Multiple dose study for a new medication to potentially treat liver diseases
Research type
Research Study
Full title
Investigation of safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of NNC0581-0001 in participants with hepatic steatosis and suspected steatohepatitis
IRAS ID
1010323
Contact name
Jake Bomford
Contact email
Sponsor organisation
Novo Nordisk A/S
Research summary
The trial is a single-centre, randomized or open label trial dependent on cohort. A total of 48 men and women (of non childbearing potential) with increased liver fat and suspected inflammation will take part in this study in the UK. A total of 38 will be randomized into the double blind placebo controlled cohort.
A total of 10 will take part in the open-label part of the study.This study is being performed to determine the safety, tolerability and how the study medicine is absorbed and eliminated from the human body. The study will also explore how the human body is affected by the study medicine.
NNC0581-0001 is an siRNA (a complex organic substance present in living cells) which is being developed as a treatment for Metabolic dysfunction-associated steatohepatitis (MASH). At the time of starting this study, single doses of up to 1000 mg have previously been tested in 24 healthy volunteers and in 12 patients with increased liver fat. No serious or severe side effects related to the study medicine have been reported.
The randomized cohort will comprise of:
- Three treatment periods where participants are hospitalised for three days for baseline assessments, administration of study medicine/placebo and a close safety monitoring.
- There will be 11 visits at the clinical unit in total
- 3 visits to NHS hospitals for MRI scans in total
- 11 Follow up phone calls
The Open label cohort will comprise of the same as above except for:
- 2 additional visits to NHS hospitals for liver biopsy (once at during screening period, once 16 weeks after first treatment)REC name
London - Surrey Borders Research Ethics Committee
REC reference
24/LO/0561
Date of REC Opinion
24 Sep 2024
REC opinion
Further Information Favourable Opinion