Testing a new medicine for people with overweight or obesity
A Randomised, Placebo Controlled, Double Blinded Study Assessing the Safety, Tolerability and Pharmacokinetics of Single and Multiple Subcutaneous Doses of NNC0638-0355 in Participants With Overweight or Obesity
This study is testing a new medicine to see if it can help adults with overweight or obesity lose weight and improve their health.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Novo Nordisk A/S Industry-sponsored |
| Locations | 2 sites (San Antonio, Texas and 1 other locations) |
| Trial ID | NCT06577766 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of a new medicine, NNC0638-0355, in individuals living with overweight or obesity. Participants will receive either the study medicine or a placebo through an injection, with the treatment assignment determined randomly. The study aims to understand how the medicine works in the body and how the body responds to it. The trial is designed for healthy adults aged 18-55 with a specific BMI range.
Who should consider this trial
Good fit: Ideal candidates are healthy males and females aged 18-55 with a BMI between 25.0 and 34.9 kg/m².
Not a fit: Patients with known hypersensitivity to the study medicine or those with certain health 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 developing new treatments for obesity, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Key inclusion criteria * Male or female. * Age 18-55 years (both inclusive) at the time of signing the informed consent. * BMI between 25.0 and 34.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator. * Considered to be generally 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. Key exclusion criteria * Known or suspected hypersensitivity to study intervention(s) or related products. * Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * HbA1c greater than or equal to 6.5 percentage (48 mmol/mol) at screening. * Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values: 1. Vitamin D (25-hydroxycholecalciferol) less than 12 ng/mL (30 nM) at screening 2. Parathyroid hormone (PTH) outside normal range at screening 3. Total calcium outside normal range at screening
Where this trial is running
San Antonio, Texas and 1 other locations
- Icon — San Antonio, Texas, United States (Recruiting)
- Icon — San Antonio, Texas, United States (Not_yet_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.