Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1318-6372 | Other Identifier | World Health Organization (WHO) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CagriSema (Cagrilintide B and Semaglutide I) | Drug | CagriSema (Cagrilintide B and Semaglutide I) will be administered subcutaneously using DV3384 pen-injector. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in body weight | Measured as percentage change. | From baseline (week 0) to week 80 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who achieve greater than or equals (≥) 20% weight reduction | Measured as count of participants. | From baseline (week 0) to week 80 |
| Number of participants who achieve ≥ 25% weight reduction |
Not provided
key Inclusion Criteria:
key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FDRC | Costa Mesa | California | 92627 | United States | ||
| Linda Vista Health Care Ctr |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
| 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. |
|
Measured as count of participants.
| From baseline (week 0) to week 80 |
| Number of participants who achieve ≥ 30% weight reduction | Measured as count of participants. | 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. | From baseline (week 0) to week 80 |
| Number of participants who achieve BMI < 30 kg/m^2 | Measured as count of participants. | From baseline (week 0) to week 80 |
| Change in waist circumference | Measured as centimeter (cm). | From baseline (week 0) to week 80 |
| Change in systolic blood pressure | Measured as millimeters of mercury (mmHg). | From baseline (week 0) to week 80 |
| Ratio to baseline in C-reactive protein (CRP) | Measured as ratio. | From baseline (week 0) to week 80 |
| Ratio to baseline in lipids: non-high density lipoprotein (HDL) cholesterol | Measured as ratio. | From baseline (week 0) to week 80 |
| Ratio to baseline in lipids: triglycerides | Measured as ratio. | From baseline (week 0) to week 80 |
| Ratio to baseline in lipids: HDL | Measured as ratio. | 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. | 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. | 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. | 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. | From baseline (week 0) to week 80 |
| Number of participants who achieve ≥ 5% weight reduction | Measured as count of participants. | From baseline (week 0) to week 80 |
| Number of participants who achieve ≥ 10% weight reduction | Measured as count of participants. | From baseline (week 0) to week 80 |
| Number of participants who achieve ≥ 15% weight reduction | Measured as count of participants. | From baseline (week 0) to week 80 |
| Change in waist to height ratio | Measured as ratio. | From baseline (week 0) to week 80 |
| Change in waist to hip ratio | Measured as ratio. | 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. | From baseline (week 0) to week 80 |
| Change in diastolic blood pressure | Measured as mmHg. | From baseline (week 0) to week 80 |
| Ratio to baseline in lipids: total cholesterol | Measured as ratio. | From baseline (week 0) to week 80 |
| Ratio to baseline in lipids: low-density lipoprotein (LDL) cholesterol | Measured as ratio. | From baseline (week 0) to week 80 |
| Ratio to baseline in lipids: very low-density lipoprotein (VLDL) cholesterol | Measured as ratio. | From baseline (week 0) to week 80 |
| Ratio to baseline in lipids: free fatty acids | Measured as ratio. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | From baseline (week 0) to week 80 |
| Number of treatment emergent adverse events (TEAEs) | Measured as count of events. | From baseline (week 0) to week 80 |
| Number of treatment emergent serious adverse events (TESAEs) | Measured as count of events. | From baseline (week 0) to week 80 |
| San Diego |
| California |
| 92111 |
| United States |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | United States |
| Northeast Research Institute | Fleming Island | Florida | 32003 | United States |
| Jacksonville Ctr For Clin Res | Jacksonville | Florida | 32216 | United States |
| South Broward Research LLC | Miramar | Florida | 33027 | United States |
| Florida Inst For Clin Res LLC | Orlando | Florida | 32825 | United States |
| Oviedo Medical Research, LLC | Oviedo | Florida | 32765 | United States |
| Cnt for Diab,Obes, and Metab | Pembroke Pines | Florida | 33024 | United States |
| Hope Clin Res & Wellness | Conyers | Georgia | 30094 | United States |
| Endocrine Research Solutions | Roswell | Georgia | 30076 | United States |
| Great Lakes Clinical Trials | Chicago | Illinois | 60640 | United States |
| Endeavor Health | Skokie | Illinois | 60077 | United States |
| Evanston Premier Hlthcr Res | Skokie | Illinois | 60077 | United States |
| Midwest Inst For Clin Res | Indianapolis | Indiana | 46260 | United States |
| Iowa Diab & Endo Res Center | West Des Moines | Iowa | 50266 | United States |
| Northern Pines Hlth Ctr, PC | Buckley | Michigan | 49620 | United States |
| StudyMetrix Research LLC | City of Saint Peters | Missouri | 63303 | United States |
| Amicis Centers of Clinical Research | St Louis | Missouri | 63128 | United States |
| Mercury Str Med Grp, PLLC | Butte | Montana | 59701 | United States |
| Southgate Medical Group, LLP | West Seneca | New York | 14224 | United States |
| Great Lakes Medical Research | Westfield | New York | 14787 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27514 | United States |
| Medication Mgmnt, LLC_Grnsboro | Greensboro | North Carolina | 27405 | United States |
| PharmQuest Life Sciences LLC | Greensboro | North Carolina | 27408 | United States |
| Accellacare_NC | Raleigh | North Carolina | 27609 | United States |
| Piedmont Healthcare/Research | Statesville | North Carolina | 28625 | United States |
| Accellacare | Wilmington | North Carolina | 28401 | United States |
| New Venture Medical Research | Wadsworth | Ohio | 44281-9236 | United States |
| Lynn Institute of Norman | Norman | Oklahoma | 73072 | United States |
| Clinical Res Collaborative | Cumberland | Rhode Island | 02864 | United States |
| Coastal Carolina Res Ctr | North Charleston | South Carolina | 29405 | United States |
| Hillcrest Clinical Research | Simpsonville | South Carolina | 29681-1538 | United States |
| Spartanburg Medical Research | Spartanburg | South Carolina | 29303 | United States |
| Holston Medical Group | Kingsport | Tennessee | 37660 | United States |
| Clinical Research Associates | Nashville | Tennessee | 37203 | United States |
| Amarillo Medical Specialists | Amarillo | Texas | 79124 | United States |
| Velocity Clin Res, Dallas | Dallas | Texas | 75230 | United States |
| PlanIt Research, PLLC | Houston | Texas | 77079 | United States |
| Radiance Clinical Research | Lampasas | Texas | 76550 | United States |
| DCOL Ctr for Clin Res | Longview | Texas | 75605 | United States |
| Northeast Clinical Research of San Antonio | Schertz | Texas | 78154 | United States |
| Washington Cntr Weight Mgmt | Arlington | Virginia | 22206 | United States |
| Health Res of Hampton Roads | Newport News | Virginia | 23606 | United States |
| Selma Medical Associates | Winchester | Virginia | 22601-3834 | United States |
| Rainier Clin Res Ctr Inc | Renton | Washington | 98057 | United States |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided