Multiple Dose Study for a New Medication to Potentially Treat Liver Diseases

NCT06891365 | Recruiting Phase 1

• 2 other identifiers: NN6581-4981U1111-1298-9628
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of NNC0581-0001 in participants with hepatic steatosis and suspected steatohepatitis (increased liver fat and suspected inflammation). NNC0581-0001 will be given in 2 different dose levels as injection under the skin (once per month for 3 months). 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.

Conditions

Healthy Volunteers; Hepatic Steatosis

Outcome Measures

Primary Outcomes (1)

• Number of treatment emergent adverse events (TEAEs)

  Measured as count of events.

  From 1st dose (day 1) until completion of the end of study visit at week 52

Secondary Outcomes (3)

• AUC0-32h: The area under the NNC0581-0001 plasma concentration-time curve from time zero to 32 hours after each of the three doses

  From dosing (day 1 in each treatment period) to 32 hours post dose

• Cmax: The maximum concentration of NNC0581-0001 in plasma after each dose of three doses

  From dosing (day 1 in each treatment period) to 32 hours post dose

• Tmax: The time from dose administration to maximum plasma concentration of NNC0581-0001 after each dose of three doses

  From dosing (day 1 in each treatment period) to 32 hours post dose

Study Arms (2)

Cohort 1: NNC0581-0001 (Dose 1)

EXPERIMENTAL

Participants will receive a subcutaneous (s.c) injection of either NNC0581-0001 Dose 1 or a matching placebo once monthly.

Drug: NNC0581-0001; Drug: Placebo (NNC0581-0001)

Cohort 2: NNC0581-0001 (Dose 2)

EXPERIMENTAL

Participants will receive a s.c injection of either NNC0581-0001 Dose 2 or a matching placebo once monthly.

Drug: NNC0581-0001; Drug: Placebo (NNC0581-0001)

Interventions

NNC0581-0001 DRUG

NNC0581-0001 will be administered subcutaneously.

Cohort 1: NNC0581-0001 (Dose 1); Cohort 2: NNC0581-0001 (Dose 2)

Placebo (NNC0581-0001) DRUG

Placebo matched to NNC0581-0001 will be administered subcutaneously.

Cohort 1: NNC0581-0001 (Dose 1); Cohort 2: NNC0581-0001 (Dose 2)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Considered eligible 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.
• Male or female (of non-childbearing potential) aged 18-64 years (both inclusive) at the time of signing the informed consent.
• Body mass index (BMI) 25.0 to 39.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening.
• Liver fat content measured by magnetic resonance imaging - estimated proton density fat fraction (MRI-PDFF) greater than or equal to (\>=) 10 percent and liver stiffness greater than 8 kilopascal (kPa) as measured by FibroScan® (vibration-controlled transient elastography \[VCTE™\]).
• Alanine aminotransferase (ALT) in men greater than (\>) 30 units per liter (U/L), women \> 19 U/L
• Liverstiffness, measured by FibroScan® (VCTE) \> 8 kPa and less than (\<) 12 kPa
• Informed consent obtained at screening for a liver biopsy to be performed at baseline and post-treatment.
• Note: Participants with confirmed metabolic dysfunction-associated steatohepatitis (MASH), based on a prior liver biopsy, can be included in the open-label cohort.

You may not qualify if:

• Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
• ALT \>= 3 × upper limit of normal (ULN)
• Aspartate aminotransferase (AST) \>= 3 × ULN
• Bilirubin \> 1.5 × ULN
• Estimated glomerular filtration rate (eGFR) \< 60 milliliter per minute per 1.73 square meters (mL/min/1.73 m\^2) at screening.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Parexel CPRU, Level 7

Harrow, HA1 3UJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

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 17, 2025
• First Posted: March 24, 2025
• Study Start: March 12, 2025
• Primary Completion (Estimated): January 25, 2027
• Study Completion (Estimated): January 25, 2027
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)