A Study to Look at Safety and Tolerability of NNC0582-0001, How it is Transported Throughout the Body and How it Works in Healthy Adults

Phase 1

Active, not recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: NNC0582-0001; Drug: Placebo

• Registration Number: NCT05624580
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This is a single-center, randomized, double-blind, sequential-group, placebo-controlled study with six sequential single dose cohorts with ascending dose levels in healthy adult participants. This study will assess the safety, tolerability, the pharmacokinetics from single subcutaneous administrations of NNC0582-0001 and explores the pharmacodynamics in healthy participants. Participants will be randomized in a 3:1 ratio to receive a fixed single dose (1-day) of NNC0582 0001 or placebo by injections under the skin. Participants will be followed up for 52 weeks post dose.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-08
• Study First Submitted QC: 2022-11-14
• Study Start: 2022-11-15
• Study First Posted: 2022-11-22
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-16
• Primary Completion: 2025-10-25
• Study Completion: 2025-10-25

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Female of non-childbearing potential or male aged 18-55 years (both inclusive) at the time of signing informed consent.
• Body Mass Index (BMI) from 20.0 to 30.0 kilogram per square meter (kg/m^2) (both inclusive) at 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.

Exclusion Criteria

• Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
• Glycated haemoglobin (HbA1c) greater than or equal to 5.7 percent (39 millimoles per mole [mmol/mol]) at screening.
• Any of the below laboratory safety parameters at screening outside normal range, see laboratory provided reference ranges for specific values (re-screening or re-sampling is NOT allowed if the participant has failed one of the exclusion criteria related to laboratory parameters):
• Alanine aminotransferase (ALT)
• Aspartate aminotransferase (AST)
• Bilirubin
• Estimated glomerular filtration rate (eGFR) below 90 milliliters per minute per 1.73m^2 (mL/min/1.73m^2)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Single Dose 1: NNC0582-0001 10 milligram (mg)	NNC0582-0001	Participants will receive a single dose of NNC0582-0001 10 mg or matching placebo injection subcutaneously.
Single Dose 3: NNC0582-0001 90 mg	NNC0582-0001	Participants will receive a single dose of NNC0582-0001 90 mg or matching placebo injection subcutaneously.
Single Dose 6: NNC0582-0001 1000 mg	NNC0582-0001	Participants will receive a single dose of NNC0582-0001 1000 mg or matching placebo injection subcutaneously.
Single Dose 4: NNC0582-0001 250 mg	NNC0582-0001	Participants will receive a single dose of NNC0582-0001 250 mg or matching placebo injection subcutaneously.
Single Dose 2: NNC0582-0001 30 mg	NNC0582-0001	Participants will receive a single dose of NNC0582-0001 30 mg or matching placebo injection subcutaneously.
Single Dose 2: NNC0582-0001 30 mg	Placebo	Participants will receive a single dose of NNC0582-0001 30 mg or matching placebo injection subcutaneously.
Single Dose 4: NNC0582-0001 250 mg	Placebo	Participants will receive a single dose of NNC0582-0001 250 mg or matching placebo injection subcutaneously.
Single Dose 1: NNC0582-0001 10 milligram (mg)	Placebo	Participants will receive a single dose of NNC0582-0001 10 mg or matching placebo injection subcutaneously.
Single Dose 3: NNC0582-0001 90 mg	Placebo	Participants will receive a single dose of NNC0582-0001 90 mg or matching placebo injection subcutaneously.
Single Dose 5: NNC0582-0001 600 mg	Placebo	Participants will receive a single dose of NNC0582-0001 600 mg or matching placebo injection subcutaneously.
Single Dose 6: NNC0582-0001 1000 mg	Placebo	Participants will receive a single dose of NNC0582-0001 1000 mg or matching placebo injection subcutaneously.
Single Dose 5: NNC0582-0001 600 mg	NNC0582-0001	Participants will receive a single dose of NNC0582-0001 600 mg or matching placebo injection subcutaneously.

Primary Outcome Measures

Name	Time	Method
Number of treatment emergent adverse events (TEAEs)	From dosing (Day 1) until End of Study visit (Week 52)	Measured as number of events.

Secondary Outcome Measures

Name	Time	Method
AUC0-∞: The area under the NNC0582-0001 plasma concentration-time curve from time zero to infinity after a single dose.	From dosing (Day 1) to 168 hours after dosing	Measured in hours \* nanogram per mililiter (h\*ng/mL).
Cmax: The maximum concentration of NNC0582-0001 in plasma	From dosing (Day 1) to 168 hours after dosing	Measured in nanogram per mililiter (ng/mL).
tmax: The time from dose administration to maximum plasma concentration of NNC0582-0001	From dosing (Day 1) to 168 hours after dosing	Measured in hours.

Trial Locations

Locations (1)

Clinical Trials Unit / Center for Medical Research; 🇦🇹 Graz, Austria