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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1313-0864 | Other Identifier | World Health Organization (WHO) | |
| 2024-517883-49 | Other Identifier | European Medical Agency (EMA) |
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In this study we will investigate how the medicine cagrilintide affects bone health in women after menopause with obesity during weight loss, compared to treatment with placebo (the dummy medicine with no active substances) and semaglutide. The purpose is to examine whether cagrilintide can reduce the decline in bone mass associated to weight loss. Participants will either get cagrilintide, semaglutide, CagriSema (cagrilintide combined with semaglutide), or placebo. Which treatment participants get is decided by chance. Semaglutide is already approved for the treatment of overweight and obesity and can be prescribed by doctors. Cagrilintide and CagriSema are new medications currently under development for weight management. The study will last for about 79 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cagrilintide | Experimental | Participants will receive once-weekly subcutaneous (s.c) injections of cagrilintide or placebo at stepwise doses every 4 weeks in a 16-week dose escalation period until target dose is achieved and maintained for 52 weeks as adjunct to a reduced calorie diet. |
|
| Semaglutide | Experimental | Participants will receive once-weekly s.c injections of semaglutide or placebo at stepwise doses every 4 weeks in a 16 week dose escalation period until target dose is achieved and maintained for 52 weeks as adjunct to a reduced calorie diet. |
|
| CagriSema | Experimental | Participants will receive once-weekly s.c injections of CagriSema (cagrilintide and semaglutide) or placebo at stepwise doses every 4 weeks in a 16 week dose escalation period until target dose is achieved and maintained for 52 weeks as adjunct to a reduced calorie diet. |
|
| Placebo | Placebo Comparator | Participants will receive once-weekly s.c injection of placebo matched to semaglutide and cagrilintide for 68 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cagrilintide | Drug | Participants will receive once-weekly cagrilintide subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in volumetric bone mineral density (vBMD) of the total hip assessed by quantitative computed tomography (QCT) | Measured in percentage (%). | From baseline to end of treatment (week 68) |
| Measure | Description | Time Frame |
|---|---|---|
| Relative changes in vBMD of the lumbar 1 (L1) - L4 vertebrae assessed by QCT | Measured in %. | From baseline to end of treatment (week 68) |
| Relative changes in vBMD of the radius assessed by QCT |
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Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novo Nordisk | Contact | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center Copenhagen | Recruiting | Herlev | 2730 | Denmark |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000717792 | cagrilintide |
| C000591245 | semaglutide |
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| Semaglutide | Drug | Participants will receive once-weekly semaglutide subcutaneously. |
|
| Placebo cagrilintide | Drug | Participants will receive once-weekly placebo matched to cagrilintide subcutaneously. |
|
| Placebo semaglutide | Drug | Participants will receive once-weekly placebo matched to semaglutide subcutaneously. |
|
Measured in %.
| From baseline to end of treatment (week 68) |
| Relative changes in vBMD of the L1 - L4 vertebrae assessed by QCT | Measured in %. | From baseline to week 20 |
| Relative changes in vBMD of the radius assessed by QCT | Measured in %. | From baseline to week 20 |
| Relative change in the Ki (bone turnover) of the femoral neck assessed by fluoride - positron emission tomography (PET) | Measured in %. | From baseline to end of treatment (week 68) |
| Relative change in the Ki (bone turnover) of the femoral neck assessed by fluoride - PET | Measured in %. | From baseline to week 20 |
| Relative changes in C-terminal telopeptide of type I collagen (CTX-1) and procollagen type 1 N-terminal propeptide (P1NP) | Measured in %. | From baseline to end of treatment (week 68) |
| Relative changes in CTX-1 and P1NP | Measured in %. | From baseline to week 20 |
| Relative changes in cortical thickness and porosity assessed by photon-counting computed tomography (PCCT) | Measured in %. | From baseline to end of treatment (week 68) |
| Relative changes in trabecular thickness assessed by PCCT | Measured in %. | From baseline to end of treatment (week 68) |
| Relative changes in number and separation of the femoral neck assessed by PCCT | Measured in %. | From baseline to end of treatment (week 68) |
| Relative changes in L1-L2 vertebrae assessed by PCCT | Measured in %. | From baseline to end of treatment (week 68) |
| Relative changes in radius assessed by PCCT | Measured in %. | From baseline to end of treatment (week 68) |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |