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Forskningsundersøgelse for at undersøge, hvor godt Semaglutid-tabletter indtaget én gang dagligt arbejde hos mennesker, der er overvægtige eller lever med fedme (OASIS 1) (OASIS 1)

16. april 2026 opdateret af: Novo Nordisk A/S

Effekt og sikkerhed af oral Semaglutid 50 mg én gang dagligt hos personer med overvægt eller fedme (OASIS 1)

Denne undersøgelse udføres for at se, om semaglutid-tabletter kan bruges som en behandling for at hjælpe mennesker, der lever med overvægt eller fedme, tabe sig.

Denne undersøgelse vil se på ændringen i deltagernes kropsvægt. Deltagerne får enten semaglutidtabletter (ny medicin) eller placebotabletter ('dummy' medicin, der ligner semaglutid, men som ikke har nogen effekt på kroppen). For en retfærdig sammenligning er folk opdelt i to grupper tilfældigt af en computer. Denne proces kaldes randomisering.

Semaglutid-tabletter er ny medicin, der testes til behandling af overvægt og fedme. Læger i mange lande kan allerede ordinere semaglutid-tabletter i lavere doser til behandling af type 2-diabetes.

Deltagerne får semaglutid- eller placebotabletter i 68 uger og skal tage 1 tablet hver morgen

Udover at tage medicinen vil deltagerne have samtaler med studiepersonalet om:

  • sunde madvalg
  • hvordan man bliver mere fysisk aktiv
  • hvad deltagerne kan gøre for at tabe sig Undersøgelsen vil vare i ca. 1½ år. Deltagerne vil have 14 klinikbesøg og 7 telefonopkald med undersøgelsens læge. Der tages blodprøver ved 10 besøg.

Deltagerne vil få lavet en test for at tjekke deres hjerte ved 3 besøg. Kvinder kan ikke deltage, hvis de er gravide, ammer eller planlægger at blive gravide i studieperioden. Hvis deltageren er en kvinde og er i stand til at blive gravid, vil deltageren blive tjekket for graviditet via urinprøver.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

