This study is designed to evaluate the efficacy and safety of semaglutide s.c. 7.2 mg once-weekly versus placebo and semaglutide s.c. 2.4 mg once-weekly as an adjunct to reduced-calorie diet and increased physical activity in adults with obesity.
The maximum duration of the study intervention for each participant is 72 weeks and the duration of the study for each participant is 81 weeks.
This study is to look at how well the new medicine CagriSema works at assisting weight loss for people with excess body weight, compared to "dummy" medicine and 2 other medicines.
The 68-week main phase of the present study is designed to compare the efficacy and safety of once-weekly cagrilintide in combination with semaglutide versus once-weekly cagrilintide, semaglutide, and placebo, all as an adjunct to a reduced-calorie diet and increased physical activity, for weight management in participants with overweight or obesity.
The study will also include a 97-week off-treatment period for participants in the CagriSema and placebo treatment arms only (extension phase), to obtain a better understanding of the impact of withdrawing the study interventions on weight, cardiovascular risk factors and glucose metabolism in people living with
overweight or obesity.
The purpose of this research study is to evaluate the safety and effectiveness of tirzepatide compared to placebo (an inactive substance) in the treatment of individuals with Heart Failure with Preserved Ejection Fraction (HFpEF) and obesity.
Participants will undergo a screening visit where they will have a physical exam to asses health and blood will be drawn. If the blood tests show that a participant qualifies to continue, then they will be randomly assigned to either tirzepatide or placebo. Each participant will have a 50:50 chance of being on tirzepatide (like the flip of a coin.) Both tirzepatide and placebo will be supplied as a single dose in an injectable pen device. Subjects will inject the study drug under the skin (or subcutaneous) once a week with the injectable pen. Participation will last at least 52 weeks and may last up to 120 weeks.
Tirzepatide has been proven to provide significant body weight loss and improvement of fat and sugar metabolism in patients with type 2 diabetes. Body weight percent reduction in this study is estimated to be 15% to 16%.