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

NCT ID: NCT07087795

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-09-25

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Part A: NNC0194-0499/Placebo

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.

Group Type: EXPERIMENTAL

NNC0194-0499

Intervention Type: DRUG

Participants will receive subcutaneous NNC0194-0499 once weekly.

Placebo

Intervention Type: DRUG

Participants will receive placebo matched to NNC0194-0499 subcutaneously.

Part B: NNC0194-0499/Placebo + Semaglutide

After the 2-week run-in phase followed by the 8-week of dose escalation period (every 4 weeks) of once weekly subcutaneous semaglutide; participants will be randomised 1:1 to a treatment sequence with two 7-week treatment periods of once weekly subcutaneous NNC0194-0499 or placebo and continued semaglutide. Between the two treatment periods; there is a wash-out period where the participant continues to receive once weekly subcutaneous semaglutide. After the wash-out period, there will be a cross over, ensuring that all the participants receive both NNC0194-0499 and placebo together with semaglutide.

Group Type: EXPERIMENTAL

NNC0194-0499

Intervention Type: DRUG

Participants will receive subcutaneous NNC0194-0499 once weekly.

Placebo

Intervention Type: DRUG

Participants will receive placebo matched to NNC0194-0499 subcutaneously.

Semaglutide

Intervention Type: DRUG

Participants will receive subcutaneous semaglutide once weekly.

Interventions

NNC0194-0499

Participants will receive subcutaneous NNC0194-0499 once weekly.

Intervention Type: DRUG

Placebo

Participants will receive placebo matched to NNC0194-0499 subcutaneously.

Intervention Type: DRUG

Semaglutide

Participants will receive subcutaneous semaglutide once weekly.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.
• Treated with multiple daily insulin injections and stable insulin dose greater than (>) 90 days prior to the day of screening, as judged by the investigator.
• Use of Continuous glucose monitoring (CGM) device > 180 consecutive days prior to the day of screening.
• Glycated haemoglobin (HbA1c) from 7.2 - 9.0% (both inclusive).
• Considered to be generally healthy (except for mild conditions under stable treatment associated with type 1 diabetes mellitus) based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
• Ability and willingness to wear the Novo Nordisk provided CGM device according to the protocol including replacement of CGM sensor at home.
• Ability and willingness to refrain from wearing own CGM/Flash glucose monitor for the duration of the study, as judged by the investigator.

Exclusion Criteria

• Any condition, except for mild conditions under stable treatment associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
• 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.
• Presence or history of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, clinically significant arrhythmias or clinically significant conduction disorders.
• Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological conditions (except conditions associated with diabetes mellitus and obesity).
• Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event within 180 days) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis within 180 days prior to the day of screening.
• Any episode of diabetic ketoacidosis within 90 days before screening.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Profil Institut für Stoffwechselforschung GmbH

Neuss, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Novo Nordisk

Role: CONTACT

clinicaltrials@novonordisk.com

(+1) 866-867-7178

Other Identifiers

U1111-1315-5122

Identifier Type: OTHER

Identifier Source: secondary_id

2024-519533-38

Identifier Type: OTHER

Identifier Source: secondary_id

NN6497-8316

Identifier Type: -

Identifier Source: org_study_id