Clinical trial

A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term

Active, not recruiting · Phase 3 · 1 countries · Registry ID NCT07011667

Active, not recruitingPhase 3Interventional

What this study is about

This study will look at how well CagriSema helps people living with obesity to lose weight and maintain the weight loss long-term. The study has 2 parts: The first part is called 'the main study' and the second part is called 'the extension study'. In the main study participants will either get CagriSema (a study medicine) or placebo (a dummy medicine that looks like CagriSema but has no active ingredient). Which treatment participants get is decided by chance. Participants are two times more likely to get CagriSema than placebo. If participants get CagriSema in the main study, participants will continue on CagriSema in the extension study. Which dose of CagriSema participants will continue on is decided by chance. If participants get placebo in the main study, participants will get CagriSema in the extension study. Participants will take one injection of study medicine once a week. The study will last for about 3 years and 3 months.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionObesity

Full registry criteria

key Inclusion Criteria: * Male or female (sex at birth). * Age 18 years or above at the time of signing the informed consent. * BMI ≥ 30.0 kilogram per square meter (kg/m\^2) at screening. * Participant has a wish to lose at least 25% of body weight within 80 weeks from randomisation. key Exclusion Criteria: * Glycated haemoglobin (HbA1c) ≥ 6.5% (48 millimole per mole \[mmol/mol\]) as measured by the central laboratory at screening. * History of type 1 or type 2 diabetes.

Treatments and study arms

CagriSema (Cagrilintide B and Semaglutide I)

Drug

CagriSema (Cagrilintide B and Semaglutide I) will be administered subcutaneously using DV3384 pen-injector.

Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)

Drug

Placebo matched to Cagrilintide B and placebo matched to Semaglutide I will be administered subcutaneously using DV3384 pen-injector.

Primary outcomes

Relative change in body weightFrom baseline (week 0) to week 80

Measured as percentage change.

Study locations

46 locations were listed when this page was built. The first 40 are shown.

Amarillo Medical Specialists🇺🇸 Amarillo, Texas, United States