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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1328-3457 | Other Identifier | WHO |
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The purpose of this clinical study is to find out if NNC0662-0419 is safe and effective to be taken together with other medicines, like birth control pills, and emptying of the stomach in women not able to become pregnant living with overweight or obesity. There are 3 study treatments in this study, participants will get all of the treatments, NNC0662-0419 the treatment being tested, Altavera a type of birth control pill, Acetaminophen a common type of mild painkiller.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0662-0419 with oral contraceptive (Altavera) and acetaminophen | Experimental | Participants will receive once-weekly subcutaneous NNC0662-0419, with multiple doses administered over the treatment period. An oral contraceptive will be administered as a number of tablets per treatment period, with dosing conducted under supervised conditions. In addition, a single dose of acetaminophen will be administered as part of a standardized meal during treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0662-0419 | Drug | Once-weekly subcutaneous NNC0662-0419 will be administered using a pen injector |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under curve (AUC) 0-24 h, EE, steady state (SS): The area under the EE plasma concentration-time curve (pre-dose to 24 hours post-dose) | Measured as picograms per milliliter (h*pg/mL) | Day 8 and 1 day after last NNC0662-0419 dose |
| AUC0-24h, LN, SS: The area under the LN plasma concentration-time curve (pre-dose to 24 hours post-dose) | Measured as h*pg/mL | Day 8 and 1 day after last NNC0662-0419 dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax), EE, SS: Maximum observed EE plasma concentration (pre-dose to 24 hours post-dose) | Measured as pg/mL | Day 8 and 1 day after last NNC0662-0419 dose |
| Cmax, LN, SS: Maximum observed LN plasma concentration (pre-dose to 24 hours post-dose) |
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Inclusion Criteria:
Exclusion Criteria:
Female (sex assigned at birth) of non-childbearing potential
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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 |
|---|---|---|---|---|---|---|
| Altasciences Clinical Kansas, Inc. | Recruiting | Overland Park | Kansas | 66212 | United States |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| Oral contraceptive | Drug | An oral contraceptive Altavera [levonorgestrel (LN) 0.15 milligram (mg) and ethinyl estradiol (EE) 0.03 mg] will be administered orally. |
|
| Acetaminophen | Drug | A single dose of acetaminophen will be administered orally. |
|
Measured as pg/mL |
| Day 8 and 1 day after last NNC0662-0419 dose |
| AUC0-60min, para: The area under the paracetamol plasma concentration-time curve (pre-dose to 60 minutes post-dose) following a standardised meal | Measured as microgram per milliliter (h*μg/mL) | Day 1 and 1 day after 3rd NNC0662-0419 dose on highest dose step |
| AUC0-300min, para: The area under the paracetamol plasma concentration-time curve (pre-dose to 300 minutes post-dose) following a standardised meal | Measured as h*μg/mL | Day 1 and 1 day after 3rd NNC0662-0419 dose on highest dose step |
| Cmax, para; Maximum observed paracetamol plasma concentration (pre-dose to 300 minutes post-dose) following a standardised meal | Measured as μg/mL | Day 1 and 1 day after 3rd NNC0662-0419 dose on highest dose step |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| 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 |
|---|---|
| D003276 | Contraceptives, Oral |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D003271 | Contraceptive Agents, Female |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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