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

NCT ID: NCT05015894

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-30
• Study Completion Date: 2022-08-02

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NNC0480-0389

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

Group Type: EXPERIMENTAL

NNC0480-0389

Intervention Type: DRUG

A single dose of 18 mg NNC0480 0389 administered subcutaneously (under the skin).

Total duration of study participation for each participant is 38 to 66 days

Interventions

NNC0480-0389

A single dose of 18 mg NNC0480 0389 administered subcutaneously (under the skin).

Total duration of study participation for each participant is 38 to 66 days

Intervention Type: DRUG

Eligibility Criteria

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

• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency (Dept. 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Berlin, , Germany

Countries

Germany

Other Identifiers

2021-001450-57

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1266-0594

Identifier Type: OTHER

Identifier Source: secondary_id

NN9389-4682

Identifier Type: -

Identifier Source: org_study_id