A Study to See How Safe a New Medicine (NNC6022-0001) is in Healthy People

NCT ID: NCT06336005

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-28
• Study Completion Date: 2025-02-17

Brief Summary

The study is testing a new study medicine, which is being tested as a potential medicine to treat cardiometabolic diseases.

The aim of this study is to see if the study medicine is safe, how it works in participants body, and what the body does to the study medicine.

Participants will either get NNC6022-0001 (the new study medicine) or placebo (a "dummy medicine" without the active ingredient). Which treatment participants get is decided by chance. The study medicine is a potential new medicine which cannot be prescribed by doctors.

The study will last for about 10 months in total.

Conditions

Healthy Volunteers; Cardiometabolic Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

NNC6022-0001

Participants will be randomised to NNC6022-0001.

Group Type: EXPERIMENTAL

NNC6022-0001

Intervention Type: DRUG

Participants will recieve single ascending dose (SAD) of NNC6022-0001. Dose is given in escalating manner for up to seven cohorts.

Placebo (NNC6022-0001)

Participants will be randomised to placebo.

Group Type: PLACEBO_COMPARATOR

Placebo (NNC6022-0001)

Intervention Type: DRUG

Participants will recieve single ascending dose (SAD) of placebo. Placebo is given in escalating manner for up to seven cohorts

Interventions

NNC6022-0001

Participants will recieve single ascending dose (SAD) of NNC6022-0001. Dose is given in escalating manner for up to seven cohorts.

Intervention Type: DRUG

Placebo (NNC6022-0001)

Participants will recieve single ascending dose (SAD) of placebo. Placebo is given in escalating manner for up to seven cohorts

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Men or women of non-childbearing potential.

2. Age 18-55 years (both inclusive) at the time of signing the informed consent.

3. Body mass index (BMI) between 18.5 to 29.9 kg/m^2 (both inclusive) at screening.

4. Body Weight: Greater than or equal to 50 kg at screening.

5. 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

1. Known or suspected hypersensitivity to study intervention(s) or similar products.

2. Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.

3. Any of the below laboratory safety parameters at screening outside normal range, see designated reference range documents for specific values:.

• Alanine Aminotransferase (ALT) above upper normal limit (UNL)
• Aspartate aminotransferase (AST) above UNL
• Total Bilirubin (BL) above UNL
• Creatinine above UNL
• International normalized ratio (INR) above UNL
• Fibrinogen outside normal range of 1.6 - 4.2 gram pr. Liter (g/L)
• C-reactive protein (CRP) above 5 milligram pr. Liter (mg/L) (males) and above 8 mg/L (females)

4. Use of prescription medicinal products or vaccines within 14 days before dosing and/or non prescription medicinal products within 7 days before dosing.

Exceptions are: Topical medications not reaching systemic circulation; less than once per week of over-the-counter paracetamol, ibuprofen and/or acetylsalicylic acid at their labelled doses for mild pain; vitamins at their labelled doses.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency (Dept. 2834).

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

ICON - location Groningen

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

U1111-1290-1002

Identifier Type: OTHER

Identifier Source: secondary_id

2023-505026-34

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN6022-7683

Identifier Type: -

Identifier Source: org_study_id