Comparing ways to increase the dose of a new obesity treatment
Evaluation of Different Dose Escalation Regimens for NNC0519-0130 in Participants With Overweight and Obesity
PHASE1 · Novo Nordisk A/S · NCT06718998
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 | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 114 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Novo Nordisk A/S (industry) |
| Locations | 1 site (Graz) |
| Trial ID | NCT06718998 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-64 with a BMI between 27.0 and 44.9 who are otherwise healthy.
Not a fit: Patients with significant health issues or those with a high HbA1c level may not benefit from this study.
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 performed: Other studies have shown promise in similar approaches to obesity treatment, indicating potential for success.
Eligibility criteria
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 this trial is running
Graz
- 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
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.
Conditions: Obesity