Clinical trial

Weight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide

Active, not recruiting · Phase 3 · 10 countries · Registry ID NCT07220642

Active, not recruitingPhase 3Interventional

What this study is about

This study will look at how much cagrilintide helps people with overweight or obesity lower their body weight. Cagrilintide is a new investigational medicine. Doctors may not yet prescribe cagrilintide. Participants will either get cagrilintide or placebo. Which treatment participants get is decided by chance. Participants are two times more likely to get cagrilintide than placebo. Like all medicines, the study medicine may have side effects. Possible side effects will be followed carefully during the study. For each participant, the study will last for about 1 year and 6 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, Overweight

Full registry criteria

Inclusion criteria: * Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study * Female or male (sex at birth) * Age 18 years or above at the time of signing the informed consent * History of at least one self-reported unsuccessful dietary effort to lose body weight (a\*) * Body mass index (BMI) greater than or equal to \>= 30.0 kilogram per square meter (kg/m\^2), or BMI greater than or equal to \>= 27.0 kg/m\^2 with the presence of at least one weight related comorbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease (a\*) Exclusion criteria: * History of type 1 or type 2 diabetes (a\*) * Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening (a\*) * Previous dosing of marketed or non-marketed amylin-based compounds (a\*) (a\*) - As declared by the participant, reported in the medical records or at the investigator's discretion.

Treatments and study arms

Cagrilintide

Drug

Cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling.

Placebo

Drug

Placebo matched to cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling.

Primary outcomes

Relative change in body weightFrom baseline (week 0) to end of treatment (week 64)

Measured as percentage (%).

Study locations

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

CIPREC Pueyrredon🇦🇷 Buenos Aires, Argentina