RecruitingPhase 1NCT07087795

A Study to See the Effect of NNC0194-0499 Alone or in Combination With Semaglutide on Blood Sugar Control in People Living With Type 1 Diabetes

A Study to Investigate Efficacy and Safety of NNC0194-0499 Versus Placebo, Both Administered Alone or in Combination With Semaglutide in People With Type 1 Diabetes

Sponsor

Novo Nordisk A/S

Enrollment

96 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 1

Summary

This study is testing the effect of a new study medicine NNC0194-0499 in type 1 diabetes. The purpose of the study is to compare the effect of NNC0194-0499 on the blood sugar levels of participants with type 1 diabetes when taken in combination with semaglutide or placebo. All participants will receive standard of care insulin treatment. The study will last for about 36 weeks.

Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new investigational drug called NNC0194-0499 — alone and combined with semaglutide (a medication already used for diabetes and weight management) — to see if it can safely improve blood sugar control in people with Type 1 diabetes. **You may be eligible if...** - You are 18–64 years old - You have been diagnosed with Type 1 diabetes for at least 1 year - Your BMI is between 22–35 (Part A) or 27–35 (Part B) - You are currently using insulin **You may NOT be eligible if...** - You have significant heart, kidney, or liver disease - You have a history of severe low blood sugar (hypoglycemia) episodes - You are pregnant or breastfeeding - You have used GLP-1 medications (like semaglutide or liraglutide) recently 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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Interventions

DRUGNNC0194-0499

Participants will receive subcutaneous NNC0194-0499 once weekly.

DRUGPlacebo

Participants will receive placebo matched to NNC0194-0499 subcutaneously.

DRUGSemaglutide

Participants will receive subcutaneous semaglutide once weekly.

Locations(1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, Germany

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NCT07087795

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