Forskningsundersøgelse for at undersøge, hvor godt Semaglutid-tabletter indtaget én gang dagligt arbejde hos østasiatiske mennesker, der er overvægtige eller lever med fedme (OASIS 2)
13. august 2026 opdateret af: Novo Nordisk A/S
Effekt og sikkerhed af oral Semaglutid 50 mg én gang dagligt hos østasiatiske deltagere med overvægt eller fedme
Novo Nordisk laver denne undersøgelse for at se, om semaglutid-tabletter kan bruges som en behandling for at hjælpe mennesker, der lever med overvægt eller fedme, med at 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 cirka 1½ år. Deltagerne vil have 14 klinikbesøg og 7 telefonopkald med undersøgelsens sundhedsperson.
Der vil blive taget blodprøver ved 12 besøg. Kvinder kan ikke deltage, hvis de er gravide, ammer eller planlægger at blive gravide i studieperioden. Hvis deltagerne er en kvinde og er i stand til at blive gravide, vil deltagerne blive tjekket for graviditet via urinprøver.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
201
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Ibaraki, Japan, 311-0113
- Naka Kinen Clinic_Internal medicine
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Minato-ku, Tokyo, Japan, 105-8470
- Toranomon Hospital, Endocrinology and Metabolism
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Osaka, Japan, 569-1045
- Takatsuki Red Cross Hospital
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Osaka, Japan, 569-1045
- Takatsuki Red Cross Hospital_Diabetes and Endocrine Div.
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Osaka, Japan, 565-0871
- The University of Osaka Hospital_Metabolic Medicine
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Tokyo, Japan, 103-0028
- Tokyo Center Clinic
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Tokyo, Japan, 160-0008
- ToCROM Clinic_Internal Medicine
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Tokyo, Japan, 103-0028
- Tokyo Center Clinic_Internal Medicine
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Hokkaido
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Sapporo, Hokkaido, Japan, 004-0004
- Shinsapporo Seiryou Hospital_General Clinical Department
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Kanagawa
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Yamato-shi, Kanagawa, Japan, 242-0004
- Tsuruma Kaneshiro Diabetes Clinic_Internal medicine
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Osaka
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Suita-shi, Osaka, Japan, 565-0853
- OCROM Clinic_Internal medicine
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Daegu, Sydkorea, 41944
- Kyungpook National University Hospital
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Incheon, Sydkorea, 21565
- Gachon University Gil Medical Center
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Seoul, Sydkorea, 03181
- Kangbuk Samsung Hospital
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Gyeonggi-do
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Seongnam-si, Gyeonggi-do, Sydkorea, 13620
- Seoul National University Bundang Hospital
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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:
Deltagere er kun berettiget til at blive inkluderet i undersøgelsen, hvis alle følgende kriterier gælder:
- Informeret samtykke opnået før alle undersøgelsesrelaterede aktiviteter. Studierelaterede aktiviteter er alle procedurer, der udføres som en del af undersøgelsen, herunder aktiviteter for at bestemme egnethed til undersøgelsen.
- Mand eller kvinde, alder over eller lig med 18 år på tidspunktet for underskrivelse af informeret samtykke
- Body mass index (BMI) på mere end eller lig med 27,0 kg/m^2 med mere end eller lig med 2 vægtrelaterede følgesygdomme (behandlet eller ubehandlet) i henhold til JASSO-retningslinjen eller BMI større end eller lig med 35,0 kg/m^ 2 med større end eller lig med 1 vægtrelateret komorbiditet (behandlet eller ubehandlet) i henhold til JASSO-retningslinjen. Mindst én komorbiditet bør være hypertension, dyslipidæmi eller type 2-diabetes (T2D)
- Historie om mindst én selvrapporteret mislykket diætforsøg for at tabe kropsvægt
For deltagere med T2D ved screening gælder følgende inklusionskriterier ud over kriterier 1-4:
- Diagnosticeret med T2D større end eller lig med 180 dage før screening
- Behandlet med enten diæt og motion alene eller stabil behandling (samme lægemiddel(er), dosis og doseringsfrekvens) i mindst 60 dage før screeningsdagen med op til 3 orale antidiabetika (OADs) alene eller i en hvilken som helst kombination (metformin , α-glucosidase (AGI), sulfonylurinstoffer (SU), glinider, SGLT2i (natrium-glucose co-transporter 2-hæmmer) eller thiazolidindioner)
- HbA1c 7,0-10,0 % (53-86 mmol/mol) (begge inklusive) målt af centralt laboratorium ved screening
Eksklusionskriterier:
Kun deltagere uden T2D:
- HbA1c større end eller lig med 6,5 % (48 mmol/mol) målt af centrallaboratoriet ved screening
- Anamnese med type 1 eller type 2 diabetes
- Behandling med glukosesænkende midler inden for 90 dage før screening
- Nedsat nyrefunktion målt som estimeret glomerulær filtrationshastighed (eGFR) værdi af eGFR brlow 15 ml/min/1,73 m^2 ifølge Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) kreatinin-ligning som defineret af nyresygdomsforbedrende globale resultater (KDIGO) 2012-klassificering af det centrale laboratorium ved screening
Kun deltagere med T2D ved screening:
- Behandling med anden medicin til indikation af diabetes end angivet i inklusionskriterierne inden for de seneste 60 dage før screening
- Modtagelse af ethvert andet antidiabetisk forsøgslægemiddel inden for 90 dage før screening for denne undersøgelse, eller modtagelse af ethvert forsøgslægemiddel, der ikke påvirker diabetes, inden for 30 dage før screening for denne undersøgelse
- Ukontrolleret og potentielt ustabil diabetisk retinopati eller makulopati. Verificeret ved fundusundersøgelse udført af en øjenlæge eller en anden passende kvalificeret sundhedsplejerske inden for de seneste 90 dage før screening eller i perioden mellem screening og randomisering. Farmakologisk pupiludvidelse er et krav, medmindre der anvendes et digitalt fundusfotograferingskamera, der er specificeret til ikke-dilateret undersøgelse.
- Nedsat nyrefunktion målt som eGFR-værdi på under 30 ml/min/1,73 m^2 i henhold til CKD EPI kreatinin ligning som defineret af KDIGO 2012 klassificering af det centrale laboratorium ved screening
- Hos deltagere behandlet med SGLT2i blev nedsat nyrefunktion målt som eGFR-værdi på under 60 ml/min/1,73 m^2 i henhold til CKD EPI kreatinin ligning som defineret af KDIGO 2012 klassificering af det centrale laboratorium ved screening
Følgende kriterier gælder for alle deltagere:
Fedme-relateret:
- Behandling med enhver medicin indiceret til vægtkontrol inden for 90 dage før screening
- Tidligere eller planlagt (i løbet af undersøgelsesperioden) fedmebehandling med operation eller vægttabsapparat. Følgende er dog tilladt: (1) fedtsugning og/eller abdominoplastik, hvis det udføres mere end 1 år før screening, (2) lapbånd, hvis båndet er blevet fjernet mere end 1 år før screening, (3) intragastrisk ballon, hvis ballonen er blevet fjernet mere end 1 år før screening eller (4) duodenal-jejunal bypass ærme, hvis ærmet er blevet fjernet mere end 1 år før screening
- Ukontrolleret skjoldbruskkirtelsygdom efter efterforskernes skøn
- 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 |
|---|---|
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Eksperimentel: oral semaglutid 50 mg én gang dagligt
Alle deltagere får semaglutid- eller placebotabletter, 1 tablet hver morgen.
|
Deltagerne vil have semaglutid i 68 uger og vil have 1 tablet hver morgen. Dosis øges gradvist til 50 mg. |
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Placebo komparator: oral semaglutid placebo én gang dagligt
Alle deltagere får semaglutid- eller placebotabletter, 1 tablet hver morgen.
|
Deltagerne får placebotabletter i 68 uger og får 1 tablet hver morgen.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percent Change From Baseline in Body Weight
Tidsramme: Baseline (week 0), week 68
|
Percent change in body weight from baseline (week 0) to week 68 is presented.
