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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-502677-42 | Other Identifier | European Medical Agency (EMA) | |
| U1111-1283-0404 | Other Identifier | World Health Organization (WHO) |
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This study will look at how much CagriSema helps participants with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. Participants will get either CagriSema or "dummy" medicine. Which treatment participants get is decided by chance. For each participant, the study will last for about one year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CagriSema Dose 2 | Active Comparator | Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 16-week dose escalation period until target dose (dose 2) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 24 weeks. |
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| Placebo Dose 2 | Placebo Comparator | Participants will receive once-weekly s.c injection of placebo matched to Cagrisema (cagrilintide and semaglutide) dose 2 for 40 weeks. |
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| Cagrisema Dose 1 | Active Comparator | 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 32 weeks. |
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| Placebo Dose 1 | Placebo Comparator | Participants will receive once-weekly s.c injection of placebo matched to Cagrisema (cagrilintide and semaglutide) dose 1 for 40 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 |
|---|---|---|
| Change in glycated haemoglobin (HbA1c) | Measured as percentage (%)-points. | From baseline (week 0) to end of treatment (week 40) |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in body weight | Measured in %. | From baseline (week 0) to end of treatment (week 40) |
| Number of participants who achieve greater than or equal to (>=) 10% body weight reduction |
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Inclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Nat Res Inst Huntington Park | Huntington Park | California | 90255 | United States | ||
| Valley Clinical Trials, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42251860 | Derived | Aroda VR, Buzzetti R, Dalskov SM, Jain AB, Larsen JH, Mathieu C, Pratley RE, Videmark A, Watt T, Buse JB. Efficacy and safety of once-weekly cagrilintide-semaglutide (CagriSema) in adults with type 2 diabetes inadequately controlled on diet and exercise (REIMAGINE 1): a randomised, double-blind, placebo-controlled, phase 3a study. Lancet Diabetes Endocrinol. 2026 Jun 7:S2213-8587(26)00126-9. doi: 10.1016/S2213-8587(26)00126-9. Online ahead of print. |
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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 placebo matched to cagrilintide and semaglutide subcutaneously. |
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Measured as count of participants.
| From baseline (week 0) to end of treatment (week 40) |
| Number of participants who achieve >=15% body weight reduction | Measured as count of participants. | From baseline (week 0) to end of treatment (week 40) |
| Number of participants who achieve HbA1c target values of less than (<) 7.0% (<53 millimoles per mole [mmol/mol]) | Measured as count of participants. | At end of treatment (week 40) |
| Number of participants who achieve HbA1c target values of less than or equal to (<=) 6.5% (<= 48 mmol/mol) | Measured as count of participants. | At end of treatment (week 40) |
| Change in Fasting Plasma Glucose (FPG) | Measured in millimoles per liter (mmol/L). | From baseline (week 0) to end of treatment (week 40) |
| Number of participants who achieve >=5% body weight reduction | Measured as count of participants. | From baseline (week 0) to end of treatment (week 40) |
| Number of participants who achieve >=20% body weight reduction | Measured as count of participants. | From baseline (week 0) to end of treatment (week 40) |
| Change in waist circumference | Measured in centimeters (cm). | From baseline (week 0) to end of treatment (week 40) |
| Change in systolic blood pressure (SBP) | Measured in millimeters of mercury (mmHg). | From baseline (week 0) to end of treatment (week 40) |
| Change in diastolic blood pressure (DBP) | Measured in mmHg. | From baseline (week 0) to end of treatment (week 40) |
| Ratio to baseline in high sensitivity C-reactive protein (hsCRP) | Measured as ratio. | From baseline (week 0) to end of treatment (week 40) |
| Ratio to baseline in lipids: Total cholesterol | Measured as ratio. | From baseline (week 0) to end of treatment (week 40) |
| Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol | Measured as ratio. | From baseline (week 0) to end of treatment (week 40) |
| Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol | Measured as ratio. | From baseline (week 0) to end of treatment (week 40) |
| Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol | Measured as ratio. | From baseline (week 0) to end of treatment (week 40) |
| Ratio to baseline in lipids: Triglycerides | Measured as ratio. | From baseline (week 0) to end of treatment (week 40) |
| Ratio to baseline in lipids: Free fatty acids | Measured as ratio. | From baseline (week 0) to end of treatment (week 40) |
| Ratio to baseline in lipids: Non-HDL cholesterol | Measured as ratio. | From baseline (week 0) to end of treatment (week 40) |
| Number of participants who achieve type 2 diabetes (T2D) remission (HbA1c <6.5% and no antidiabetic medication) | Measured as count of participants. | At end of study (week 52) |
| Ratio to baseline in oral glucose tolerance test (OGTT) based oral glucose disposition index (DIo) | Measured as ratio. | From baseline (week 0) to end of treatment (week 40) |
| Change in experienced level of energy as measured by the SF-36v2 Health Survey Acute (SF-36v2) Vitality score | Measured as score points. 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, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The vitality score range is from 25.6 to 69.1. | From baseline (week 0) to end of treatment (week 40) |
| Change in SF-36v2 score: Physical Component Summary score | Measured as score points. 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, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The score range for physical component summary is 6.1 to 79.7. | From baseline (week 0) to end of treatment (week 40) |
| Change in SF-36v2 score: Mental Component Summary score | Measured as score points. 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, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The score range for mental component summary score is -3.8 to 78.7. | From baseline (week 0) to end of treatment (week 40) |
| Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score | Measured as score points. DTSQs measures treatment satisfaction and diabetes-specific quality of life. The measure consists of 8 items yielding 1 global score and 2 single item scores. Higher scores on the global score indicate greater satisfaction with treatment. Lower scores on the single-item scores indicate BG levels closer to the ideal, while higher scores indicate problems. Single-item scores (score range): Perceived frequency of hyperglycaemia (0-6), Perceived frequency of hypoglycaemia (0-6). Global score (score range): Total Treatment Satisfaction (0-36). | From baseline (week 0) to end of treatment (week 40) |
| Change in leptin | Measured in nanograms per milliliter (ng/mL). | From baseline (week 0) to end of treatment (week 40) |
| Change in soluble leptin receptor | Measured in ng/mL. | From baseline (week 0) to end of treatment (week 40) |
| Number of Treatment Emergent Adverse Events (TEAEs) | Measured as count of events. | From baseline (week 0) to end of treatment +7 weeks (week 47) |
| Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol (54 milligrams per deciliter [mg/dL]), confirmed by blood glucose (BG) meter | Measured as count of episodes. | From baseline (week 0) to end of treatment +7 weeks (week 47) |
| Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold | Measured as count of episodes. | From baseline (week 0) to end of treatment + 7 weeks (week 47) |
| Northridge |
| California |
| 91325 |
| United States |
| Southern California Dermatology | Santa Ana | California | 92701 | United States |
| Encore Medical Research LLC | Hollywood | Florida | 33024 | United States |
| Headlands Research Orlando | Orlando | Florida | 32819 | United States |
| Encore Medical Research of Weston | Weston | Florida | 33331 | United States |
| Alliance for Multispec Res | Newton | Kansas | 67114 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Arcturus HC PLC Troy Med Res | Troy | Michigan | 48098 | United States |
| Southgate Medical Group, LLP | West Seneca | New York | 14224 | United States |
| Summit Research Network Oregon Inc. | Portland | Oregon | 97210 | United States |
| Holston Medical Group | Kingsport | Tennessee | 37660 | United States |
| Amarillo Medical Specialists | Amarillo | Texas | 79124 | United States |
| Elligo Clin Res Centre | Austin | Texas | 78704 | United States |
| Headlands Research Brownsville | Brownsville | Texas | 78526 | United States |
| Velocity Clinical Res-Dallas | Dallas | Texas | 75230 | United States |
| Northeast Clinical Research of San Antonio | San Antonio | Texas | 78233 | United States |
| Consano Clinical Research, LLC | Shavano Park | Texas | 78231 | United States |
| Sugar Lakes Family Practice PA | Sugar Land | Texas | 77479 | United States |
| Valley Diab. & Endo Comp Ctr | Weslaco | Texas | 78596 | United States |
| TPMG Clinical Research | Newport News | Virginia | 23606 | United States |
| Chinese People's Liberation Army General Hospital-Endocrinology | Beijing | Beijing Municipality | 100853 | China |
| The Second Affiliated Hospital of Nanjing Medical University-Endocrinology | Nanjing | Jiangsu | 210011 | China |
| The Affiliated Hospital of Jiangsu University-Endocrinology | Zhenjiang | Jiangsu | 212001 | China |
| Jinan Central Hospital | Ji'Nan | Shandong | 250000 | China |
| Jinan Central Hospital | Jinan | Shandong | 250000 | China |
| Belinus Bt. | Debrecen | Hajdú-Bihar | 4025 | Hungary |
| Borbánya Praxis E.Ü. Kft. | Nyíregyháza | Szabolcs-Szatmar Varmegye | 4405 | Hungary |
| Szent Margit Rendelőintézet Nonprofit Kft. | Budapest | 1032 | Hungary |
| PVN Kutató Kft. | Budapest | 1102 | Hungary |
| Azienda Ospedaliera Papa Giovanni XXIII | Bergamo | 24127 | Italy |
| Policlinico Mater Domini Università di Catanzaro | Catanzaro | 88100 | Italy |
| IRCCS Ospedale San Raffaele Milano | Milan | 20132 | Italy |
| Azienda Ospealiero Universitaria Policlinico Umberto I | Roma | 00161 | Italy |
| Centrum Medyczne Medyk Sp. z o.o. | Rzeszów | Podkarpackie Voivodeship | 35-055 | Poland |
| Osteo-Medic s.c. A. Racewicz, J. Supronik | Bialystok | 15-351 | Poland |
| Renew Clinic Sp. z o.o. | Bialystok | 15-797 | Poland |
| Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A. | Lodz | 90-338 | Poland |
| NBR Polska Tomasz Klodawski | Warsaw | 00-710 | Poland |
| Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji | Warsaw | 02-507 | Poland |
| Velocity Nova Sp. z o.o. | Zamość | 22-400 | Poland |
| King Abdulaziz Hospital-Al Ahsa-National Guard | Al Ahsa | 36428 | Saudi Arabia |
| National Guard Hospital - Jeddah | Jeddah | 21423 | Saudi Arabia |
| King Fahad Medical City | Riyadh | 11525 | Saudi Arabia |
| King Khaled University Hospital,King Saud Univ. Med. City | Riyadh | 12372 | Saudi Arabia |
| King Salman Bin Abdulaziz Hospital | Riyadh | 12769 | Saudi Arabia |
| CHC Zvezdara, Clinical department for endocrinology | Belgrade | 11000 | Serbia |
| Clinical Hospital Center Bezanijska Kosa | Belgrade | 11080 | Serbia |
| Clinical Hospital Centre Zemun | Belgrade | 11080 | Serbia |
| Policlinic for diabetes | Zaječar | 19000 | Serbia |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000717792 | cagrilintide |
| C000591245 | semaglutide |
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