In short
NNC0638-0355 is an investigational medicine being developed by Novo Nordisk for the treatment of obesity and overweight. It is a new molecular entity currently in Phase 1/2 clinical development. One authorised trial (2026-526797-16-00) is planned to enrol 380 participants to compare the effect of multiple doses of NNC0638-0355 versus placebo on body weight over 26 weeks.
Key points
- NNC0638-0355 is a new molecular entity in development for obesity and overweight.
- The only registered trial is Phase 1/2, planned to enrol 380 participants.
- The trial compares multiple doses of NNC0638-0355 against placebo.
- The primary outcome is relative change in body weight from baseline to week 26.
- The trial is currently authorised but not yet recruiting.
- NNC0638-0355 is given by subcutaneous injection.
What is NNC0638-0355?
NNC0638-0355 is an investigational medicine being developed by Novo Nordisk, a company known for its research in diabetes and obesity therapies. It is classified as a new molecular entity, meaning it is a chemical substance that has not previously been approved as a medicine. The substance is also known by the alternative names NN 9638 – Amylin 355, NN-9638, and NNC0638-0355. NNC0638-0355 belongs to the class of obesity therapies and has no marketing authorisation in these records, meaning it is still in the research stage.
How does NNC0638-0355 work?
The mechanism of action of NNC0638-0355 is described as undefined in the available sources. This means that the exact way the substance acts in the body has not yet been fully characterised or publicly described. The alternative name "Amylin 355" suggests a possible connection to amylin, a hormone involved in regulating appetite and blood sugar, but this has not been confirmed in the provided data. The ongoing Phase 1/2 trial is designed to investigate how the medicine works in people living with overweight or obesity.
Which conditions is it studied for?
NNC0638-0355 is being studied for the following conditions:
- Obesity and overweight — the trial investigates the effect of NNC0638-0355 on body weight in people with overweight or obesity.
How is NNC0638-0355 given?
NNC0638-0355 is given by subcutaneous injection, which means it is injected under the skin. The trial uses multiple doses of NNC0638-0355, with different dose levels being tested. The exact dose amounts have not been reported in the available registry data.
What do the clinical trials show?
One clinical trial is registered for NNC0638-0355 in the EU Clinical Trials Information System (CTIS). This is a Phase 1/2 interventional study, meaning it combines early testing of safety and dosing with initial assessment of effectiveness. The trial is currently authorised but not yet recruiting participants. It is planned to enrol 380 participants with overweight or obesity. The primary outcome is the relative change in body weight from baseline (week 0) to week 26. Participants will receive one of several dose levels of NNC0638-0355 or a placebo, which is an inactive substance used for comparison.
What side effects are known?
The available sources do not provide information on side effects of NNC0638-0355. As the medicine is still in early clinical development, its safety profile is not yet established.