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 either obesity or type 2 diabetes, or with both conditions. If successful, CagriSema will eventually have both a generic and brand name.
REDEFINE 1
Trial status: Active, not recruiting
Clinical Trials Identifier: NCT05567796
Trial Name: A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight
Recruiting: Adults with obesity, but not type 1 or 2 diabetes
Trial Sponsor: Novo Nordisk
REDEFINE 1 is expected to last approximately 1.5 to 3.5 years with roughly 3,400 participants enrolled worldwide. The study will track changes in body weight across four groups: CagriSema (cagrilintide + semaglutide), cagrilintide alone, semaglutide alone, and a placebo.
REDEFINE 2
Trial status: Active, not recruiting
Clinical Trials Identifier: NCT05394519
Trial Name: A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight
Recruiting: Adults with type 2 diabetes and obesity or overweight
Trial Sponsor: Novo Nordisk
The study plans to last approximately 1.5 years with roughly 1,200 participants. Researchers will track changes in body weight and A1C, as well as other related measures, such as waist circumference and blood pressure.
REDEFINE 3
Trial status: Active, not recruiting
Clinical Trials Identifier: NCT05669755
Trial Name: A Research Study to See the Effects of CagriSema on Heart Disease in People Living With Obesity and Diseases in the Heart and Blood Vessels
Recruiting: Adults with obesity and heart disease, with or without type 2 diabetes
Trial Sponsor: Novo Nordisk
The study aims to last approximately three years and includes around 4,000 participants. Researchers will track cardiovascular events (heart attack, stroke, or heart-related deaths) as well as changes in body weight and A1C. Participants will need to visit a trial site 22 times throughout the study.
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.
Previous results 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%.
With the REDEFINE trials, researchers hope to understand whether the two drugs used together could have a greater impact on weight loss, glycemic control, and reducing heart disease than either drug alone.
Are you interested?
CagriSema trials currently recruiting include:
- A Research Study to See if Kidney Damage in People With Chronic Kidney Disease and Type 2 Diabetes Living With Overweight or Obesity Can be Reduced by CagriSema Compared to Semaglutide, Cagrilintide and Placebo, learn more here
- A Research Study to See How Much CagriSema (1.0 mg Once Weekly) Lowers Blood Sugar and Body Weight Compared to Tirzepatide (5 mg Once Weekly) in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both, learn more here
To learn more about these studies, contact Novo Nordisk directly at [email protected] or call (+1) 866-867-7178. You can also contact your provider to discuss participating in clinical trials.