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New diabetes drug shows promise in early human tests

NCT ID NCT06685185

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study tested a new medicine called NNC0363-1063 in 117 healthy volunteers and people with type 1 diabetes. The goal was to check safety, how the body processes the drug, and its effect on blood sugar. The study had three parts, including single and multiple doses, and compared the drug to placebo and standard insulins.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NNC0363-1063
What this could lead to
If it works, this could point toward a new treatment option for type 1 diabetes that helps control blood sugar.
What could go wrong
This is a very early Phase 1 trial, so the drug may not prove safe or effective. Only 117 people are enrolled, and results may not apply to everyone.

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

117 people

The number who actually took part.

Started

Nov 2024

Finished

Mar 2026

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

Accepted

You do not need to have the condition being studied to take part.

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: Part 1A SAD (healthy participants) * Male or female of non-child bearing potential. Non-child bearing potential being defined as surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to the day of screening. * Age 18-64 years (both inclusive) at the time of signing the informed consent. * Body mass index between 18.5-29.9 kilogram per square metre( kg/m\^2) (both inclusive) at the day of screening. * Considered to be generally healthy 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. Part 1B SAD, Part 2 PoP and Part 3 Meal test (participants with T1D) * Male or female of non-child bearing potential. Non-child bearing potential being defined as surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to the day of screening. * Age 18-64 years (both inclusive) at the time of signing the informed consent. * Body mass index between 18.5-29.9 kg/m\^2 (both inclusive) at the day of screening. * Diagnosed with type 1 diabetes mellitus greater than or equal to( ≥)1 year prior to the day of screening. * 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. Exclusion Criteria: Part 1A SAD (healthy participants) * Male of reproductive age who, or whose female partner(s), is not using an adequate contraceptive method. * Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. Part 1B SAD, Part 2 PoP and Part 3 Meal test (participants with T1D) * Male of reproductive age who, or whose female partner(s), is not using an adequate contraceptive method. * 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.

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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

More trials for these conditions

Other studies related to the condition(s) this trial covers.