RecruitingPhase 1NCT07305805

A Research Study of a New Medicine NNC0363-1063 in Participants With Type 1 Diabetes

A Multiple Dose Study Investigating Pharmacodynamics and Pharmacokinetics of Subcutaneous NNC0363-1063 in Participants With Type 1 Diabetes

Sponsor

Novo Nordisk A/S

Enrollment

36 participants

Start Date

Dec 15, 2025

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 1

Summary

The purpose of this clinical study is to find out how the novel insulin NNC0363-1063 and a non-glucose carbohydrate used in food and beverage might interact in participants with type 1 diabetes and if co-administration of these substances is safe and tolerable. All participants will get a fixed dose of NNC0363-1063 and an oral administration of different amounts of the non-glucose carbohydrate in a random order during 4 interaction tests. The participants will be in this clinical study for about 5 to 12 weeks.

Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study tests a new investigational drug called NNC0363-1063 in adults with Type 1 diabetes to evaluate its safety, tolerability, and how the body absorbs and processes it. This type of study focuses on finding the right dose and detecting any early safety signals before larger trials. **You may be eligible if...** - You are between 18 and 64 years old (inclusive) - You have Type 1 diabetes - Your BMI is between 18.5 and 29.9 (healthy to normal-overweight range) - You are not of childbearing potential — meaning you are either surgically sterilized (hysterectomy, removal of both ovaries or fallopian tubes) or post-menopausal (no menstrual period for at least 12 months) **You may NOT be eligible if...** - You are of childbearing potential (could become pregnant) - Your BMI is outside the 18.5–29.9 range - You have other significant medical conditions your doctor would assess Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.