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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: NNC0582-0001; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05624580

2022-001813-38 (EudraCT Number)

2023-506928-83 (Registry Identifier)

NN6582-4838

U1111-1274-4316 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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56 participants in 6 patient groups

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

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: NNC0582-0001

Single Dose 2: NNC0582-0001 30 mg

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: NNC0582-0001

Single Dose 3: NNC0582-0001 90 mg

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: NNC0582-0001

Single Dose 4: NNC0582-0001 250 mg

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: NNC0582-0001

Single Dose 5: NNC0582-0001 600 mg

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: NNC0582-0001

Single Dose 6: NNC0582-0001 1000 mg

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: NNC0582-0001