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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

Description

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.

Conditions

Obesity
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Related Conditions:

Obesity

Study Overview

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Study Details

Study overview

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.

Efficacy and Safety of Cagrilintide s.c. in Combination With Semaglutide s.c. (CagriSema s.c.) Once Weekly for Weight Management and Long-term Weight Maintenance in Participants With Obesity

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

Condition
Obesity
Intervention / Treatment

-

Contacts and Locations

Costa Mesa

FDRC, Costa Mesa, California, United States, 92627

San Diego

Linda Vista Health Care Ctr, San Diego, California, United States, 92111

Walnut Creek

Diablo Clinical Research, Inc., Walnut Creek, California, United States, 94598

Fleming Island

Northeast Research Institute, Fleming Island, Florida, United States, 32003

Jacksonville

Jacksonville Ctr For Clin Res, Jacksonville, Florida, United States, 32216

Miramar

South Broward Research LLC, Miramar, Florida, United States, 33027

Orlando

Florida Inst For Clin Res LLC, Orlando, Florida, United States, 32825

Oviedo

Oviedo Medical Research, LLC, Oviedo, Florida, United States, 32765

Pembroke Pines

Cnt for Diab,Obes, and Metab, Pembroke Pines, Florida, United States, 33024

Conyers

Hope Clin Res & Wellness, Conyers, Georgia, United States, 30094

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novo Nordisk A/S,

Clinical Transparency (dept. 2834), STUDY_DIRECTOR, Novo Nordisk A/S

Study Record Dates

2028-11-01