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
Novo Nordisk A/S
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Female of non-childbearing potential, or male. * For US only: Female of childbearing potential using highly effective non-systemic methods of contraception with low user-dependency at least 2 months prior to screening and willingness to continue using it through-out the study, 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. * HbA1c of 6.5 percentage (%)-10.5 percentage (%) \[48 - 91 millimole…
Interventions
- DrugNNC0519-0130
NNC0519-0130 will be administered subcutaneously.
- DrugPlacebo
Placebo matching NNC0519-0130 will be administered subcutaneously.
- DrugSemaglutide
Semaglutide will be administered subcutaneously.
Locations (147)
- N America Res Inst - San DimasSan Dimas, California
- NorCal Endocrinology and Internal MedicineSan Ramon, California
- Rocky Mount Reg VA Med-DNAurora, Colorado
- Northeast Research InstituteFleming Island, Florida
- Encore Medical Research LLCHollywood, Florida
- Northeast Research InstituteSaint Augustine, Florida