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

Healthy Volunteers Clinical Trial

Official title:

A First Human Dose Study Investigating Safety, Tolerability, and Pharmacokinetics of Single Subcutaneous Injections of NNC0581-0001 in Healthy Adults and in Participants With Hepatic Steatosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05599945
• Other study ID #: NN6581-4860
• Secondary ID: U1111-1274-45772
• Status: Recruiting
• Phase: Phase 1
• Start date: November 23, 2022
• Est. completion date: August 28, 2025

Study information

• Verified date: May 2024
• Source: Novo Nordisk A/S
• Contact: Novo Nordisk
• Phone: (+1) 866-867-7178
• Email: clinicaltrials[@]novonordisk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: August 28, 2025
• Est. primary completion date: January 22, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria, for healthy participants in Part A:

• 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 18.5 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.

Inclusion criteria for participants with hepatic steatosis in Part B:

• 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 25.0 to 34.9 kilogram per square meter (kg/m^2) (both inclusive) at screening.

• Hepatic steatosis identified by a score above 248 dB/m by Fibroscan® (Controlled Attenuated Parameter, CAP) at screening.

Exclusion Criteria

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

• For Part A: Any laboratory safety parameters at screening outside the below laboratory ranges, 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) greater than upper normal limit (UNL) plus 10 percent

• Aspartate aminotransferase (AST) greater than UNL plus 10 percent

• Bilirubin greater than UNL plus 10 percent

• Estimated glomerular filtration rate (eGFR) below 90 milliliters per minute per 1.73 square meters (90 mL/min/1.73m^2)

• Glycated haemoglobin (HbA1c) greater than or equal to 5.7 percent (39 millimole per mole [mmol/mol]) at screening.

Related Conditions & MeSH terms

• Fatty Liver
• Healthy Volunteers
• Hepatic Steatosis

Intervention

Drug:
• NNC0581-0001
Participants will receive up to six single dose levels of subcutaneous NNC0581-0001 in a sequential manner with the dose increasing between cohorts.
• Placebo (NNC0581-0001)
Participants will receive single dose of subcutaneous injection of placebo matched to NNC0581-0001.

Locations

Country	Name	City	State
United Kingdom	Parexel CPRU, Level 7	Harrow	Middlesex

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatment emergent adverse events (TEAEs)	Measured as number of events.	From dosing (Day 1) until completion of the End of Study Visit at week 52
Secondary	AUC0-8: The area under the NNC0581-0001 plasma concentration-time curve from time zero to infinity after a single dose	Measured in nanogram hour per mililiter (ng*h/mL).	From dosing (Day 1) to 168 hours after dosing
Secondary	Cmax: The maximum concentration of NNC0581-0001 in plasma after a single dose	Measured in nanogram per mililiter (ng/mL).	From dosing (Day 1) to 168 hours after dosing
Secondary	tmax: The time from dose administration to maximum plasma concentration of NNC0581-0001 after a single dose	Measured in Hours.	From dosing (Day 1) to 168 hours after dosing