A Research Study to Investigate the Effects of CagriSema Compared to Placebo in People With Type … (NCT06797869) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Research Study to Investigate the Effects of CagriSema Compared to Placebo in People With Type 2 Diabetes and Painful Diabetic Peripheral Neuropathy
United States142 participantsStarted 2025-01-29
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* 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.
\-- For participants on anti-diabetic drugs: Stable daily and/or weekly dose(s) ≥90 days before screening of any of the following anti-diabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose, as judged by the investigator:
* Treatment with 1-3 marketed oral anti-diabetic drugs (OADs) (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitors (SGLT2i), thiazolidinediones, or sulphonylureas (SU) as a single agent or in combination) according to local guidelines.
* Treatment with basal or basal-bolus insulin (including premixed insulin formulations) according to local guidelines.
* HbA1c ≤10.5 % (91 millimole per mole \[mmol/mol\]) and ≥6.0 % (42 mmol/mol), as determined by central laboratory at screening.
* Diagnosis of painful diabetic peripheral neuropathy (pDPN) at screening as well as at the following criteria:
\-- Participant with self-reported pain consistent with pDPN for a minimum of 3 months before screening, as judged by the investigator.
* Stable pharmacological and non-pharmacological treatment of pain for a minimum of 3 months before screening, in the opinion of the investigator. The treatment regimen should adhere to local guidelines (if a…
What they're measuring
1
Change in weekly average Pain Intensity-Numerical Rating Scale (PI-NRS)
Timeframe: From baseline (week 0) to end of treatment (week 32)