New diabetes drug shows promise in early human tests
NCT ID NCT06685185
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
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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 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: 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
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Other studies related to the condition(s) this trial covers.
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