A Research Study Looking Into Blood Levels of the Medicine NNC0480-0389 in Participants With Reduced Kidney Function Compared to Participants With Normal Kidney Function

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: NNC0480-0389

• Registration Number: NCT05015894
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

Novo Nordisk is developing a combination therapy with the study medicine NNC0480-0389 and an already approved medicine called "semaglutide" for the treatment of type-2 diabetes (T2D). It is expected that the combination will further improve the blood sugar control compared to semaglutide therapy alone.In this study the blood levels of NNC0480-0389 will be compared in people with various degrees of reduced kidney function to the blood levels in people with normal kidney function, after administration of one dose of 18 mg NNC0480-0389. Participants will only get the study medicine as two injections into a skinfold of participants belly (subcutaneous).

The study will last for about 65 days including a screening phase of up to 28 days prior to dosing.

If participants are eligible for the study, participants will have 11 visits to the study centre including one in-house stay of 5 days and 4 nights (Visit 2) and nine ambulatory visits (Visit 3 to Visit 11).

Participants' vital signs (heart rate, blood pressure, body temperature) will be measured, participants will have blood drawn, urine will be collected and electrocardiograms (ECGs) will be recorded.If participants are women and can get pregnant they cannot take part in the study. A hormone test will be done to check if participants may be post-menopausal.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-19
• Study First Submitted QC: 2021-08-20
• Study First Posted: 2021-08-23
• Study Start: 2021-08-30
• Primary Completion: 2022-08-02
• Study Completion: 2022-08-02
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-10
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Male or female of non-childbearing potential, aged 18-75 years (both inclusive) at the time of signing informed consent.

• Body mass index (BMI) between 20.0 and 39.9 kg/m^2 (both inclusive)

• Meeting the pre-defined GFR criteria using estimated GFR (eGFR) based on serum creatinine for any of the renal function groups:

  • For participants with normal renal function: eGFR of equal to or greater than 90 mL/min
  • For participants with mild renal impairment: eGFR of 60-89 mL/min
  • For participants with moderate renal impairment: eGFR of 30-59 mL/min
  • For participants with severe renal impairment: eGFR of 15-29 mL/min not requiring dialysis
  • For participants with kidney failure: eGFR of less than 15 mL/min or requiring dialysis treatment

Specific inclusion criteria for participants with kidney failure requiring dialysis treatment:

* Current treatment with haemodialysis

Exclusion Criteria

• Any disorder 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 drugs known to affect creatinine clearance including cephalosporin and aminoglycoside antibiotics, flucytosine, cisplatin, cimetidine, trimethoprim and cibenzoline within 14 days or 5 half-lives, whichever is greater, before dosing the investigational medicinal product (IMP).
• Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions (except conditions associated with renal impairment or kidney failure).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NNC0480-0389	NNC0480-0389	All participants will be administered a single s.c. dose of 18 mg NNC0480-0389

Primary Outcome Measures

Name	Time	Method
AUC0-∞,NNC0480-0389,SD, area under the NNC0480-0389 plasma concentration time curve after a single dose	From baseline (visit 2, day 1, pre-dose) until completion of the end-of-study visit (visit 11, day 36)	h\*nmol/L

Secondary Outcome Measures

Name	Time	Method
Cmax,NNC0480-0389,SD, Maximum observed NNC0480-0389 plasma concentration after a single dose	From baseline (visit 2, day 1, pre-dose) until completion of the end-of-study visit (visit 11, day 36)	nmol/L

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Berlin, Germany