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Saroglitazar Magnesium til behandling af ikke-alkoholisk Steatohepatitis med fibrose (NASH)

9. september 2026 opdateret af: Zydus Therapeutics Inc.

En fase 2b, prospektiv, multicenter, randomiseret, dobbeltblind, placebokontrolleret undersøgelse til evaluering af effektivitet og sikkerhed af Saroglitazar-magnesium hos personer med ikke-alkoholisk steatohepatitis og fibrose

Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

A Phase 2b, Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Saroglitazar Magnesium in Subjects with Nonalcoholic Steatohepatitis and Fibrosis.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

189

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Males or females, between 18 and 75 years of age, both inclusive at screening.
  • BMI ≤45 kg/m²
  • Histological confirmation of NASH with liver fibrosis by central pathologist on a diagnostic liver biopsy with a NAS ≥4 with at least one-point score in each of the three components of the NAFLD activity score [NAS] (steatosis scored 0-3, ballooning degeneration scored 0-2, and lobular inflammation scored 0-3) and NASH by pattern recognition Note: The biopsy must not have been performed more than 24 weeks before randomization.
  • The subjects must have a stable body weight (no more than 5% change) between the time of biopsy and randomization.
  • Fibrosis stage 2 and 3, according to the NASH CRN fibrosis staging, reported by central pathologist.
  • If the subjects have type 2 diabetes mellitus, then it must be moderately controlled with HbA1c ≤ 9.5% and on a stable dose of permitted anti-diabetic medication for at least 90 days before screening until randomization.
  • If the subjects are taking vitamin E > 400 IU/day, then it must be on a stable dose for at least 24 weeks prior to screening or, if a historical biopsy is used, at least 24 weeks prior to baseline liver biopsy until randomization.
  • Must provide written informed consent and agree to comply with the trial protocol.

Exclusion Criteria:

  • Consumption of >2 units of alcohol per day (>14 units per week) if male and >1 units of alcohol per day (>7 units per week) if female for at least 12 consecutive weeks within 5 years before screening (Note: 1 unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits/hard liquor)

  • 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: 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.

Andre navne:
  • Undersøgelsesprodukt
Eksperimentel: 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.
Medicin: 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.

Andre navne:
  • Undersøgelsesprodukt
Placebo komparator: Placebo

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

Andre navne:
  • Sammenligningsagent

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Resolution of steatohepatitis with no worsening of fibrosis
Tidsramme: 52 Weeks/EOT

Resolution of steatohepatitis is defined as absent fatty liver disease or isolated or simple steatosis without steatohepatitis and a NAS of 0-1 for inflammation, 0 for ballooning, and any value for Steatosis
52 Weeks/EOT

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Improvement in liver fibrosis with no increase in NAS for ballooning, inflammation or steatosis
Tidsramme: Week 52/EOT

Proportion of subjects achieving improvement in liver fibrosis (reduction of at least one stage) with no increase in NAS for ballooning, inflammation or steatosis
Week 52/EOT
2 points improvement in NAS
Tidsramme: Week 52/EOT

Proportion of subjects with at least 2 points improvement in NAS at Week 52/EOT with at least 1-point improvement in either ballooning or inflammation and no worsening of liver fibrosis
Week 52/EOT
Improvement in steatosis, ballooning, inflammation and fibrosis from liver biopsy
Tidsramme: Week 52/EOT

Proportion of subjects with ≥1 point improvement in steatosis, ballooning, inflammation and fibrosis
Week 52/EOT
Decrease in SAF score on liver biopsy
Tidsramme: Week 52/EOT

Proportion of subjects with decrease in SAF score ≥2 combining hepatocellular inflammation and ballooning without worsening of fibrosis
Week 52/EOT
Histological score changes in steatosis, ballooning, inflammation, and fibrosis
Tidsramme: Week 52/EOT

Change from baseline in steatosis, ballooning, inflammation, and fibrosis
Week 52/EOT
Change in liver enzyme parameters including (ALT, AST, ALP, GGT, total bilirubin, albumin)
Tidsramme: Week 52/EOT

Change from baseline in liver enzyme parameters (ALT, AST, ALP, GGT, total bilirubin, albumin)
Week 52/EOT
Change in non-invasive markers of steatosis
Tidsramme: Week 52/EOT

Change from baseline in non-invasive markers of steatosis (Enhanced Liver Fibrosis [ELF] test, Fibrosis 4 [FIB 4], APRI [AST to Platelet Ratio Index], NFS [NAFLD Fibrosis Score], PRO-C3)
Week 52/EOT
Change in n lipid parameters including (TG, LDLC, TC, HDL-C, non-HDL-C, VLDL-C
Tidsramme: Week 52/EOT

Change from baseline in lipid parameters (TG, LDLC, TC, HDL-C, non-HDL-C, VLDL-C)
Week 52/EOT
Change in body weight (any change from baseline)
Tidsramme: Week 52/EOT

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

Change from baseline in insulin resistance marker (HOMA-IR)
Week 52/EOT
Change in inflammatory markers including (CK-18 [M30], IL-6, CRP)
Tidsramme: Week 52/EOT

Change from baseline in inflammatory markers (CK-18 [M30], IL-6, CRP)
Week 52/EOT
Change in glucose homeostasis markers including (HbA1c, FPG)
Tidsramme: Week 52/EOT

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Zydus Therapeutics Inc.

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

18. august 2021

Primær færdiggørelse (Faktiske)

12. september 2025

Studieafslutning (Faktiske)

12. september 2025

Datoer for studieregistrering

Først indsendt

11. juli 2021

Først indsendt, der opfyldte QC-kriterier

10. august 2021

Først opslået (Faktiske)

18. august 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SARO.20.002

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Abonner