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Saroglitazar magnésico para el tratamiento de la esteatohepatitis no alcohólica con fibrosis (NASH)

9 de septiembre de 2026 actualizado por: Zydus Therapeutics Inc.

Estudio de fase 2b, prospectivo, multicéntrico, aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia y la seguridad de saroglitazar magnésico en sujetos con esteatohepatitis no alcohólica y fibrosis

Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

189

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Argentina
      • Buenos Aires, Argentina, B1629ODT
        • Zydus AR004
      • CABA, Argentina, C1056ABJ
        • Zydus AR001
      • CABA, Argentina, C1180AAX
        • Zydus AR013
      • CABA, Argentina, C1199ABB
        • Zydus AR007
      • CABA, Argentina, C1221ADC
        • Zydus AR006
      • CABA, Argentina, C1264AAA
        • Zydus AR005
      • CABA, Argentina, C1425AGC
        • Zydus AR008
      • CABA, Argentina, C1426ABP
        • Zydus AR012
      • CABA, Argentina, CP143CKE
        • Zydus AR003
      • Mar del Plata, Argentina, B7600
        • Zydus AR009
      • Mar del Plata, Argentina
        • Zydus AR011
      • Ramos Mejía, Argentina
        • Zydus AR002
      • Rosario, Argentina, S2002KDS
        • Zydus AR010
  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35294
        • Zydus US032
      • Homewood, Alabama, Estados Unidos, 35209
        • Zydus US079
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85013
        • Zydus US047
      • Tucson, Arizona, Estados Unidos, 85712
        • Zydus US025
      • Tucson, Arizona, Estados Unidos, 85712
        • Zydus US087
      • Tucson, Arizona, Estados Unidos, 85724
        • Zydus US029
    • California
      • Chula Vista, California, Estados Unidos, 91911
        • Zydus US118
      • Fresno, California, Estados Unidos, 93720
        • Zydus US041
      • Gardena, California, Estados Unidos, 90247
        • Zydus US111
      • Huntington Park, California, Estados Unidos, 90255
        • Zydus US013
      • La Jolla, California, Estados Unidos, 92037
        • Zydus US065
      • Lancaster, California, Estados Unidos, 93534
        • Zydus US094
      • Long Beach, California, Estados Unidos, 90808
        • Zydus US080
      • Long Beach, California, Estados Unidos, 90815
        • Zydus US090
      • Los Angeles, California, Estados Unidos, 90027
        • Zydus US022
      • Los Angeles, California, Estados Unidos, 90033
        • Zydus US062
      • Murrieta, California, Estados Unidos, 92563
        • Zydus US023
      • Orange, California, Estados Unidos, 92868
        • Zydus US052
      • Panorama City, California, Estados Unidos, 91402
        • Zydus US012
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
        • Zydus US039
    • Florida
      • Clearwater, Florida, Estados Unidos, 33761
        • Zydus US122
      • Fort Myers, Florida, Estados Unidos, 33907
        • Zydus US057
      • Hallandale, Florida, Estados Unidos, 33009
        • Zydus US108
      • Hialeah Gardens, Florida, Estados Unidos, 33016
        • Zydus US096
      • Lakeland, Florida, Estados Unidos, 33803
        • Zydus US003
      • Lakewood Rch, Florida, Estados Unidos, 34211
        • Zydus US016
      • Largo, Florida, Estados Unidos, 33777
        • Zydus US125
      • Maitland, Florida, Estados Unidos, 32751
        • Zydus US001
      • Maitland, Florida, Estados Unidos, 32751
        • Zydus US124
      • Miami, Florida, Estados Unidos, 33014
        • Zydus US007
      • Miami, Florida, Estados Unidos, 33135
        • Zydus US024
      • Miami, Florida, Estados Unidos, 33136
        • Zydus US034
      • Miami, Florida, Estados Unidos, 33136
        • Zydus US038
      • Miami, Florida, Estados Unidos, 33155
        • Zydus US121
      • Miami, Florida, Estados Unidos, 33173
        • Zydus US054
      • Miami Lakes, Florida, Estados Unidos, 33016
        • Zydus US098
      • Naples, Florida, Estados Unidos, 34102
        • Zydus US099
      • Ocala, Florida, Estados Unidos, 34471
        • Zydus US081
      • Orlando, Florida, Estados Unidos, 32806
        • Zydus US085
      • Port Orange, Florida, Estados Unidos, 32127
        • Zydus US104
      • Winter Park, Florida, Estados Unidos, 32789
        • Zydus US004
    • Georgia
      • Dalton, Georgia, Estados Unidos, 30720
        • Zydus US107
      • Gainesville, Georgia, Estados Unidos, 30501
        • Zydus US113
      • Marietta, Georgia, Estados Unidos, 30060
        • Zydus US114
      • Savannah, Georgia, Estados Unidos, 31406
        • Zydus US119
    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46202
        • Zydus US020
    • Iowa
      • West Des Moines, Iowa, Estados Unidos, 50652
        • Zydus US100
    • Kansas
      • Kansas City, Kansas, Estados Unidos, 66160
        • Zydus US049
    • Louisiana
      • Houma, Louisiana, Estados Unidos, 70363
        • Zydus US071
      • Marrero, Louisiana, Estados Unidos, 70072
        • Zydus US014
      • West Monroe, Louisiana, Estados Unidos, 71291
        • Zydus US123
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02215
        • Zydus US017
    • Michigan
      • Chesterfield, Michigan, Estados Unidos, 48047
        • Zydus US092
      • Wyoming, Michigan, Estados Unidos, 49519
        • Zydus US019
    • Minnesota
      • Saint Paul, Minnesota, Estados Unidos, 55101
        • Zydus US115
    • Missouri
      • Columbia, Missouri, Estados Unidos, 65201
        • Zydus US074
      • Kansas City, Missouri, Estados Unidos, 64131
        • Zydus US120
    • Nevada
      • Reno, Nevada, Estados Unidos, 89511
        • Zydus US116
    • New Jersey
      • Sparta, New Jersey, Estados Unidos, 07871
        • Zydus US077
    • New York
      • Manhasset, New York, Estados Unidos, 11030
        • Zydus US069
      • New York, New York, Estados Unidos, 10033
        • Zydus US066
    • North Carolina
      • Asheville, North Carolina, Estados Unidos, 28801
        • Zydus US018
      • Charlotte, North Carolina, Estados Unidos, 28204
        • Zydus US027
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45044
        • Zydus US010
      • Cincinnati, Ohio, Estados Unidos, 45267-0595
        • Zydus US009
      • Cleveland, Ohio, Estados Unidos, 44109
        • Zydus US035
      • Springboro, Ohio, Estados Unidos, 45066
        • Zydus US072
    • Pennsylvania
      • Hershey, Pennsylvania, Estados Unidos, 17033
        • Zydus US060
      • Philadelphia, Pennsylvania, Estados Unidos, 19141
        • Zydus US053
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29401
        • Zydus US015
      • Charleston, South Carolina, Estados Unidos, 29425
        • Zydus US030
      • Columbia, South Carolina, Estados Unidos, 29204
        • Zydus US073
      • Greenwood, South Carolina, Estados Unidos, 29646
        • Zydus US075
      • Summerville, South Carolina, Estados Unidos, 29485
        • Zydus US112
    • Tennessee
      • Hermitage, Tennessee, Estados Unidos, 37067
        • Zydus US011
      • Nashville, Tennessee, Estados Unidos, 37232
        • Zydus US028
    • Texas
      • Arlington, Texas, Estados Unidos, 76012
        • Zydus US002
      • Austin, Texas, Estados Unidos, 78745
        • Zydus US051
      • Austin, Texas, Estados Unidos, 78757
        • Zydus US101
      • Bellaire, Texas, Estados Unidos, 77401
        • Zydus US089
      • Brownsville, Texas, Estados Unidos, 78520
        • Zydus US105
      • Edinburg, Texas, Estados Unidos, 78539
        • Zydus US095
      • Edinburg, Texas, Estados Unidos, 78539
        • Zydus US106
      • Fort Worth, Texas, Estados Unidos, 76104
        • Zydus US061
      • Houston, Texas, Estados Unidos, 77030
        • Zydus US067
      • Houston, Texas, Estados Unidos, 77030
        • Zydus US109
      • Houston, Texas, Estados Unidos, 77058
        • Zydus US005
      • Houston, Texas, Estados Unidos, 77079
        • Zydus US110
      • Katy, Texas, Estados Unidos, 77084
        • Zydus US117
      • San Antonio, Texas, Estados Unidos, 78215
        • Zydus US031
      • San Antonio, Texas, Estados Unidos, 78222
        • Zydus US103
      • San Antonio, Texas, Estados Unidos, 78229
        • Zydus US036
      • San Antonio, Texas, Estados Unidos, 78229
        • Zydus US102
      • San Antonio, Texas, Estados Unidos, 78234
        • Zydus US043
      • San Antonio, Texas, Estados Unidos, 78240
        • Zydus US008
      • Waco, Texas, Estados Unidos, 76712
        • Zydus US078
      • Wichita Falls, Texas, Estados Unidos, 76301
        • Zydus US076
    • Utah
      • Ogden, Utah, Estados Unidos, 84405
        • Zydus US088
    • Virginia
      • Manassas, Virginia, Estados Unidos, 20110
        • Zydus US070
      • Richmond, Virginia, Estados Unidos, 23236
        • Zydus US082
      • Richmond, Virginia, Estados Unidos, 23298
        • Zydus US021
  • Puerto Rico
    • Puerto Rico
      • San Juan, Puerto Rico, Puerto Rico, 00927
        • Zydus US097
  • Turquía (Türkiye)
      • Adana, Turquía (Türkiye), 01240
        • Zydus TR003
      • Ankara, Turquía (Türkiye), 06230
        • Zydus TR002
      • Ankara, Turquía (Türkiye), 06800
        • Zydus TR001
      • Bursa, Turquía (Türkiye), 16059
        • Zydus TR004
      • Gaziantep, Turquía (Türkiye), 27310
        • Zydus TR005
      • Istanbul, Turquía (Türkiye), 34093
        • Zydus TR009
      • Istanbul, Turquía (Türkiye), 34760
        • Zydus TR008
      • Izmir, Turquía (Türkiye), 35100
        • Zydus TR007
      • Izmir, Turquía (Türkiye), 35150
        • Zydus TR006
      • Kayseri, Turquía (Türkiye), 38039
        • Zydus TR011
      • Kocaeli, Turquía (Türkiye), 41000
        • Zydus TR010
      • Mersin, Turquía (Türkiye), 33110
        • Zydus TR012
      • Rize, Turquía (Türkiye), 53020
        • Zydus TR013
      • Trabzon, Turquía (Türkiye), 61080
        • Zydus TR014

