Obesity, Overweight
Conditions
Brief summary
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
Interventions
DRUGUBT251
Administered subcutaneously.
DRUGOral contraceptive
Administered orally.
DRUGAcetaminophen
Administered orally.
Sponsors
Novo Nordisk A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Female (sex assigned at birth) of NCBP. * Age 18-65 years (both inclusive) at the time of signing the informed consent. * Body mass index (BMI) between 27.0-39.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator. * Body weight \>= 60.0 kg. * Considered to be generally healthy, except for overweight or obesity, based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Exclusion criteria
* Known or suspected hypersensitivity to study intervention(s) or related products. * Treatment with any compound containing glucagon-like peptide 1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), or glucagon (GCG) receptor agonism within 90 days before screening. * Any contraindications for the use of the oral contraception used in the study according to the PORTIA Product Information. * Use of hormone replacement therapy within 28 days before screening or intention to initiate treatment with hormone replacement therapy during the study. * Use of prescription medicinal products or non-prescription drugs, including any herbal medicine known to interfere with the metabolic cytochrome P450 (CYP) pathways, such as perikon (St. John's Wort), within 14 days (or within 5 half-lives of the medicinal product, whichever is longest) of screening, with the exception of use of routine vitamins (vitamins used within a normal dose reference interval), occasional use of acetaminophen, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation. * Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, or as judged by the investigator. * History of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC,EE,SS: The area under the EE plasma concentration time curve during a dosing interval at steady state | From pre-dose on Day 8 up to 157 days | Measured in hours picograms per millilitre (h\*pg/mL). |
| AUC ,LN,SS: The area under the LN plasma concentration time curve during a dosing interval at steady state | From pre-dose on Day 8 up to 157 days | Measured in h\*pg/mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax,EE,SS: Maximum EE plasma concentration at steady state | From pre-dose on Day 8 up to 157 days | Measured in picograms per millilitre (pg/mL). |
| Cmax,LN,SS: Maximum LN plasma concentration at steady state | From pre-dose on Day 8 up to 157 days | Measured in pg/mL. |
| AUC,para: The area under the acetaminophen plasma concentration-time curve | From pre-dose on Day 1 up to 150 days | Measured in hour microgram per millilitre (h\*μg/mL). |
| Cmax,para: Maximum observed acetaminophen plasma concentration | From pre-dose on Day 1 up to 150 days | Measured in microgram per millilitre (μg/mL). |
Countries
Canada
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed