Clinical trial NCT05599945: First Human Dose Trial for a New Medication to Potentially Treat Liver Diseases
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Hepatic Steatosis
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2022-10-31
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Number of treatment emergent adverse events (TEAEs)
timeFrame: From dosing (Day 1) until completion of the End of Study Visit at week 52
Secondary outcomes:
measure: AUC0-∞: The area under the NNC0581-0001 plasma concentration-time curve from time zero to infinity after a single dose
timeFrame: From dosing (Day 1) to 168 hours after dosing
measure: Cmax: The maximum concentration of NNC0581-0001 in plasma after a single dose
timeFrame: From dosing (Day 1) to 168 hours after dosing
measure: tmax: The time from dose administration to maximum plasma concentration of NNC0581-0001 after a single dose
timeFrame: From dosing (Day 1) to 168 hours after dosing
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: Parexel CPRU, Level 7
state: Middlesex
city: Harrow
country: United Kingdom
facility: Parexel Research Unit
state: Middlesex
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency dept. 2834
role: STUDY_DIRECTOR
References: