First Human Dose Trial for a New Medication to Potentially Treat Liver Diseases

Phase 1

Active, not recruiting

• Conditions: Healthy Volunteers; Hepatic Steatosis
• Interventions: Drug: NNC0581-0001; Drug: Placebo (NNC0581-0001)

• Registration Number: NCT05599945
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study will assess the safety, tolerability, the pharmacokinetics from single injection (under the skin) of NNC0581-0001 and explores the pharmacodynamics in healthy participants and participants with hepatic steatosis (increased liver fat). Participants will either get NNC0581-001 or Placebo (dummy treatment). Which treatment participants get is decided by chance.NNC0581-0001 is a new medicine which cannot be prescribed by doctors. The study will last about 58 weeks.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-10-26
• Study First Posted: 2022-10-31
• Study Start: 2022-11-23
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-27
• Primary Completion: 2025-08-28
• Study Completion: 2025-08-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Single Dose 5: NNC0581-001 600 mg	Placebo (NNC0581-0001)	Part B: Participants with hepatic steatosis will receive a single dose of NNC0581-0001 600 mg or matching placebo injection subcutaneously.
Single Dose 3: NNC0581-0001 90 mg	Placebo (NNC0581-0001)	Part A: Healthy participants will receive a single dose of NNC0581-0001 90 mg or matching placebo injection subcutaneously.
Single Dose 2: NNC0581-0001 30 mg	NNC0581-0001	Part A: Healthy participants will receive a single dose of NNC0581-0001 30 mg or matching placebo injection subcutaneously.
Single Dose 1: NNC0581-0001 10 milligram (mg)	Placebo (NNC0581-0001)	Part A: Healthy participants will receive a single dose of NNC0581-0001 10 mg or matching placebo injection subcutaneously.
Single Dose 3: NNC0581-0001 90 mg	NNC0581-0001	Part A: Healthy participants will receive a single dose of NNC0581-0001 90 mg or matching placebo injection subcutaneously.
Single Dose 4: NNC0581-0001 250 mg	Placebo (NNC0581-0001)	Part A: Healthy participants will receive a single dose of NNC0581-0001 250 mg or matching placebo injection subcutaneously.
Single Dose 4: NNC0581-0001 250 mg	NNC0581-0001	Part A: Healthy participants will receive a single dose of NNC0581-0001 250 mg or matching placebo injection subcutaneously.
Single Dose 6: NNC0581-001 1000 mg	NNC0581-0001	Part B: Participants with hepatic steatosis will receive a single dose of NNC0581-0001 1000 mg or matching placebo injection subcutaneously.
Single Dose 2: NNC0581-0001 30 mg	Placebo (NNC0581-0001)	Part A: Healthy participants will receive a single dose of NNC0581-0001 30 mg or matching placebo injection subcutaneously.
Single Dose 6: NNC0581-001 1000 mg	Placebo (NNC0581-0001)	Part B: Participants with hepatic steatosis will receive a single dose of NNC0581-0001 1000 mg or matching placebo injection subcutaneously.
Single Dose 5: NNC0581-001 600 mg	NNC0581-0001	Part B: Participants with hepatic steatosis will receive a single dose of NNC0581-0001 600 mg or matching placebo injection subcutaneously.
Single Dose 1: NNC0581-0001 10 milligram (mg)	NNC0581-0001	Part A: Healthy participants will receive a single dose of NNC0581-0001 10 mg or matching placebo injection subcutaneously.

Primary Outcome Measures

Name	Time	Method
Number of treatment emergent adverse events (TEAEs)	From dosing (Day 1) until completion of the End of Study Visit at week 52	Measured as number of events.

Secondary Outcome Measures

Name	Time	Method
tmax: The time from dose administration to maximum plasma concentration of NNC0581-0001 after a single dose	From dosing (Day 1) to 168 hours after dosing	Measured in Hours.
AUC0-∞: The area under the NNC0581-0001 plasma concentration-time curve from time zero to infinity after a single dose	From dosing (Day 1) to 168 hours after dosing	Measured in nanogram hour per mililiter (ng\*h/mL).
Cmax: The maximum concentration of NNC0581-0001 in plasma after a single dose	From dosing (Day 1) to 168 hours after dosing	Measured in nanogram per mililiter (ng/mL).

Trial Locations

Locations (2)

Parexel Research Unit; 🇬🇧 Harrow, Middlesex, United Kingdom

Parexel CPRU, Level 7; 🇬🇧 Harrow, Middlesex, United Kingdom