RecruitingPhase 1NCT06685185

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

A Study Investigating Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of NNC0363-1063 in Healthy Participants and Participants With Type 1 Diabetes

Sponsor

Novo Nordisk A/S

Enrollment

154 participants

Start Date

Nov 12, 2024

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 1

Summary

This study will look into testing a new medicine called NNC0363-1063 which may be used to treat people with diabetes. The study consists of three parts: Part 1 is a single ascending dose (SAD) study that comprises two subtypes: Part 1A conducted in healthy participants and Part 1B conducted in participants with type 1 diabetes (T1D). This study part will last for about 1½ to 5½ weeks. Part 2 is a proof-of-principle (PoP) study part conducted in participants with T1D and will last for about 3½ to 8½ weeks. Part 3 is a meal test multiple dose study part conducted in participants with T1D and will last for 7 to 11 weeks.

Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study testing a new experimental medicine called NNC0363-1063 — which aims to help manage insulin levels — first in healthy volunteers, and then in people with Type 1 diabetes. **You may be eligible if...** - You are 18–64 years old - You have a healthy body weight (BMI 18.5–29.9) - For the diabetes portion: you have had Type 1 diabetes for at least 1 year - You are postmenopausal or have been surgically sterilized (for female participants) **You may NOT be eligible if...** - You are a male of reproductive age not using contraception - You have any medical or psychiatric condition that your doctor believes could make participation unsafe - For the diabetes portion: you have any conditions beyond well-controlled Type 1 diabetes that would affect your safety 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.

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