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A Study to See How Safe a New Medicine (NNC6022-0004) is in Healthy People and People Living With Obesity

3. juli 2026 opdateret af: Novo Nordisk A/S

An NNC6022-0004 Single and Multiple Ascending Dose Study Investigating Safety, Tolerability, Pharmacokinetics, Food Effect and Target Engagement in Healthy Adults Including a Single Cohort in Adults Living With Obesity

This study is being done to look at the efficacy single and multiple ascending dose study investigating safety, tolerability, pharmacokinetics, food effect and target engagement in healthy adults including a single cohort in adults living with obesity. Participants will either get NNC6022-0004, (the treatment being tested) or Placebo (a treatment that has no active medicine in it) and which treatment participants get is decided by chance.

Studieoversigt

Status

Ikke rekrutterer endnu

Detaljeret beskrivelse

The study consists of 5 Parts (Parts A to E and the participants will be assessed based on the study intervention received (NNC6022-0004 or Placebo).

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

128

Fase

  • Fase 1

Kontakter og lokationer

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

Studiekontakt

Studiesteder

      • Groningen, Holland, 9728 NZ
        • ICON - location Groningen

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

Ja

Beskrivelse

Inclusion Criteria:

  • Male, or female of non-childbearing potential.
  • For Parts A, B, C and D: Age 18-55 years (both inclusive) at the time of signing the informed consent.

For optional Part E only: Age 18-65 years (both inclusive) at the time of signing the informed consent.

-For Parts A, B, C and D: Body mass index (BMI) between 18.5 to 29.9 kilogram per meter square (kg/m^2) (both inclusive) at screening.

For optional Part E only: BMI between greater than or equal to (≥) 30.0 to less than or equal to (≤) 45.0 kg/m^2 at screening, or if BMI is between 27.0 and <30.0 kg/m^2, waist to height ratio should be greater than (>)0.5.

  • Body weight: ≥50.0 kilogram (kg) at screening.
  • Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
  • For optional Part E only: hsCRP ≥2.00 and ≤8.00 milligrams per liter (mg/L) during screening period in 2 separate samples taken ≥4 days apart.

Exclusion Criteria:

  • Known or suspected hypersensitivity to study intervention(s) or similar products.
  • Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
  • Any of the below laboratory safety parameters at screening outside normal range, see designated reference range documents for specific values.
  • Alanine Aminotransferase (ALT) > Upper limit of normal (ULN).
  • Alkaline Phosphatase (ALP) > ULN.
  • Aspartate aminotransferase (AST) > ULN.
  • Total Bilirubin (TBL) > ULN.
  • Creatinine > ULN.
  • International normalized ratio (INR) > ULN.
  • Fibrinogen outside normal range of 1.6 - 4.2 grams per liter (g/L).
  • hsCRP > 5.00 mg/L (males) and > 8.00 mg/L (females)*.

    • applicable for Parts A, B, C and D and for optional Part E: hsCRP >8.00 mg/L.
  • Use of prescription medicinal products or vaccines within 14 days before screening and/or non prescription medicinal products within 7 days before dosing. Exceptions are: Topical medications not reaching systemic circulation; less than once per week of over-the-counter paracetamol, ibuprofen and/or acetylsalicylic acid at their labelled doses for mild pain; vitamins at their labelled doses.

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: NNC6022-0004
Participants will receive NNC6022-0004 administered orally as a single ascending dose (SAD), multiple ascending dose (MAD), or under fed/fasted conditions.
Participants will receive single dose of NNC6022-0004 administered orally in capsule form.
Placebo komparator: Placebo
Participants will receive placebo matched to NNC6022-0004 administered orally as a SAD, MAD, or under fed/fasted conditions.
Participants will receive placebo matched to NNC6022-0004 administered orally in capsule form.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Part A: Area under the NNC6022-0001 plasma concentration-time curve from time 0 to last measurable plasma concentration (AUC0-tz) after a single dose
Tidsramme: From pre-dose (Day 1) until visit 3 (Day 9)
Measured as micromolar per hour (µM*h).
From pre-dose (Day 1) until visit 3 (Day 9)
Part A: Maximum observed plasma concentration (Cmax) of NNC6022-0001 after a single dose
Tidsramme: From pre-dose (Day 1) until visit 3 (Day 9)
Measured as micromolar (µM).
From pre-dose (Day 1) until visit 3 (Day 9)
Part B: Number of treatment emergent adverse events (TEAE)
Tidsramme: From time of dosing (Day 1) to end of study visit (Day 14)
Measured as number of events.
From time of dosing (Day 1) to end of study visit (Day 14)
Part C: Number of treatment emergent adverse events
Tidsramme: From time of dosing (Day 1) to end of study visit (Day 41)
Measured as number of events.
From time of dosing (Day 1) to end of study visit (Day 41)
Part D: Area under the NNC6022-0001 plasma concentration-time curve from time 0 to last measurable plasma concentration (AUC0-tz) after a single dose
Tidsramme: From pre-dose (Day 1 or Day 8) to end of visit (Day 5 or Day 12)
Measured as µM*h.
From pre-dose (Day 1 or Day 8) to end of visit (Day 5 or Day 12)
Part E: Number of treatment emergent adverse events
Tidsramme: From time of dosing (Day 1) to end of study visit (Day 13)
Measured as number of events.
From time of dosing (Day 1) to end of study visit (Day 13)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Part A: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to infinity (AUC0-∞) after a single dose
Tidsramme: From pre-dose (Day 1) until visit 3 (Day 9)
Measured as µM*h.
From pre-dose (Day 1) until visit 3 (Day 9)
Part A: Number of treatment emergent adverse events
Tidsramme: From time of dosing (Day 1) to end of study visit (Day 9)
Measured as number of events.
From time of dosing (Day 1) to end of study visit (Day 9)
Part B: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to last measurable plasma concentration (AUC0-tz) after a single dose
Tidsramme: From pre-dose (Day 1) until visit 3 (Day 9)
Measured as µM*h.
From pre-dose (Day 1) until visit 3 (Day 9)
Part B: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to infinity (AUC0-∞) after a single dose
Tidsramme: From pre-dose (Day 1) until visit 3 (Day 9)
Measured as µM*h.
From pre-dose (Day 1) until visit 3 (Day 9)
Part B: The maximum observed plasma concentration (Cmax) of NNC6022-0001 after a single dose
Tidsramme: From pre-dose (Day 1) until visit 3 (Day 9)
Measured as µM.
From pre-dose (Day 1) until visit 3 (Day 9)
Part B: Proportion of administered dose recovered as unchanged drug in urine (Fe0-72h), calculated as Ae0-72hour/ dose
Tidsramme: From dose (Day 1) until 72h post-dose
Measured as proportion of dose.
From dose (Day 1) until 72h post-dose
Part C: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to tau (AUCtau) after the last dose
Tidsramme: From pre-dose (Day 28) to tau after last dose (Day 29)
Measured as µM*h.
From pre-dose (Day 28) to tau after last dose (Day 29)
Part C: The maximum observed plasma concentration (Cmax) of NNC6022-0001 after last dose
Tidsramme: From pre-dose (Day 28) until visit 3 (Day 35)
Measured as µM.
From pre-dose (Day 28) until visit 3 (Day 35)
Part C: interleukin β (IL-1β) (ex vivo): ratio of plasma level at time tau after last dose to baseline
Tidsramme: From pre-dose (Day 1) to tau after last dose (Day 29)
Measured as ratio
From pre-dose (Day 1) to tau after last dose (Day 29)
Part D: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to infinity (AUC0-∞) after a single dose
Tidsramme: From pre-dose (Day 1 or Day 8) to end of visit (Day 5 or Day 12)
Measured as µM*h.
From pre-dose (Day 1 or Day 8) to end of visit (Day 5 or Day 12)
Part D: The maximum observed plasma concentration (Cmax) of NNC6022-0001 after a single dose
Tidsramme: From pre-dose (Day 1 or Day 8) to end of visit (Day 5 or Day 12)
Measured as µM.
From pre-dose (Day 1 or Day 8) to end of visit (Day 5 or Day 12)
Part D: Number of treatment emergent adverse events
Tidsramme: From time of dosing (Day 1) to end of visit (Day 16)
Measured as number of events.
From time of dosing (Day 1) to end of visit (Day 16)
Part E: Ratio of plasma level at time tau after last dose to baseline (hsCRP)
Tidsramme: From pre-dose (Day 1) to tau after last dose (Day 8)
Measured as ratio.
From pre-dose (Day 1) to tau after last dose (Day 8)
Part E: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to tau (AUCtau) after last dose
Tidsramme: From pre-dose (Day 7) to tau after last dose (Day 8)
Measured as µM*h .
From pre-dose (Day 7) to tau after last dose (Day 8)
Part E: The maximum observed plasma concentration (Cmax) of NNC6022 0001 after last dose
Tidsramme: From pre-dose (Day 7) until visit 3 (Day 13)
Measured as µM.
From pre-dose (Day 7) until visit 3 (Day 13)

Samarbejdspartnere og efterforskere

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

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 (Anslået)

6. juli 2026

Primær færdiggørelse (Anslået)

1. august 2027

Studieafslutning (Anslået)

1. august 2027

Datoer for studieregistrering

Først indsendt

3. juli 2026

Først indsendt, der opfyldte QC-kriterier

3. juli 2026

Først opslået (Faktiske)

9. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • NN6022-8271
  • U1111-1333-6460 (Anden identifikator: World Health Organization (WHO))
  • 2026-525179-26 (Anden identifikator: EU CT Number)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

According to the Novo Nordisk disclosure commitment on novonordisktrials.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 .

Kliniske forsøg med NNC6022-0004

3
Abonner