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Clinical Trials in the USA / NCT07011667
Active, not recruiting Phase 3

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 · tracked via the Priya Life Science USA tracker
Sponsor
Novo Nordisk A/S
Phase
Phase 3
Started
2025-06-03
Last updated
2026-07-24

Condition(s) studied

Obesity

Investigational drug(s) / intervention(s)

CagriSema (Cagrilintide B and Semaglutide I) →Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)

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

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.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (46)

FacilityCityRegionStatus
FDRC Costa Mesa California
Linda Vista Health Care Ctr San Diego California
Diablo Clinical Research, Inc. Walnut Creek California
Northeast Research Institute Fleming Island Florida
Jacksonville Ctr For Clin Res Jacksonville Florida
South Broward Research LLC Miramar Florida
Florida Inst For Clin Res LLC Orlando Florida
Oviedo Medical Research, LLC Oviedo Florida
Center for Diab,Obes & Metab Pembroke Pines Florida
Hope Clin Res & Wellness Conyers Georgia
Endocrine Research Solutions Roswell Georgia
Great Lakes Clinical Trials Chicago Illinois
Endeavor Health Skokie Illinois
Evanston Premier Hlthcr Res Skokie Illinois
Midwest Inst For Clin Res Indianapolis Indiana
Iowa Diab & Endo Res Center West Des Moines Iowa
Northern Pines Hlth Ctr, PC Buckley Michigan
StudyMetrix Research LLC City of Saint Peters Missouri
Amicis Centers of Clinical Research St Louis Missouri
Mercury Str Med Grp, PLLC Butte Montana
Southgate Medical Group, LLP West Seneca New York
Great Lakes Medical Research Westfield New York
University of North Carolina Chapel Hill North Carolina
Medication Mgmnt, LLC_Grnsboro Greensboro North Carolina
PharmQuest Life Sciences LLC Greensboro North Carolina
Accellacare_NC Raleigh North Carolina
Piedmont Healthcare/Research Statesville North Carolina
Accellacare Wilmington North Carolina
New Venture Medical Research Wadsworth Ohio
Lynn Institute of Norman Norman Oklahoma
Clinical Res Collaborative Cumberland Rhode Island
Coastal Carolina Res Ctr North Charleston South Carolina
Hillcrest Clinical Research Simpsonville South Carolina
Spartanburg Medical Research Spartanburg South Carolina
Holston Medical Group Kingsport Tennessee
Clinical Research Associates Nashville Tennessee
Amarillo Medical Specialists Amarillo Texas
Velocity Clin Res, Dallas Dallas Texas
PlanIt Research, PLLC Houston Texas
Radiance Clinical Research Lampasas Texas

+ 6 more sites — see the full list on the official registry below.

More Novo Nordisk A/S trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07011667 on ClinicalTrials.gov ↗ ← All trials in the USA