4609: REDEFINE 2 - CagriSema effect in people with obesity and Type 2 diabetes

• Research type

  Research Study

• Full title

  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

• IRAS ID

  1005905

• Contact name

  Clinical Transparency Dept. (2834)

• Contact email

  pactadmin@novonordisk.com

• Sponsor organisation

  Novo Nordisk A/S

• Eudract number

  2021-005121-24

• Clinicaltrials.gov Identifier

  NCT05394519

• Research summary

  Obesity is currently one of the most significant public health challenges. People with both obesity and type 2 diabetes (T2D) can have multiple medical needs as well as reduced health related quality of life. The risk of obesity-related complications and concurrent diseases/conditions increases with increasing body mass index (BMI), and a body weight loss of 5–10% has been shown to have significant health benefits in individuals with obesity. It has also been shown that weight loss in people with T2D has a beneficial impact on both diabetes control and other cardiovascular risk markers.
  The purpose of this study is to evaluate the effect and safety of a once-weekly administered subcutaneous (s.c) medicine called CagriSema in people living with obesity and T2D. It will be compared to placebo. CagriSema is a new medicine that is being developed by the company Novo Nordisk A/S and is a combination of cagrilintide and semaglutide which have two different modes of action. Combining two anti-obesity medications with different modes of action has the potential of becoming a new preferable option in the treatment of obesity by combining the weight loss benefits of the two medications.
  The study includes a screening period to assess the participant’s eligibility, a 68-week treatment period and a 7- week follow-up period. The total study duration for each participant will be approximately 78 weeks. Participants will attend 15 clinic visits and 11 phone/ video calls whilst participating in the study. During the treatment period, participants will take either CagriSema or placebo and will receive regular diet and exercise counselling. Various assessments will be undertaken during the course of the study.

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  22/YH/0142

• Date of REC Opinion

  26 Jul 2022

• REC opinion

  Further Information Favourable Opinion