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Active Not RecruitingNCT06797869

A Research Study to Investigate the Effects of CagriSema Compared to Placebo in People With Type 2 Diabetes and Painful Diabetic Peripheral Neuropathy

Efficacy and Safety of co Administered Cagrilintide and Semaglutide (CagriSema) Once Weekly Versus Placebo in Participants With Type 2 Diabetes and Painful Diabetic Peripheral Neuropathy

Status
Active Not Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
142 (actual)
Sponsor
Novo Nordisk A/S · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This study will look at the effects of CagriSema in people with both type 2 diabetes and painful diabetic peripheral neuropathy, compared to placebo. Participants will either get an active medicine or a "dummy" medicine (placebo). Which treatment participants get is decided by chance. In this study the active, investigational medicine is called CagriSema. Doctors cannot yet prescribe CagriSema. For each participant, the study will last for about 10 months.

Conditions

Interventions

TypeNameDescription
DRUGCagriSema (Cagrilintide B and Semaglutide I)Cagrilintide B and Semaglutide I will be administered subcutaneously using DV3384 pen-injector.
DRUGPlacebo matched to CagriSema (Cagrilintide B and Semaglutide I)Placebo matched to Cagrilintide B and Placebo matched to Semaglutide I will be administered subcutaneously using DV3384 pen-injector.

Timeline

Start date
2025-01-29
Primary completion
2026-08-21
Completion
2026-08-21
First posted
2025-01-29
Last updated
2025-12-05

Locations

54 sites across 7 countries: United States, Canada, Denmark, France, Norway, Spain, United Kingdom

Regulatory

Source: ClinicalTrials.gov record NCT06797869. Inclusion in this directory is not an endorsement.