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 | Recruiting Phase 1

• 3 other identifiers: NN6497-8316U1111-1315-51222024-519533-38
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Part A: Change in time in range (TIR) 3.9-10.0 mmol/L (70-80 mg/dL)

  Percentage point (%-points).

  From baseline (day -14 - -1) to day 36-49 / day 106-119

• Part B: Change in time in range (TIR) 3.9-10.0 mmol/L (70-80 mg/dL)

  %-points.

  From baseline (day -14 - -1) to day 92-105 / day 162-175

Secondary Outcomes (11)

• Change in coefficient of variation (CV) of sensor glucose, total

  Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175

• Change in mean sensor glucose (SG)

  Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175

• Change in time above range (TAR) >10.0 mmol/L (>180 mg/dL)

  Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175

• Change in time above range (TAR) >13.9 mmol/L (>250 mg/dL)

  Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175

• Time below range (TBR) <3.9 mmol/L (70 mg/dL)

  Part A: day 36-49/ day 106-119; Part B: day 92-105/ day 162-175

Study Arms (2)

Part A: NNC0194-0499/Placebo

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.

Drug: NNC0194-0499; Drug: Placebo

Part B: NNC0194-0499/Placebo + Semaglutide

EXPERIMENTAL

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.

Drug: NNC0194-0499; Drug: Placebo; Drug: Semaglutide

Interventions

NNC0194-0499 DRUG

Participants will receive subcutaneous NNC0194-0499 once weekly.

Part A: NNC0194-0499/Placebo; Part B: NNC0194-0499/Placebo + Semaglutide

Placebo DRUG

Participants will receive placebo matched to NNC0194-0499 subcutaneously.

Part A: NNC0194-0499/Placebo; Part B: NNC0194-0499/Placebo + Semaglutide

Semaglutide DRUG

Participants will receive subcutaneous semaglutide once weekly.

Part B: NNC0194-0499/Placebo + Semaglutide

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 28, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): September 12, 2026
• Study Completion (Estimated): September 25, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)