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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1332-9333 | Other Identifier | World Health Organization (WHO) |
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The purpose of this clinical study is to find out if UBT251 is safe and effective to be taken together with medicines, like birth control tablets, and emptying of the stomach in women not able to become pregnant living with overweight or obesity
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UBT251 | Experimental | UBT251 will be administered by subcutaneous injection during the treatment period with dose escalation to a maintenance treatment level. |
|
| Oral Contraceptive (ethinylestradiol [EE] and levonorgestrel [LN]) | Experimental | An oral contraceptive will be administered during baseline and treatment assessment periods to evaluate the effect of UBT251 on oral contraceptive pharmacokinetics. |
|
| Acetaminophen (equivalent to paracetamol [para]) | Experimental | A single dose of acetaminophen will be administered with a standardised meal during baseline and treatment assessment periods to evaluate gastric emptying |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UBT251 | Drug | Administered subcutaneously. |
| |
| Oral contraceptive |
| Measure | Description | Time Frame |
|---|---|---|
| AUC,EE,SS: The area under the EE plasma concentration time curve during a dosing interval at steady state | Measured in hours picograms per millilitre (h*pg/mL). | From pre-dose on Day 8 up to 157 days |
| AUC ,LN,SS: The area under the LN plasma concentration time curve during a dosing interval at steady state | Measured in h*pg/mL. | From pre-dose on Day 8 up to 157 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax,EE,SS: Maximum EE plasma concentration at steady state | Measured in picograms per millilitre (pg/mL). | From pre-dose on Day 8 up to 157 days |
| Cmax,LN,SS: Maximum LN plasma concentration at steady state |
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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 |
|---|---|---|---|---|---|---|
| Altasciences Clinical Company, Inc | Montreal | Quebec | H3P 3P1 | Canada |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| Drug |
Administered orally. |
|
| Acetaminophen | Drug | Administered orally. |
|
Measured in pg/mL.
| From pre-dose on Day 8 up to 157 days |
| AUC,para: The area under the acetaminophen plasma concentration-time curve | Measured in hour microgram per millilitre (h*μg/mL). | From pre-dose on Day 1 up to 150 days |
| Cmax,para: Maximum observed acetaminophen plasma concentration | Measured in microgram per millilitre (μg/mL). | From pre-dose on Day 1 up to 150 days |
| 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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