, 78757
- Zydus US101
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Bellaire, Texas, Forente stater, 77401
- Zydus US089
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Brownsville, Texas, Forente stater, 78520
- Zydus US105
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Edinburg, Texas, Forente stater, 78539
- Zydus US095
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Edinburg, Texas, Forente stater, 78539
- Zydus US106
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Fort Worth, Texas, Forente stater, 76104
- Zydus US061
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Houston, Texas, Forente stater, 77030
- Zydus US067
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Houston, Texas, Forente stater, 77030
- Zydus US109
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Houston, Texas, Forente stater, 77058
- Zydus US005
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Houston, Texas, Forente stater, 77079
- Zydus US110
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Katy, Texas, Forente stater, 77084
- Zydus US117
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San Antonio, Texas, Forente stater, 78215
- Zydus US031
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San Antonio, Texas, Forente stater, 78222
- Zydus US103
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San Antonio, Texas, Forente stater, 78229
- Zydus US036
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San Antonio, Texas, Forente stater, 78229
- Zydus US102
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San Antonio, Texas, Forente stater, 78234
- Zydus US043
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San Antonio, Texas, Forente stater, 78240
- Zydus US008
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Waco, Texas, Forente stater, 76712
- Zydus US078
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Wichita Falls, Texas, Forente stater, 76301
- Zydus US076
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Utah
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Ogden, Utah, Forente stater, 84405
- Zydus US088
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Virginia
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Manassas, Virginia, Forente stater, 20110
- Zydus US070
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Richmond, Virginia, Forente stater, 23236
- Zydus US082
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Richmond, Virginia, Forente stater, 23298
- Zydus US021
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Puerto Rico
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San Juan, Puerto Rico, Puerto Rico, 00927
- Zydus US097
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Adana, Tyrkia (Türkiye), 01240
- Zydus TR003
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Ankara, Tyrkia (Türkiye), 06230
- Zydus TR002
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Ankara, Tyrkia (Türkiye), 06800
- Zydus TR001
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Bursa, Tyrkia (Türkiye), 16059
- Zydus TR004
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Gaziantep, Tyrkia (Türkiye), 27310
- Zydus TR005
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Istanbul, Tyrkia (Türkiye), 34093
- Zydus TR009
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Istanbul, Tyrkia (Türkiye), 34760
- Zydus TR008
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Izmir, Tyrkia (Türkiye), 35100
- Zydus TR007
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Izmir, Tyrkia (Türkiye), 35150
- Zydus TR006
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Kayseri, Tyrkia (Türkiye), 38039
- Zydus TR011
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Kocaeli, Tyrkia (Türkiye), 41000
- Zydus TR010
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Mersin, Tyrkia (Türkiye), 33110
- Zydus TR012
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Rize, Tyrkia (Türkiye), 53020
- Zydus TR013
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Trabzon, Tyrkia (Türkiye), 61080
- Zydus TR014
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Males or females, between 18 and 75 years of age, both inclusive at screening.
- BMI ≤45 kg/m²
- Histological confirmation of NASH with liver fibrosis by central pathologist on a diagnostic liver biopsy with a NAS ≥4 with at least one-point score in each of the three components of the NAFLD activity score [NAS] (steatosis scored 0-3, ballooning degeneration scored 0-2, and lobular inflammation scored 0-3) and NASH by pattern recognition Note: The biopsy must not have been performed more than 24 weeks before randomization.
- The subjects must have a stable body weight (no more than 5% change) between the time of biopsy and randomization.
- Fibrosis stage 2 and 3, according to the NASH CRN fibrosis staging, reported by central pathologist.
- If the subjects have type 2 diabetes mellitus, then it must be moderately controlled with HbA1c ≤ 9.5% and on a stable dose of permitted anti-diabetic medication for at least 90 days before screening until randomization.
- If the subjects are taking vitamin E > 400 IU/day, then it must be on a stable dose for at least 24 weeks prior to screening or, if a historical biopsy is used, at least 24 weeks prior to baseline liver biopsy until randomization.
- Must provide written informed consent and agree to comply with the trial protocol.
Exclusion Criteria:
-
Consumption of >2 units of alcohol per day (>14 units per week) if male and >1 units of alcohol per day (>7 units per week) if female for at least 12 consecutive weeks within 5 years before screening (Note: 1 unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits/hard liquor)
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History or presence of other concomitant liver diseases at screening:
- Chronic hepatitis B (HBV) or hepatitis C virus (HCV) infection (However, If the subject has been treated for the HCV infection and has been cured at least 5 years from screening, such subjects can be enrolled in the study)
- Primary biliary cholangitis (PBC)
- Primary sclerosing cholangitis (PSC)
- Definite autoimmune liver disease or overlap syndrome
- Alcoholic liver disease
- Hemochromatosis
- Wilsons disease
- Alpha-1 antitrypsin deficiency
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Subject with known cirrhosis, either based on histology, clinical criteria or any non-invasive diagnostic modality, within 24 weeks prior to the randomization.
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Evidence of portal hypertension (low platelet count, esophageal varices, ascites, history of hepatic encephalopathy, splenomegaly) at screening.
