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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1325-4319 | Other Identifier | World Health Organization (WHO) | |
| 2025-523978-16 | EudraCT Number |
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The purpose of this clinical study is to find out if NNC0497-0040 is safe, tolerable and effective for healthy people living with normal weight or overweight, people living with overweight or obesity and people who have type 1 diabetes and are living with overweight or obesity. There are 2 study treatments in this study, where participants will get either NNC0497-0040, the new treatment being tested or placebo, a treatment that has no active medicine in it. Participants will be in this clinical study for up to 29 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD | Experimental | Participants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously. |
|
| MAD1 | Experimental | Participants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously. |
|
| MAD2 | Experimental | Participants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously. |
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| MAD3 | Experimental | Participants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously. |
|
| MAD4 | Experimental | Participants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0497-0040 | Drug | NNC0497-0040 will be administered subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | Measured in events | Day 1 up to Week 6 |
| Number of adverse events | Measured in events | MAD1-2: Day 1 up to Week 17; MAD3: Day 1 up to Week 25 |
| Number of adverse events | Measured in events | Day 1 up to Week 25 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum NNC0497-0040 concentration time curve | Measured in hours * nanomoles per litre (h*nmol/L) | Day 1 |
| Cmax: Maximum observed serum NNC0497-0040 concentration | Measured in nanomoles per litre (nmol/L) |
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For SAD cohorts
Inclusion Criteria:
Exclusion Criteria:
For MAD1-3 cohorts
Inclusion Criteria:
Exclusion Criteria:
For MAD4 cohorts
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 |
|---|---|---|---|---|---|---|
| Profil Institut für Stoffwechselforschung GmbH | Recruiting | Neuss | 41460 | Germany |
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 will be administered subcutaneously. |
|
| Day 1 |
| Area under the serum NNC0497-0040 concentration time curve at steady state | Measured in hours * nanomoles per litre (h*nmol/L) | MAD1-2: Week 12; MAD3: Week 20 |
| Cmax: Maximum observed serum NNC0497-0040 concentration at steady state | Measured in nanomoles per litre (nmol/L) | MAD1-2: Week 12; MAD3: Week 20 |
| Number of severe hypoglycaemic episodes | Measured in events | Day 1 up to Week 25 |
| AUC: Area under the serum NNC0497-0040 concentration time curve during at steady state | Measured in hours * nanomoles per litre (h*nmol/L) | MAD4: Week 20 |
| Cmax: Maximum observed serum NNC0497-0040 concentration at steady state | Measured in nanomoles per litre (nmol/L) | MAD4: Week 20 |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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