Study S001014

Efficacy, Safety and Pharmacokinetics of NNC0519-0130 Once Weekly s.c. Versussemaglutide 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

ClinicalTrials.gov record

Registration

Registration: NCT06717698
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: QUADRUPLE
Status: RECRUITING
Enrollment: 465
Start: 2024-12-02
Primary completion: 2026-09-01
Lead sponsor: Novo Nordisk A/S
Conditions: Chronic Kidney Disease
Interventions: DRUG:NNC0519-0130; DRUG:Placebo; DRUG:Semaglutide
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1302-5591; OTHER:2024-510846-15

Registered primary outcomes

Change in urinary albumin-to-creatinine ratio (UACR) at week 12 [From baseline (week 0) to end of a given maintenance dose period (week 12)]
Change in urinary albumin-to-creatinine ratio (UACR) at week 24 [From baseline (week 0) to end of a given maintenance dose period (week 24)]
Change in urinary albumin-to-creatinine ratio (UACR) at week 36 [From baseline (week 0) to end of a given maintenance dose period (week 36)]

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