Testing a new medicine for overweight and obesity
A Single- and Multiple-ascending Dose Study to Investigate Safety, Tolerability and Pharmacokinetics of NNC0662-0419 in Participants Living With Overweight or Obesity
This study is testing a new medicine to see if it can help people who are overweight or obese lose weight safely over about nine months.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 19 Years to 55 Years |
| Sex | All |
| Sponsor | Novo Nordisk A/S Industry-sponsored |
| Locations | 1 site (Lincoln, Nebraska) |
| Trial ID | NCT06737536 on ClinicalTrials.gov |
What this trial studies
This study is evaluating the safety and effectiveness of a new medication, NNC0662-0419, in individuals living with overweight or obesity. Participants will receive either the study medication or a placebo through an injection, with the treatment assignment determined randomly. The study aims to understand how the medication works in the human body and how the body responds to it. This is the first time this medication is being administered to humans, and the study will last approximately 9 months.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 19-55 with a BMI between 27.0 and 39.9 kg/m².
Not a fit: Patients with known hypersensitivity to the study medication or those with certain heart conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a new treatment option for individuals struggling with overweight or obesity.
How similar studies have performed: Other studies have shown promise in similar approaches, but this specific medication is being tested for the first time in humans.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female (sex at birth) * Aged 19-55 years (both inclusive) at the time of signing the informed consent. * Body mass index (BMI) between 27.0 and 39.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator. * Considered eligible 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. * Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * 2nd or 3rd degree atrioventricular-block, prolongation of the QRS complex over 120 milliseconds (ms), or of the corrected QT interval by Fridericia (QTcF) calculation over 450 ms (females) or 430 ms (males), or any other clinically significant abnormal ECG results as judged by the investigator, at screening. * Glycated haemoglobin (HbA1c) greater than or equal to (\>=) 6.5 percent (%) (48 millimoles per mole \[mmol/mol\]) at screening. * Calcitonin \>= 50 nanogram per liter (ng/L) at screening
Where this trial is running
Lincoln, Nebraska
- Celerion, Lincoln — Lincoln, Nebraska, United States (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.