Trial Testing New GLP-1 Drug To Reduce Pain of Peripheral Neuropathy
Preliminary evidence suggests that GLP-1 drugs may help people with diabetes-related peripheral neuropathy. This study will explore whether CagriSema, a new GLP-1 drug under investigation, can lessen pain from peripheral neuropathy.
Trial Status: Recruiting
Clinical Trials Identifier: NCT06797869
Trial Name: A Research Study to Investigate the Effects of CagriSema Compared to Placebo in People With Type 2 Diabetes and Painful Diabetic Peripheral Neuropathy
Diabetes Type: Type 2 diabetes
Trial Sponsor: Novo Nordisk A/S
Why is this study important?
This study is investigating whether CagriSema – a potential new blood sugar and weight management drug – can lessen the amount of pain that people with type 2 diabetes experience due to peripheral neuropathy, or nerve damage in the arms and legs.
Metabolic and cardiovascular health are deeply intertwined, and people with diabetes have a heightened risk for nerve damage resulting from problems with their blood vessels. In the case of peripheral neuropathy, this damage may manifest initially as burning, tingling, and numbness in the hands and feet, before progressing to more severe, debilitating pain.
At the moment, there is no cure or disease-modifying treatment for painful diabetes-related peripheral neuropathy, but people can try medications and other interventions to manage the pain caused by nerve damage.
Recently, some researchers have found preliminary evidence that GLP-1 medications may improve nerve health and reduce the pain associated with neuropathy. However, many of the studies that have explored this question have been fairly small, short in duration, and focused on the most severe cases.
This study aims to be larger, more diverse, and more rigorous than previous ones. It will focus specifically on CagriSema, which combines two hormone-mimicking molecules into a single, weekly injection. The injection includes semaglutide – Ozempic for type 2 diabetes, Wegovy for overweight and obesity – and cagrilinitide, an investigational drug that mimics the hormone amylin, which also regulates blood sugar and appetite.
CagriSema has not yet been approved for medical use, but previous research has shown that it can cause weight loss in people who have obesity with or without type 2 diabetes. The initial numbers from those trials suggest that the combination medication may be more effective than either semaglutide or cagrilinitide alone.
A closer look at the data from people without type 2 diabetes also showed that, compared to people taking a placebo, CagriSema users achieved bigger drops in their blood pressure and reported greater improvements in their quality of life over a 15-month period.
How does the trial work?
The study is planning to enroll 134 participants. All of the participants will receive weekly injections for 32 weeks. Half will receive CagriSema, and half will receive a placebo. Each participant will be randomly assigned to one of the groups.
The researchers will assess how effectively CagriSema treats the pain of peripheral neuropathy by regularly asking participants to rate the amount of pain they are experiencing on a scale of zero to 10. At the end of the trial, the researchers will check how much each participant’s average weekly pain rating has changed.
Are you interested in participating?
You may be eligible to participate if you are 18 or older and have:
- Been diagnosed with painful diabetic peripheral neuropathy or report pain that is consistent with a diagnosis and has been going on for at least three months
- Been diagnosed with type 2 diabetes at least six months prior to screening
- Been taking any diabetes or pain medications that you are using regularly for at least three months prior to screening
- An A1C of 6.0-10.5% at screening
- A BMI greater than 25
Women who are pregnant, breastfeeding, or planning to become pregnant are not eligible to participate. Additionally, there are many medications and potentially overlapping medical conditions that may affect eligibility. The trial is currently recruiting in 54 locations across the U.S., Canada, and Europe. See a full list of inclusion/exclusion criteria here.
Learn more about CagriSema and peripheral neuropathy here: