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Saroglitazar magnésio para o tratamento da esteatohepatite não alcoólica com fibrose (NASH)

9 de setembro de 2026 atualizado por: Zydus Therapeutics Inc.

Um estudo de fase 2b, prospectivo, multicêntrico, randomizado, duplo-cego, controlado por placebo para avaliar a eficácia e a segurança do saroglitazar magnésio em indivíduos com esteato-hepatite não alcoólica e fibrose

Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Real)

189

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • 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
  • Porto Rico
    • Puerto Rico
      • San Juan, Puerto Rico, Porto Rico, 00927
        • Zydus US097
  • Turquia (Türkiye)
      • Adana, Turquia (Türkiye), 01240
        • Zydus TR003
      • Ankara, Turquia (Türkiye), 06230
        • Zydus TR002
      • Ankara, Turquia (Türkiye), 06800
        • Zydus TR001
      • Bursa, Turquia (Türkiye), 16059
        • Zydus TR004
      • Gaziantep, Turquia (Türkiye), 27310
        • Zydus TR005
      • Istanbul, Turquia (Türkiye), 34093
        • Zydus TR009
      • Istanbul, Turquia (Türkiye), 34760
        • Zydus TR008
      • Izmir, Turquia (Türkiye), 35100
        • Zydus TR007
      • Izmir, Turquia (Türkiye), 35150
        • Zydus TR006
      • Kayseri, Turquia (Türkiye), 38039
        • Zydus TR011
      • Kocaeli, Turquia (Türkiye), 41000
        • Zydus TR010
      • Mersin, Turquia (Türkiye), 33110
        • Zydus TR012
      • Rize, Turquia (Türkiye), 53020
        • Zydus TR013
      • Trabzon, Turquia (Türkiye), 61080
        • Zydus TR014

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 75 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Medicamento: 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.

Outros nomes:
  • Produto Investigacional
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.
Medicamento: 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.

Outros nomes:
  • Produto Investigacional
Comparador de Placebo: Placebo

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

Outros nomes:
  • Agente Comparador

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Resolution of steatohepatitis with no worsening of fibrosis
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Improvement in liver fibrosis with no increase in NAS for ballooning, inflammation or steatosis
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: Week 52/EOT

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

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Zydus Therapeutics Inc.

Investigadores

  • Diretor de estudo: Deven V. Parmar, MD, FCP, Zydus Therapeutics Inc.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

18 de agosto de 2021

Conclusão Primária (Real)

12 de setembro de 2025

Conclusão do estudo (Real)

12 de setembro de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

11 de julho de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de agosto de 2021

Primeira postagem (Real)

18 de agosto de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

21 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

9 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • SARO.20.002

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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