A Research Study Looking Into Blood and Urine Levels of the Medicine NNC0194-0499 in the Body and How Well it is Tolerated in Participants With Reduced Kidney Function and Normal Kidney Function
Non-alcoholic Steatohepatitis (NASH)
About this trial
This is an interventional treatment trial for Non-alcoholic Steatohepatitis (NASH)
Eligibility Criteria
Inclusion Criteria: Male or female, aged 18-80 years (both inclusive) at the time of signing informed consent. Body mass index (BMI) between 18.5-39.9 kilogram per meter square (kg/m2) (both inclusive). Meeting the pre-defined estimated glomerular filtration rate (eGFR) values based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation according to Kidney Disease: Improving Global Outcomes (KDIGO) 20121, 2 standardized to the individual body surface area (BSA). Group description eGFR (mL/min) Normal renal function greater than or equal to 90 Mild renal impairment 60 - 89 Moderate renal impairment 30 - 59 Severe renal impairment 15 - 29 not requiring dialysis End-Stage Renal Disease (ESRD) less than 15 or requiring dialysis treatment Renal group 5 (ESRD). Participants requiring dialysis treatment should be on treatment with haemodialysis. Exclusion Criteria: Any disorder, except for conditions associated with renal impairment, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. Use of prescription medicinal products or non-prescription drugs, or non-routine vitamins, which at the investigators judgement may affect participant safety or the results of the study within 14 days before screening. Use of the following are allowed: Routine vitamins, occasional use of paracetamol, ibuprofen and topical medication not reaching systemic circulation. Use of drugs known to affect creatinine clearance including cephalosporin and aminoglycoside antibiotics, flucytosine, cisplatin, cimetidine, trimethoprim, cibenzoline and nitrofurantoin within 14 days or 5 half-lives, whichever is greater, before planned dosing of the investigational medicinal product (IMP). Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions (except conditions associated with renal impairment or ESRD).
Sites / Locations
- Novo Nordisk Investigational SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Participants with normal renal function
Participants with impaired renal function
Participants will receive a single subcutaneous injection of 30 mg NNC0194-0499.
Participants will receive a single subcutaneous injection of 30 mg NNC0194-0499.