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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

NCT ID: NCT05624580

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-15

Study Completion Date

2025-10-16

Brief Summary

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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

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Single Dose 1: NNC0582-0001 10 milligram (mg)

Participants will receive a single dose of NNC0582-0001 10 mg or matching placebo injection subcutaneously.

Group Type EXPERIMENTAL

NNC0582-0001

Intervention Type DRUG

Participants will receive single dose of any of the six dose levels of subcutaneous NNC0582-0001 in a sequential manner with the dose increasing between cohorts.

Placebo

Intervention Type DRUG

Participants will receive single dose of subcutaneous injection of placebo matched to NNC0582-0001.

Single Dose 2: NNC0582-0001 30 mg

Participants will receive a single dose of NNC0582-0001 30 mg or matching placebo injection subcutaneously.

Group Type EXPERIMENTAL

NNC0582-0001

Intervention Type DRUG

Participants will receive single dose of any of the six dose levels of subcutaneous NNC0582-0001 in a sequential manner with the dose increasing between cohorts.

Placebo

Intervention Type DRUG

Participants will receive single dose of subcutaneous injection of placebo matched to NNC0582-0001.

Single Dose 3: NNC0582-0001 90 mg

Participants will receive a single dose of NNC0582-0001 90 mg or matching placebo injection subcutaneously.

Group Type EXPERIMENTAL

NNC0582-0001

Intervention Type DRUG

Participants will receive single dose of any of the six dose levels of subcutaneous NNC0582-0001 in a sequential manner with the dose increasing between cohorts.

Placebo

Intervention Type DRUG

Participants will receive single dose of subcutaneous injection of placebo matched to NNC0582-0001.

Single Dose 4: NNC0582-0001 250 mg

Participants will receive a single dose of NNC0582-0001 250 mg or matching placebo injection subcutaneously.

Group Type EXPERIMENTAL

NNC0582-0001

Intervention Type DRUG

Participants will receive single dose of any of the six dose levels of subcutaneous NNC0582-0001 in a sequential manner with the dose increasing between cohorts.

Placebo

Intervention Type DRUG

Participants will receive single dose of subcutaneous injection of placebo matched to NNC0582-0001.

Single Dose 5: NNC0582-0001 600 mg

Participants will receive a single dose of NNC0582-0001 600 mg or matching placebo injection subcutaneously.

Group Type EXPERIMENTAL

NNC0582-0001

Intervention Type DRUG

Participants will receive single dose of any of the six dose levels of subcutaneous NNC0582-0001 in a sequential manner with the dose increasing between cohorts.

Placebo

Intervention Type DRUG

Participants will receive single dose of subcutaneous injection of placebo matched to NNC0582-0001.

Single Dose 6: NNC0582-0001 1000 mg

Participants will receive a single dose of NNC0582-0001 1000 mg or matching placebo injection subcutaneously.

Group Type EXPERIMENTAL

NNC0582-0001

Intervention Type DRUG

Participants will receive single dose of any of the six dose levels of subcutaneous NNC0582-0001 in a sequential manner with the dose increasing between cohorts.

Placebo

Intervention Type DRUG

Participants will receive single dose of subcutaneous injection of placebo matched to NNC0582-0001.

Interventions

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NNC0582-0001

Participants will receive single dose of any of the six dose levels of subcutaneous NNC0582-0001 in a sequential manner with the dose increasing between cohorts.

Intervention Type DRUG

Placebo

Participants will receive single dose of subcutaneous injection of placebo matched to NNC0582-0001.

Intervention Type DRUG

Eligibility Criteria

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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.
* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Transparency dept. 2834

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Clinical Trials Unit / Center for Medical Research

Graz, , Austria

Site Status

Countries

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Austria

Other Identifiers

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U1111-1274-4316

Identifier Type: OTHER

Identifier Source: secondary_id

2022-001813-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-506928-83

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN6582-4838

Identifier Type: -

Identifier Source: org_study_id