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

NCT07011667

Active Not RecruitingPhase 3

Sponsor: Novo Nordisk A/S

Conditions: Obesity

Interventions: CagriSema (Cagrilintide B and Semaglutide I), Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.
Locations (46)
  • Costa Mesa, California, United States
  • San Diego, California, United States
  • Walnut Creek, California, United States
  • Fleming Island, Florida, United States
  • Jacksonville, Florida, United States
  • Miramar, Florida, United States
  • Orlando, Florida, United States
  • Oviedo, Florida, United States
  • Pembroke Pines, Florida, United States
  • Conyers, Georgia, United States
  • Roswell, Georgia, United States
  • Chicago, Illinois, United States
  • Skokie, Illinois, United States
  • Skokie, Illinois, United States
  • Indianapolis, Indiana, United States
  • West Des Moines, Iowa, United States
  • Buckley, Michigan, United States
  • City of Saint Peters, Missouri, United States
  • St Louis, Missouri, United States
  • Butte, Montana, United States
  • West Seneca, New York, United States
  • Westfield, New York, United States
  • Chapel Hill, North Carolina, United States
  • Greensboro, North Carolina, United States
  • Greensboro, North Carolina, United States
  • Raleigh, North Carolina, United States
  • Statesville, North Carolina, United States
  • Wilmington, North Carolina, United States
  • Wadsworth, Ohio, United States
  • Norman, Oklahoma, United States
  • + 16 more on CT.gov