Efficacy and safety of a once-weekly injectable medicine in participants with overweight or obesity. (REDEFINE 1)
Brief description of study
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.
Detailed description of study
- 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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Obesity,overweight,prediabetes
-
Age: Between 18 Years - 100 Years
-
Gender: All
Are overweight
Are free of type 1 and type 2 diabetes
Updated on
14 Jul 2023.
Study ID: 852053