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

Investigation of Pharmacokinetics, Safety and Tolerability of Oral NNC0385-0434 in Participants With Various Degrees of Impaired Renal Function and in Participants With Normal Renal Function

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Drug: NNC0385-0434 A 100 mg

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Normal renal function; All participants will receive 100 mg of NNC0385-0434 in an oral tablet per day for 10 days	Drug: NNC0385-0434 A 100 mg; 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.
Experimental: Mildly decreased renal function; All participants will receive 100 mg of NNC0385-0434 in an oral tablet per day for 10 days	Drug: NNC0385-0434 A 100 mg; 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.
Experimental: Moderately decreased renal function; All participants will receive 100 mg of NNC0385-0434 in an oral tablet per day for 10 days	Drug: NNC0385-0434 A 100 mg; 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.
Experimental: Severely decreased renal function; All participants will receive 100 mg of NNC0385-0434 in an oral tablet per day for 10 days	Drug: NNC0385-0434 A 100 mg; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-24h,0434,Day10: the area under the NNC0385-0434 plasma concentration-time curve from time 0 to 24 hours after last dose of oral NNC0385-0434	Measured in h*nmol/L	From last dose (Day 10) to 24 hours post treatment (Day 11)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax,0434,Day10: the maximum plasma concentration of NNC0385-0434 after last dose of oral NNC0385-0434	nmol/L	From last dose (Day 10) to post treatment follow-up (Day 65)
tmax,0434,Day10: time from last dose administration to maximum plasma concentration of oral NNC0385-0434	h	From last dose (Day 10) to post treatment follow-up (Day 65)
t½,0434,Day10; the terminal half-life of NNC0385-0434 after last dose of oral NNC0385-0434	h	From last dose (Day 10) to post treatment follow-up (Day 65)
CLR,0434,Day10; the renal clearance of NNC0385-0434 after last dose of oral NNC0385-0434	mL/h	From last dose (Day 10) to 48 hours post treatment (Day 12)
AUC0-24h,SNAC,Day10: the area under the SNAC plasma concentration-time curve from time 0 to 24 hours after last dose of oral NNC0385-0434	h*ng/mL	From last dose (Day 10) to 24 hours post treatment (Day 11)
Cmax,SNAC,Day10; the maximum plasma concentration of SNAC after last dose of oral NNC0385-0434	ng/mL	From last dose (Day 10) to 24 hours post treatment (Day 11)
Cmin,SNAC,Day10; the minimum plasma concentration of SNAC before last dose of oral NNC0385-0434	nmol/L	Pre-dose (Day 10)
tmax,SNAC,Day10; the time to maximum observed plasma concentration of SNAC after last dose of oral NNC0385-0434	hours	From last dose (Day 10) to 24 hours post treatment (Day 11)
CLR,SNAC,Day10; the renal clearance of SNAC after last dose of oral NNC0385-0434	mL/h	From last dose (Day 10) to 48 hours post treatment (Day 12)
Number of treatment emergent adverse events (TEAEs)	Number of events	From first dose (Day 1) until completion of the post-treatment period at follow-up (Day 65)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2021
• Primary Completion (Actual): July 15, 2022
• Study Completion (Actual): August 24, 2022

Study Registration Dates

• First Submitted: September 27, 2021
• First Submitted That Met QC Criteria: October 15, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: NN6435-4749; U1111-1264-2693 (Other Identifier: World Health Organization (WHO)); 2021-000462-16 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No