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New combo shot aims to tame type 1 diabetes

NCT ID NCT07087795

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Anyone

Healthy volunteers

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

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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