New combo shot aims to tame type 1 diabetes
NCT ID NCT07087795
First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 2 times
Summary
This early-stage trial tests a new weekly injection called NNC0194-0499, alone or with another drug (semaglutide), in 96 adults with type 1 diabetes. The goal is to see if it improves blood sugar levels compared to placebo. All participants continue their usual insulin. The study lasts about 36 weeks and focuses on safety and blood sugar control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NNC0194-0499 (a new weekly injection) and semaglutide (a diabetes drug)
- What this could lead to
- If it works, this could point toward a new combination treatment to help people with type 1 diabetes manage their blood sugar levels more effectively.
- What could go wrong
- This is an early Phase 1 trial with only 96 people, so it is not yet proven to be safe or effective. The results may not lead to a widely available treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 96 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jul 2025
- Expected to finish
-
Sep 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 64 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Profil Institut für Stoffwechselforschung GmbH
Neuss, 41460, Germany
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