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NCT05599945 | RECRUITING | Healthy Volunteers

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

Condition or disease

Healthy Volunteers

Hepatic Steatosis

Intervention/treatment

NNC0581-0001

Placebo (NNC0581-0001)

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 48 participants
Masking : QUADRUPLE
Masking Description : Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2022-11-23
Estimated Primary Completion Date : 2025-01-22
Estimated Study Completion Date : 2025-08-28

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 55 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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.
First Human Dose Trial for a New Medication to Potentially Treat Liver Diseases

Location Details

NCT05599945

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United Kingdom, Middlesex

Parexel CPRU, Level 7

Harrow, Middlesex, United Kingdom, HA1 3UJ