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Saroglitazar magnesio per il trattamento della steatoepatite non alcolica con fibrosi (NASH)

9 settembre 2026 aggiornato da: Zydus Therapeutics Inc.

Uno studio di fase 2b, prospettico, multicentrico, randomizzato, in doppio cieco, controllato con placebo per valutare l'efficacia e la sicurezza del magnesio Saroglitazar in soggetti con steatoepatite e fibrosi non alcoliche

Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

189

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.

Altri nomi:
  • Prodotto sperimentale
Sperimentale: 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.

Altri nomi:
  • Prodotto sperimentale
Comparatore placebo: 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.

Altri nomi:
  • Agente comparatore

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Resolution of steatohepatitis with no worsening of fibrosis
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Improvement in liver fibrosis with no increase in NAS for ballooning, inflammation or steatosis
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: Week 52/EOT

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

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Zydus Therapeutics Inc.

Investigatori

  • Direttore dello studio: Deven V. Parmar, MD, FCP, Zydus Therapeutics Inc.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

18 agosto 2021

Completamento primario (Effettivo)

12 settembre 2025

Completamento dello studio (Effettivo)

12 settembre 2025

Date di iscrizione allo studio

Primo inviato

11 luglio 2021

Primo inviato che soddisfa i criteri di controllo qualità

10 agosto 2021

Primo Inserito (Effettivo)

18 agosto 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

21 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • SARO.20.002

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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