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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers; Cardiometabolic Diseases

Treatments: Drug: NNC6022-0001; Drug: Placebo (NNC6022-0001)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06336005

U1111-1290-1002 (Other Identifier)

NN6022-7683

2023-505026-34 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups, including a placebo group

NNC6022-0001

Experimental group

Description:

Participants will be randomised to NNC6022-0001.

Treatment:

Drug: NNC6022-0001

Placebo (NNC6022-0001)

Placebo Comparator group

Description:

Participants will be randomised to placebo.

Treatment:

Drug: Placebo (NNC6022-0001)