A Research Study Comparing How Well Different Doses of the Medicine NNC0519-0130 Can Reduce Kidney Damage in People Living With Chronic Kidney Disease

Conditions

• Chronic Kidney Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• NNC0519-0130 — DRUG
  NNC0519-0130 will be administered subcutaneously.
• Placebo — DRUG
  Placebo matching NNC0519-0130 will be administered subcutaneously.
• Semaglutide — DRUG
  Semaglutide will be administered subcutaneously.

Study Details

The study evaluates the safety of different doses of a new medicine called NNC0519 0130. It also looks into how the medicine may improve kidney function in participants with chronic kidney disease with or without type 2 diabetes, living with overweight or obesity. The participants will either get NNC0519-0130 (a new medicine), semaglutide (a medicine that doctors can already prescribe), or placebo (a "dummy" substance). Which treatment the participant will get is decided by chance. The study will last for up to 43 weeks.

Key Dates

Start date

Dec 2, 2024

Status verified

Mar 2026

Primary completion

Sep 1, 2026

Completion

Sep 17, 2026

Study Design

Enrollment

465 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dosing scheme a: NNC0519-0130
  Participants will receive once-weekly subcutaneous (s.c) injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.
• Placebo Comparator: Dosing scheme a: Placebo
  Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.
• Experimental: Dosing scheme b: NNC0519-0130
  Participants will receive once-weekly s.c injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.
• Placebo Comparator: Dosing scheme b: Placebo
  Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.
• Experimental: Dosing scheme c: NNC0519-0130
  Participants will receive once-weekly s.c injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.
• Placebo Comparator: Dosing scheme c: Placebo
  Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.
• Experimental: Dosing scheme d: NNC0519-0130
  Participants will receive once-weekly s.c injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.
• Placebo Comparator: Dosing scheme d: Placebo
  Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.
• Active Comparator: Dosing scheme e: Semaglutide
  Participants will receive once-weekly s.c injections of semaglutide with a dose escalation done until maintenance dose is reached.

Primary Outcome Measure

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

Central Contacts

• Novo Nordisk
  (+1) 866-867-7178
  [email protected]

Locations (18)

Find similar trials in San Dimas, CA

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