REDEFINE2: Efficacy and safety of cagrilintide s.c. 2.4 mg in combination with semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) once-weekly in participants with overweight or obesity and type 2 diabetes.
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Enrollment
This study is not currently enrolling. -
Associated Conditions
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Research Area
Translational Research -
Location
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Principal Investigator
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Sponsor
Novo Nordisk
Study Purpose: The purpose of the study is to investigate the efficacy and safety of two medications, cagrilintide and semaglutide. Cagrilintide in combination with semaglutide is currently under development by Novo Nordisk for the indication of weight management.
Study Duration: 78 weeks
Study Commitment: One screening visit plus 19 in-person visits and 5 remote (phone call) assessments
Age: 18 years old and up
Sex: Male and Female
Conditions/Eligibility:
-Type 2 diabetes
-BMI greater than or equal to 27
-No prescribed weight management or obesity medications within the past 90 days
-Not currently using a GLP-1, DPP4 or Amylin medication for diabetes
Study Procedures: Physical exam, breast exam (females only), vital signs, height, weight, BMI measurement, blood and urine collection, measurement of waist circumference, ECG, questionnaires, using an electronic diary, using a blood glucose meter, wearing a continuous glucose monitor at specified study intervals, and counseling sessions with a registered dietician.
Compensation: $2,125 for completing all study visits