Trials / Completed
CompletedNCT06131372
A Research Study to See if Kidney Damage in People With Chronic Kidney Disease and Type 2 Diabetes Living With Overweight or Obesity Can be Reduced by CagriSema Compared to Semaglutide, Cagrilintide and Placebo
Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema 2.4 mg/2.4 mg) Once Weekly Versus Semaglutide 2.4 mg, Cagrilintide 2.4 mg and Placebo in People With Chronic Kidney Disease and Type 2 Diabetes Living With Overweight or Obesity
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 626 (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will look if CagriSema can lower kidney damage in people with chronic kidney disease (CKD), type 2 diabetes (T2D) and overweight or obesity. CagriSema is a new investigational medicine. CagriSema cannot yet be prescribed by doctors. The study will compare CagriSema to the 2 medicines semaglutide and cagrilintide, when they are taken alone. It will also compare CagriSema to a "dummy" medicine (also called placebo) without any active ingredient. Participant will either get CagriSema, semaglutide, cagrilintide or placebo. Which treatment participant will get is decided by chance (like flipping a coin). Study doctor will not know which of the study medicines participant will get. For each participant, the study will last for about 35 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cagrilintide | Participants will receive Cagrilintide subcutaneously. |
| DRUG | Semaglutide | Participants will receive semaglutide subcutaneously. |
| DRUG | Placebo | Participants will receive placebo matched to cagrilintide or placebo matched to semaglutide subcutaneously. |
Timeline
- Start date
- 2024-04-01
- Primary completion
- 2025-09-24
- Completion
- 2025-11-06
- First posted
- 2023-11-14
- Last updated
- 2026-04-01
Locations
128 sites across 13 countries: United States, Argentina, Brazil, Canada, France, Greece, Hungary, India, Japan, Poland, Slovakia, Spain, Thailand
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06131372. Inclusion in this directory is not an endorsement.