A Research Study Looking Into Levels of the Medicine NNC0385-0434 in the Body and How Well it is Tolerated in Participants With Impaired Kidney Function Compared to Participants With Normal Kidney Function

Novo Nordisk

Status and phase: Terminated; Phase 1

Conditions: Chronic Kidney Disease

Treatments: Drug: NNC0385-0434 A 100 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05094934

2021-000462-16 (EudraCT Number)

NN6435-4749

U1111-1264-2693 (Other Identifier)

Details and patient eligibility

About

Novo Nordisk is developing a new medicine, NNC0385-0434, to help people lower their cholesterol level.

The aim of this study is to look at how NNC0385-0434 works in the body and how it is removed from the body in people with impaired kidney function.

All participants will receive the same dose (100 mg) of the study medicine NNC0385-0434, which will be given for 10 days in a row. Participants will get the study medicine in a tablet taken orally once-daily. The study medicine needs to be taken in the morning after overnight fasting and 30 minutes before the first meal of the day.

The study will last for about 9-14 weeks.

Participants will have 15 visits to the study centre, including 2 in-house stays of 3 days and 2 nights and 13 ambulatory visits.

Participants' vital signs (heart rate, blood pressure, body temperature) will be measured, participants will have blood draws, urine will be collected and electrocardiograms (ECGs) will be recorded.

Participants cannot take part in the study if they have gastrointestinal disorders or unusual meal habits and special dietary requirements.

Women can only take part in the study if they cannot get pregnant.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) between 20.0 and 34.9 kg/m^2 (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 KDIGO 2012:

Group description eGFR (mL/min)

1. Normal renal function more than or equal to 90
2. Mildly decreased renal function 60 - less than 90
3. Moderately decreased renal function 30 - less than 60
4. Severely decreased renal function less than 30 not requiring dialysis

Exclusion criteria

• Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the study doctor.
• Unusual meal habits and special dietary requirements or unwillingness to eat the food provided in the study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

Normal renal function

Active Comparator group

Description:

All participants will receive 100 mg of NNC0385-0434 in an oral tablet per day for 10 days

Treatment:

Drug: NNC0385-0434 A 100 mg

Mildly decreased renal function

Experimental group

Description:

All participants will receive 100 mg of NNC0385-0434 in an oral tablet per day for 10 days

Treatment:

Drug: NNC0385-0434 A 100 mg

Moderately decreased renal function

Experimental group

Description:

All participants will receive 100 mg of NNC0385-0434 in an oral tablet per day for 10 days

Treatment:

Drug: NNC0385-0434 A 100 mg

Severely decreased renal function

Experimental group

Description:

All participants will receive 100 mg of NNC0385-0434 in an oral tablet per day for 10 days

Treatment:

Drug: NNC0385-0434 A 100 mg