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

NCT06797869 · Active, not recruiting

Last updated 2026-05-28

This study is testing whether the medication CagriSema reduces pain in people with type 2 diabetes who experience painful nerve damage in their feet or legs, compared to a placebo.

Status Active, not recruiting Ongoing, but no longer enrolling new participants.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 142 people

Who can join Ages 18+ · all sexes

Timeline Started 2025-01 · est. completion 2026-08

Where 54 sites · Canada, Denmark, France, Norway, Spain, United Kingdom, United States

What this study is testing ClinicalTrials.gov NCT06797869 ↗

Description as written by the study sponsor.

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.

Treatments tested

CagriSema (Cagrilintide B and Semaglutide I) Drug

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

Placebo matched to Cagrilintide B and Placebo matched to Semaglutide I will be administered subcutaneously using DV3384 pen-injector.

Main thing measured	Change in weekly average Pain Intensity-Numerical Rating Scale (PI-NRS)
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes Mellitus, Type 2, Diabetic Peripheral Neuropathy
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06797869 ↗