Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Saroglitazar Magnesium voor de behandeling van niet-alcoholische steatohepatitis met fibrose (NASH)

9 september 2026 bijgewerkt door: Zydus Therapeutics Inc.

Een prospectieve, multicenter, gerandomiseerde, dubbelblinde, placebogecontroleerde fase 2b-studie om de werkzaamheid en veiligheid van Saroglitazar-magnesium te evalueren bij proefpersonen met niet-alcoholische steatohepatitis en fibrose

Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Werkelijk)

189

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: 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.

Andere namen:
  • Onderzoeksproduct
Experimenteel: 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.
Geneesmiddel: 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.

Andere namen:
  • Onderzoeksproduct
Placebo-vergelijker: Placebo

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

Andere namen:
  • Vergelijkingsagent

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Resolution of steatohepatitis with no worsening of fibrosis
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Improvement in liver fibrosis with no increase in NAS for ballooning, inflammation or steatosis
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: Week 52/EOT

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

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Zydus Therapeutics Inc.

Onderzoekers

  • Studie directeur: Deven V. Parmar, MD, FCP, Zydus Therapeutics Inc.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

18 augustus 2021

Primaire voltooiing (Werkelijk)

12 september 2025

Studie voltooiing (Werkelijk)

12 september 2025

Studieregistratiedata

Eerst ingediend

11 juli 2021

Eerst ingediend dat voldeed aan de QC-criteria

10 augustus 2021

Eerst geplaatst (Werkelijk)

18 augustus 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

21 september 2026

Laatste update ingediend die voldeed aan QC-criteria

9 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • SARO.20.002

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren