NCT06891365 Multiple Dose Study for a New Medication to Potentially Treat Liver Diseases
| NCT ID | NCT06891365 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Novo Nordisk A/S |
| Condition | Healthy Volunteers |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2025-03-12 |
| Primary Completion | 2027-10-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 48 participants in total. It began in 2025-03-12 with a primary completion date of 2027-10-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 18-69 years (both inclusive) at the time of signing the informed consent. * Body mass index (BMI) greater than or equal to (\>=) 25.0 at screening. * Liver fat content measured by magnetic resonance imaging - estimated proton density fat fraction (MRI-PDFF) \>= 10 percent at screening. Additional inclusion criteria for participants in the open-label liver biopsy cohort apply: * 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. Exclusion Criteria: * Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * Any laboratory safety parameter, at screening, outside the extended laboratory ranges, and considered clinically significant per the principal investigator (see laboratory provided reference ranges for specific values). Of note, re-screening or re-sampling is NOT allowed if the individual has failed one of the exclusion criteria related to the following laboratory parameters: * ALT \>= 3 × upper limit of normal (ULN) * Aspartate aminotransferase (AST) \>= 3 × ULN * Bilirubin \> 1.5 × ULN * Estimated glomerular filtration rate (eGFR) \< 50 milliliter per minute per 1.73 square meters (mL/min/1.73 m\^2) at screening. Additional exclusion criteria for participants in the open-label liver biopsy group apply: * Medical history of abnormal bleeding * BMI \> 34.9 kilograms per square meters (kg/m\^2) * Presence of ascites * Cirrhosis based on screening tests or historical biopsy * Lab abnormalities of platelets count \< 150 × 10\^9 per liter or International Normalized Ratio (INR) \> 1.2 * Concomitant use of medication: * anticoagulants or herbal supplements with an anticoagulative effect (as judged by the principal investigator) * antiplatelet medications * exception for aspirin that must be stopped 5 days prior to procedure and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) that must not be taken within 3 days of the procedure.
Contact & Investigator
Clinical Transparency (dept. 2834)
STUDY DIRECTOR
Novo Nordisk A/S
Frequently Asked Questions
Who can join the NCT06891365 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Healthy Volunteers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06891365 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06891365 currently recruiting?
Yes, NCT06891365 is actively recruiting participants. Contact the research team at clinicaltrials@novonordisk.com for enrollment information.
Where is the NCT06891365 trial being conducted?
This trial is being conducted at Harrow, United Kingdom.
Who is sponsoring the NCT06891365 clinical trial?
NCT06891365 is sponsored by Novo Nordisk A/S. The principal investigator is Clinical Transparency (dept. 2834) at Novo Nordisk A/S. The trial plans to enroll 48 participants.