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

NCT07087795 · Active, not recruiting

Last updated 2026-05-28

This clinical trial is testing how a new medication, NNC0194-0499, alone or combined with semaglutide, affects blood sugar control in adults with type 1 diabetes.

Status Active, not recruiting Ongoing, but no longer enrolling new participants.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 96 people Planned (estimated).

Who can join Ages 18–64 · all sexes

Timeline Started 2025-07 · est. completion 2026-09

Where 1 site · Germany

What this study is testing ClinicalTrials.gov NCT07087795 ↗

Description as written by the study sponsor.

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.

Treatments tested

NNC0194-0499 Drug

Participants will receive subcutaneous NNC0194-0499 once weekly.
Placebo Drug

Participants will receive placebo matched to NNC0194-0499 subcutaneously.
Semaglutide Drug

Participants will receive subcutaneous semaglutide once weekly.

Main thing measured	Part A: Change in time in range (TIR) 3.9-10.0 mmol/L (70-80 mg/dL)
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes Mellitus, Type 1
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07087795 ↗