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

What Was Tested

In this phase 1 trial, researchers set out to test Semaglutide.

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.

It had two arms (groups): Part A: NNC0194-0499/Placebo (experimental) and Part B: NNC0194-0499/Placebo + Semaglutide (experimental).

After a 2-week run-in period; participants will be randomised 1:1 to a treatment sequence with two 7-week treatment periods of once weekly subcutaneous NNC0194-0499 or placebo. Between the two treatment periods; there is a wash-out period. After the wash-out period, there will be a cross over, ensuring that all the participants receive both NNC0194-0499 and placebo.

The registry classes the interventions as drug.

Who Took Part

96 planned participants were the target.

It was open to people of any sex aged from 18 years up to 64 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female. Age 18-64 years (both inclusive) at the time of signing the informed consent. Body mass index 22-35 kilogram per square meter (kg/m\^2) (both inclusive) for Part A and 27-35(kg/m\^2) (both inclusive) for Part B at the day of screening. Diagnosed with type 1 diabetes mellitus greater than equal to (≥) 1 year prior to the day of screening. Use of Continuous glucose monitoring (CGM) device \> 180 consecutive days prior to the day of screening.

The full record lists 10 inclusion and 7 exclusion criteria; among the exclusions: treatment with glucagon-like peptide-1(glp-1) ra within 90 days before screening; use of any medication with unknown or unspecified content within 90 days before screening; any episode of diabetic ketoacidosis within 90 days before screening.

How the Study Was Run

The set-up was randomized, crossover and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Semaglutide and the comparison in turn, acting as their own control.

Blinding on both sides kept the participants and researchers unaware of who received Semaglutide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2025-07-01 with completion listed for 2026-09-12.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Part A: Change in time in range (TIR) [amount hidden]/L ([amount hidden]/dL). Part B: Change in time in range (TIR) [amount hidden]/L ([amount hidden]/dL).

It also tracked 11 secondary outcomes, for example Change in coefficient of variation (CV) of sensor glucose, total, Change in mean sensor glucose (SG), Change in triglycerides, Number of adverse events (AEs) and Number of severe hypoglycaemic episodes (level 3).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 96 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.