Testing a new medicine for type 1 diabetes and healthy participants

A Study Investigating Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of NNC0363-1063 in Healthy Participants and Participants With Type 1 Diabetes

This study is testing a new medicine for type 1 diabetes in both healthy people and those with the condition to see how safe and effective it is.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 154 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Novo Nordisk A/S (Industry-sponsored)
• Locations: 1 site (Neuss)
• Trial ID: NCT06685185 on ClinicalTrials.gov

What this trial studies

This study investigates a new medicine called NNC0363-1063 in both healthy individuals and those with type 1 diabetes. It consists of three parts: a single ascending dose study in healthy participants and participants with type 1 diabetes, a proof-of-principle study in participants with type 1 diabetes, and a multiple ascending dose study also in participants with type 1 diabetes. Each part varies in duration, ranging from approximately 1½ to 8½ weeks, and aims to assess the safety and efficacy of the new medicine. The study will also include a placebo and insulin degludec for comparison.

Who should consider this trial

Good fit: Ideal candidates include healthy adults aged 18-64 and individuals with type 1 diabetes who meet specific eligibility criteria.

Not a fit: Patients who are not of non-child bearing potential or those outside the age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new treatment options for individuals with type 1 diabetes.

How similar studies have performed: Other studies have shown promise in similar approaches, but the specific medicine NNC0363-1063 is novel.

Eligibility criteria

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 MAD (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 MAD (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.

Where this trial is running

Neuss

• Profil Institut für Stoffwechselforschung GmbH — Neuss, Germany (Recruiting)

Study contacts

• Study coordinator: Novo Nordisk

Conditions Diabetes Mellitus, Type 1