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

What Was Tested

In this phase 2 trial, researchers set out to test Cagrilintide and Semaglutide.

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.

It had two arms (groups): CagriSema (experimental) and Placebo (placebo comparator).

Participants will receive CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 32 weeks.

Participants will receive placebo matched to CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 32 weeks.

The registry classes the interventions as drug.

Who Took Part

142 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female. Age 18 years or above at the time of signing the informed consent. Body mass index (BMI) ≥25.0 kilogram per square meter (kg/m\^2) at screening. Diagnosis of type 2 diabetes (T2D) ≥180 days before screening. Treatment with basal or basal-bolus insulin (including premixed insulin formulations) according to local guidelines.

The full record lists 9 inclusion and 13 exclusion criteria; among the exclusions: use of any glucagon-like peptide-1 receptor agonist (glp-1 ra), including medication with glp-1 ra activity, (dpp-4), or amylin analogue within 60 days before screening; presence or history of epilepsy and fibromyalgia; presence of non-diabetic neuropathies, in the opinion of the investigator.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Cagrilintide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Cagrilintide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2025-01-29 with completion listed for 2026-06-26.

It ran at 55 sites in United States (20), Canada (7), Spain (7), United Kingdom (7), Denmark (5) and France (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in weekly average Pain Intensity-Numerical Rating Scale (PI-NRS) (time frame: From baseline (week 0) to end of treatment (week 32)).

It also tracked 25 secondary outcomes, for example Change in Brief Pain Inventory-Short Form (BPI-SF), Change in Chronic Pain Sleep Inventory 3-item (CPSI 3), Change in Michigan Neuropathy Screening Instrument (MNSI), Change in systolic blood pressure, Change in diastolic blood pressure and Change in glycated haemoglobin (HbA1c).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Cagrilintide and Semaglutide in 142 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cagrilintide compound page and the Semaglutide compound page, all human trials.