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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1314-9328 | Other Identifier | World Health Organization (WHO) | |
| 2024-519531-41 | Other Identifier | European Medical Agency (EMA) |
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This study will look at how much cagrilintide helps people with overweight or obesity and type 2 diabetes lower their body weight. Cagrilintide is a new investigational medicine. Doctors may not yet prescribe cagrilintide. Participant will either get cagrilintide or placebo. Which treatment participant get is decided by chance. Participants are two times more likely to get cagrilintide than placebo. Like all medicines, the study medicine may have side effects. For each participant, the study will last for about 1 year and 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cagrilintide | Experimental | Participants will receive cagrilintide subcutaneously once weekly for 64 weeks. |
|
| Placebo | Placebo Comparator | Participants will receive placebo matched to cagrilintide subcutaneously once weekly for 64 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cagrilintide | Drug | Cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in body weight | Measured as percentage (%) of body weight. | From baseline (week 0) to end of treatment (week 64) |
| Number of participants with achievement of greater than or equals (>=) 5% body weight reduction | Measured as count of participants. | From baseline (week 0) to end of treatment (week 64) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with achievement of >= 10% body weight reduction | Measured as count of participants. | From baseline (week 0) to end of treatment (week 64) |
| Number of participants with achievement of >= 15% body weight reduction |
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Key Inclusion Criteria:
Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
Female or male (sex at birth).
Age 18 years or above at the time of signing the informed consent.
History of at least one self-reported unsuccessful dietary effort to lose body weight.(a*)
Body mass index (BMI) >= 27.0 kilogram per square meter (kg/m^2).(a*)
Diagnosed with type 2 diabetes >= 180 days before screening.
Treatment with either lifestyle intervention(a*), or:
Stable treatment (same drug(s), dose and dosing frequency) for at least 90 days before screening with 1-3 marketed oral antidiabetic drugs (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i), thiazolidinediones, Dipeptidyl peptidase-4 inhibitor (DPP-4i) or sulphonylureas (SU) as a single agent or in combination according to local practice.(a*)
For up to 30% of participants the following concomitant medication is allowed:
Key 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 |
|---|---|---|---|---|---|---|
| Univ of Alabama_Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Chambliss Clinical Trials, LLC |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| Placebo (matched to Cagrilintide) | Drug | Placebo matched to cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling. |
|
Measured as count of participants.
| From baseline (week 0) to end of treatment (week 64) |
| Change in waist circumference | Measured as centimeter (cm). | From baseline (week 0) to end of treatment (week 64) |
| Ratio to baseline in lipids: triglycerides | Measured as ratio. | From baseline (week 0) to end of treatment (week 64) |
| Ratio to baseline in high sensitivity C-reactive protein (hsCRP) | Measured as ratio. | From baseline (week 0) to end of treatment (week 64) |
| Change in impact of weight on quality of life-lite clinical trials version (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. Higher scores indicate better levels of functioning. The physical function score ranges from 0-100. | From baseline (week 0) to end of treatment (week 64) |
| Change in body weight | Measured as kilogram (kg). | From baseline (week 0) to end of treatment (week 64) |
| Change in SF-36v2® health survey acute (SF-36v2® acute) physical component summary score | Measured as score on a scale. 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 physical component summary score ranges from 6.1 to 79.7. | From baseline (week 0) to end of treatment (week 64) |
