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

Purpose

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.

Condition

  • Obesity

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Participants in the main phase will be randomised in double blinded manner to receive either CagriSema or matching placebo. In the extension phase, eligible participants will be re-randomised and enter the open label extension phase. Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
CagriSema 		Participants will receive CagriSema subcutaneously once weekly in a dose escalation manner (dose increases every 4 weeks) for up to 16 weeks followed by CagriSema maintenance dose subcutaneously once weekly for 64 weeks in the main phase of the study. Participants randomised to this arm will be included in the extension phase to receive 1 of the 3 dose levels of CagriSema for 80 weeks.
  • Drug: CagriSema (Cagrilintide B and Semaglutide I)
    CagriSema (Cagrilintide B and Semaglutide I) will be administered subcutaneously using DV3384 pen-injector.
Placebo Comparator
Placebo 		Participants will receive placebo matched to CagriSema subcutaneously once weekly for 80 weeks in the main phase of the study. Participants randomised to this arm will be included in the extension phase to receive CagriSema with flexible dose escalation for 80 weeks.
  • Drug: CagriSema (Cagrilintide B and Semaglutide I)
    CagriSema (Cagrilintide B and Semaglutide I) will be administered subcutaneously using DV3384 pen-injector.
  • Drug: Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)
    Placebo matched to Cagrilintide B and placebo matched to Semaglutide I will be administered subcutaneously using DV3384 pen-injector.

Recruiting Locations

FDRC
Costa Mesa, California 92627

Linda Vista Health Care Ctr
San Diego, California 92111

Diablo Clinical Research, Inc.
Walnut Creek, California 94598

Northeast Research Institute
Fleming Island, Florida 32003

Jacksonville Ctr For Clin Res
Jacksonville, Florida 32216

South Broward Research LLC
Miramar, Florida 33027

Florida Inst For Clin Res LLC
Orlando, Florida 32825

Oviedo Medical Research, LLC
Oviedo, Florida 32765

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

Hope Clin Res & Wellness
Conyers, Georgia 30094

Endocrine Research Solutions
Roswell, Georgia 30076

Great Lakes Clinical Trials
Chicago, Illinois 60640

Endeavor Health
Skokie, Illinois 60077

Evanston Premier Hlthcr Res
Skokie, Illinois 60077

Midwest Inst For Clin Res
Indianapolis, Indiana 46260

Iowa Diab & Endo Res Center
West Des Moines, Iowa 50266

Northern Pines Hlth Ctr, PC
Buckley, Michigan 49620

Amicis Centers of Clinical Research
Saint Louis, Missouri 63128

StudyMetrix Research LLC
Saint Peters, Missouri 63303

Mercury Str Med Grp, PLLC
Butte, Montana 59701

Southgate Medical Group, LLP
West Seneca, New York 14224

Great Lakes Medical Research
Westfield, New York 14787

University of North Carolina
Chapel Hill, North Carolina 27514

Medication Mgmnt, LLC_Grnsboro
Greensboro, North Carolina 27405

PharmQuest Life Sciences LLC
Greensboro, North Carolina 27408

Accellacare_NC
Raleigh, North Carolina 27609

Piedmont Healthcare/Research
Statesville, North Carolina 28625

Accellacare
Wilmington, North Carolina 28401

New Venture Medical Research
Wadsworth, Ohio 44281-9236

Lynn Institute of Norman
Norman, Oklahoma 73072

Clinical Res Collaborative
Cumberland, Rhode Island 02864

Coastal Carolina Res Ctr
North Charleston, South Carolina 29405

Hillcrest Clinical Research
Simpsonville, South Carolina 29681-1538

Spartanburg Medical Research
Spartanburg, South Carolina 29303

Holston Medical Group
Kingsport, Tennessee 37660

Clinical Research Associates
Nashville, Tennessee 37203

Amarillo Med Spec LLP
Amarillo, Texas 79106

Velocity Clin Res, Dallas
Dallas, Texas 75230

PlanIt Research, PLLC
Houston, Texas 77079

Radiance Clinical Research
Lampasas, Texas 76550

Northeast Clinical Research of San Antonio
Schertz, Texas 78154

Washington Cntr Weight Mgmt
Arlington, Virginia 22206

Health Res of Hampton Roads
Newport News, Virginia 23606

Selma Medical Associates
Winchester, Virginia 22601-3834

Rainier Clin Res Ctr Inc
Renton, Washington 98057

More Details

NCT ID
NCT07011667
Status
Recruiting
Sponsor
Novo Nordisk A/S

Study Contact

Novo Nordisk
(+1) 866-867-7178
clinicaltrials@novonordisk.com

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center