Comparing ways to increase the dose of a new obesity treatment
Official title: Evaluation of Different Dose Escalation Regimens for NNC0519-0130 in Participants With Overweight and Obesity
Run by Novo Nordisk A/S · NCT06718998 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing different ways to safely increase the dose of a new obesity medication for people with obesity and type 2 diabetes to see which method has the fewest side effects while helping with weight management.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Enrollment | 114 (estimated) |
| Sponsor | Novo Nordisk A/S Industry-sponsored |
| Locations | 1 site (Graz) |
| Trial ID | NCT06718998 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-64 with a BMI between 27.0 and 44.9 who are otherwise healthy.
✕Probably not a fit
Patients with significant health issues or those with a high HbA1c level may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the safety and tolerability of a new medication, NNC0519-0130, designed for individuals with obesity and type 2 diabetes. Participants will be randomly assigned to one of four methods for increasing the medication dose over a 24-week period. The goal is to determine which dosing method minimizes side effects while effectively managing weight. The study aims to enhance treatment options for those struggling with excess body weight.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective treatment option for individuals with obesity.
How similar studies have gone: Other studies have shown promise in similar approaches to obesity treatment, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: * Female of non-childbearing potential, or male. * Age 18-64 years (both inclusive) at the time of signing the informed consent. * Body mass index (BMI) between 27.0 and 44.9 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 to be otherwise 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: * Any disorder, unwillingness or inability which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol. * Glycated haemoglobin (HbA1c) greater than or equal to (\>=) 6.5 percentage (48 millimoles per mole \[mmol/mol\]) at screening. * Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, NSAIDs (nonsteroidal anti-inflammatory drugs), acetylsalicylic acid, or topical medication not reaching systemic circulation, within 14 days before screening. * Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
Where it's running
-
Clinical Trials Unit / Center for Medical Research
Graz, Austria Recruiting
Study contacts
- Study coordinator: Novo Nordisk
- Email: clinicaltrials@novonordisk.com
- Phone: (+1) 866-867-7178
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.