Clinical trial NCT07011667: A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2025-06-09
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Relative change in body weight
timeFrame: From baseline (week 0) to week 80
Secondary outcomes:
measure: Number of participants who achieve greater than or equals (≥) 20% weight reduction
timeFrame: From baseline (week 0) to week 80
measure: Number of participants who achieve ≥ 25% weight reduction
timeFrame: From baseline (week 0) to week 80
measure: Number of participants who achieve ≥ 30% weight reduction
timeFrame: From baseline (week 0) to week 80
measure: Number of participants who achieve normal body mass index (BMI) (18.5 kilograms per meter square (kg/m^2) less than or equal to (≤ ) BMI < 25 kg/m^2)
timeFrame: From baseline (week 0) to week 80
measure: Number of participants who achieve BMI < 30 kg/m^2
timeFrame: From baseline (week 0) to week 80
measure: Change in waist circumference
timeFrame: From baseline (week 0) to week 80
measure: Change in systolic blood pressure
timeFrame: From baseline (week 0) to week 80
measure: Ratio to baseline in C-reactive protein (CRP)
timeFrame: From baseline (week 0) to week 80
measure: Ratio to baseline in lipids: non-high density lipoprotein (HDL) cholesterol
timeFrame: From baseline (week 0) to week 80
measure: Ratio to baseline in lipids: triglycerides
timeFrame: From baseline (week 0) to week 80
measure: Ratio to baseline in lipids: HDL
timeFrame: From baseline (week 0) to week 80
measure: Change in impact of weight on quality of life-lite for clinical trials (IWQOL-Lite-CT) physical function score
timeFrame: From baseline (week 0) to week 80
measure: Change in short form (SF)-36v2 physical function
timeFrame: From baseline (week 0) to week 80
measure: Change in IWQOL-Lite-CT physical function for subgroup with poor physical functioning at baseline (according to patient global impression of status [PGI-S])
timeFrame: From baseline (week 0) to week 80
measure: Change in SF-36v2 physical function for subgroup with poor physical functioning at baseline (according to PGI-S)
timeFrame: From baseline (week 0) to week 80
measure: Number of participants who achieve ≥ 5% weight reduction
timeFrame: From baseline (week 0) to week 80
measure: Number of participants who achieve ≥ 10% weight reduction
timeFrame: From baseline (week 0) to week 80
measure: Number of participants who achieve ≥ 15% weight reduction
timeFrame: From baseline (week 0) to week 80
measure: Change in waist to height ratio
timeFrame: From baseline (week 0) to week 80
measure: Change in waist to hip ratio
timeFrame: From baseline (week 0) to week 80
measure: Number of participants with reduction in weight category
timeFrame: From baseline (week 0) to week 80
measure: Change in diastolic blood pressure
timeFrame: From baseline (week 0) to week 80
measure: Ratio to baseline in lipids: total cholesterol
timeFrame: From baseline (week 0) to week 80
measure: Ratio to baseline in lipids: low-density lipoprotein (LDL) cholesterol
timeFrame: From baseline (week 0) to week 80
measure: Ratio to baseline in lipids: very low-density lipoprotein (VLDL) cholesterol
timeFrame: From baseline (week 0) to week 80
measure: Ratio to baseline in lipids: free fatty acids
timeFrame: From baseline (week 0) to week 80
measure: Change in control of eating questionnaire (CoEQ): craving control score
timeFrame: From baseline (week 0) to week 80
measure: Change in CoEQ: positive mood score
timeFrame: From baseline (week 0) to week 80
measure: Change in CoEQ: craving for sweets score
timeFrame: From baseline (week 0) to week 80
measure: Change in CoEQ: craving for savoury score
timeFrame: From baseline (week 0) to week 80
measure: Change in CoEQ: hunger score
timeFrame: From baseline (week 0) to week 80
measure: Change in CoEQ: satiety score
timeFrame: From baseline (week 0) to week 80
measure: Change in IWQOL-Lite-CT: physical score
timeFrame: From baseline (week 0) to week 80
measure: Change in IWQOL-Lite-CT: psychosocial score
timeFrame: From baseline (week 0) to week 80
measure: Change in IWQOL-Lite-CT: total score
timeFrame: From baseline (week 0) to week 80
measure: Change in SF-36v2 health survey acute: physical component summary score
timeFrame: From baseline (week 0) to week 80
measure: Change in SF-36v2 health survey acute: mental component summary
timeFrame: From baseline (week 0) to week 80
measure: Number of treatment emergent adverse events (TEAEs)
timeFrame: From baseline (week 0) to week 80
measure: Number of treatment emergent serious adverse events (TESAEs)
timeFrame: From baseline (week 0) to week 80
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: FDRC
state: California
city: San Diego
country: United States
facility: Linda Vista Health Care Ctr
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Fleming Island
country: United States
facility: Northeast Research Institute
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Ctr For Clin Res
state: Florida
city: Miramar
country: United States
facility: South Broward Research LLC
state: Florida
city: Orlando
country: United States
facility: Florida Inst For Clin Res LLC
state: Florida
city: Oviedo
country: United States
facility: Oviedo Medical Research, LLC
state: Florida
city: Pembroke Pines
country: United States
facility: Cnt for Diab,Obes, and Metab
state: Florida
city: Conyers
country: United States
facility: Hope Clin Res & Wellness
state: Georgia
city: Roswell
country: United States
facility: Endocrine Research Solutions
state: Georgia
city: Chicago
country: United States
facility: Great Lakes Clinical Trials
state: Illinois
city: Skokie
country: United States
facility: Endeavor Health
state: Illinois
city: Skokie
country: United States
facility: Evanston Premier Hlthcr Res
state: Illinois
city: Indianapolis
country: United States
facility: Midwest Inst For Clin Res
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Diab & Endo Res Center
state: Iowa
city: Buckley
country: United States
facility: Northern Pines Hlth Ctr, PC
state: Michigan
city: Saint Louis
country: United States
facility: Amicis Centers of Clinical Research
state: Missouri
city: Saint Peters
country: United States
facility: StudyMetrix Research LLC
state: Missouri
city: Butte
country: United States
facility: Mercury Str Med Grp, PLLC
state: Montana
city: West Seneca
country: United States
facility: Southgate Medical Group, LLP
state: New York
city: Westfield
country: United States
facility: Great Lakes Medical Research
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Greensboro
country: United States
facility: Medication Mgmnt, LLC_Grnsboro
state: North Carolina
city: Greensboro
country: United States
facility: PharmQuest Life Sciences LLC
state: North Carolina
city: Greensboro
country: United States
facility: PharmQuest Life Sciences LLC
state: North Carolina
city: Raleigh
country: United States
facility: Accellacare_NC
state: North Carolina
city: Statesville
country: United States
facility: Piedmont Healthcare/Research
state: North Carolina
city: Wilmington
country: United States
facility: Accellacare
state: North Carolina
city: Wadsworth
country: United States
facility: New Venture Medical Research
state: Ohio
city: Norman
country: United States
facility: Lynn Institute of Norman
state: Oklahoma
city: Cumberland
country: United States
facility: Clinical Res Collaborative
state: Rhode Island
city: North Charleston
country: United States
facility: Coastal Carolina Res Ctr
state: South Carolina
city: Simpsonville
country: United States
facility: Hillcrest Clinical Research
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Med Spec LLP
state: Texas
city: Dallas
country: United States
facility: Velocity Clin Res, Dallas
state: Texas
city: Houston
country: United States
facility: PlanIt Research, PLLC
state: Texas
city: Lampasas
country: United States
facility: Radiance Clinical Research
state: Texas
city: Longview
country: United States
facility: DCOL Ctr for Clin Res
state: Texas
city: Schertz
country: United States
facility: Northeast Clinical Research of San Antonio
state: Texas
city: Arlington
country: United States
facility: Washington Cntr Weight Mgmt
state: Virginia
city: Newport News
country: United States
facility: Health Res of Hampton Roads
state: Virginia
city: Winchester
country: United States
facility: Selma Medical Associates
state: Virginia
city: Renton
country: United States
facility: Rainier Clin Res Ctr Inc
state: Washington
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: