Clinical trial NCT06685185: A Research Study of a New Medicine NNC0363-1063 in Healthy Participants and Participants With Type 1 Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-11-12
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study will look into testing a new medicine called NNC0363-1063 which may be used to treat people with diabetes. The study consists of three parts: Part 1 is a single ascending dose (SAD) study that comprises two subtypes: Part 1A conducted in healthy participants and Part 1B conducted in participants with type 1 diabetes (T1D). This study part will last for about 1½ to 5½ weeks. Part 2 is a proof-of-principle (PoP) study part conducted in participants with T1D and will last for about 2½ to 6½ weeks. Part 3 is a multiple ascending dose (MAD) study part conducted in participants with T1D and will last for 3½ to 8½ weeks.


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.

Primary outcomes:
measure: Part 1 SAD: Number of adverse events
timeFrame: From investigational medicinal product (IMP) administration (day 1) until end of study visit (day 8)
measure: Part 2 PoP: CL/F,I1063,SD- Apparent serum clearance of NNC0363-1063 after a single dose
timeFrame: From IMP administration at day 1 up to 7 days
measure: Part 3 MAD: Number of adverse events
timeFrame: From IMP administration at day 1 until day of the end of study visit at day 15
Secondary outcomes:
measure: Part 1 SAD: Number of hypoglycaemic episodes
timeFrame: From investigational medicinal product (IMP) administration (day 1) until end of study visit (day 8)
measure: Part 1 SAD: AUC0-inf,I1063,SD: Area under the serum NNC0363-1063 concentration-time curve from 0 to infinity after a single dose
timeFrame: Up to 7 days
measure: Part 1 SAD: AUC,I1063,SD- Area under the serum NNC0363-1063 concentration time curve after a single dose
timeFrame: Up to 2 days
measure: Part 1 SAD: Cmax,I1063,SD- Maximum observed serum NNC0363-1063 concentration after a single dose
timeFrame: Up to 7 days
measure: Part 2 PoP: AUC0-inf,I1063,SD: Area under the serum NNC0363-1063 concentration-time curve from 0 to infinity after a single dose
timeFrame: Up to 7 days
measure: Part 2 PoP: AUC,I1063,SD- Area under the serum NNC0363-1063 concentration time curve after a single dose
timeFrame: Up to 2 days
measure: Part 2 PoP: Cmax,I1063,SD- Maximum observed serum NNC0363-1063 concentration after a single dose
timeFrame: Up to 7 days
measure: Part 3 MAD: Number of hypoglycaemic episodes
timeFrame: From IMP administration (day 1) until day of the end of study visit (day 15)
measure: Part 3 MAD: AUCτ,I1063,SS: Area under the serum NNC0363-1063 concentration-time curve during one dosing interval at steady state
timeFrame: At day 5 and 8
measure: Part 3 MAD: Cmax,I1063,SS- Maximum observed serum NNC0363-1063 concentration during one dosing interval at steady state
timeFrame: At day 5 and 8
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Profil Institut für Stoffwechselforschung GmbH
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: