GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Research Study Looking Into Blood Levels of the Medicine NNC0487-0111 in the Body and How Well it is Tolerated in Participants With Reduced Kidney Function and Normal Kidney Function

Investigation of Pharmacokinetics, Safety and Tolerability of a Single Subcutaneous Dose of NNC0487-0111 in Participants With Various Degrees of Renal Impairment and Normal Renal Function

Lead sponsor

Novo Nordisk A/S

Asset

Amycretin / zenagamtide

Oral · GLP-1 / amylin

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers, Renal impairment

Key I/E criterion

•BMI 20-39.9

Primary endpoint

•AUC0111,0-∞,SD

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06559527

Org study IDNN9490-7611

Secondary ID2023-509961-19European Medical Agency (EMA)

Secondary IDU1111-1298-6886World Health Organization (WHO)

Timeline

Milestones

Study first posted2024-08-19actual

Study start2024-08-20actual

Primary completion2025-02-24actual

Study completion2025-03-05actual

Last update posted2025-03-30actual

Assets

Investigational agents

Amycretin / zenagamtide

Study populations

Who this study enrolls

Healthy volunteersRenal impairment

Eligibility

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female, aged 18-80 years (both inclusive) at the time of signing the informed consent

•Body mass index (BMI) between 20.0 and 39.9 kilogram per square meter (kg/m^2) (both inclusive) at screening.

•Meeting the pre-defined eGFR values based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation (2021) adjusted for the estimated individual body surface area (BSA);

–Normal renal function - greater than or equal to 90 mL/min

–Mild renal impairment - 60 - 89 (mL/min)

–Moderate renal impairment - 30 - 59 (mL/min)

–Severe renal impairment - less than 30 (mL/min) not requiring dialysis

–End-stage renal disease (ESRD) - Requiring dialysis treatment

•For ESRD: Participants requiring dialysis treatment should be on current treatment with haemodialysis.

Exclusion criteria

•Any disorder, unwillingness, or inability which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol.

•Use of drugs known to affect creatinine clearance including cephalosporin and aminoglycoside, antibiotics, flucytosine, cisplatin, cimetidine, trimethoprim, cibenzoline, and nitrofurantoin 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, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions(except conditions associated with renal impairment or ESRD).

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

7 endpoints

Primary/protocol endpoint

AUC0111,0-∞,SD: Area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose