CagriSema: Ongoing Trials for Type 2 Diabetes and Obesity
Clinical trials are recruiting participants to see how well the investigational drug CagriSema can reduce blood glucose, body weight, and heart disease.
Multiple clinical trials are investigating the impact of CagriSema, a combination of two drugs – semaglutide (brand names Ozempic and Wegovy) and cagrilintide (not yet approved) – on blood sugar, weight, and heart disease in people with obesity, type 2 diabetes, or both conditions.
Clinical trial results so far have been promising, with CagriSema showing significant improvements in A1C, weight loss, and time in range, marking it as a potential new treatment for type 2 diabetes and weight management. Here are CagriSema trials currently recruiting.
CagriSema for type 2 diabetes and peripheral neuropathy
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
Recruiting: Adults with type 2 diabetes and overweight or obesity diagnosed with painful diabetic peripheral neuropathy
Trial Sponsor: Novo Nordisk
This is a phase 2 trial recruiting 134 people and is estimated to last until August 2026. The study will look at the effects of CagriSema on painful peripheral neuropathy compared to a "dummy" drug (placebo) by having participants rate their pain intensity each week.
Long-term effects of CagriSema in people with obesity
Clinical Trials Identifier: NCT06780449
Trial Name: A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity
Recruiting: Adults with obesity (but not diabetes)
Trial Sponsor: Novo Nordisk
This larger phase 3 trial is enrolling 400 participants and is estimated to be completed in 2028. Researchers will observe how participants lose weight over time on CagriSema compared to a placebo, and track other measures like waist circumference, cholesterol, and blood pressure.
CagriSema and bone metabolism
Clinical Trials Identifier: NCT07010432
Trial Name: The Role of the Amylin Analogue Cagrilintide in Bone Metabolism (RAMBO)
Recruiting: Women ages 50-70 with obesity who have been through menopause
Trial Sponsor: Novo Nordisk
Only available to people in Denmark, this early-stage phase 1 study is recruiting 144 participants and is estimated to be completed in 2028. This study will investigate how CagriSema affects bone health in women with obesity after menopause compared to cagrilintide alone, semaglutide alone, or a placebo.
Why are these trials important?
GLP-1 receptor agonists like semaglutide have been highly effective for managing blood glucose, losing weight, and preventing heart disease. The REDEFINE program is the first group of clinical trials to study semaglutide and cagrilintide alone and in combination.
Recent studies have found that participants taking CagriSema reduced their A1C by an average of 2.2 percentage points and lost almost 16% of their body weight. These reductions in A1C and body weight with CagriSema were significantly greater than reductions seen with cagrilintide alone. Full results confirmed these findings over 32 weeks and also showed time in range improvements of 43%.
Through clinical trials, researchers hope to understand whether the two drugs used together could have a greater impact on weight loss, blood sugar management, and reducing heart disease than either drug alone. Positive results so far indicate that CagriSema could be a first-of-its-kind new potential treatment option for type 2 diabetes and weight management.
To learn more about these studies, contact Novo Nordisk directly at clinicaltrials@novonordisk.com or call (+1) 866-867-7178. You can also contact your health provider to discuss participating in clinical trials.