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Treatment with glucagon-like peptide-1 receptor agonists (GLP-1RAs), sodium glucose cotransporter- 2 (SGLT-2) inhibitors, and dipeptidyl peptidase 4 inhibitors (gliptins) unless stable for 120 days prior to screening or, if a historical biopsy is used, from 120 days prior to baseline liver biopsy until randomization.
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Use of concurrent medications prior to screening including:
- Anti-NASH therapy(s) including S-adenosyl methionine (SAMe), ursodeoxycholic acid (UDCA), and obeticholic acid in the period from 90 days prior to screening or, if a historical biopsy is used, from 90 days prior to baseline liver biopsy until randomization. For resmetirom; 120 days prior to screening or if a historical biopsy is used, from 120 days prior to baseline liver biopsy until randomization.
- Antidiabetic mediation which may impact NASH histology including thiazolidinediones (pioglitazone, rosiglitazone) in the period from 90 days prior to screening or, if a historical biopsy is used, from 90 days prior to baseline liver biopsy until randomization.
- Immune modulatory agents including anti-TNF-α therapies (infliximab, adalimumab, etanercept) or anti-integrin therapy (namixilab) in the period from 28 days prior to screening or if a historical biopsy is used from 28 days prior to baseline liver biopsy until randomization.
- Any treatment or anticipated initiation (intended use for more than 14 consecutive days) of medications known to have an effect on steatosis (e.g. treatment with corticosteroids [topical and inhaled are allowed]), methotrexate, tamoxifen, valproic acid, amiodarone or tetracycline, estrogens in doses higher than used in oral contraceptives, vitamin A, L-asparaginase, valproate, chloroquine, or antiretroviral drugs in the period from 28 days prior to screening or, if a historical biopsy is used, from 28 days prior to baseline liver biopsy until randomization.
- Treatment with orlistat, zonisamide, topiramate, phentermine, lorcaserin, bupropion, or naltrexone alone, or in combination or any other medication, that could promote weight loss, in the opinion of the investigator, in the period from 28 days prior to screening or if a historical biopsy is used from 28 days prior to baseline liver biopsy until randomization.
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Changing doses of statins (simvastatin, pitavastatin, pravastatin, atorvastatin, fluvastatin, lovastatin, rosuvastatin) or fibrates (clofibrate, Fenofibrate) in the 90 days preceding screening until randomization.
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Use of drugs that are known CYP2C8 inhibitors/substrate in the 28 days preceding screening until randomization.
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History of liver transplant
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Any weight reduction surgery in the 2 years prior to screening or planned during the study (weight reduction surgery is disallowed during the study), and malabsorptive weight loss surgery (Rouxen-Y or distal gastric bypass) at any time prior to screening.
Note: Lap banding, if the band has been removed >6 months before baseline liver biopsy, or intragastric balloon, if the balloon has been removed > 6 months before baseline liver biopsy, is allowed.
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Type 1 diabetes mellitus
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History of stomach or intestinal surgery or resection within the six months prior to screening that would potentially alter absorption and/or excretion of orally administered drugs as judged by the investigator.
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Unstable cardiovascular disease, including:
- unstable angina, (i.e., new or worsening symptoms of coronary heart disease) in the 90 days before screening and throughout the screening period; acute coronary syndrome in the 24 weeks before screening and throughout the screening period;
- acute myocardial infarction in the 90 days before screening and throughout the screening period; or heart failure of New York Heart Association class (III - IV), worsening congestive heart failure, or coronary artery intervention, in the 24 weeks before screening and throughout the screening period.
- history of unstable cardiac dysrhythmias
- uncontrolled hypertension at screening
- stroke or transient ischemic attack in the 24 weeks before screening
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History of myopathies or evidence of active muscle disease demonstrated by CPK ≥ 5 times ULN at screening.
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For subjects with elevated baseline ALT, AST, or ALP; ALT, AST, or ALP exceeding by more than 50% at Visit 2 reading compared to Visit 1 Note: If the ALT, AST or ALP values at Visit 2 exceed by more than 50% from Visit 1, then a third value will be measured to assess for the trend. If the third value shows continued increase ≥ 10%, then subject is considered ineligible for randomization.
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Any of the following laboratory values at screening:
- Hemoglobin <9 g/dL
- WBC count <2.5 × 103/µL
- Neutrophil count <1.5 × 103/µL
- Platelets <140 × 103/µL [if low platelet count is due to reasons other than liver disease as assessed by a hematologist, participants may be eligible if the platelet count is > 75 x 103/µL] as per investigator's discretion]
- INR ≥ 1.3 (in the absence of anticoagulants)
- Total bilirubin > ULN except in Gilbert's syndrome. In subjects with known Gilbert's syndrome, direct bilirubin > 2 x ULN
- Albumin <3.5 g/dL
- eGFR <60 mL/min/1.73 m2
- ALP ≥ 2x ULN
- ALT or AST ≥ 250 U/L
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Participation in any other therapeutic clinical study and on active treatment in the past 90 days of the screening.
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History of benign or malignant bladder tumors, and/or hematuria or has current hematuria except due to a urinary tract infection.
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History of malignancy in the past 5 years and/or active neoplasm with the exception of resolved superficial nonmelanoma skin cancer.
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Known allergy, sensitivity or intolerance to the study drug, comparator or formulation ingredients.
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Pregnancy-related exclusions, including:
- Pregnant/lactating female (including positive pregnancy test at screening)
- Pregnancy should be avoided by male and female participants either by true abstinence or the use of an acceptable effective contraceptive measures for the duration of the study and for at least 1 month after the end of the study treatment
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History or other evidence of severe illness or any other conditions that would make the subject, in the opinion of the investigator, unsuitable for the study (such as poorly controlled psychiatric disease, HIV, coronary artery disease or active gastrointestinal conditions that might interfere with drug absorption)
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Receiving an elemental diet or parenteral nutrition.
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Chronic pancreatitis or pancreatic insufficiency.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Saroglitazar Magnesium 2 mg
Saroglitazar Magnesium 2 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment. |
Patients randomly assigned to this group will receive Saroglitazar Magnesium 2 mg tablet orally once daily in the morning before breakfast without food, for the duration of treatment.
Andre navn:
|
|
Eksperimentell: Saroglitazar Magnesium 4 mg
Saroglitazar Magnesium 4 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment. |
Patients randomly assigned to this group will receive Saroglitazar Magnesium 4 mg tablet orally once daily in the morning before breakfast without food, for the duration of treatment.
Andre navn:
|
|
Placebo komparator: Placebo
Placebo tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment. |
Patients randomly assigned to this group will receive Placebo tablet orally once daily in the morning before breakfast without food, for the duration of treatment.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Resolution of steatohepatitis with no worsening of fibrosis
Tidsramme: 52 Weeks/EOT
|
Resolution of steatohepatitis is defined as absent fatty liver disease or isolated or simple steatosis without steatohepatitis and a NAS of 0-1 for inflammation, 0 for ballooning, and any value for Steatosis |
52 Weeks/EOT
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Improvement in liver fibrosis with no increase in NAS for ballooning, inflammation or steatosis
Tidsramme: Week 52/EOT
|
Proportion of subjects achieving improvement in liver fibrosis (reduction of at least one stage) with no increase in NAS for ballooning, inflammation or steatosis |
Week 52/EOT
|
|
2 points improvement in NAS
Tidsramme: Week 52/EOT
|
Proportion of subjects with at least 2 points improvement in NAS at Week 52/EOT with at least 1-point improvement in either ballooning or inflammation and no worsening of liver fibrosis |
Week 52/EOT
|
|
Improvement in steatosis, ballooning, inflammation and fibrosis from liver biopsy
Tidsramme: Week 52/EOT
|
Proportion of subjects with ≥1 point improvement in steatosis, ballooning, inflammation and fibrosis |
Week 52/EOT
|
|
Decrease in SAF score on liver biopsy
Tidsramme: Week 52/EOT
|
Proportion of subjects with decrease in SAF score ≥2 combining hepatocellular inflammation and ballooning without worsening of fibrosis |
Week 52/EOT
|
|
Histological score changes in steatosis, ballooning, inflammation, and fibrosis
Tidsramme: Week 52/EOT
|
Change from baseline in steatosis, ballooning, inflammation, and fibrosis |
Week 52/EOT
|
|
Change in liver enzyme parameters including (ALT, AST, ALP, GGT, total bilirubin, albumin)
Tidsramme: Week 52/EOT
|
Change from baseline in liver enzyme parameters (ALT, AST, ALP, GGT, total bilirubin, albumin) |
Week 52/EOT
|
|
Change in non-invasive markers of steatosis
Tidsramme: Week 52/EOT
|
Change from baseline in non-invasive markers of steatosis (Enhanced Liver Fibrosis [ELF] test, Fibrosis 4 [FIB 4], APRI [AST to Platelet Ratio Index], NFS [NAFLD Fibrosis Score], PRO-C3) |
Week 52/EOT
|
|
Change in n lipid parameters including (TG, LDLC, TC, HDL-C, non-HDL-C, VLDL-C
Tidsramme: Week 52/EOT
|
Change from baseline in lipid parameters (TG, LDLC, TC, HDL-C, non-HDL-C, VLDL-C) |
Week 52/EOT
|
|
Change in body weight (any change from baseline)
Tidsramme: Week 52/EOT
|
Change from baseline in body weight |
Week 52/EOT
|
|
Change in insulin resistance marker, HOMA-IR
Tidsramme: Week 52/EOT
|
Change from baseline in insulin resistance marker (HOMA-IR) |
Week 52/EOT
|
|
Change in inflammatory markers including (CK-18 [M30], IL-6, CRP)
Tidsramme: Week 52/EOT
|
Change from baseline in inflammatory markers (CK-18 [M30], IL-6, CRP) |
Week 52/EOT
|
|
Change in glucose homeostasis markers including (HbA1c, FPG)
Tidsramme: Week 52/EOT
|
Change from baseline in glucose homeostasis markers (HbA1c, FPG) |
Week 52/EOT
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Deven V. Parmar, MD, FCP, Zydus Therapeutics Inc.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SARO.20.002
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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