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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)

  • History or presence of other concomitant liver diseases at screening:

    1. 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)
    2. Primary biliary cholangitis (PBC)
    3. Primary sclerosing cholangitis (PSC)
    4. Definite autoimmune liver disease or overlap syndrome
    5. Alcoholic liver disease
    6. Hemochromatosis
    7. Wilsons disease
    8. Alpha-1 antitrypsin deficiency

  • Subject with known cirrhosis, either based on histology, clinical criteria or any non-invasive diagnostic modality, within 24 weeks prior to the randomization.

  • Evidence of portal hypertension (low platelet count, esophageal varices, ascites, history of hepatic encephalopathy, splenomegaly) at screening.

  • 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.

  • Use of concurrent medications prior to screening including:

    1. 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.
    2. 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.
    3. 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.
    4. 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.
    5. 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.

  • Changing doses of statins (simvastatin, pitavastatin, pravastatin, atorvastatin, fluvastatin, lovastatin, rosuvastatin) or fibrates (clofibrate, Fenofibrate) in the 90 days preceding screening until randomization.

  • Use of drugs that are known CYP2C8 inhibitors/substrate in the 28 days preceding screening until randomization.

  • History of liver transplant

  • 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.

  • Type 1 diabetes mellitus

  • 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.

  • Unstable cardiovascular disease, including:

    1. 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;
    2. 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.
    3. history of unstable cardiac dysrhythmias
    4. uncontrolled hypertension at screening
    5. stroke or transient ischemic attack in the 24 weeks before screening

  • History of myopathies or evidence of active muscle disease demonstrated by CPK ≥ 5 times ULN at screening.

  • 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.

  • Any of the following laboratory values at screening:

    1. Hemoglobin <9 g/dL
    2. WBC count <2.5 × 103/µL
    3. Neutrophil count <1.5 × 103/µL
    4. 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]
    5. INR ≥ 1.3 (in the absence of anticoagulants)
    6. Total bilirubin > ULN except in Gilbert's syndrome. In subjects with known Gilbert's syndrome, direct bilirubin > 2 x ULN
    7. Albumin <3.5 g/dL
    8. eGFR <60 mL/min/1.73 m2
    9. ALP ≥ 2x ULN
    10. ALT or AST ≥ 250 U/L

  • Participation in any other therapeutic clinical study and on active treatment in the past 90 days of the screening.

  • History of benign or malignant bladder tumors, and/or hematuria or has current hematuria except due to a urinary tract infection.

  • History of malignancy in the past 5 years and/or active neoplasm with the exception of resolved superficial nonmelanoma skin cancer.

  • Known allergy, sensitivity or intolerance to the study drug, comparator or formulation ingredients.

  • Pregnancy-related exclusions, including:

    1. Pregnant/lactating female (including positive pregnancy test at screening)
    2. 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

  • 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)

  • Receiving an elemental diet or parenteral nutrition.

  • Chronic pancreatitis or pancreatic insufficiency.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Droga: Saroglitazar Magnesium 2 mg

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.

Otros nombres:
  • Producto en investigación
Experimental: 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.
Droga: Saroglitazar Magnesium 4 mg

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.

Otros nombres:
  • Producto en investigación
Comparador de placebos: Placebo

Placebo tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment.
Droga: Placebo

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.

Otros nombres:
  • Agente comparador

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Resolution of steatohepatitis with no worsening of fibrosis
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Improvement in liver fibrosis with no increase in NAS for ballooning, inflammation or steatosis
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: Week 52/EOT

Change from baseline in body weight
Week 52/EOT
Change in insulin resistance marker, HOMA-IR
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: Week 52/EOT

Change from baseline in glucose homeostasis markers (HbA1c, FPG)
Week 52/EOT

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Zydus Therapeutics Inc.

Investigadores

  • Director de estudio: Deven V. Parmar, MD, FCP, Zydus Therapeutics Inc.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

18 de agosto de 2021

Finalización primaria (Actual)

12 de septiembre de 2025

Finalización del estudio (Actual)

12 de septiembre de 2025

Fechas de registro del estudio

Enviado por primera vez

11 de julio de 2021

Primero enviado que cumplió con los criterios de control de calidad

10 de agosto de 2021

Publicado por primera vez (Actual)

18 de agosto de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

21 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

9 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • SARO.20.002

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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