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

NCT ID: NCT05727644

Last Updated: 2023-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-15
• Study Completion Date: 2023-11-10

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)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Participants with normal renal function

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

Group Type: ACTIVE_COMPARATOR

NNC0194-0499

Intervention Type: DRUG

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

Participants with impaired renal function

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

Group Type: EXPERIMENTAL

NNC0194-0499

Intervention Type: DRUG

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

Interventions

NNC0194-0499

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

Intervention Type: DRUG

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)

1. Normal renal function greater than or equal to 90

2. Mild renal impairment 60 - 89

3. Moderate renal impairment 30 - 59

4. Severe renal impairment 15 - 29 not requiring dialysis

5. 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Berlin, , Germany

Countries

Germany

Other Identifiers

U1111-1277-3646

Identifier Type: OTHER

Identifier Source: secondary_id

2022-001849-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN9500-4620

Identifier Type: -

Identifier Source: org_study_id