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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1298-3451 | Other Identifier | World Health Organization (WHO) | |
| 2023-509273-24 | Other Identifier | European Medical Agency (EMA) |
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This study will look at how well CagriSema helps people with excess body weight lose weight. CagriSema is a new medicine developed by Novo Nordisk that combines cagrilintide and semaglutide. CagriSema cannot yet be prescribed by doctors. In the study, participant will either get CagriSema or dummy medicine and which treatment participant get is decided by chance. The study will last for about 1½ years for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CagriSema Dose 1 | Experimental | Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 8-week dose escalation period until target dose (dose 1) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 60 weeks. |
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| Placebo Dose 1 | Placebo Comparator | Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 1 (cagrilintide and semaglutide) for 68 weeks. |
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| CagriSema Dose 2 | Active Comparator | Participants will receive once-weekly s.c injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 12-week dose escalation period until target dose (dose 2) of CagriSema(cagrilintide and semaglutide) is achieved and maintained up to 56 weeks. |
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| Placebo Dose 2 | Placebo Comparator | Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 2 (cagrilintide and semaglutide) for 68 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cagrilintide | Drug | Participants will receive once-weekly cagrilintide subcutaneously. |
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| Measure | Description | Time Frame |
|---|---|---|
| Relative change in body weight | Measured in percentage (%). | From baseline (week 0) to end of treatment (week 68) |
| Achievement of ≥5% weight reduction | Measured as count of participant. | From baseline (week 0) to end of treatment (week 68) |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of ≥10% weight reduction | Measured as count of participant. | From baseline (week 0) to end of treatment (week 68) |
| Achievement of ≥15% weight reduction | Measured as count of participant. |
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Inclusion Criteria:
Male or female
Age above or equal to 18 years at the time of signing informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aurora FDRC Inc. | Costa Mesa | California | 92627 | United States | ||
| Clinical Trial Res Assoc,Inc |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| Semaglutide | Drug | Participants will receive once-weekly semaglutide subcutaneously. |
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| Placebo | Drug | Participants will receive once-weekly placebo matched to cagrilintide and semaglutide subcutaneously. |
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| From baseline (week 0) to end of treatment (week 68) |
| Achievement of ≥20% weight reduction | Measured as count of participant. | From baseline (week 0) to end of treatment (week 68) |
| Change in waist circumference | Measured in centimeter (cm). | From baseline (week 0) to end of treatment (week 68) |
| Change in systolic blood pressure | Measured in millimeters of mercury. | From baseline (week 0) to end of treatment (week 68) |
| Ratio to baseline in lipids: Total cholesterol | Measured in ratio. | From baseline (week 0) to end of treatment (week 68) |
| Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol | Measured in ratio. | From baseline (week 0) to end of treatment (week 68) |
| Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol | Measured in ratio. | From baseline (week 0) to end of treatment (week 68) |
| Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol | Measured in ratio. | From baseline (week 0) to end of treatment (week 68) |
| Ratio to baseline in lipids: Triglycerides | Measured in ratio. | From baseline (week 0) to end of treatment (week 68) |
| Ratio to baseline in lipids: Free fatty acids | Measured in ratio. | From baseline (week 0) to end of treatment (week 68) |
| Number of treatment emergent adverse events (TEAEs) | Measured as count of events. | From baseline (week 0) to end of study (week 74) |
| Number of treatment emergent serious adverse events (TESAEs) | Measured as count of events. | From baseline (week 0) to end of study (week 74) |
| Plantation |
| Florida |
| 33324 |
| United States |
| Midwest Inst For Clin Res | Indianapolis | Indiana | 46260 | United States |
| Accellacare | Wilmington | North Carolina | 28401 | United States |
| Velocity Clinical Res-Dallas | Dallas | Texas | 75230 | United States |
| Washington Cntr Weight Mgmt | Arlington | Virginia | 22206 | United States |
| Capital Clin Res Ctr,LLC | Olympia | Washington | 98502 | United States |
| Ocean West Research Clinic | Surrey | British Columbia | V3Z 2N6 | Canada |
| Nova Scotia Health Authority | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Wharton Medical Clinic Clinical Trials (Hamilton) | Hamilton | Ontario | L8L 5G8 | Canada |
| Hospices Civils de Lyon-Hopital Lyon Sud-1 | Pierre-Bénite | 69310 | France |
| Hospices Civils de Lyon-Hopital Lyon Sud | Pierre-Bénite | 69310 | France |
| Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec | Saint-Herblain | 44800 | France |
| Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil | Toulouse | 31059 | France |
| InnoDiab Forschung GmbH | Essen | 45136 | Germany |
| Wendisch - Dahl Hamburg - DZHW | Hamburg | 22607 | Germany |
| AmBeNet GmbH | Leipzig | 04107 | Germany |
| Institut für Diabetesforschung GmbH Münster - Dr. med. Rose | Münster | 48145 | Germany |
| Forschungszentrum Ruhr KliFoCenter GmbH, Kahrmann | Witten | 58455 | Germany |
| The Health Centre | Bradford-on-Avon | BA15 1DQ | United Kingdom |
| Southmead Hospital | Bristol | BS10 5NB | United Kingdom |
| Addenbrooke's Hospital_Cambridge | Cambridge | CB2 0QQ | United Kingdom |
| University Hospital Coventry - WISDEM Centre | Coventry | CV2 2DX | United Kingdom |
| Staploe Medical Centre | Soham | CB7 5JD | United Kingdom |
| Joint Clinical Research Facility - Swansea | Swansea | SA2 8PP | United Kingdom |
| 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 |
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| ID | Term |
|---|---|
| C000717792 | cagrilintide |
| C000591245 | semaglutide |
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