Join Ongoing Trials for Type 2 Diabetes and Obesity
By April Hopcroft
Clinical trials are recruiting participants to see how well the investigational drug CagriSema can reduce blood glucose, body weight, and heart disease.
These three clinical trials are investigating the impact of 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.
The combination of the two drugs is currently called CagriSema by the company. If successful, CagriSema will eventually have both a generic and brand name.
REDEFINE 1
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 and researchers plan to enroll 3,400 participants worldwide. The study will track changes in body weight across four groups: CagriSema (cagrilintide + semaglutide), cagrilintide alone, semaglutide alone, and a placebo.
You may be eligible to participate if:
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You are 18 years or older.
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You have a BMI of at least 30, or a BMI of at least 27 with one weight-related condition like hypertension (high blood pressure), dyslipidemia (more “bad” cholesterol and less “good” cholesterol), obstructive sleep apnea, or cardiovascular disease.
You are not eligible to participate if:
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You have type 1 or type 2 diabetes or an A1C of 6.5% or greater.
See a full list of inclusion/exclusion criteria for REDEFINE 1 and view a list of study site locations here.
REDEFINE 2
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 and enroll 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.
You may be eligible to participate if:
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You are 18 years or older, have been diagnosed with type 2 diabetes for at least six months, and have a BMI of at least 27.
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Your diabetes treatment involves either lifestyle changes, or treatment with up to three oral medications including metformin, alpha glucosidase inhibitors (AGI), glinides, SGLT-2 inhibitors, TZDs, and sulfonylureas.
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Your A1C is between 7-10%.
See a full list of inclusion/exclusion criteria for REDEFINE 2 and view a list of study site locations here.
REDEFINE 3
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 enroll 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.
You may be eligible to participate if:
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You are 55 years or older, have been diagnosed with cardiovascular disease, and have a BMI of at least.
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If you’ve had type 2 diabetes for at least six months.
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Your A1C is between 7-10%.
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Your diabetes treatment involves either lifestyle changes alone, treatment with up to three oral glucose-lowering medications, or treatment with basal insulin alone or in combination with up to two oral medications.
See a full list of inclusion/exclusion criteria for REDEFINE 3 and view a list of study site locations here.
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?
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.
