Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

En forskningsundersøgelse for at se, hvor godt Semaglutid hjælper mennesker, der har en kropsvægt over det sunde vægtområde (STEP12)

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

Effekt og sikkerhed af Semaglutid 2,4 mg en gang om ugen hos voksne med overvægt og fedme

Denne undersøgelse vil se på, hvordan undersøgelsesdosis af semaglutid virker ved at hjælpe mennesker med overskydende kropsvægt til at tabe sig. Denne undersøgelse vil sammenligne vægttabet hos personer, der tager semaglutid, med personer, der tager "dummy" medicin (placebo). Studiet vil vare i omkring 1 år. Deltagerne vil have 12 besøg på klinikken og 3 fjernbesøg ved telefonopkald med undersøgelsens læge eller personale.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

242

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100730
        • Beijing Hospital
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Kina, 404000
        • Chongqing University Three Gorges Hospital
    • Fujian
      • Fuzhou, Fujian, Kina, 350001
        • Fujian Medical University Union Hospital-Endocrinology
    • Guangdong
      • Huizhou, Guangdong, Kina, 516001
        • Huizhou Central People's Hospital-Endocrinology
    • Hebei
      • Hengshui, Hebei, Kina, 053000
        • Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology
    • Hubei
      • Shiyan, Hubei, Kina, 442008
        • Shiyan Taihe Hospital (Affiliated Hospital of Hubei University of Medicine)-Endocrinology
    • Jiangsu
      • Changzhou, Jiangsu, Kina, 213003
        • Changzhou No.2 People's Hospital, Yanghu Branch
      • Nanjing, Jiangsu, Kina, 210011
        • The Second Affiliated Hospital of Nanjing Medical University_Nanjing
      • Nanjing, Jiangsu, Kina, 210011
        • The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
      • Zhenjiang, Jiangsu, Kina, 212001
        • The Affiliated Hospital of Jiangsu University-Endocrinology
    • Jilin
      • Changchun, Jilin, Kina, 130061
        • The First Bethune hospital of Jilin University-Endocrinology
    • Qinghai
      • Xining, Qinghai, Kina, 810007
        • Qinghai Provincial People's Hospital
    • Shandong
      • Jinan, Shandong, Kina, 250013
        • Jinan Central Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 201200
        • Shanghai Pudong New Area People's Hospital-Endocrinology
      • Shanghai, Shanghai Municipality, Kina, 200240
        • Shanghai Fifth People's Hospital-Endocrinology
      • Shanghai, Shanghai Municipality, Kina, 200336
        • Tongren Hospital Shanghai Jiao Tong University School of Medicine
  • Taiwan
      • Chiayi City, Taiwan, 600
        • Ditmanson Medical Foundation Chia-Yi Christian Hospital
      • Taichung, Taiwan, 404
        • China Medical University Hospital
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 110
        • Taipei Medical University Hospital
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital_main

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Alder over eller lig med 18 år på tidspunktet for underskrivelse af informeret samtykke.
  • Body mass index (BMI) på mere end eller lig med 24 og mindre end 28 kilogram pr. kvadratmeter (kg/m^2) med tilstedeværelsen af ​​mindst én vægtrelateret komplikation (behandlet eller ubehandlet): Type 2 diabetes (T2D) , hypertension, dyslipidæmi, obstruktiv søvnapnø eller kardiovaskulær sygdom eller BMI større end eller lig med 28 og større end 30 kg/m^2, med eller uden vægtrelaterede komplikationer ved screening.
  • Historie om mindst én selvrapporteret mislykket diætforsøg for at tabe kropsvægt.

For deltagere med T2D ved screening:

- Diagnosticeret med T2D større end eller lig med 180 dage før screeningsdagen

Behandlet med enten:

  • Kost og motion alene eller med 1-3 markedsførte orale antidiabetika (metformin, alfa-glucosidase, sulfonylurinstoffer (SU), glinider, natrium-glucose co-transporter 2-hæmmere (SGLT2i) eller glitazon som enkeltstof eller i kombination) i henhold til lokale etiket.
  • Behandling med orale antidiabetiske lægemidler bør være stabil (samme lægemiddel(er) eller aktive ingrediens, dosis og doseringsfrekvens) i mindst 60 dage før screening
  • Glyceret hæmoglobin (HbA1c) på mindre end eller lig med 10,0 procent (mindre end eller lig med 86 millimol pr. mol [mmol/mol]) målt af det centrale laboratorium ved screening.