The outcome measure was evaluated based on the data from in-trial observation period.
In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site.
|
Baseline (week 0), week 68
|
|
Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 5% (Yes/No)
Tidsramme: At week 68
|
Number of participants who achieved >=5% weight reduction at week 68 is presented.
In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 5% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 5% weight reduction.
The outcome measure was evaluated based on the data from in-trial observation period.
In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site.
|
At week 68
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 10% (Yes/No)
Tidsramme: At week 68
|
Number of participants who achieved >=10% weight reduction at week 68 is presented.
In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 10% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 10% weight reduction.
The outcome measure was evaluated based on the data from in-trial observation period.
In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site.
|
At week 68
|
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Change From Baseline in Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQOL-Lite for CT) - Physical Function Domain (5-items) Score
Tidsramme: Baseline (week 0), week 68
|
The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patient's quality of life within the context of clinical trials.
IWQOL-Lite-CT is a 20-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL).
All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning.
Results for Physical Function Domain are presented in this outcome measure.
The outcome measure was evaluated based on the data from in-trial observation period which is the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site.
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Baseline (week 0), week 68
|
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Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 15% (Yes/No)
Tidsramme: At week 68
|
Number of participants who achieved >=15% weight reduction at week 68 is presented.
In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 15% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 15% weight reduction.
The outcome measure was evaluated based on in-trial observation period.
In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
|
At week 68
|
|
Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 20% (Yes/No)
Tidsramme: At week 68
|
Number of participants who achieved >=20% weight reduction at week 68 is presented.
In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 20% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 20% weight reduction.
The outcome measure was evaluated based on in-trial observation period.
In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
|
At week 68
|
|
Change From Baseline in Body Mass Index (BMI)
Tidsramme: Baseline (week 0), week 68
|
Change in BMI from baseline (week 0) to week 68 is presented.
The outcome measure was evaluated based on the data from in-trial observation period.
In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
|
Baseline (week 0), week 68
|
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Change From Baseline in Waist Circumference Measured According to the JASSO (Japan Society for the Study of Obesity) Guideline
Tidsramme: Baseline (week 0), week 68
|
Change in waist circumference measured according to JASSO guideline from baseline (week 0) to week 68 is presented.
The outcome measure was evaluated based on the data from in-trial observation period.
In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
|
Baseline (week 0), week 68
|
|
Change From Baseline in Visceral Fat Area (VFA) Measured by CT Scan in a Subset of the Japanese Study Population (%)
Tidsramme: Baseline (week 0), week 68
|
Change in VFA measured by CT Scan in a subset of the japanese study population from baseline (week 0) to week 68 is presented in %.
The outcome measure was evaluated based on the data from in-trial observation period.
In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
|
Baseline (week 0), week 68
|
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Change From Baseline in Visceral Fat Area (VFA) Measured by CT Scan in a Subset of the Japanese Study Population (Centimeter Square [cm^2])
Tidsramme: Baseline (week 0), week 68
|
Change in VFA measured by CT Scan in a subset of the japanese study population from baseline (week 0) to week 68 is presented in cm^2.
The outcome measure was evaluated based on the data from in-trial observation period.
In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
|
Baseline (week 0), week 68
|
|
Change From Baseline in Systolic Blood Pressure
Tidsramme: Baseline (week 0), week 68
|
Change in systolic blood pressure from baseline (week 0) to week 68 is presented.
The outcome measure was evaluated based on the data from in-trial observation period.
In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
|
Baseline (week 0), week 68
|
|
Change From Baseline in Diastolic Blood Pressure
Tidsramme: Baseline (week 0), week 68
|
Change in diastolic blood pressure from baseline (week 0) to week 68 is presented.
The outcome measure was evaluated based on the data from in-trial observation period.
In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
|
Baseline (week 0), week 68
|
|
Change From Baseline in Glycosylated Haemoglobin (HbA1c)
Tidsramme: Baseline (week 0), week 68
|
Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 68 is presented.
The outcome measure was evaluated based on the data from in-trial observation period.
In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
|
Baseline (week 0), week 68
|
|
Change From Baseline in Total Cholesterol: Ratio to Baseline
Tidsramme: Baseline (week 0), week 68
|
Change in total cholesterol measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline.
The outcome measure was evaluated based on the data from in-trial observation period.
In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
|
Baseline (week 0), week 68
|
|
Change From Baseline in High-Density Lipoproteins (HDL): Ratio to Baseline
Tidsramme: Baseline (week 0), week 68
|
Change in HDL measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline.
The outcome measure was evaluated based on the data from in-trial observation period.
In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
|
Baseline (week 0), week 68
|
|
Change From Baseline in Low-Density Lipoproteins (LDL): Ratio to Baseline
Tidsramme: Baseline (week 0), week 68
|
Change in LDL measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline.
The outcome measure was evaluated based on the data from in-trial observation period.
In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
|
Baseline (week 0), week 68
|
|
Change From Baseline in Very Low-Density Lipoproteins (VLDL): Ratio to Baseline
Tidsramme: Baseline (week 0), week 68
|
Change in VLDL measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline.
The outcome measure was evaluated based on the data from in-trial observation period.
In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
|
Baseline (week 0), week 68
|
|
Change From Baseline in Triglycerides: Ratio to Baseline
Tidsramme: Baseline (week 0), week 68
|
Change in triglycerides measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline.
The outcome measure was evaluated based on the data from in-trial observation period.
In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
|
Baseline (week 0), week 68
|
|
Change From Baseline in Free Fatty Acids: Ratio to Baseline
Tidsramme: Baseline (week 0), week 68
|
Change in free fatty acids measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline.
The outcome measure was evaluated based on the data from in-trial observation period.
In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
|
Baseline (week 0), week 68
|
|
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) : Ratio to Baseline
Tidsramme: Baseline (week 0), week 68
|
Change in hsCRP measured as milligrams per liter (mg/L) from baseline (week 0) to week 68 is presented as ratio to baseline.
The outcome measure was evaluated based on the data from in-trial observation period.
In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site.
|
Baseline (week 0), week 68
|
|
Number of Treatment Emergent Adverse Events (TEAEs)
Tidsramme: Week 0 to week 75
|
An adverse event (AE) defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of an investigational medicinal product (IMP), whether or not considered related to the IMP.
All AEs mentioned are treatment emergent adverse events (TEAE) defined as an event with onset during the on-treatment observation period.
On-treatment: the date of first trial product administration (week 0) to the date of last trial product administration (week 68) excluding potential off-treatment time intervals of more than 3 consecutive days.
For the evaluation of adverse events the lag time for each on-treatment time interval is 7 weeks.
|
Week 0 to week 75
|
|
Number of Serious Adverse Events (SAEs)
Tidsramme: Week 0 to week 75
|
A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage.
SAE results occurred from week 0 to week 75 is presented based on the on-treatment observation, which was defined as the date of first trial product administration (week 0) to the date of last trial product administration (week 68) excluding potential off-treatment time intervals of more than 3 consecutive days.
For the evaluation of adverse events the lag time for each on-treatment time interval is 7 weeks.
|
Week 0 to week 75
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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.
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)
16. november 2021
Primær færdiggørelse (Faktiske)
11. juli 2023
Studieafslutning (Faktiske)
1. september 2023
Datoer for studieregistrering
Først indsendt
11. november 2021
Først indsendt, der opfyldte QC-kriterier
11. november 2021
Først opslået (Faktiske)
24. november 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NN9932-4738
- U1111-1258-7561 (Anden identifikator: World Health Organization (WHO))
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
produkt fremstillet i og eksporteret fra U.S.A.
Ja
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 .