Comparing two preparations of a new medicine for people with obesity
Investigation of Pharmacokinetics of 2 Different Formulations of NNC0519-0130 in Adult Participants With Overweight or Obesity
This study is testing two different forms of a new medicine for people with obesity or type 2 diabetes to see which one works better in their bodies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Novo Nordisk A/S Industry-sponsored |
| Locations | 1 site (San Antonio, Texas) |
| Trial ID | NCT06642571 on ClinicalTrials.gov |
What this trial studies
This study investigates a new medication called NNC0519-0130 aimed at improving treatment options for individuals with excess body weight or type 2 diabetes. Participants will receive two different preparations of the medicine, NNC0519-0130 B and NNC0519-0130 C, in a randomized manner to compare the levels of the drug in their blood. The study is designed to last approximately 24 weeks and includes a thorough screening process to ensure participant safety and eligibility.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-64 with a BMI between 27.0 and 39.9 kg/m².
Not a fit: Patients with a glycated hemoglobin (HbA1c) level of 6.5% or higher may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for individuals struggling with obesity.
How similar studies have performed: Other studies have shown promise with similar approaches, but this specific medication is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female of non-childbearing potential. * Age 18-64 years (both inclusive) at the time of signing the informed consent. * Body Mass Index (BMI) between 27.0 kilogram per square meter (kg/m\^2) and 39.9 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: * Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * Glycated hemoglobin (HbA1c) greater than or equal to (≥) 6.5 % (48 millimoles per mole \[mmol/mol\]) at screening. * Use of prescription medicinal products or nonprescription drugs, except routine vitamins, occasional use of acetaminophen, ibuprofen, acetylsalicylic acid, or topical medication (including eye drops for pupil dilation) 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
San Antonio, Texas
- Icon — San Antonio, Texas, 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.