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

NCT05727644 | Completed Phase 1

• 3 other identifiers: NN9500-4620U1111-1277-36462022-001849-20
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Novo Nordisk is developing the study medicine NNC0194-0499 for the treatment of non-alcoholic steatohepatitis (NASH). NASH is a serious disease where fat, inflammation and scar tissue builds up in the liver. In this study the blood and urine levels of NNC0194-0499 will be compared in people with various degrees of reduced kidney function to the blood and urine levels in people with normal kidney function, after administration of one dose of 30 milligrams (mg) NNC0194-0499. Participant will only get the study medicine in one injection into a skinfold in the thigh (subcutaneous). The study will last for about 66 days including a screening phase of up to 28 days prior to dosing.

Conditions

Non-alcoholic Steatohepatitis (NASH)

Outcome Measures

Primary Outcomes (1)

• AUC0499,0-∞,SD: Area under the NNC0194-0499 serum concentration-time curve after a single dose

  Measured as hours\*nanomoles per litre (h\*nmol/L)

  From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36)

Secondary Outcomes (6)

• Cmax,0499,SD: Maximum observed serum NNC0194-0499 concentration after a single dose

  From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36)

• tmax,0499,SD: Time to maximum observed serum NNC0194-0499 concentration after a single dose

  From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36)

• t½,0499,SD: Terminal half-life of NNC0194-0499 after a single dose

  From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36)

• Vz/F0499,SD: Apparent volume of distribution of NNC0194-0499 after a single dose

  From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36)

• CL/F0499,SD: Apparent clearance of NNC0194-0499 after a single dose

  From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36)

Study Arms (2)

Participants with normal renal function

ACTIVE COMPARATOR

Participants will receive a single subcutaneous injection of 30 mg NNC0194-0499.

Drug: NNC0194-0499

Participants with impaired renal function

EXPERIMENTAL

Participants will receive a single subcutaneous injection of 30 mg NNC0194-0499.

Drug: NNC0194-0499

Interventions

NNC0194-0499 DRUG

Participants will receive a single subcutaneous injection of 30 mg NNC0194-0499.

Participants with impaired renal function; Participants with normal renal function

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2023
• First Posted: February 14, 2023
• Study Start: February 15, 2023
• Primary Completion: November 10, 2023
• Study Completion: November 10, 2023
• Last Updated: December 6, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)