- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07225816
Undersøkelse av hvordan varigheten av faste og midlertidig stans av GLP-1-medisiner påvirker mengden mat som er igjen i magen hos personer som bruker liraglutid (injisert), semaglutid (tatt via munnen) eller semaglutid (injisert)
20. juli 2026 oppdatert av: Novo Nordisk A/S
Undersøkelse av effekten av fastetid og midlertidig utsetting av GLP-1 RA-er på gjenværende mageinnhold hos deltakere behandlet med s.c. liraglutid, oral semaglutid eller s.c. semaglutid
Formålet med denne studien er å undersøke hvordan varigheten av faste og midlertidig stans av Glucagon-Like-Peptide 1 (GLP-1)-medisiner påvirker mengden mat som blir igjen i magen hos personer som bruker liraglutid (injisert), semaglutid (tatt via munnen) eller semaglutid (injisert).
Lengden på deltakernes deltakelse i studien vil avhenge av hvilken type GLP-1 RA-behandling deltakerne allerede bruker.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
71
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Novo Nordisk
- Telefonnummer: (+1) 866-867-7178
- E-post: clinicaltrials@novonordisk.com
Studiesteder
-
-
California
-
Cypress, California, Forente stater, 90630
- Rekruttering
- Altasciences Clinical LA, Inc.
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inklusjonskriterier:
- På vedlikeholdsbehandling med enten liraglutid 3,0 milligram (mg) i minst 5 dager, oral semaglutid 14 mg (R1-formulering) eller 9 mg (R2-formulering) i minst 5 uker eller semaglutid 2,4 mg i minst 5 uker før screening.
Eksklusjonskriterier:
- Tidligere dosering i denne studien.
- Tidligere ny screening for denne studien.
- Kvinne som er gravid, ammer eller har til hensikt å bli gravid, eller er i fruktbar alder og ikke bruker tilstrekkelig prevensjonsmetode.
- Nåværende deltakelse (dvs. signert informert samtykke) i en hvilken som helst annen intervensjonell klinisk studie.
- Eksponering for undersøkelsesmedisiner, unntatt vedlikeholdsbehandling med liraglutid 3,0 mg, oral semaglutid 9 eller 14 mg, eller semaglutid 2,4 mg som kreves av inklusjonskriteriet, innen 30 dager eller 5 halveringstider for undersøkelsesmedisinen (hvis kjent), avhengig av hva som er lengst, før screening (Besøk 1).
- Enhver tilstand som etter forskerens vurdering kan true deltakerens sikkerhet eller overholdelse av protokollen.
- Forventet endring i livsstil (f.eks. spise-, trenings- eller søvnmønster) under studien.
- Deltakeren er forskeren eller annet studiestedspersonale eller deres pårørende som er direkte involvert i gjennomføringen av studien.
- Mental inhabilitet, språkbarrierer eller uvillighet til å følge protokollens krav, som kan hindre tilstrekkelig forståelse eller samarbeid under studien etter forskerens skjønn.
- Tilstedeværelse av klinisk signifikante gastrointestinale lidelser eller symptomer på gastrointestinale lidelser som potensielt kan påvirke absorpsjon av legemidler eller næringsstoffer, eller etter forskerens vurdering.
- Historie med store kirurgiske inngrep som involverer spiserøret eller magen som potensielt kan påvirke absorpsjon av prøveprodukter (f.eks. delvis og total gastrektomi, sleeve-gastrektomi, gastric bypass-kirurgi) eller nåværende tilstedeværelse av gastrointestinalt implantat*.
- Nyrerfunksjonssvikt med estimert glomerulær filtreringsrate (eGFR) mindre enn (<) 30 milliliter per min per 1,73 kvadratmeter (ml/min/1,73 m^2) ved screening basert på Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) kreatininligning i henhold til Kidney Disease Improving Global Outcomes (KDIGO) 20246.
- Nåværende behandling med insulin eller sekretagoger som kan forårsake hypoglykemi under fasteperioder.
- Historie med ketoacidose.
- Diagnostisert med eller mistenkt for å lide av gastroparese, hiatushernie eller alvorlig gastroøsofageal reflukssykdom med daglige symptomer og/eller i liggende stilling.
- Bruk av andre medikamenter kjent for å påvirke mage-tarmkanalens motilitet.
- Inne evne til å ligge i høyre laterale decubitus-stilling for gastrisk ultralyd.
Uvanlige spisevaner og spesielle diettkrav eller uvillighet til å spise måltidene som tilbys i studien.
- Som oppgitt av deltakeren eller rapportert i pasientjournalen.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Liraglutid
Deltakerne vil motta liraglutid subkutant.
|
Deltakerne vil få liraglutid subkutant.
|
|
Eksperimentell: Oralt semaglutid
Deltakerne vil motta semaglutid oralt.
|
Deltakerne vil motta semaglutid oralt.
|
|
Eksperimentell: Semaglutid
Deltakerne vil motta semaglutid subkutant.
|
Deltakerne vil få semaglutid subkutant.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal after dosing of subcutaneous (s.c.) liraglutide once daily (Yes/No)
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 40
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 40
|
|
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal after dosing of oral semaglutide once daily (Yes/No)
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 161
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 161
|
|
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal after dosing of s.c. semaglutide once weekly (Yes/No)
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 141
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 141
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Gastric volume after fasting following a solid, high-fat meal after dosing of s.c. liraglutide once daily
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 40
|
Measured as milliliters per kilogram (mL/kg).
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 40
|
|
Gastric volume after fasting following a solid, high-fat meal after dosing of oral semaglutide once daily
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 161
|
Measured as mL/kg.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 161
|
|
Gastric volume after fasting following a solid, high-fat meal after dosing of s.c. semaglutide once weekly
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 141
|
Measured as mL/kg.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 141
|
|
Presence of solids in the stomach (antrum grade 'solid') after fasting following a solid, high-fat meal after dosing of s.c. liraglutide once daily (Yes/No)
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 40
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 40
|
|
Presence of solids in the stomach (antrum grade 'solid') after fasting following a solid, high-fat meal after dosing of oral semaglutide once daily (Yes/No)
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 161
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 161
|
|
Presence of solids in the stomach (antrum grade 'solid') after fasting following a solid, high-fat meal after dosing of s.c. semaglutide once weekly (Yes/No)
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 141
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 141
|
|
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a liquid meal after dosing of s.c. liraglutide once daily (Yes/No)
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 44
|
Measured as count of participants
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 44
|
|
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a liquid meal after dosing of oral semaglutide once daily (Yes/No)
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 165
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 165
|
|
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a liquid meal after dosing of s.c. semaglutide once weekly (Yes/No)
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 8, Day 148
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 8, Day 148
|
|
Gastric volume after fasting following liquid meal after dosing of s.c. liraglutide once daily
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 44
|
Measured as mL/kg
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 44
|
|
Gastric volume after fasting following liquid meal after dosing of oral semaglutide once daily
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 165
|
Measured as mL/kg
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 165
|
|
Gastric volume after fasting following a liquid meal after dosing of s.c. semaglutide once weekly
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 8, Day 148
|
Measured as mL/kg
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 8, Day 148
|
|
Presence of solids in the stomach (antrum grade 'solid') after fasting following a liquid meal after dosing of s.c. liraglutide once daily (Yes/No)
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 44
|
Measured as count of participants
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 44
|
|
Presence of solids in the stomach (antrum grade 'solid') after fasting following a liquid meal after dosing of oral semaglutide once daily (Yes/No)
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 165
|
Measured as count of participants
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 11, Day 165
|
|
Presence of solids in the stomach (antrum grade 'solid') after fasting following a liquid meal after dosing of s.c. semaglutide once weekly (Yes/No)
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 8, Day 148
|
Measured as count of participants
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 8, Day 148
|
|
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal 1 day after dosing of s.c. liraglutide once daily (Yes/No)
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 48
|
Measured as count of participants
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 48
|
|
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal 7 days after dosing of oral semaglutide once daily (Yes/No)
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 12, Day 171
|
Measured as count of participants
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 12, Day 171
