EFFICACY AND SAFETY OF A ONCE-WEEKLY INJECTABLE MEDICINE IN PARTICIPANTS WITH OVERWEIGHT OR OBESITY. (REDEFINE 1)

  • STATUS
    Recruiting
  • participants needed
    90
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Updated on 19 February 2024

Summary

This study has 2 parts: The first part is the main study and the second part is the extension study. During the main study participants will receive 1 of 4 study medicines. If participants continue in the extension study, they will not receive any study medicine during the extension. The main study will look at how well CagriSema (i.e., a combination of 2.4 mg/day of cagrilinitide and 2.4 mg/day of semaglutide) helps persons with excess body weight lose weight compared to a dummy medicine (i.e., placebo) and 2 other medicines, cagrilinitide (2.4 mg/day) and semaglutide (2.4 mg/day). Participants will either get CagriSema, cagrilintide,semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. They will take one injection once a week. The study medicine is injected briefly with a thin needle, typically in the stomach, thighs or upper arms.
Extension study: After the main study, not all participants will continue in the extension study. The study staff will tell the participant if they will continue or not into the extension study. In the extension study we will look at what happens to the participant's body weight and diseases related to excess body weight after the participant stops taking the study medicine. The main study will last for about 1½ years and the extension study will last for another 2 years. 

Description

  • Study participants will be randomly assigned to one of four groups.
  • All participants, regardless of group assignment, will receive the 18 sessions of lifestyle counseling over the treatment period of 68 weeks. We believe that lifestyle counseling alone will induce weight loss.

Details
Condition Obesity, overweight,prediabetes
Age 18years - 100years
Clinical Study IdentifierTX6693
Last Modified on19 February 2024

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