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

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified November 2025 by Novo Nordisk A/S
Sponsor
Novo Nordisk A/S
Information Provided by (Responsible Party)
Novo Nordisk A/S
Clinicaltrials.gov Identifier
NCT07011667
Other Study ID Numbers:
NN9838-8484
First Submitted
May 31, 2025
First Posted
June 8, 2025
Last Update Posted
December 11, 2025
Last Verified
November 2025

ClinicalTrials.gov processed this data on December 2025Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Obesity
Drug: CagriSema (Cagrilintide B and Semaglutide I)Drug: CagriSema (Cagrilintide B and Semaglutide I)

Study Design

Study TypeInterventional
Actual Enrollment609 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleEfficacy 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 Start DateJune 2, 2025
Actual Primary Completion Date9mos 5h from now
Actual Study Completion Date2yrs 4mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
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
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.

Outcome Measures

Primary Outcome Measures
  1. Relative change in body weight
    Measured as percentage change.
Secondary Outcome Measures
  1. Number of participants who achieve greater than or equals (≥) 20% weight reduction
    Measured as count of participants.
  2. Number of participants who achieve ≥ 25% weight reduction
    Measured as count of participants.
  3. Number of participants who achieve ≥ 30% weight reduction
    Measured as count of participants.
  4. 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)
    Measured as count of participants.
  5. Number of participants who achieve BMI < 30 kg/m^2
    Measured as count of participants.
  6. Change in waist circumference
    Measured as centimeter (cm).
  7. Change in systolic blood pressure
    Measured as millimeters of mercury (mmHg).
  8. Ratio to baseline in C-reactive protein (CRP)
    Measured as ratio.
  9. Ratio to baseline in lipids: non-high density lipoprotein (HDL) cholesterol
    Measured as ratio.
  10. Ratio to baseline in lipids: triglycerides
    Measured as ratio.
  11. Ratio to baseline in lipids: HDL
    Measured as ratio.
  12. Change in impact of weight on quality of life-lite for clinical trials (IWQOL-Lite-CT) physical function score
    Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Physical function score ranges from 0 to 100, with higher scores indicating better levels of functioning.
  13. Change in short form (SF)-36v2 physical function
    Measured as score on a scale. The SF-36v2 acute measures health-related quality of life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 acute scores are norm-based scores, i.e. transformed to a scale where the 2009 United States general population has a mean of 50 and a standard deviation of 10. Physical functioning score ranges from 19.0-57.6, with higher scores indicating better functional health and well-being.
  14. Change in IWQOL-Lite-CT physical function for subgroup with poor physical functioning at baseline (according to patient global impression of status [PGI-S])
    Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Physical function score ranges from 0 to 100, with higher scores indicating better levels of functioning. PGI-S at baseline is used to define the subgroup with &quot;poor&quot; physical function in IWQOL-Lite-CT.
  15. Change in SF-36v2 physical function for subgroup with poor physical functioning at baseline (according to PGI-S)
    Measured as score on a scale. SF-36v2 acute measures HRQOL. The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 acute scores are norm-based scores, i.e. transformed to a scale where the 2009 United States general population has a mean of 50 and a standard deviation of 10. Physical functioning score ranges from 19.0-57.6, with higher scores indicating better functional health and well-being. PGI-S at baseline is used to define the subgroup with &quot;poor&quot; physical function in SF-36V2.
  16. Number of participants who achieve ≥ 5% weight reduction
    Measured as count of participants.
  17. Number of participants who achieve ≥ 10% weight reduction
    Measured as count of participants.
  18. Number of participants who achieve ≥ 15% weight reduction
    Measured as count of participants.
  19. Change in waist to height ratio
    Measured as ratio.
  20. Change in waist to hip ratio
    Measured as ratio.
  21. Number of participants with reduction in weight category
    Measured as count of participants. Reduction in weight categories: underweight, BMI \&lt; 18.5 kg/m\^2; normal weight 18.5 kg/m\^2 &le; BMI \&lt; 25 kg/m\^2; overweight 25 kg/m\^2 &le; BMI \&lt; 30 kg/m\^2; obesity class I 30 kg/m\^2 &le; BMI \&lt; 35 kg/m\^2; obesity class II 35 kg/m\^2 &le; BMI \&lt; 40 kg/m\^2; obesity class III BMI &ge; 40 kg/m\^2.
  22. Change in diastolic blood pressure
    Measured as mmHg.
  23. Ratio to baseline in lipids: total cholesterol
    Measured as ratio.
  24. Ratio to baseline in lipids: low-density lipoprotein (LDL) cholesterol
    Measured as ratio.
  25. Ratio to baseline in lipids: very low-density lipoprotein (VLDL) cholesterol
    Measured as ratio.
  26. Ratio to baseline in lipids: free fatty acids
    Measured as ratio.
  27. Change in control of eating questionnaire (CoEQ): craving control score
    Measured as score on a scale. CoEQ is a 19-item multidimensional PRO that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the craving control subscale, the subscale score is reversed so that a higher score represents a greater level of craving control.
  28. Change in CoEQ: positive mood score
    Measured as score on a scale. CoEQ is a 19-item multidimensional PRO that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), and craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the Positive Mood subscale, item 6 &#039;How anxious have you felt?&#039; is reversed.
  29. Change in CoEQ: craving for sweets score
    Measured as score on a scale. CoEQ is a 19-item multidimensional PRO that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the craving sweets food subscale, higher score represents a greater level of craving.
  30. Change in CoEQ: craving for savoury score
    Measured as score on a scale. CoEQ is a 19-item multidimensional PRO that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the craving savoury food subscale, higher score represents a greater level of craving.
  31. Change in CoEQ: hunger score
    Measured as score on a scale. CoEQ is a 19-item multidimensional PRO that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the hunger subscale, higher score represents a greater level of craving.
  32. Change in CoEQ: satiety score
    Measured as score points. CoEQ is a 19-item multidimensional PRO that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the satiety subscale, higher score represents a greater level of craving.
  33. Change in IWQOL-Lite-CT: physical score
    Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Physical score ranges from 0 to 100, with higher scores indicating better levels of functioning.
  34. Change in IWQOL-Lite-CT: psychosocial score
    Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Psychosocial score ranges from 0 to 100, with higher scores indicating better levels of functioning.
  35. Change in IWQOL-Lite-CT: total score
    Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Total score ranges from 0 to 100, with higher scores indicating better levels of functioning.
  36. Change in SF-36v2 health survey acute: physical component summary score
    Measured as score on a scale. The SF-36v2 acute measures HRQOL. The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 acute scores are norm-based scores, i.e. transformed to a scale where the 2009 United States general population has a mean of 50 and a standard deviation of 10. The physical component summary score ranges from 6.1-79.7, with higher scores indicating better functional health and well-being.
  37. Change in SF-36v2 health survey acute: mental component summary
    Measured as score on a scale. The SF-36v2 acute measures HRQOL. The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 acute scores are norm-based scores, i.e. transformed to a scale where the 2009 United States general population has a mean of 50 and a standard deviation of 10. The mental component summary score ranges from -3.8-78.7, with higher scores indicating better functional health and well-being.
  38. Number of treatment emergent adverse events (TEAEs)
    Measured as count of events.
  39. Number of treatment emergent serious adverse events (TESAEs)
    Measured as count of events.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsNovo Nordisk A/S
Locations
FDRC | Costa Mesa California, United States, 92627Linda Vista Health Care Ctr | San Diego California, United States, 92111Diablo Clinical Research, Inc. | Walnut Creek California, United States, 94598Northeast Research Institute | Fleming Island Florida, United States, 32003Jacksonville Ctr For Clin Res | Jacksonville Florida, United States, 32216South Broward Research LLC | Miramar Florida, United States, 33027Florida Inst For Clin Res LLC | Orlando Florida, United States, 32825Oviedo Medical Research, LLC | Oviedo Florida, United States, 32765Cnt for Diab,Obes, and Metab | Pembroke Pines Florida, United States, 33024Hope Clin Res & Wellness | Conyers Georgia, United States, 30094Endocrine Research Solutions | Roswell Georgia, United States, 30076Great Lakes Clinical Trials | Chicago Illinois, United States, 60640Endeavor Health | Skokie Illinois, United States, 60077Evanston Premier Hlthcr Res | Skokie Illinois, United States, 60077Midwest Inst For Clin Res | Indianapolis Indiana, United States, 46260Iowa Diab & Endo Res Center | West Des Moines Iowa, United States, 50266Northern Pines Hlth Ctr, PC | Buckley Michigan, United States, 49620StudyMetrix Research LLC | City of Saint Peters Missouri, United States, 63303Amicis Centers of Clinical Research | St Louis Missouri, United States, 63128Mercury Str Med Grp, PLLC | Butte Montana, United States, 59701Southgate Medical Group, LLP | West Seneca New York, United States, 14224Great Lakes Medical Research | Westfield New York, United States, 14787University of North Carolina | Chapel Hill North Carolina, United States, 27514Medication Mgmnt, LLC_Grnsboro | Greensboro North Carolina, United States, 27405PharmQuest Life Sciences LLC | Greensboro North Carolina, United States, 27408Accellacare_NC | Raleigh North Carolina, United States, 27609Piedmont Healthcare/Research | Statesville North Carolina, United States, 28625Accellacare | Wilmington North Carolina, United States, 28401New Venture Medical Research | Wadsworth Ohio, United States, 44281-9236Lynn Institute of Norman | Norman Oklahoma, United States, 73072Clinical Res Collaborative | Cumberland Rhode Island, United States, 02864Coastal Carolina Res Ctr | North Charleston South Carolina, United States, 29405Hillcrest Clinical Research | Simpsonville South Carolina, United States, 29681-1538Spartanburg Medical Research | Spartanburg South Carolina, United States, 29303Holston Medical Group | Kingsport Tennessee, United States, 37660Clinical Research Associates | Nashville Tennessee, United States, 37203Amarillo Medical Specialists | Amarillo Texas, United States, 79124Velocity Clin Res, Dallas | Dallas Texas, United States, 75230PlanIt Research, PLLC | Houston Texas, United States, 77079Radiance Clinical Research | Lampasas Texas, United States, 76550DCOL Ctr for Clin Res | Longview Texas, United States, 75605Northeast Clinical Research of San Antonio | Schertz Texas, United States, 78154Washington Cntr Weight Mgmt | Arlington Virginia, United States, 22206Health Res of Hampton Roads | Newport News Virginia, United States, 23606Selma Medical Associates | Winchester Virginia, United States, 22601-3834Rainier Clin Res Ctr Inc | Renton Washington, United States, 98057
Investigators
Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S