|
|
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal 14 days after dosing of oral semaglutide once daily (Yes/No)
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 13, Day 178
|
Measured as count of participants
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 13, Day 178
|
|
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal 7 days after dosing of s.c. semaglutide once weekly (Yes/No)
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 9, Day 153
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 9, Day 153
|
|
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal 14 days after dosing of s.c. semaglutide once weekly (Yes/No)
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 10, Day 160
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 10, Day 160
|
|
Gastric volume after fasting following a solid, high-fat meal 1 day after dosing of s.c. liraglutide once daily
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 48
|
Measured as mL/kg
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 48
|
|
Gastric volume after fasting following a solid, high-fat meal 7 days after dosing of oral semaglutide once daily
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 12, Day 171
|
Measured as mL/kg
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 12, Day 171
|
|
Gastric volume after fasting following a solid, high-fat meal 14 days after dosing of oral semaglutide once daily
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 13, Day 178
|
Measured as mL/kg
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 13, Day 178
|
|
Gastric volume after fasting following a solid, high-fat meal 7 days after dosing of s.c. semaglutide once weekly
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 9, Day 153
|
Measured as mL/kg
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 9, Day 153
|
|
Gastric volume after fasting following a solid, high-fat meal 14 days after dosing of s.c. semaglutide once weekly
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 10, Day 160
|
Measured as mL/kg
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 10, Day 160
|
|
Presence of solids in the stomach (antrum grade 'solid') after fasting following a solid, high-fat meal 1 day after dosing of s.c. liraglutide once daily (Yes/No)
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 48
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 7, Day 48
|
|
Presence of solids in the stomach (antrum grade 'solid') after fasting following a solid, high-fat meal 7 days after dosing of oral semaglutide once daily (Yes/No)
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 12, Day 171
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 12, Day 171
|
|
Presence of solids in the stomach (antrum grade 'solid') after fasting following a solid, high-fat meal 14 days after dosing of oral semaglutide once daily (Yes/No)
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 13, Day 178
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 13, Day 178
|
|
Presence of solids in the stomach (antrum grade 'solid') after fasting following a solid, high-fat meal 7 days after dosing of s.c. semaglutide once weekly (Yes/No)
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 9, Day 153
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 9, Day 153
|
|
Presence of solids in the stomach (antrum grade 'solid') after fasting following a solid, high-fat meal 14 days after dosing of s.c. semaglutide 2.4 mg once weekly (Yes/No)
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 10, Day 160
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 10, Day 160
|
|
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a solid, high-fat meal (Yes/No)
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 1
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 1
|
|
Gastric volume after fasting following a solid, high-fat meal
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 1
|
Measured as mL/kg.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 1
|
|
Presence of solids in the stomach (antrum grade 'solid') after fasting following a solid, high-fat meal (Yes/No)
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 1
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 1
|
|
Occurrence of empty stomach (antrum grade 0 or 1) after fasting following a liquid meal (Yes/No)
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 5
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 5
|
|
Gastric volume after fasting following a liquid meal
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 5
|
Measured as mL/kg
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 5
|
|
Presence of solids in the stomach (antrum grade 'solid') after fasting following a liquid meal (Yes/No)
Tidsramme: 6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 5
|
Measured as count of participants.
|
6, 8, 10, 12, 18 and 24 hours after start of fasting on Visit 2, Day 5
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
7. november 2025
Primær fullføring (Antatt)
13. desember 2026
Studiet fullført (Antatt)
6. januar 2027
Datoer for studieregistrering
Først innsendt
5. november 2025
Først innsendt som oppfylte QC-kriteriene
5. november 2025
Først lagt ut (Faktiske)
10. november 2025
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Ernæringsforstyrrelser
- Overernæring
- Kroppsvekt
- Overvektig
- Patologiske tilstander, tegn og symptomer
- Ernæringsmessige og metabolske sykdommer
- Tegn og symptomer
- Overvekt
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Gastrointestinale hormoner
- Glukagonlignende peptider
- Proglucagon
- Glukagonlignende peptid 1
- Liraglutid
- semaglutid
Andre studie-ID-numre
- NN9536-8438
- U1111-1323-7355 (Annen identifikator: World Health Organization (WHO))
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
I henhold til Novo Nordisks offentliggjøringsforpliktelse på novonordisk-trials.com.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .