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NCT Number: 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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

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

    Percentage point (%-points).

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

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

    %-points.

Secondary outcomes

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

    Time frame: 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

    %-points.

  2. Change in mean sensor glucose (SG)

    Time frame: 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

    Millimoles per liter (mmol/L).

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

    Time frame: 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

    %-points.

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

    Time frame: 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

    %-points.

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

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

    % of time.

  6. Time below range (TBR)<3.0 mmol/L (54 mg/dL)

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

    % of time.

  7. Change in time in tight range (TITR) 3.9-7.8 mmol/L (70-140 mg/dL)

    Time frame: 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

    %-points.

  8. Change in mean total daily insulin dose per kg

    Time frame: Part A: From baseline (day -3 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -3 - -1) to day 92-105 / day 162-175

    Ratio to baseline.

  9. Change in triglycerides

    Time frame: Part A: From baseline (day 1) to day 50/ day 120; Part B: From baseline (day 1) to day 106/ day 176

    Ratio to baseline.

  10. Number of adverse events (AEs)

    Time frame: Part A: From baseline (day 1) to day 155; Part B: From baseline (day 1) to day 211

    Number of events.

  11. Number of severe hypoglycaemic episodes (level 3)

    Time frame: Part A: From baseline (day 1) to day 155; Part B: From baseline (day 1) to day 211

    Number of episodes.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2025
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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