Ekskluderingskriterier:

  • En selvrapporteret ændring i kropsvægt på mere end 5 kg (kg) inden for 90 dage før screening, uanset lægejournaler.
  • Behandling med enhver form for medicin til indikation af fedme inden for de seneste 90 dage før screening.
  • Personlig eller førstegradsslægtning(e) historie med multipel endokrin neoplasi type 2 eller medullært thyreoideacarcinom.

For deltagere uden T2D ved screening:

- HbA1c større end eller lig med 6,5 procent (48 mmol/mol) målt af laboratoriet.

For deltagere med T2D ved screening:

  • Nedsat nyrefunktion med estimeret glomerulær filtrationshastighed (eGFR) værdi på mindre end 30 milliliter pr. minut pr. 1,73 kvadratmeter (mL/min/1,73) m^2) i henhold til Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) kreatinin-ligning som defineret af Kidney Disease Improving Global Outcomes (KDIGO) 2012 klassificering af det centrale laboratorium ved screening.
  • Ukontrolleret og potentielt ustabil diabetisk retinopati eller makulopati. Verificeret ved fundusundersøgelse udført 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.

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: Semaglutid 2,4 milligram (mg)
Deltagerne vil modtage en gang ugentlig subkutan (s.c) injektion af semaglutid i 44 uger.
Medicin: Semaglutid
Subkutane injektioner af semaglutid én gang ugentligt med eskalerende doser hver fjerde uge, indtil vedligeholdelsesdosis på 2,4 mg semaglutid er nået.
Placebo komparator: Placebo
Deltagerne vil modtage en gang ugentlig subkutan (s.c) injektion af placebo i 44 uger.
Medicin: Placebo
Subkutane injektioner af placebo én gang ugentligt ved eskalerende doser som semaglutid hver fjerde uge, indtil vedligeholdelsesdosis af placebo matchet til 2,4 mg er nået.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Body Weight (%)
Tidsramme: Baseline (week 0), end of treatment (week 44)
Percentage change in body weight from baseline (week 0) to end of treatment (week 44) is presented.
Baseline (week 0), end of treatment (week 44)
Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal to (≥) 5% (Yes/No)
Tidsramme: At end of treatment (week 44)
Number of participants who achieved ≥5% body weight reduction at the end of treatment (week 44) 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.
At end of treatment (week 44)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants Who Achieved Body Weight Reduction ≥ 10% (Yes/No)
Tidsramme: At end of treatment (week 44)
Number of participants who achieved ≥10% body weight reduction at the end of treatment (week 44) 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.
At end of treatment (week 44)
Change in Waist Circumference
Tidsramme: Baseline (week 0), end of treatment (week 44)
Change in waist circumference from baseline (week 0) to end of treatment (week 44) is presented.
Baseline (week 0), end of treatment (week 44)
Change in Body Weight (kg)
Tidsramme: Baseline (week 0), end of treatment (week 44)
Change in body weight in kilogram (kg) from baseline (week 0) to end of treatment (week 44) is presented.
Baseline (week 0), end of treatment (week 44)
Change in Body Mass Index
Tidsramme: Baseline (week 0), end of treatment (week 44)
Change in body mass index from baseline (week 0) to end of treatment (week 44) is presented.
Baseline (week 0), end of treatment (week 44)
Change in Waist-height Ratio (WtHR)
Tidsramme: Baseline (week 0), end of treatment (week 44)
Change in waist-height ratio (WtHR) from baseline (week 0) to end of treatment (week 44) is presented.
Baseline (week 0), end of treatment (week 44)
Change in Systolic Blood Pressure
Tidsramme: Baseline (week 0), end of treatment (week 44)
Change in systolic blood pressure from baseline (week 0) to end of treatment (week 44) is presented.
Baseline (week 0), end of treatment (week 44)
Change in Diastolic Blood Pressure
Tidsramme: Baseline (week 0), end of treatment (week 44)
Change in diastolic blood pressure from baseline (week 0) to end of treatment (week 44) is presented
Baseline (week 0), end of treatment (week 44)
Change in Total Cholesterol (mmol/L) - Ratio to Baseline
Tidsramme: Baseline (week 0), end of treatment (week 44)
Change in total cholesterol measured in millimoles per liter (mmol/L) from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.
Baseline (week 0), end of treatment (week 44)
Change in High Density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline
Tidsramme: Baseline (week 0), end of treatment (week 44)
Change in high density lipoprotein (HDL) cholesterol measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.
Baseline (week 0), end of treatment (week 44)
Change in Low Density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline
Tidsramme: Baseline (week 0), end of treatment (week 44)
Change in low density lipoprotein (LDL) cholesterol measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.
Baseline (week 0), end of treatment (week 44)
Change in Very Low-Density Lipoproteins (VLDL) Cholesterol (mmol/L) - Ratio to Baseline
Tidsramme: Baseline (week 0), end of treatment (week 44)
Change in VLDL cholesterol measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.
Baseline (week 0), end of treatment (week 44)
Change in Triglycerides (mmol/L) - Ratio to Baseline
Tidsramme: Baseline (week 0), end of treatment (week 44)
Change in triglycerides measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.
Baseline (week 0), end of treatment (week 44)
Change in Free Fatty Acids (mmol/L) - Ratio to Baseline
Tidsramme: Baseline (week 0), end of treatment (week 44)
Change in free fatty acids measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.
Baseline (week 0), end of treatment (week 44)
Change in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline
Tidsramme: Baseline (week 0), end of treatment (week 44)
Change in high sensitivity C-Reactive Protein (hsCRP) measured in milligram per litre (mg/L) from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.
Baseline (week 0), end of treatment (week 44)
Change in HbA1c (%)
Tidsramme: Baseline (week 0), end of treatment (week 44)
Change in glycosylated haemoglobin (HbA1c) in percentage from baseline (week 0) to end of treatment (week 44) is presented.
Baseline (week 0), end of treatment (week 44)
Change in HbA1c (mmol/Mol)
Tidsramme: Baseline (week 0), end of treatment (week 44)
Change in HbA1c measured in millimoles per mole (mmol/mol) from baseline (week 0) to end of treatment (week 44) is presented.
Baseline (week 0), end of treatment (week 44)
Change in Fasting Plasma Glucose (mg/dL)
Tidsramme: Baseline (week 0), end of treatment (week 44)
Change in fasting plasma glucose (FPG) measured in milligrams per deciliter (mg/dL) from baseline (week 0) to end of treatment (week 44) is presented.
Baseline (week 0), end of treatment (week 44)
Change in Fasting Plasma Glucose (mmol/L)
Tidsramme: Baseline (week 0), end of treatment (week 44)
Change in FPG measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented.
Baseline (week 0), end of treatment (week 44)
Number of Treatment Emergent Adverse Events (TEAEs)
Tidsramme: From baseline (week 0) to end of study (week 49)
Number of TEAEs from baseline (week 0) to end of study (week 49) 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.
From baseline (week 0) to end of study (week 49)
Number of Serious Adverse Events (SAEs)
Tidsramme: From baseline (week 0) to end of study (week 49)
Number of SAEs from baseline (week 0) to end of study (week 49) is presented. A serious adverse event (SAE) is any untoward medical occurrence that fulfils at least one of following criteria: results in death; is life-threatening; requires inpatient or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is congenital anomaly/birth defect; important medical event.
From baseline (week 0) to end of study (week 49)
Change in Pulse
Tidsramme: Baseline (week 0), end of treatment (week 44)
Change in pulse from baseline (week 0) to end of treatment (week 44) is presented.
Baseline (week 0), end of treatment (week 44)
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) Less Than (<) 3.0 mmol/L Confirmed by Blood Glucose (BG) Meter - Participants With Type 2 Diabetes (T2D)
Tidsramme: From baseline (week 0) to end of study (week 49)
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L) confirmed by BG meter for participants with T2D from baseline (week 0) to end of study (week 49) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than 3.0 mmol/L (54 mg/dL) confirmed by BG meter.
From baseline (week 0) to end of study (week 49)

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. 2834), Novo Nordisk A/S

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)

15. september 2023

Primær færdiggørelse (Faktiske)

2. april 2025

Studieafslutning (Faktiske)

7. maj 2025

Datoer for studieregistrering

Først indsendt

11. september 2023

Først indsendt, der opfyldte QC-kriterier

11. september 2023

Først opslået (Faktiske)

18. september 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NN9536-4706
  • U1111-1273-4538 (Anden identifikator: World Health Organization (WHO))

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Ifølge Novo Nordisks oplysningsforpligtelse på novonordisktrials.com

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

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 .

Kliniske forsøg med Semaglutid

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Djibouti

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner