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A Research Study Comparing How Well Different Doses of the Medicine NNC0519-0130 Can Reduce Kidney Damage in People Living With Chronic Kidney Disease
Plain-language guide to NCT06717698: phase 2 randomized trial of Semaglutide, 465 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06717698
- Phase
- phase 2
- Status
- recruiting participants
- Start
- 2024-12-02
- Completion (planned or actual)
- 2026-09-01
- Participants
- 465 (estimated)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Chronic Kidney Disease
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around Semaglutide.
The participants will either get NNC0519-0130 (a new medicine), semaglutide (a medicine that doctors can already prescribe), or placebo (a "dummy" substance).
It had nine arms (groups): one (experimental), one (placebo comparator), one (experimental), one (placebo comparator) and one (experimental).
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.
The registry classes the interventions as drug.
Who Took Part
The registry lists 465 planned participants were the target.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Female of non-childbearing potential, or male. Age 18 years or above at the time of signing the informed consent. Diagnosed with type 2 diabetes mellitus greater than or equal to (≥) 180 days before screening, or not diagnosed with type 2 diabetes mellitus. BMI greater than or equal to (≥) 27.0 kilogram per square metre (kg/m\^2) at screening. Albuminuria defined by Urine Albumin-to-Creatinine Ratio (UACR) greater than or equal (≥)100 and less than (\<) a set amount per gram (mg/g).
The full record lists 9 inclusion and 8 exclusion criteria; among the exclusions: lupus nephritis or antineutrophil cytoplasmic antibody (anca)-associated vasculitis; receiving immunosuppressive therapy for primary or secondary renal disease within 6 months prior to screening; use of any glucagon-like peptide-1 (glp-1) ra (including medication with glp-1 ra activity, e.g., gip/glp-1 ra) within 90 days prior to screening.
How the Study Was Run
The set-up was randomized, parallel-group and quadruple-blind.
Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
Groups ran in parallel: each of the participants stayed in one arm throughout.
As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2024-12-02 with completion listed for 2026-09-01.
It ran at 147 sites in Japan (19), Poland (19), United States (18), Turkey (Türkiye) (14), Spain (13) and Malaysia (10).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Change in urinary albumin-to-creatinine ratio (UACR) at week 12. Change in urinary albumin-to-creatinine ratio (UACR) at week 24. Change in urinary albumin-to-creatinine ratio (UACR) at week 36.
It also tracked 10 secondary outcomes, for example Change in estimated glomerular filtration rate (eGFR) (creatinine-based CKD-EPI 2021), Relative change in body weight, Change in waist circumference, Change in glycated haemoglobin (HbA1c), Change in systolic blood pressure and Change in diastolic blood pressure.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Semaglutide in 465 people.
It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Semaglutide compound page, all human trials.
Our Notes on the Compound
Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.