667

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3Z 2N6
        • Ocean West Research Clinic
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1G 1A7
        • G.A. Research Associates Ltd.
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Nova Scotia Health Authority
    • Ontario
      • Hamilton, Ontario, Canada, L8M 1K7
        • Premier Clinical Trial Research Network (PCTRN)
      • Hamilton, Ontario, Canada, L8L 5G8
        • Wharton Medical Clinic Clinical Trials (Hamilton)
  • Danmark
      • Hellerup, Danmark, 2900
        • Gentofte Hospital - Center for Klinisk Metabolisk Forskning
      • Hvidovre, Danmark, 2650
        • Hvidovre Hospital Endokrinologisk forsknings afsnit 159
      • Slagelse, Danmark, 4200
        • Slagelse Sygehus Ambulatorium for hjertesygdomme
    • Region Sjælland
      • Køge, Region Sjælland, Danmark, 4600
        • Sjællands Universitetshospital, Køge - Medicinsk Afdeling
  • Finland
      • Helsinki, Finland, 00014
        • Obesity Research Unit
      • Jyväskylä, Finland, 40620
        • StudyCor
      • Seinäjoki, Finland, 60220
        • Seinäjoen keskussairaala
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35233
        • Univ of Alabama Birmingham
    • California
      • Los Angeles, California, Forenede Stater, 90017
        • Velocity Clin Res Los Angeles
    • Florida
      • Kissimmee, Florida, Forenede Stater, 34744
        • The Chappel Group Research
      • Plantation, Florida, Forenede Stater, 33324
        • Clinical Trial Res Assoc,Inc
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96814
        • East West Med Res Inst
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46260
        • Midwest Inst For Clin Res
    • New York
      • Rochester, New York, Forenede Stater, 14609
        • Rochester Clinical Research, Inc.
    • North Carolina
      • Wilmington, North Carolina, Forenede Stater, 28401
        • Accellacare
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104-3317
        • The University of Penn Center
    • Texas
      • Dallas, Texas, Forenede Stater, 75230
        • Velocity Clinical Res-Dallas
    • Virginia
      • Arlington, Virginia, Forenede Stater, 22206
        • Washington Cntr Weight Mgmt
      • Winchester, Virginia, Forenede Stater, 22601-3834
        • Selma Medical Associates
    • Washington
      • Olympia, Washington, Forenede Stater, 98502
        • Capital Clin Res Ctr,LLC
  • Frankrig
      • Le Coudray, Frankrig, 28630
        • Les Hopitaux de Chartres-Hopital Louis Pasteur
      • Le Creusot, Frankrig, 71200
        • Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu-2
      • Le Creusot, Frankrig, 71200
        • Fondation Hôtel-Dieu
      • Pessac, Frankrig, 33600
        • Centre Hospitalier Universitaire de Bordeaux-Hopital Haut Leveque-2
      • Saint-Herblain, Frankrig, 44800
        • Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec
      • Toulouse, Frankrig, 31054
        • Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-2
      • Vénissieux, Frankrig, 69200
        • Centre de Recherche Clinique Portes Du Sud
  • Japan
      • Chiba-shi, Chiba, Japan, 260-8677
        • Chiba University Hospital_Diabetes, Metabolism and Endocrinology
      • Chiyoda-ku, Tokyo, Japan, 101-0065
        • Suidoubashi Medical Clinic_Internal Medicine
      • Tokyo, Japan, 169-0072
        • Higashi-Shinjuku Clinic
  • Polen
      • Lodz, Polen, 90-338
        • Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
    • Lubelski
      • Lublin, Lubelski, Polen, 20-538
        • NZOZ Przychodnia Specjalistyczna Medica
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Polen, 15-281
        • Gabinet Leczenia Otylosci i Chorob Dietozaleznych
    • Pomeranian Voivodeship
      • Gdynia, Pomeranian Voivodeship, Polen, 81-338
        • Centrum Medyczne Pratia Gdynia
    • Wielkopolskie Voivodeship
      • Poznan, Wielkopolskie Voivodeship, Polen, 60-589
        • Centrum Zdrowia Metabolicznego Paweł Bogdański
  • Rusland
      • Dzerzhinskiy, Rusland, 140091
        • LLC "Clinic of new technologies in Medicine"
      • Moscow, Rusland, 117292
        • FSBI 'I.I. Dedov National Medical Research Center of Endocrinology' of the MH of Russia
      • Moscow, Rusland, 119034
        • Endocrinological Dispensary of Department of healthcare ser.
      • Moscow, Rusland, 127486
        • Federal Bureau for Medical and Social Expertise
      • Saint Petersburg, Rusland, 194291
        • Leningrad Regional Clinical Hospital
      • Saint Petersburg, Rusland, 190013
        • Joint Stock Company "Polyclinic Complex"
      • Yekaterinburg, Rusland, 620075
        • Joint Stock Company "Medical technologies"
    • Russia
      • Tyumen, Russia, Rusland, 625023
        • Tumen State Medical University
  • Tyskland
      • Essen, Tyskland, 45136
        • InnoDiab Forschung GmbH
      • Essen, Tyskland, 45219
        • Praxis Dr. med. M. Esser
      • Hamburg, Tyskland, 22041
        • Diabetes Zentrum Wandsbek Berufsausuebungsgemeinschaft GbR
      • Hohenmölsen, Tyskland, 06679
        • Dr. Milek medikum
      • Oldenburg in Holstein, Tyskland, 23758
        • RED-Institut für medizinische Forschung und Fortbildung GmbH
      • Rehlingen-Siersburg, Tyskland, 66780
        • Praxis Dr. med. Wenzl-Bauer
      • Stuttgart, Tyskland, 70378
        • MZM Praxis Drs. Erlinger
      • Wangen, Tyskland, 88239
        • Zentrum für klinische Studien Allgäu Oberschwaben

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Mand eller kvinde, alder større end eller lig med 18 år på tidspunktet for underskrivelse af informeret samtykke
  • Body Mass Index (BMI):

større end eller lig med 27,0 kg/m^2 med tilstedeværelsen af ​​mindst én af følgende vægtrelaterede komplikationer (behandlet eller ubehandlet): hypertension, dyslipidæmi, obstruktiv søvnapnø eller hjerte-kar-sygdom ELLER større end eller lig med 30,0 kg/ m^2

  • Historie om mindst én selvrapporteret mislykket diætforsøg for at tabe kropsvægt

Ekskluderingskriterier:

  • HbA1c større end eller lig med 6,5 % (48 mmol/mol) målt af centrallaboratoriet ved screening
  • En selvrapporteret ændring i kropsvægt på mere end 5 kg (11 lbs) inden for 90 dage før screening, uanset lægejournaler

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: Oral semaglutid
Deltagerne vil modtage semaglutidtabeller én gang dagligt på en dosiseskalerende måde i 68 uger: 3 mg (uge 1-4), 7 mg (uge 5-8), 14 mg (uge 9-12), 25 mg (uge 13-16). ) og 50 mg (uge 17-68)
Medicin: Oral semaglutid
Deltagerne vil modtage en daglig dosis oral semaglutid.
Placebo komparator: Oral semaglutid placebo
Alle deltagere får én gang daglig dosis i 68 uger
Medicin: Placebo (semaglutid)
Oral placebo (semaglutid) én gang dagligt. Den planlagte behandlingsvarighed vil være 68 uger.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage Change in Body Weight
Tidsramme: Baseline (week 0), end-of-treatment (week 68)
Percentage change in body weight from baseline (week 0) to end-of-treatment (week 68) is presented.
Baseline (week 0), end-of-treatment (week 68)
Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 5% (Yes/No)
Tidsramme: At end-of-treatment (week 68)
Number of participants who achieved weight loss greater than or equal to 5% of their baseline body weight (yes/no) at end-of-treatment (week 68) is presented.
At end-of-treatment (week 68)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 10% (Yes/No)
Tidsramme: At end-of-treatment (week 68)
Number of participants who achieved weight loss greater than or equal ≥10% (Yes/No) at end-of-treatment (week 68) is presented.
At end-of-treatment (week 68)
Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 15% (Yes/No)
Tidsramme: At end-of-treatment (week 68)
Number of participants who achieved weight loss greater than or equal (≥) 15% (Yes/No) at end-of-treatment (week 68) is presented.
At end-of-treatment (week 68)
Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 20% (Yes/No)
Tidsramme: At end-of-treatment (week 68)
Number of participants who achieved weight loss greater than or equal (≥) 20% (Yes/No) at end-of-treatment (week 68) is presented.
At end-of-treatment (week 68)
Change in Waist Circumference
Tidsramme: Baseline (week 0), end-of-treatment (week 68)
Change in waist circumference from baseline (week 0) to end-of-treatment (week 68) is presented.
Baseline (week 0), end-of-treatment (week 68)
Change in Body Mass Index (BMI)
Tidsramme: Baseline (week 0), end-of-treatment (week 68)
Change in BMI from baseline (week 0) to end-of-treatment (week 68) is presented.
Baseline (week 0), end-of-treatment (week 68)
Change in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function
Tidsramme: Baseline (week 0), end-of-treatment (week 68)
The IWQOL-Lite-CT is a 20-item, obesity-specific patient-reported outcome (PRO) instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items), and psychosocial (13 items). A 5-item subset of the physical domain, the physical-function composite is also supported. Items in the physical-function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life.
Baseline (week 0), end-of-treatment (week 68)
Change in Short Form 36 v2.0 Acute (SF-36) Physical Functioning Domain
Tidsramme: Baseline (week 0), end-of-treatment (week 68)
Change in SF-36 v2.0 physical functioning domain from baseline (week 0) to end of treatment (week 68) is presented. The SF-36 form, assesses participants' health-related quality of life (HRQoL) on eight domains of functional health and well-being as well as two component summary scores (physical component summary and mental component summary). The scores for SF-36v2 Acute (SF-36) are norm-based scores, i.e., scores transformed to a scale where the 2009 US general population has a mean of 50 (indicates population mean) with a SD of 10. The range of possible scores for the SF-36 Physical Functioning score is 19.03-57.60. Higher scores indicate better physical functioning. A positive change score indicates an improvement since baseline.
Baseline (week 0), end-of-treatment (week 68)
Change in Systolic Blood Pressure
Tidsramme: Baseline (week 0), end-of-treatment (week 68)
Change in systolic blood pressure from baseline (week 0) to end-of-treatment (week 68) is presented.
Baseline (week 0), end-of-treatment (week 68)
Change in Diastolic Blood Pressure
Tidsramme: Baseline (week 0), end-of-treatment (week 68)
Change in diastolic blood pressure from baseline (week 0) to end-of-treatment (week 68) is presented.
Baseline (week 0), end-of-treatment (week 68)
Change in Glycosylated Haemoglobin (HbA1c)
Tidsramme: Baseline (week 0), end-of-treatment (week 68)
Change in HbA1c from baseline (week 0) to end-of-treatment (week 68) is presented.
Baseline (week 0), end-of-treatment (week 68)
Change in Fasting Plasma Glucose (FPG)
Tidsramme: Baseline (week 0), end-of-treatment (week 68)
Change in FPG from baseline (week 0) to end-of-treatment (week 68) is presented.
Baseline (week 0), end-of-treatment (week 68)
Change in Fasting Serum Insulin (Pmol/L) - Ratio to Baseline
Tidsramme: Baseline (week 0), end-of-treatment (week 68)
Change in fasting serum insulin (measured in picomoles per liter (pmol/L)) from baseline (week 0) to end-of-treatment (week 68) is presented as ratio to baseline.
Baseline (week 0), end-of-treatment (week 68)
Change in Total Cholesterol (mg/dL) - Ratio to Baseline
Tidsramme: Baseline (week 0), end-of-treatment (week 68)
Change in total cholesterol (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented.
Baseline (week 0), end-of-treatment (week 68)
Change in High Density Lipoprotein (HDL) Cholesterol (mg/dL) - Ratio to Baseline
Tidsramme: Baseline (week 0), end-of-treatment (week 68)
Change in high density lipoprotein (HDL) cholesterol (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented.
Baseline (week 0), end-of-treatment (week 68)
Change in Low Density Lipoprotein (LDL) Cholesterol (mg/dL) - Ratio to Baseline
Tidsramme: Baseline (week 0), end-of-treatment (week 68)
Change in low density lipoprotein (LDL) cholesterol (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented.
Baseline (week 0), end-of-treatment (week 68)
Change in Very Low Density Lipoprotein (VLDL) Cholesterol (mg/dL) - Ratio to Baseline
Tidsramme: Baseline (week 0), end-of-treatment (week 68)
Change in very low density lipoprotein (VLDL) cholesterol (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented.
Baseline (week 0), end-of-treatment (week 68)
Change in Triglycerides (mg/dL) - Ratio to Baseline
Tidsramme: Baseline (week 0), end-of-treatment (week 68)
Change in triglycerides (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented.
Baseline (week 0), end-of-treatment (week 68)
Change in Free Fatty Acids (mg/dL) - Ratio to Baseline
Tidsramme: Baseline (week 0), end-of-treatment (week 68)
Change in free fatty acids (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented.
Baseline (week 0), end-of-treatment (week 68)
Change in High Sensitivity C-reactive Protein (hsCRP) (mg/L) - Ratio to Baseline
Tidsramme: Baseline (week 0), end-of-treatment (week 68)
Change in high sensitivity C-reactive protein (measured in Milligrams per liter (mg/L)) from baseline (week 0) to end-of-treatment (week 68) is presented.
Baseline (week 0), end-of-treatment (week 68)
Number of Treatment Emergent Adverse Events
Tidsramme: From baseline (week 0) to end-of-study (week 75)
Number of treatment emergent adverse events from baseline (week 0) to end-of-study (week 75) is presented. An adverse event is any untoward medical occurrence in a clinical trial participant that is temporally associated with the use of an investigational medicinal product (IMP), whether or not considered related to the IMP. Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period. It is the time period in which participant was considered exposed to trial product.
From baseline (week 0) to end-of-study (week 75)
Number of Serious Adverse Events
Tidsramme: From baseline (week 0) to end-of-study (week 75)
Number of serious adverse events from baseline (week 0) to end-of-study (week 75) is presented. A serious adverse event (SAE) was defined as any event that resulted in any of the following: death, life-threatening experience, in-patient hospitalisation or prolongation of existing hospitalisation, persistent or significant disability or incapacity, congenital anomaly or birth defect or important medical event.
From baseline (week 0) to end-of-study (week 75)
Change in Body Weight - Kilogram (Kg)
Tidsramme: Baseline (week 0), end-of-treatment (week 68)
Change in body weight from baseline (week 0) to end-of-treatment (week 68) is presented.
Baseline (week 0), end-of-treatment (week 68)
Number of Participants With Body Mass Index (BMI) Greater Than or Equal (≥) 30 at Baseline and BMI Lesser Than (<) 30 at Week 68 (Yes/no)
Tidsramme: At end-of-treatment (week 68)
Number of participants who's body mass index (BMI) greater than or equal (≥) 30 at baseline and BMI lesser than (<) 30 at week 68 (yes/no) from (week 0) to end-of-treatment (week 68) is presented.
At end-of-treatment (week 68)
Change in Pulse
Tidsramme: Baseline (week 0), end-of-treatment (week 68)
Change in pulse from baseline (week 0) to end-of-study (week 68) is presented.
Baseline (week 0), end-of-treatment (week 68)
Number of Participants at Baseline and End of Treatment in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes)
Tidsramme: Baseline (week 0), end-of-treatment (week 68)
Number of participants in glycaemic categories, "normo-glycaemia, pre-diabetes and type 2 diabetes" at baseline (week 0) and end-of-treatment (week 68) are presented. These categories were set as per the following criteria: 1) Normo-glycaemia: glycated haemoglobin (HbA1c) less than (<) 5.7%; 2) Pre-diabetes: HbA1c 5.7 - 6.4% (both inclusive); 3) Type 2 diabetes: HbA1c greater than or equal to (>=) 6.5%.
Baseline (week 0), end-of-treatment (week 68)
Number of Participants With Change in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Domain (PFD) Greater Than or Equal (≥) 14.6 (Yes/No)
Tidsramme: At end-of-treatment (week 68)
The IWQOL-Lite-CT (measured as score on a scale) is a 20-item, obesity-specific PRO instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items), and psychosocial (13 items). A 5-item subset of the physical domain, the physical-function composite is also supported. Items in the physical-function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life.
At end-of-treatment (week 68)
Number of Participants With Change in Short Form 36 v2.0 Acute (SF-36) Physical Functioning Score Greater Than or Equal (≥) 3.7 (Yes/No)
Tidsramme: From baseline (week 0) to end-of-treatment (week 68)
Number of participants with change in SF-36 v2.0 physical functioning score ≥ 3.7 (yes/no) is presented. The SF-36 form, assesses participants' health-related quality of life (HRQoL) on eight domains of functional health and well-being as well as two component summary scores (physical component summary and mental component summary). A positive change score indicates an improvement since baseline. The scores for SF-36v2 Acute (SF-36) are norm-based scores, i.e., scores transformed to a scale where the 2009 US general population has a mean of 50 and an SD of 10. The range of possible scores for the SF-36 Physical Functioning score is 19.03-57.60. Higher scores indicate better physical functioning.
From baseline (week 0) to end-of-treatment (week 68)

Samarbejdspartnere og efterforskere

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

Sponsor

Novo Nordisk A/S

Efterforskere

  • Studieleder: Clinical Transparency (dept. 1452), Novo Nordisk A/S

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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)

13. september 2021

Primær færdiggørelse (Faktiske)

24. marts 2023

Studieafslutning (Faktiske)

12. maj 2023

Datoer for studieregistrering

Først indsendt

30. august 2021

Først indsendt, der opfyldte QC-kriterier

30. august 2021

Først opslået (Faktiske)

5. september 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NN9932-4737
  • U1111-1253-1670 (Anden identifikator: World Health Organization (WHO))
  • 2020-002953-11 (EudraCT nummer)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

"Ifølge Novo Nordisks offentliggørelsesforpligtelse på novonordisk-trials.com"

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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