Efficacy, safety, and pharmacokinetics of NNC0519-0130 once weekly s.c. versus semaglutide 1.0 mg and placebo in people with chronic kidney disease, with or without type 2 diabetes, and with overweight or obesity: a proof-of-concept and dose-finding study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-510846-15-00

Acronym

NN9541-7841

Enrollment

120

Registered

2024-11-26

Start date

2025-04-14

Completion date

Unknown

Last updated

2025-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, with or without Type 2 diabetes, Obesity

Brief summary

Change in UACR From baseline (week 0) to end of a given maintenance dose period (week 12, 24 or 36)

Detailed description

Change in eGFR (creatinine and cystatin C-based CKD-EPI 2021) from baseline to end of treatment, Change in eGFR (creatinine-based CKD-EPI 2021) from baseline to end of treatment, Relative change in body weight from baseline to end of treatment, Achievement of ≥ 5 % weight reduction from baseline to end of treatment, Achievement of ≥ 10 % weight reduction from baseline to end of treatment, Change in waist circumference from baseline to end of treatment, Change in glycated haemoglobin (HbA1c) from baseline to end of a given maintenance dose period (week 12, 24 or 36), Change in systolic blood pressure from baseline to end of treatment, Change in diastolic blood pressure from baseline to end of treatment, Number of treatment emergent adverse events (TEAEs) from baseline to end of study

Interventions

DRUGPlacebo A

DRUGNNC0519-0130

DRUGOzempic 0.5 mg solution for injection in pre-filled pen

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change in UACR From baseline (week 0) to end of a given maintenance dose period (week 12, 24 or 36)	—

Secondary

Measure	Time frame
Change in eGFR (creatinine and cystatin C-based CKD-EPI 2021) from baseline to end of treatment, Change in eGFR (creatinine-based CKD-EPI 2021) from baseline to end of treatment, Relative change in body weight from baseline to end of treatment, Achievement of ≥ 5 % weight reduction from baseline to end of treatment, Achievement of ≥ 10 % weight reduction from baseline to end of treatment, Change in waist circumference from baseline to end of treatment, Change in glycated haemoglobin (HbA1c) from baseline to end of a given maintenance dose period (week 12, 24 or 36), Change in systolic blood pressure from baseline to end of treatment, Change in diastolic blood pressure from baseline to end of treatment, Number of treatment emergent adverse events (TEAEs) from baseline to end of study	—

Measure

Time frame

—

Countries

Bulgaria, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026