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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

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05015894
Collaborator
(none)
42
Enrollment
1
Location
1
Arm
11
Anticipated Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Investigation of the Pharmacokinetics of Subcutaneously Administered NNC0480-0389 in Participants With Various Degrees of Impaired Renal Function Compared to Participants With Normal Renal Function
Actual Study Start Date :
Aug 30, 2021
Anticipated Primary Completion Date :
Jul 30, 2022
Anticipated Study Completion Date :
Jul 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: NNC0480-0389

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

Drug: 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novo Nordisk Investigational Site Berlin Germany 10117

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (Dept. 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT05015894
Other Study ID Numbers:
  • NN9389-4682
  • 2021-001450-57
  • U1111-1266-0594
First Posted:
Aug 23, 2021
Last Update Posted:
Sep 5, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Sep 5, 2021