A Research Study Comparing Different Ways of Increasing the Dose of NNC0519-0130 in Participants With Overweight or Obesity
Launched by NOVO NORDISK A/S · Dec 2, 2024
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medication called NNC0519-0130, which is being developed by Novo Nordisk to help people with obesity and type 2 diabetes. The main goal of the study is to determine the best way to increase the dose of this medication while minimizing any side effects that might occur. Participants will be randomly assigned to one of four different methods for increasing the medication dose. The study will last about 24 weeks, during which researchers will monitor how well the participants tolerate the treatment.
To be eligible for this trial, participants need to be between 18 and 64 years old and have a body mass index (BMI) between 27 and 44.9, which indicates they are overweight. They should also be generally healthy, without serious medical conditions that could affect their safety during the study. It's important to note that individuals with certain health issues, or those taking specific medications, may not qualify. Participants can expect regular check-ups and assessments to ensure their safety and to gather information about how the medication is working.
Gender
ALL
Eligibility 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.
About Novo Nordisk A/S
Novo Nordisk A/S is a global healthcare company headquartered in Denmark, specializing in the research, development, manufacturing, and marketing of innovative pharmaceuticals, particularly in the fields of diabetes care, obesity treatment, and hormone replacement therapies. With a strong commitment to improving patient outcomes, Novo Nordisk invests significantly in clinical trials to advance scientific knowledge and develop effective therapies. The company is dedicated to sustainability and ethical practices, striving to deliver high-quality healthcare solutions while addressing the evolving needs of patients worldwide. Through collaboration and innovation, Novo Nordisk aims to lead the way in transforming diabetes and other chronic diseases into manageable conditions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Graz, , Austria
Patients applied
Trial Officials
Clinical Transparency (dept. 2834)
Study Director
Novo Nordisk A/S
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported