ObesityPhase 3NCT07011667
A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term
A Phase 3 study testing CagriSema (Cagrilintide B and Semaglutide I) in people with Obesity, run by Novo Nordisk A/S at 47 sites in United States.
Trial 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'. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- CagriSema (Cagrilintide B and Semaglutide I)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 609 participants
- Where
- 47 sitesUnited States
- Study dates
- 3 Jun 2025to 17 Oct 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
United States47 sites
Amarillo Medical Specialists
Amarillo, Texas, 79124
Washington Cntr Weight Mgmt
Arlington, Virginia, 22206
Northern Pines Hlth Ctr, PC
Buckley, Michigan, 49620
Mercury Str Med Grp, PLLC
Butte, Montana, 59701
University of North Carolina
Chapel Hill, North Carolina, 27514
Great Lakes Clinical Trials
Chicago, Illinois, 60640
StudyMetrix Research LLC
City of Saint Peters, Missouri, 63303
Hope Clin Res & Wellness
Conyers, Georgia, 30094
FDRC
Costa Mesa, California, 92627
Clinical Res Collaborative
Cumberland, Rhode Island, 02864
Velocity Clin Res, Dallas
Dallas, Texas, 75230
Northeast Research Institute
Fleming Island, Florida, 32003
Medication Mgmnt, LLC_Grnsboro
Greensboro, North Carolina, 27405
PharmQuest Life Sciences LLC
Greensboro, North Carolina, 27408
PlanIt Research, PLLC
Houston, Texas, 77079
Midwest Inst For Clin Res
Indianapolis, Indiana, 46260
Jacksonville Ctr For Clin Res
Jacksonville, Florida, 32216
Holston Medical Group
Kingsport, Tennessee, 37660
Radiance Clinical Research
Lampasas, Texas, 76550
DCOL Ctr for Clin Res
Longview, Texas, 75605
South Broward Research LLC
Miramar, Florida, 33027
Clinical Research Associates
Nashville, Tennessee, 37203
Health Res of Hampton Roads
Newport News, Virginia, 23606
Lynn Institute of Norman
Norman, Oklahoma, 73072
Coastal Carolina Res Ctr
North Charleston, South Carolina, 29405
Florida Inst For Clin Res LLC
Orlando, Florida, 32825
Oviedo Medical Research, LLC
Oviedo, Florida, 32765
Center for Diab,Obes & Metab
Pembroke Pines, Florida, 33024
Accellacare_NC
Raleigh, North Carolina, 27609
Rainier Clin Res Ctr Inc
Renton, Washington, 98057
Endocrine Research Solutions
Roswell, Georgia, 30076
Linda Vista Health Care Ctr
San Diego, California, 92111
Northeast Clinical Research of San Antonio
Schertz, Texas, 78154
Consano Clinical Research, LLC
Shavano Park, Texas, 78231
Hillcrest Clinical Research
Simpsonville, South Carolina, 29681-1538
Endeavor Health
Skokie, Illinois, 60077
Evanston Premier Hlthcr Res
Skokie, Illinois, 60077
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
Amicis Centers of Clinical Research
St Louis, Missouri, 63128
Piedmont Healthcare/Research
Statesville, North Carolina, 28625
New Venture Medical Research
Wadsworth, Ohio, 44281-9236
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
Iowa Diab & Endo Res Center
West Des Moines, Iowa, 50266
Southgate Medical Group, LLP
West Seneca, New York, 14224
Great Lakes Medical Research
Westfield, New York, 14787
Accellacare
Wilmington, North Carolina, 28401
Selma Medical Associates
Winchester, Virginia, 22601-3834
About this study
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
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
- Being tested
- CagriSema (Cagrilintide B and Semaglutide I), Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CagriSema (Cagrilintide B and Semaglutide I)Drug
CagriSema (Cagrilintide B and Semaglutide I) will be administered subcutaneously using DV3384 pen-injector.
Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)Drug
Placebo matched to Cagrilintide B and placebo matched to Semaglutide I will be administered subcutaneously using DV3384 pen-injector.
| Study group | Role | What they receive |
|---|---|---|
| CagriSema | Experimental | 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. Receives: Drug: CagriSema (Cagrilintide B and Semaglutide I) |
| Placebo | Placebo comparator | 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. Receives: Drug: CagriSema (Cagrilintide B and Semaglutide I); Drug: Placebo matched to CagriSema (Cagrilintide B and Semaglutide I) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change in body weight
Measured as percentage change.
Measured: From baseline (week 0) to week 80
Secondary outcomes (40)
Relative change in body weight in women
Measured as percentage change.
Measured: From baseline (week 0) to week 80
Number of participants who achieve greater than or equals (≥) 20% weight reduction
Measured as count of participants.
Measured: From baseline (week 0) to week 80
Number of participants who achieve ≥ 25% weight reduction
Measured as count of participants.
Measured: From baseline (week 0) to week 80
Number of participants who achieve ≥ 30% weight reduction
Measured as count of participants.
Measured: From baseline (week 0) to week 80
Number of participants who achieve BMI < 30 kg/m^2
Measured as count of participants.
Measured: From baseline (week 0) to week 80
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.
Measured: From baseline (week 0) to week 80
Change in waist circumference
Measured as centimeter (cm).
Measured: From baseline (week 0) to week 80
Change in systolic blood pressure
Measured as millimeters of mercury (mmHg).
Measured: From baseline (week 0) to week 80
Ratio to baseline in C-reactive protein (CRP)
Measured as ratio.
Measured: From baseline (week 0) to week 80
Ratio to baseline in lipids: non-high density lipoprotein (HDL) cholesterol
Measured as ratio.
Measured: From baseline (week 0) to week 80
Ratio to baseline in lipids: triglycerides
Measured as ratio.
Measured: From baseline (week 0) to week 80
Ratio to baseline in lipids: HDL
Measured as ratio.
Measured: From baseline (week 0) to week 80
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.
Measured: From baseline (week 0) to week 80
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.
Measured: From baseline (week 0) to week 80
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 "poor" physical function in IWQOL-Lite-CT.
Measured: From baseline (week 0) to week 80
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 "poor" physical function in SF-36V2.
Measured: From baseline (week 0) to week 80
Number of participants who achieve ≥ 5% weight reduction
Measured as count of participants.
Measured: From baseline (week 0) to week 80
Number of participants who achieve ≥ 10% weight reduction
Measured as count of participants.
Measured: From baseline (week 0) to week 80
Number of participants who achieve ≥ 15% weight reduction
Measured as count of participants.
Measured: From baseline (week 0) to week 80
Change in waist to height ratio
Measured as ratio.
Measured: From baseline (week 0) to week 80
Change in waist to hip ratio
Measured as ratio.
Measured: From baseline (week 0) to week 80
Number of participants with reduction in weight category
Measured as count of participants. Reduction in weight categories: underweight, BMI < 18.5 kg/m^2; normal weight 18.5 kg/m^2 ≤ BMI < 25 kg/m^2; overweight 25 kg/m^2 ≤ BMI < 30 kg/m^2; obesity class I 30 kg/m^2 ≤ BMI < 35 kg/m^2; obesity class II 35 kg/m^2 ≤ BMI < 40 kg/m^2; obesity class III BMI ≥ 40 kg/m^2.
Measured: From baseline (week 0) to week 80
Change in diastolic blood pressure
Measured as mmHg.
Measured: From baseline (week 0) to week 80
Ratio to baseline in lipids: total cholesterol
Measured as ratio.
Measured: From baseline (week 0) to week 80
Ratio to baseline in lipids: low-density lipoprotein (LDL) cholesterol
Measured as ratio.
Measured: From baseline (week 0) to week 80
Ratio to baseline in lipids: very low-density lipoprotein (VLDL) cholesterol
Measured as ratio.
Measured: From baseline (week 0) to week 80
Ratio to baseline in lipids: free fatty acids
Measured as ratio.
Measured: From baseline (week 0) to week 80
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.
Measured: From baseline (week 0) to week 80
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 'How anxious have you felt?' is reversed.
Measured: From baseline (week 0) to week 80
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.
Measured: From baseline (week 0) to week 80
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.
Measured: From baseline (week 0) to week 80
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.
Measured: From baseline (week 0) to week 80
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.
Measured: From baseline (week 0) to week 80
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.
Measured: From baseline (week 0) to week 80
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.
Measured: From baseline (week 0) to week 80
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.
Measured: From baseline (week 0) to week 80
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.
Measured: From baseline (week 0) to week 80
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.
Measured: From baseline (week 0) to week 80
Number of treatment emergent adverse events (TEAEs)
Measured as count of events.
Measured: From baseline (week 0) to week 80
Number of treatment emergent serious adverse events (TESAEs)
Measured as count of events.
Measured: From baseline (week 0) to week 80
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2025
- Study start3 Jun 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion17 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 609 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011667
- Sponsor's protocol ID
- NN9838-8484
- Other IDs
- U1111-1318-6372
- Status last verified
- Sep 2026
- First submitted
- 1 Jun 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07011667
- Acronym / sponsor ID
- NN9838-8484
- Conditions
- Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 609 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 17 Oct 2028 (estimated)
- First posted
- 9 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CagriSema | Experimental | Drug: CagriSema (Cagrilintide B and Semaglutide I)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. |
| Placebo | Placebo comparator | Drug: CagriSema (Cagrilintide B and Semaglutide I), Drug: Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CagriSema (Cagrilintide B and Semaglutide I)CagriSema (Cagrilintide B and Semaglutide I) will be administered subcutaneously using DV3384 pen-injector. | Drug | CagriSema, Placebo |
| 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. | Drug | Placebo |
Primary outcome
Relative change in body weight
Time frame: From baseline (week 0) to week 80
Measured as percentage change.
40 secondary outcomes
Relative change in body weight in women
Time frame: From baseline (week 0) to week 80
Number of participants who achieve greater than or equals (≥) 20% weight reduction
Time frame: From baseline (week 0) to week 80
Number of participants who achieve ≥ 25% weight reduction
Time frame: From baseline (week 0) to week 80
Number of participants who achieve ≥ 30% weight reduction
Time frame: From baseline (week 0) to week 80
Number of participants who achieve BMI < 30 kg/m^2
Time frame: From baseline (week 0) to week 80
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)
Time frame: From baseline (week 0) to week 80
Change in waist circumference
Time frame: From baseline (week 0) to week 80
Change in systolic blood pressure
Time frame: From baseline (week 0) to week 80
Ratio to baseline in C-reactive protein (CRP)
Time frame: From baseline (week 0) to week 80
Ratio to baseline in lipids: non-high density lipoprotein (HDL) cholesterol
Time frame: From baseline (week 0) to week 80
Ratio to baseline in lipids: triglycerides
Time frame: From baseline (week 0) to week 80
Ratio to baseline in lipids: HDL
Time frame: From baseline (week 0) to week 80
Change in impact of weight on quality of life-lite for clinical trials (IWQOL-Lite-CT) physical function score
Time frame: From baseline (week 0) to week 80
Change in short form (SF)-36v2 physical function
Time frame: From baseline (week 0) to week 80
Change in IWQOL-Lite-CT physical function for subgroup with poor physical functioning at baseline (according to patient global impression of status [PGI-S])
Time frame: From baseline (week 0) to week 80
Change in SF-36v2 physical function for subgroup with poor physical functioning at baseline (according to PGI-S)
Time frame: From baseline (week 0) to week 80
Number of participants who achieve ≥ 5% weight reduction
Time frame: From baseline (week 0) to week 80
Number of participants who achieve ≥ 10% weight reduction
Time frame: From baseline (week 0) to week 80
Number of participants who achieve ≥ 15% weight reduction
Time frame: From baseline (week 0) to week 80
Change in waist to height ratio
Time frame: From baseline (week 0) to week 80
Change in waist to hip ratio
Time frame: From baseline (week 0) to week 80
Number of participants with reduction in weight category
Time frame: From baseline (week 0) to week 80
Change in diastolic blood pressure
Time frame: From baseline (week 0) to week 80
Ratio to baseline in lipids: total cholesterol
Time frame: From baseline (week 0) to week 80
Ratio to baseline in lipids: low-density lipoprotein (LDL) cholesterol
Time frame: From baseline (week 0) to week 80
Ratio to baseline in lipids: very low-density lipoprotein (VLDL) cholesterol
Time frame: From baseline (week 0) to week 80
Ratio to baseline in lipids: free fatty acids
Time frame: From baseline (week 0) to week 80
Change in control of eating questionnaire (CoEQ): craving control score
Time frame: From baseline (week 0) to week 80
Change in CoEQ: positive mood score
Time frame: From baseline (week 0) to week 80
Change in CoEQ: craving for sweets score
Time frame: From baseline (week 0) to week 80
Change in CoEQ: craving for savoury score
Time frame: From baseline (week 0) to week 80
Change in CoEQ: hunger score
Time frame: From baseline (week 0) to week 80
Change in CoEQ: satiety score
Time frame: From baseline (week 0) to week 80
Change in IWQOL-Lite-CT: physical score
Time frame: From baseline (week 0) to week 80
Change in IWQOL-Lite-CT: psychosocial score
Time frame: From baseline (week 0) to week 80
Change in IWQOL-Lite-CT: total score
Time frame: From baseline (week 0) to week 80
Change in SF-36v2 health survey acute: physical component summary score
Time frame: From baseline (week 0) to week 80
Change in SF-36v2 health survey acute: mental component summary
Time frame: From baseline (week 0) to week 80
Number of treatment emergent adverse events (TEAEs)
Time frame: From baseline (week 0) to week 80
Number of treatment emergent serious adverse events (TESAEs)
Time frame: From baseline (week 0) to week 80
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Related trials for Obesity
RecruitingPhase 4
Translational Health Research Into Vascular and Neurocognitive Effects of Weight Loss
Class I/II Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
A Phase 1/2a Study of WVE-007 in Adults Living With Overweight or Obesity
Overweight and Obesity
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
47 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CagriSema (Cagrilintide B and Semaglutide I) in people with Obesity, run by Novo Nordisk A/S at 47 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative change in body weight (time frame: From baseline (week 0) to week 80). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.