Testing a new medicine for heart failure in healthy individuals
A First-in-human Randomised, Placebo-controlled and Double-blinded Single Ascending Dose Study Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Administrations of NNC0537-1482 in Healthy Participants.
This study is testing a new heart medication in healthy adults to see how it works and if it's safe.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 22 Years to 55 Years |
| Sex | All |
| Sponsor | Novo Nordisk A/S Industry-sponsored |
| Locations | 2 sites (Groningen and 1 other locations) |
| Trial ID | NCT06625307 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effects of a new medication, NNC0537-1482, in healthy volunteers. Participants, aged 22-55, will receive either the study medication or a placebo through a single injection under the skin. The study consists of six cohorts with varying doses and will last approximately nine months, with individual participation lasting up to 42 days. The aim is to gather initial data on how the medication works in the body.
Who should consider this trial
Good fit: Ideal candidates are healthy males and postmenopausal females aged 22-55 with a BMI between 18.5 and 30.0.
Not a fit: Patients with known hypersensitivity to the study medication or those with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatment options for individuals suffering from heart failure.
How similar studies have performed: Other studies testing similar medications in healthy volunteers have shown promise, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or postmenopausal female. * Age 22-55 years (both inclusive) at the time of signing the informed consent. * Body Mass Index (BMI) between 18.5 and 30.0 kilogram/meter per square (kg/m\^2) (both inclusive) at screening. * Considered eligible and 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. Exclusion Criteria: * Known or suspected hypersensitivity to study intervention(s) or related products. * Use of prescription or non-prescription medicinal products, including herbal medications, within 14 days before screening. Occasional use of over-the-counter vitamins, or paracetamol or Non-steroidal anti-inflammatory drugs (NSAIDs) at their labelled doses for mild pain is permitted. * Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * Orthostatic hypotension, defined as a decrease in systolic blood pressure greater than or equal to 20 millimetres of mercury (mmHg) or a decrease in diastolic blood pressure greater than or equal to 10 (mmHg) from supine to standing after 3 minutes, at the screening visit. * Any laboratory safety parameters at screening outside the below laboratory ranges for: * Alanine Aminotransferase (ALT) greater than (\>) Upper normal limits (UNL) plus (+) 10 Percentage (%) * Aspartate Aminotransferase (AST) \> Upper limit normal (ULN) +20% * Bilirubin \> ULN + 20% * Creatinine \> ULN + 10%
Where this trial is running
Groningen and 1 other locations
- ICON - location Groningen — Groningen, Netherlands (Active_not_recruiting)
- ICON - location Groningen — Groningen, Netherlands (Recruiting)
Study contacts
- Study coordinator: Novo Nordisk
- Email: clinicaltrials@novonordisk.com
- Phone: (+1) 866-867-7178
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.