New medication for treating liver diseases

Investigation of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of NNC0581-0001 in Participants With Hepatic Steatosis and Suspected Steatohepatitis

This study is testing a new medication for people with liver diseases to see if it is safe and helps reduce liver fat and inflammation.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Novo Nordisk A/S (Industry-sponsored)
• Locations: 1 site (Harrow)
• Trial ID: NCT06891365 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, and pharmacokinetics of a new medication, NNC0581-0001, in participants with hepatic steatosis and suspected steatohepatitis. Participants will receive either the medication or a placebo through monthly injections over three months. The study aims to determine how well the medication is tolerated and its effects on liver fat and inflammation. The overall duration of the study is approximately 58 weeks.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-64 with a body mass index between 25.0 and 39.9 and specific liver fat and stiffness measurements.

Not a fit: Patients outside the specified age range, with a BMI outside the inclusion criteria, or without the required liver conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this medication could provide a new treatment option for patients with liver diseases, potentially improving liver health and reducing fat accumulation.

How similar studies have performed: While this approach is novel, similar studies targeting liver diseases have shown promise, indicating potential for success.

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.

Where this trial is running

Harrow

• Parexel Research Unit — Harrow, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Novo Nordisk

Conditions Healthy Volunteers; Hepatic Steatosis