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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1314-8906 | Other Identifier | World Health Organization (WHO) | |
| 2024-519530-24 | Other Identifier | European Medical Agency (EMA) |
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This study will look at how much cagrilintide helps people with overweight or obesity lower their body weight. Cagrilintide is a new investigational medicine. Doctors may not yet prescribe cagrilintide. Participants will either get cagrilintide or placebo. Which treatment participants 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. Possible side effects will be followed carefully during the study. 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 (%). | From baseline (week 0) to end of treatment (week 64) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with achievement of greater than or equal to (>=) 10 percent (%) body weight reduction (yes/no) | 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 (yes/no) |
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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 |
|---|---|---|---|---|---|---|
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | United States | ||
| Univ of Colorado at Denver |
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 | 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 centimeters (cm). | From baseline (week 0) to end of treatment (week 64) |
| Ratio to baseline in 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) |
| Relative change in visceral abdominal fat volume | Measured as %. | 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 Systolic Blood Pressure (SBP) | Measured as millimeter of mercury (mmHg). | From baseline (week 0) to end of treatment (week 64) |
| Change in body weight | Measured as kilograms (kg). | From baseline (week 0) to end of treatment (week 64) |
| Number of participants with achievement of >= 5 % body weight reduction (yes/no) | Measured as count of participants. | 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 Diastolic Blood Pressure (DBP) | Measured as mmHg. | From baseline (week 0) to end of treatment (week 64) |
| Ratio to baseline of total cholesterol | Measured as ratio. | From baseline (week 0) to end of treatment (week 64) |
| Ratio to baseline of High-Density Lipoprotein (HDL) cholesterol | Measured as ratio. | From baseline (week 0) to end of treatment (week 64) |
| Ratio to baseline of Low-Density Lipoprotein (LDL) cholesterol | Measured as ratio. | From baseline (week 0) to end of treatment (week 64) |
| Ratio to baseline of Very Low-Density Lipoprotein (VLDL) cholesterol | Measured as ratio. | From baseline (week 0) to end of treatment (week 64) |
| Ratio to baseline of non-HDL cholesterol | Measured as ratio. | From baseline (week 0) to end of treatment (week 64) |
| Ratio to baseline of free fatty acids | Measured as ratio. | From baseline (week 0) to end of treatment (week 64) |
| Change in glycated haemoglobin (HbA1c) percentage-points (%-points) | Measured as %-points. | From baseline (week 0) to end of treatment (week 64) |
| Change in HbA1c millimoles per mole (mmol/mol) | Measured as mmol/mol. | From baseline (week 0) to end of treatment (week 64) |
| Change in Fasting Plasma Glucose (FPG) millimoles per litre (mmol/L) | Measured as mmol/L. | From baseline (week 0) to end of treatment (week 64) |
| Change in FPG milligrams 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 (TEAEs) | 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) |
| Relative change from baseline in ectopic fat percentage: Liver fat | Measured as %. | From baseline (week 0) to end of treatment (week 64) |
| Relative change from baseline in ectopic fat percentage: Pancreatic fat | Measured as %. | From baseline (week 0) to end of treatment (week 64) |
| Relative change from baseline in ectopic fat percentage: Thigh muscle fat | Measured as %. | From baseline (week 0) to end of treatment (week 64) |
| Relative to baseline change in subcutaneous abdominal fat volume to abdominal non-fat volume | Measured as %. | From baseline (week 0) to end of treatment (week 64) |
| Relative to baseline change in visceral abdominal fat volume to abdominal non-fat volume | Measured as %. | From baseline (week 0) to end of treatment (week 64) |
