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

A clinical trial will test whether a weekly injection combining two drugs—cagrilintide and semaglutide, together called CagriSema—can relieve the burning, stabbing nerve pain that afflicts many people with type 2 diabetes. About one in four people with type 2 diabetes develops painful diabetic peripheral neuropathy (pDPN), a condition where damaged nerves in the feet and legs cause chronic pain that现有 treatments often fail to control. The trial will randomise roughly 134 participants to receive either CagriSema or a placebo for several weeks, with neither patients nor doctors knowing who gets what. Cagrilintide mimics a hormone that regulates appetite and blood sugar, while semaglutide (already used in drugs like Ozempic) boosts insulin release. Together, they may reduce inflammation and oxidative stress in nerves, potentially easing pain beyond what glucose control alone achieves. If the drug combination proves safe and effective, it could become the first treatment specifically targeting the nerve damage underlying pDPN, rather than just masking symptoms. For patients, that could mean fewer days lost to pain, reduced reliance on opioids or gabapentinoids, and a slower progression of nerve damage that currently leads to foot ulcers and amputations. The trial is a proof-of-concept study—if positive, it would justify larger phase 3 trials needed for regulatory approval.