Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1292-4835 | 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 compared to Tirzepatide helps people lower their body weight. CagriSema is a new investigational medicine developed by Novo Nordisk that combines Cagrilintide and Semaglutide. CagriSema is not yet being prescribed by doctors. Participant will get injections once a week throughout the treatment period. Participant will inject the study medicine under the skin with a pen injector in the thigh, stomach, or upper arm. After a first low dose, the study medicine will be gradually increased until reaching the planned dose (2.4 mg CagriSema or 15 mg Tirzepatide). The study will last for about one and a half year for each participant.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CagriSema 2.4 mg/2.4 mg | Experimental | Participants will receive 2.4 mg cagrilintide and 2.4 mg semaglutide subcutaneously once-weekly (dose escalation period of 16 weeks) for up to 84 weeks. |
|
| Tirzepatide 15 mg | Active Comparator | Participants will receive 15 mg tirzepatide subcutaneously once-weekly (dose escalation period of 20 weeks) for up to 84 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cagrilintide | Drug | Cagrilintide will be administered subcutaneously. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To confirm non-inferiority of CagriSema versus tirzepatide: Relative change in body weight | Measured in percentage (%). | From baseline (week 0) to end of treatment (week 84) |
| Measure | Description | Time Frame |
|---|---|---|
| To confirm superiority of CagriSema versus tirzepatide: Relative change in body weight | Measured in percentage (%). | From baseline (week 0) to end of treatment (week 84) |
| Achievement of greater than or equal to (≥) 25% weight reduction |
Not provided
Inclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Univ of Alabama Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Chambliss Clinical Trials LLC |
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
Not provided
Not provided
| Semaglutide |
| Drug |
Semaglutide will be administered subcutaneously. |
|
| Tirzepatide | Drug | Tirzepatide will be administered subcutaneously. |
|
Count of participants.
| From baseline (week 0) to end of treatment (week 84) |
| Achievement of ≥ 30% weight reduction | Count of participants. | From baseline (week 0) to end of treatment (week 84) |
| Change in waist circumference | Measured in centimeter (cm). | From baseline (week 0) to end of treatment (week 84) |
| Change in systolic blood pressure (SBP) | Measured in millimeter of mercury (mmHg). | From baseline (week 0) to end of treatment (week 84) |
| Change in diastolic blood pressure (DBP) | Measured in mmHg. | From baseline (week 0) to end of treatment (week 84) |
| Relative change in lipids: Total cholesterol | Measured in percentage. | From baseline (week 0) to end of treatment (week 84) |
| Relative change in lipids: High-density lipoprotein (HDL) cholesterol | Measured in percentage. | From baseline (week 0) to end of treatment (week 84) |
| Relative change in lipids: Non-HDL cholesterol | Measured in percentage. | From baseline (week 0) to end of treatment (week 84) |
| Relative change in lipids: Low-density lipoprotein (LDL) cholesterol | Measured in percentage. | From baseline (week 0) to end of treatment (week 84) |
| Relative change in lipids: Very low-density lipoprotein (VLDL) cholesterol | Measured in percentage. | From baseline (week 0) to end of treatment (week 84) |
| Relative change in lipids: Triglycerides | Measured in percentage. | From baseline (week 0) to end of treatment (week 84) |
| Number of Treatment-emergent Adverse Events (TEAEs) | Count of events. | From baseline (week 0) to end of study (week 90) |
| Number of Treatment Emergent Serious adverse events (TESAEs) | Count of events. | From baseline (week 0) to end of study (week 90) |
| Montgomery |
| Alabama |
| 36106 |
| United States |
| FDRC | Costa Mesa | California | 92627 | United States |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | United States |
| Univ of Colorado at Denver | Aurora | Colorado | 80045 | United States |
| Yale University School Of Medicine | New Haven | Connecticut | 06519 | 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 |
| Hope Clin Res & Wellness | Conyers | Georgia | 30094 | United States |
| East West Med Res Inst | Honolulu | Hawaii | 96814 | 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 |
| Northern Pines Hlth Ctr, PC | Buckley | Michigan | 49620 | United States |
| StudyMetrix Research LLC | City of Saint Peters | Missouri | 63303 | United States |
| Comprehensive Weight Ctrl Prog | New York | New York | 10021 | 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 |
| Accellacare | Wilmington | North Carolina | 28401 | United States |
| New Venture Medical Research | Wadsworth | Ohio | 44281 | United States |
| Lynn Institute of Norman | Norman | Oklahoma | 73072 | United States |
| The University of Penn Center | Philadelphia | Pennsylvania | 19104-3317 | United States |
| Clinical Res Collaborative | Cumberland | Rhode Island | 02864 | United States |
| Medical University Of South Carolina | Charleston | South Carolina | 29425 | 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_Bristol | Bristol | Tennessee | 37620 | United States |
| Holston Medical Group | Kingsport | Tennessee | 37660 | United States |
| Amarillo Med Spec LLP | Amarillo | Texas | 79124 | United States |
| Elligo Clin Res Centre | Austin | Texas | 78704 | United States |
| UT Health University of Texas | Bellaire | Texas | 77401 | United States |
| Baylr Sctt White Rs Inst, Endo | Dallas | Texas | 75226 | United States |
| Velocity Clin Res, Dallas | Dallas | Texas | 75230 | United States |
| UT Southwestern Medical Center-CRU | Dallas | Texas | 75390 | United States |
| DCOL Ctr for Clin Res | Longview | Texas | 75605 | United States |
| Washington Cntr Weight Mgmt | Arlington | Virginia | 22206 | United States |
| Health Res of Hampton Roads | Newport News | Virginia | 23606 | United States |
| National Clin Res Inc. | Richmond | Virginia | 23294 | United States |
| Selma Medical Associates | Winchester | Virginia | 22601-3834 | United States |
| Capital Clin Res Ctr,LLC | Olympia | Washington | 98502 | 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
| ID | Term |
|---|---|
| C000717792 | cagrilintide |
| C000591245 | semaglutide |
| D000098860 | Tirzepatide |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |
Not provided
Not provided