Diabetes Mellitus, Type 2
Conditions
Brief summary
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.
Interventions
DRUGNNC9836-0001
NNC9836-0001 will be administered subcutaneously.
DRUGPlacebo (NaCl)
Placebo (NaCl) will be administered subcutaneously.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Eligibility
Sex/Gender
ALL
Age
25 Years to 69 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Single ascending dose (SAD): Number of Treatment emergent adverse events (TEAEs) | From dosing (day 1) until week 26 | Measured as events. |
| Multiple ascending dose (MAD): Number of TEAEs | From dosing (day 1) to week 34 | Measured as events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | From predose day 1 to day 57 | Measured as hours\*nanograms per milliliter (h\*ng/ml). |
| SAD:Cmax,SD: The maximum observed NNC9836-0001 plasma concentration after a single dose | From predose day 1 to day 57 | Measured as nanograms per milliliter (ng/ml). |
| MAD: AUC0-28d,MD: The area under the NNC9836-0001 plasma concentration-time curve after multiple doses | From predose day 29 to day 57 | Measured as hour\*ng/mL. |
| MAD: Cmax,MD: The maximum observed NNC9836-0001 plasma concentration after multiple doses | From predose day 29 to day 57 | Measured as ng/mL. |
Countries
Germany
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency dept. 2834
Novo Nordisk A/S
Outcome results
None listed