| Change in SF-36v2® mental component summary score | Measured as score on a scale. 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 mental component summary score ranges from -3.8 to 78.7. | From baseline (week 0) to end of treatment (week 64) |
| 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. Higher scores indicate better levels of functioning. The total score ranges from 0-100. | From baseline (week 0) to end of treatment (week 64) |
| Number of participants with achievement of at least 14.6-point increase in IWQOL-Lite-CT physical function score (yes/no) | Measured as count of participants. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The physical function score ranges from 0-100. | From baseline (week 0) to end of treatment (week 64) |
| Change in systolic blood pressure (SBP) | Measured as millimeter of mercury (mmHg). | From baseline (week 0) to end of treatment (week 64) |
| Change in diastolic blood pressure (DBP) | Measured as mmHg. | From baseline (week 0) to end of treatment (week 64) |
| Ratio to baseline in lipids: total cholesterol | Measured as ratio. | From baseline (week 0) to end of treatment (week 64) |
| Ratio to baseline in lipids: high-density lipoprotein (HDL) cholesterol | Measured as ratio. | From baseline (week 0) to end of treatment (week 64) |
| Ratio to baseline in lipids: low-density lipoprotein (LDL) cholesterol | Measured as ratio. | From baseline (week 0) to end of treatment (week 64) |
| Ratio to baseline in lipids: very low-density lipoprotein (VLDL) cholesterol | Measured as ratio. | From baseline (week 0) to end of treatment (week 64) |
| Ratio to baseline in lipids: non-HDL cholesterol | Measured as ratio. | From baseline (week 0) to end of treatment (week 64) |
| Ratio to baseline in lipids: free fatty acids | Measured as ratio. | From baseline (week 0) to end of treatment (week 64) |
| Change in glycated haemoglobin (HbA1c) in percentage-points (%-points) | Measured as %-points. | From baseline (week 0) to end of treatment (week 64) |
| Change in HbA1c in millimole per mole (mmol/mol) | Measured as mmol/mol. | From baseline (week 0) to end of treatment (week 64) |
| Change in fasting plasma glucose (FPG) in millimole per liter (mmol/L) | Measured as mmol/L. | From baseline (week 0) to end of treatment (week 64) |
| Change in FPG in milligram per deciliter (mg/dL) | Measured as mg/dL. | From baseline (week 0) to end of treatment (week 64) |
| Ratio to baseline in fasting serum insulin | Measured as ratio. | From baseline (week 0) to end of treatment (week 64) |
| Number of treatment emergent adverse events | Measured as count of events. | From baseline (week 0) to end of study (week 71) |
| Number of treatment emergent serious adverse events (TESAEs) | Measured as count of events. | From baseline (week 0) to end of study (week 71) |
| Number of clinically significant hypoglycaemic episodes (level 2):<3.0 mmol/L [54 mg/dL], confirmed by blood glucose meter | Measured as count of events. | From baseline (week 0) to end of study (week 71) |
| 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 events. | From baseline (week 0) to end of study (week 71) |
| Montgomery |
| Alabama |
| 36106 |
| United States |
| Elite Clinical Network - Tucson | Tucson | Arizona | 85704 | United States |
| Scripps Whittier Diabetes Inst | La Jolla | California | 92037 | United States |
| Clinical Trials Research | Lincoln | California | 95648 | United States |
| Pacific Clinical Studies | Los Alamitos | California | 90720 | United States |
| Walgreens - Store 4442 | Kissimmee | Florida | 34746 | United States |
| Optimal Research Sites | Orange City | Florida | 32763 | United States |
| Center for Diab,Obes & Metab | Pembroke Pines | Florida | 33024 | United States |
| Palm Beach Research Center | West Palm Beach | Florida | 33409 | United States |
| East West Med Res Inst | Honolulu | Hawaii | 96814 | United States |
| MediSphere Medical RC | Evansville | Indiana | 47714 | United States |
| Walgreens - Store 3915 | Las Vegas | Nevada | 89146 | United States |
| Chear Center LLC | The Bronx | New York | 10455 | United States |
| Centricity Res New Bern Multispeciality | New Bern | North Carolina | 28562 | United States |
| Accellacare | Wilmington | North Carolina | 28401 | United States |
| Spartanburg Medical Research | Spartanburg | South Carolina | 29303 | United States |
| Holston Medical Group_Bristol | Bristol | Tennessee | 37620 | United States |
| Velocity Clinical Res-Dallas | Dallas | Texas | 75230 | United States |
| TPMG Clinical Research | Newport News | Virginia | 23606 | United States |
| National Clin Res Inc. | Richmond | Virginia | 23294 | United States |
| Buenos Aires Mácula | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1061AAE | Argentina |
| CICEMO- Consultorio de Investigación Clínica EMO | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1405BUB | Argentina |
| Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli | Buenos Aires | C1425AGC | Argentina |
| OCT Research ULC (dba Okanagan Clinical Trials) | Kelowna | British Columbia | V1Y 1Z9 | Canada |
| G.A. Research Associates Ltd. | Moncton | New Brunswick | E1G 1A7 | Canada |
| Nova Scotia Hlth Halifax | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Centricity Research Brampton Endocrinology | Brampton | Ontario | L6S 0C6 | Canada |
| Hamilton Medical Rsrch Grp | Hamilton | Ontario | L8L 5G4 | Canada |
| Wharton Medical Clinic Clinical Trials (Hamilton) | Hamilton | Ontario | L8L 5G8 | Canada |
| Milestone Research | London | Ontario | N5W 6A2 | Canada |
| Centricity Res Pointe-Claire | Pointe-Claire | Quebec | H9R 4S3 | Canada |
| Diex Recherche Victoriaville | Victoriaville | Quebec | G6P 3Z8 | Canada |
| Opca bolnica Karlovac | Karlovac | 47000 | Croatia |
| Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology | Krapinske Toplice | 49217 | Croatia |
| Poliklinika SLAVONIJA OSIJEK | Osijek | 31000 | Croatia |
| Poliklinika Solmed | Zagreb | 10000 | Croatia |
| Lékařský dům Géčko | České Budějovice | 370 11 | Czechia |
| Milan Kvapil s.r.o. | Prague | 149 00 | Czechia |
| EUC Klinika Praha a.s. | Prague | 150 00 | Czechia |
| Debreceni Egyetem | Debrecen | Hajdú-Bihar | 4032 | Hungary |
| QUALICLINIC Egészségügyi Szolgáltató és Kutatásszervező Kft | Budapest | Pest County | 1036 | Hungary |
| Óbudai Egészségügyi Centrum | Budapest | Pest County | 1036 | Hungary |
| Komáromi Selye János Kórház | Komárom | 2900 | Hungary |
| Diabmed Dr Popescu Alexandrina SRL | Ploieşti | Prahova | 100179 | Romania |
| CMI Dr. Pletea Noemi SRL | Bacau | 600154 | Romania |
| Diabet Med SRL | Bucharest | 050913 | Romania |
| S.C Milena Sante SRL | Galati | 800001 | Romania |
| Clinica Korall S.R.L. Satu Mare | Satu Mare | 440055 | Romania |
| Nemocnica akademika L. Derera, UNB | Bratislava | 831 01 | Slovakia |
| DIAB s.r.o. | Rožňava | 04801 | Slovakia |
| IRIDIA s.r.o. | Vrútky | 038 61 | Slovakia |
| Pusan National University Yangsan Hospital | Yangsan | Gyeongsangnam-do | 50612 | South Korea |
| Chonnam National University Hospital | Gwangju | 61469 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| The Catholic University of Korea, Seoul ST. Mary's Hospital | Seoul | 06591 | South Korea |
| The Catholic University of Korea, Yeouido ST. Mary's Hospital | Seoul | 07345 | South Korea |
| Kyunghee University Medical Center | Seoul | 130-872 | South Korea |
| Universitätsspital Basel | Basel | 4031 | Switzerland |
| Centre hospitalier universitaire vaudois CHUV | Lausanne | 1011 | Switzerland |
| Kantonsspital Olten | Olten | 4600 | Switzerland |
| Diabetes Adipositas Zentrum Zürich | Zollikerberg | 8125 | Switzerland |
| Oak Tree Surgery | Liskeard | Cornwall | PL14 3XA | United Kingdom |
| North Coast Medical Ltd | Newquay | Cornwall | TR7 1RU | United Kingdom |
| Brunel Medical Practice | Torquay | Devon | TQ1 4QX | United Kingdom |
| Attenborough Surgery | Bushey | Hertfordshire | WD23 2NN | United Kingdom |
| Hammersmith and Fulham Partnership Research Unit - Richford Gate Primary Care Centre | London | W6 7HY | United Kingdom |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000717792 | cagrilintide |
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