A Research Study to Check the Safety of NNC9836-0001 When Given to Healthy Participants and Participants With Type 2 Diabetes
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.
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Typ studiów
Typ studiów
Zapisy (Szacowany)
Zapisy
Faza
Faza
- Faza 1
Kontakty i lokalizacje
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: Novo Nordisk
- Numer telefonu: (+1) 866-867-7178
- E-mail: clinicaltrials@novonordisk.com
Lokalizacje studiów
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Neuss, Niemcy, 41460
- Rekrutacyjny
- Profil Institut für Stoffwechselforschung GmbH
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Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie sekwencyjne
- Maskowanie: Podwójnie
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
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Eksperymentalny: NNC9836-0001
Participants will receive NNC9836-0001 subcutaneously. |
NNC9836-0001 will be administered subcutaneously. |
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Komparator placebo: Placebo
Participants will receive placebo subcutaneously. |
Placebo (NaCl) will be administered subcutaneously. |
Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Single ascending dose (SAD): Number of Treatment emergent adverse events (TEAEs)
Ramy czasowe: From dosing (day 1) until week 26
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Measured as events. |
From dosing (day 1) until week 26
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Multiple ascending dose (MAD): Number of TEAEs
Ramy czasowe: From dosing (day 1) to week 34
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Measured as events. |
From dosing (day 1) to week 34
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Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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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
Ramy czasowe: From predose day 1 to day 57
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Measured as hours*nanograms per milliliter (h*ng/ml). |
From predose day 1 to day 57
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SAD:Cmax,SD: The maximum observed NNC9836-0001 plasma concentration after a single dose
Ramy czasowe: From predose day 1 to day 57
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Measured as nanograms per milliliter (ng/ml). |
From predose day 1 to day 57
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MAD: AUC0-28d,MD: The area under the NNC9836-0001 plasma concentration-time curve after multiple doses
Ramy czasowe: From predose day 29 to day 57
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Measured as hour*ng/mL. |
From predose day 29 to day 57
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MAD: Cmax,MD: The maximum observed NNC9836-0001 plasma concentration after multiple doses
Ramy czasowe: From predose day 29 to day 57
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Measured as ng/mL. |
From predose day 29 to day 57
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Współpracownicy i badacze
Sponsor
Sponsor
Śledczy
Śledczy
- Dyrektor Studium: Clinical Transparency dept. 2834, Novo Nordisk A/S
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Rozpoczęcie studiów
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- NN9836-8513
- U1111-1328-6439 (Inny identyfikator: World Health Organization (WHO))
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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