| Relative to baseline change in subcutaneous fat (percent relative to total thigh volume) | Measured as %. | From baseline (week 0) to end of treatment (week 64) |
| Relative to baseline change in intramuscular fat (percent relative to total thigh volume) | Measured as %. | From baseline (week 0) to end of treatment (week 64) |
| Relative to baseline change in intermuscular fat (percent relative to total thigh volume) | Measured as %. | From baseline (week 0) to end of treatment (week 64) |
| Relative to baseline change in contractile thigh muscle (percent relative to total thigh volume) | Measured as %. | From baseline (week 0) to end of treatment (week 64) |
| Relative to baseline change in total thigh muscle volume to total thigh fat volume | Measured as %. | From baseline (week 0) to end of treatment (week 64) |
| Relative to baseline change in contractile thigh muscle volume to total thigh fat volume | Measured as %. | From baseline (week 0) to end of treatment (week 64) |
| Relative to baseline change in contractile thigh muscle volume to inter and intramuscular thigh fat volume | Measured as %. | From baseline (week 0) to end of treatment (week 64) |
| Relative change from baseline in total fat volume to total lean volume | Measured as %. | From baseline (week 0) to end of treatment (week 64) |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Florida Inst For Clin Res LLC | Orlando | Florida | 32825 | United States |
| Oviedo Medical Research, LLC | Oviedo | Florida | 32765 | United States |
| Walgreens - Store 11760 | Oak Park | Illinois | 60302 | United States |
| Midwest Inst For Clin Res | Indianapolis | Indiana | 46260 | United States |
| StudyMetrix Research LLC | City of Saint Peters | Missouri | 63303 | United States |
| PharmQuest Life Sciences LLC | Greensboro | North Carolina | 27408 | United States |
| Selma Medical Associates | Winchester | Virginia | 22601-3834 | United States |
| CIPREC Pueyrredon | Buenos Aires | C1119ACN | Argentina |
| CEDIC Centro de Investigación Clínica | CABA | C1060ABA | Argentina |
| Sydney Cardiometabolic Centre | Liverpool | New South Wales | 2170 | Australia |
| Hunter Diabetes Centre | Merewether | New South Wales | 2291 | Australia |
| G.A. Research Associates Ltd. | Moncton | New Brunswick | E1G 1A7 | Canada |
| Nova Scotia Hlth Halifax | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Hamilton Medical Research Group | Hamilton | Ontario | L8L 5G4 | Canada |
| Wharton Medical Clinic Clinical Trials (Hamilton) | Hamilton | Ontario | L8L 5G8 | Canada |
| Milestone Research | London | Ontario | N5W 6A2 | Canada |
| Centricity Research Oshawa | Oshawa | Ontario | L1J 2K9 | Canada |
| Centricity Research Toronto | Toronto | Ontario | M4G 3E8 | Canada |
| Centricity Research Mirabel | Mirabel | Quebec | J7J 2K8 | Canada |
| Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec | Saint-Herblain | 44800 | France |
| Centre de Recherche Clinique Portes Du Sud | Vénissieux | 69200 | France |
| InnoDiab Forschung GmbH | Essen | 45136 | Germany |
| Wendisch - Dahl Hamburg - DZHW | Hamburg | 22607 | Germany |
| RED-Institut für medizinische Forschung und Fortbildung GmbH | Oldenburg in Holstein | 23758 | Germany |
| Fondazione Policlinico Universitario Agostino Gemelli IRCS | Rome | RM | 00168 | Italy |
| AOUP Giaccone Palermo | Palermo | Sicily | 90127 | Italy |
| A.O.U. Bologna_ Policlinico S.Orsola Malpighi | Bologna | 40138 | Italy |
| IRCCS Ospedale San Raffaele Milano | Milan | 20132 | Italy |
| Haukeland Universitetssykehus | Bergen | 5021 | Norway |
| Drammen sykehus - Vestre Viken HF | Drammen | 3004 | Norway |
| St. Olavs Hospital HF_Endokrinologisk avdeling | Trondheim | NO-7030 | Norway |
| Osteo-Medic s.c. A. Racewicz, J. Supronik | Bialystok | 15-351 | Poland |
| Care Clinic Sp. z o. o. | Katowice | 40-568 | Poland |
| Terpa Sp. z o.o. Sp. k. | Lublin | 20-333 | Poland |
| NBR Polska Tomasz Klodawski | Warsaw | 00-710 | Poland |
| 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 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| 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 |
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| ID | Term |
|---|---|
| C000717792 | cagrilintide |
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