NCT07087795

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	NNC0194-0499	Participants will receive subcutaneous NNC0194-0499 once weekly.
DRUG	Placebo	Participants will receive placebo matched to NNC0194-0499 subcutaneously.
DRUG	Semaglutide	Participants will receive subcutaneous semaglutide once weekly.

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-09-12
• Completion: 2026-09-25
• First posted: 2025-07-28
• Last updated: 2026-04-03

Locations

1 site across 1 country: Germany