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

NCT06336005 | Completed Phase 1 FDA Drug

• 3 other identifiers: NN6022-7683U1111-1290-10022023-505026-34
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of treatment emergent adverse events (TEAE)

  Number of events

  From time of dosing (Day 1) to end of study (Day 14)

Secondary Outcomes (4)

• AUC0-t, SD; the area under the NNC6022 0001 plasma concentration-time curve from time 0 to last measurable plasma concentration after a single dose

  From pre-dose (Day 1) to end of exposure (Day 7)

• AUC0-∞, SD; the area under the NNC6022 0001 plasma concentration-time curve from time 0 to infinity after a single dose

  From pre-dose (Day 1) to end of exposure (Day 7)

• Cmax, SD; the maximum plasma concentration of NNC6022 0001 after a single dose

  From pre-dose (Day 1) to end of exposure (Day 7)

• IL-1β, SD; ratio of <Timepoint> (time of the maximal plasma concentration of NNC6022 0001) to baseline

  From pre-dose (Day 1) to estimated tmax (Day 1)

Study Arms (2)

NNC6022-0001

EXPERIMENTAL

Participants will be randomised to NNC6022-0001.

Drug: NNC6022-0001

Placebo (NNC6022-0001)

PLACEBO COMPARATOR

Participants will be randomised to placebo.

Drug: Placebo (NNC6022-0001)

Interventions

NNC6022-0001 DRUG

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

NNC6022-0001

Placebo (NNC6022-0001) DRUG

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

Placebo (NNC6022-0001)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men or women of non-childbearing potential.
• Age 18-55 years (both inclusive) at the time of signing the informed consent.
• Body mass index (BMI) between 18.5 to 29.9 kg/m\^2 (both inclusive) at screening.
• Body Weight: Greater than or equal to 50 kg 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.

You may not qualify if:

• Known or suspected hypersensitivity to study intervention(s) or similar products.
• Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
• 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)
• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

ICON - location Groningen

Groningen, 9728 NZ, Netherlands

Location

Study Officials

• Clinical Transparency (Dept. 2834).

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 28, 2024
• Study Start: March 28, 2024
• Primary Completion: February 10, 2025
• Study Completion: February 17, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)