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NN9838-4609 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.

NCT05394519

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.

Associated Conditions

Diabetes-Drug Study

Principal Investigator

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