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A Research Study to Check the Safety of NNC9836-0001 When Given to Healthy Participants and Participants With Type 2 Diabetes

5 november 2026 bijgewerkt door: Novo Nordisk A/S

A Phase 1 Randomised, Double-blinded, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of NNC9836-0001 Administered to Healthy Participants and Participants With Type 2 Diabetes

The purpose of this clinical study is to determine if the study medicine NNC9836-0001 is safe and tolerable in healthy participants with overweight or obesity or who have type 2 diabetes (T2D). Participants will either get the study medicine NNC9836-0001 or placebo. Which treatment participants get is decided by chance. NNC9836-0001 is a new medicine aimed to treat type 2 diabetes.

Studie Overzicht

Studietype

Ingrijpend

Inschrijving (Geschat)

121

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

      • Neuss, Duitsland, 41460
        • Werving
        • Profil Institut für Stoffwechselforschung GmbH

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

25 jaar tot 69 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

All participants:

  • Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
  • Male or female (sex assigned at birth, inclusive of all gender identities).

Metabolically healthy participants with overweight or mild obesity:

  • Age 25 to 59 years (both inclusive) at the time of signing the informed consent.
  • Body Mass Index (BMI) 25 to 34.9 kilogram per square meter (kg/m^2) (both inclusive) at screening.
  • Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG), and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Participants with type 2 diabetes:

  • Age at the time of signing the informed consent: Age 25 to 69 years (both inclusive)
  • BMI at screening: BMI 27 to 39.9 kg/m^2 (both inclusive)
  • Diagnosed with T2D greater than equal to (≥) 180 days before screening.
  • Concomitant medications before screening: Stable (as judged by the investigator) with daily dose(s) on monotherapy (metformin, sodium-glucose cotransporter 2 inhibitors (SGLT2i), or dipeptidyl peptidase-4 inhibitor (DPP4i) or dual therapy (metformin + SGLT2i or metformin + DPP4i)) ≥90 days before screening. or; Stable weight and stable doses of glucagon-like peptide-1 receptor agonists (GLP-1 RA) with no further titration (as judged by the investigator). GLP-1 RA ≥180 days before screening combined with daily dose(s) of either metformin or SGLT2i or dual therapy (metformin + SGLT2i)) ≥90 days before screening.
  • Background pharmacotherapy for all MAD cohort T2D participants should be on stable therapy for ≥90 days before screening with no initiation, discontinuation, or dose changes.
  • Considered to be generally healthy as judged by the investigator except for T2D-associated mild conditions under stable treatment.

Exclusion Criteria:

All participants:

  • Known or suspected hypersensitivity to study intervention(s) or related products.
  • Previous dose administration in this study.
  • Participation (i.e., signed informed consent and dosed with Investigational medicinal product (IMP)) in any other interventional clinical study within 30 days or 5 times the half-life of the drug, whichever is longest, before screening.
  • Any disorder, which in the investigator's opinion might jeopardise participants safety or compliance with the protocol.
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
  • Minimal to mild hepatic impairment, defined as alanine aminotransferase (ALT) values greater than (>)1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) values >1.5 × ULN, or total bilirubin >ULN + 20 percent (%) (except in case of Gilbert's disease, as reported by participant or in medical records) at screening.

Metabolically healthy participants with overweight or mild obesity:

  • Supine blood pressure outside the range of 90-139 millimetres of mercury (mmHg) for systolic or 50-89 mmHg for diastolic at screening. To consider re-assessment of vital signs in case white-coat hypertension is known or suspected.
  • Heart rate outside the range of 45-89 beats per minute (bpm) at screening.
  • Unwilling or unable to refrain from use of nonprescription products within 14 days prior to start of run-in, including herbal products and nonroutine vitamins (as judged by the investigator), except the occasional use of over the counter (OTC) acetaminophen or non-steroidal anti-inflammatory drugs (NSAIDs) at their labelled doses for mild pain.
  • Recent (<90 days) or planned major change in diet, use of weight-lowering medication, regularly extended fasting periods, or dietary habits that, per investigator's judgment, may interfere with the conduct of the study.

Participants with type 2 diabetes:

  • Any disorder which in the investigator's opinion might jeopardise participant safety or compliance with the protocol. This does not apply for T2D-associated mild conditions under stable treatment.
  • Supine blood pressure outside the range of 90-159 mmHg for systolic or 50-99 mmHg for diastolic at screening. This exclusion criterion also pertains to participants being on antihypertensive treatment. To consider re-assessment of vital signs in case white-coat hypertension is known or suspected.
  • Heart rate outside the range of 50-99 bpm at screening.
  • Unwilling or unable to check self-monitored plasma glucose (SMPG) and unwilling to treat hypoglycaemia per instructions.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: NNC9836-0001

Participants will receive NNC9836-0001 subcutaneously.

NNC9836-0001 will be administered subcutaneously.

Placebo-vergelijker: Placebo

Participants will receive placebo subcutaneously.

Placebo (NaCl) will be administered subcutaneously.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Single ascending dose (SAD): Number of Treatment emergent adverse events (TEAEs)
Tijdsspanne: From dosing (day 1) until week 26

Measured as events.

From dosing (day 1) until week 26
Multiple ascending dose (MAD): Number of TEAEs
Tijdsspanne: From dosing (day 1) to week 34

Measured as events.

From dosing (day 1) to week 34

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
SAD: Area under the curve (AUC)0-last, standard deviation (SD): The area under the NNC9836-0001 plasma concentration-time curve from time zero to last measurable concentration after a single dose
Tijdsspanne: From predose day 1 to day 57

Measured as hours*nanograms per milliliter (h*ng/ml).

From predose day 1 to day 57
SAD:Cmax,SD: The maximum observed NNC9836-0001 plasma concentration after a single dose
Tijdsspanne: From predose day 1 to day 57

Measured as nanograms per milliliter (ng/ml).

From predose day 1 to day 57
MAD: AUC0-28d,MD: The area under the NNC9836-0001 plasma concentration-time curve after multiple doses
Tijdsspanne: From predose day 29 to day 57

Measured as hour*ng/mL.

From predose day 29 to day 57
MAD: Cmax,MD: The maximum observed NNC9836-0001 plasma concentration after multiple doses
Tijdsspanne: From predose day 29 to day 57

Measured as ng/mL.

From predose day 29 to day 57

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Studie directeur: Clinical Transparency dept. 2834, Novo Nordisk A/S

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

22 oktober 2026

Primaire voltooiing (Geschat)

26 juli 2028

Studie voltooiing (Geschat)

26 juli 2028

Studieregistratiedata

Eerst ingediend

19 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

19 oktober 2026

Eerst geplaatst (Werkelijk)

26 oktober 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 november 2026

Laatste update ingediend die voldeed aan QC-criteria

5 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • NN9836-8513
  • U1111-1328-6439 (Andere identificatie: World Health Organization (WHO))

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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