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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1308-5620 | Other Identifier | World Health Organization (WHO) |
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This study is testing a new study medicine to treat people living with overweight or obesity. The aim of this study is to see if the medicine is safe, how it works in human body, and what human body does to the study medicine. Participants will either get the new study medicine NNC0174-1213, a study medicine called "cagrilintide" or a placebo (a "dummy medicine" similar to the new study medicine and study medicine but without active ingredients). Which treatment participants will get is decided by chance. The new study medicine and the study medicine are potential new medicines which cannot be prescribed by doctors. This study will last for about a year in total.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: NNC0174-1213 (SD1-SD5) | Experimental | Part A: Single ascending dose (SAD) of NNC0174-1213 will be administered in cohorts 1-5. |
|
| Part A: Cagrilintide (SDA and SDB) | Experimental | Part A: Single ascending dose (SAD): Cagrilintide SDA will be administered in cohort 1 and 2. Cagrilintide SDB will be administered in cohort 3 and 4. |
|
| Part A: Placebo | Experimental | Part A: Single ascending dose (SAD) of placebo will be administered to cohorts 1-5. |
|
| Part B: NNC0174-1213 (MD1-MD5) | Experimental | Part B: Multiple ascending doses (MAD) of NNC0174-1213 will be administered to cohorts 1-5. |
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| Part B: Cagrilintide (MDA) | Experimental | Part B: Multiple ascending doses (MAD) of Cagrilintide MDA will be administered to cohorts 1-5. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0174-1213 A | Drug | Participants will be randomized to receive NNC0174-1213 A administered as subcutaneous (s.c. under the skin) injection. Single ascending dose (SAD) will be injected for Part A cohorts and multiple ascending doses (MAD) will be injected for Part B cohorts. |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Number of treatment emergent adverse events (TEAE) reported by participants exposed to NNC0174 1213 | Number of events | From NNC0174 1213 administration (Day 1) to completion of the end of study visit (Day 46) |
| Part B: Number of treatment emergent adverse events (TEAE) | Number of events | From first administration (Day 1) to completion of the end of study visit (Day 67) |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: AUC; area under the NNC0174 1213 plasma concentration-time curve | measured in hour*nanomoles per liter (h*nmol/L). | From pre-dose on Day 1 to completion of the end of study visit (Day 46) |
| Part A: Cmax; maximum observed NNC0174 1213 plasma concentration |
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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 |
|---|---|---|---|---|---|---|
| ICON Early Phase Services, LLC | Recruiting | San Antonio | Texas | 78209 | United States | |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
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| Part B: Placebo | Experimental | Part B: Multiple ascending doses (MAD) of placebo will be administered to cohorts 1-5. |
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| Cagrilintide B | Drug | Participants will be randomized to receive Cagrilintide B administered as subcutaneous (s.c. under the skin) injection. Single ascending dose (SAD) will be injected for Part A cohorts and multiple ascending doses (MAD) will be injected for Part B cohorts. |
|
| Placebo A (NNC0174 1213 A) | Drug | Participants will be randomized to receive Placebo administered as subcutaneous (s.c. under the skin) injection. Single ascending dose (SAD) will be injected for Part A cohorts and multiple ascending doses (MAD) will be injected for Part B cohorts. |
|
measured in nanomoles per liter (nmol/L). |
| From pre-dose on Day 1 to completion of the end of study visit (Day 46) |
| Part B: AUC; area under the NNC0174 1213 plasma concentration-time curve | measured in h*nmol/L. | From first administration (Day 1) to completion of the end of study visit (Day 67) |
| Part B: Cmax; maximum observed NNC0174 1213 plasma concentration | measured in nmol/L. | From first administration (Day 1) to completion of the end of study visit (Day 67) |
| ICON Early Phase Services, LLC |
| Recruiting |
| Salt Lake City |
| Utah |
| 84124 |
| United States |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |