Obesity
Conditions
Brief summary
This study medicine NNC0487-0111 to improve the treatment options for people living with overweight and obesity or with type 2 diabetes. The purpose of the study is to investigate if NNC0487-0111 affects how effective birth control pills are. Participants will take 1-tablet once daily. The study medicine will taken orally for 18 weeks and then study medicine will be injected with a thin needle in a skin fold in the abdomen for 9 weeks.The study will last for about 35 weeks.
Interventions
DRUGNNC0487-0111 A
NNC0487-0111 A will be administered subcutaneously.
DRUGNNC0487-0111 C
NNC0487-0111 C will be taken orally.
DRUGLevonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC)
Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC) will be taken orally.
DRUGAcetaminophen - 500 mg/15 ml
Acetaminophen - 500 mg/15 ml will be taken orally.
Sponsors
Novo Nordisk A/S
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Females of non-childbearing potential. * Age 18 - 65 years (both inclusive) at the time of signing the informed consent. * Body mass index (BMI) between 25.0 and 39.9 kg/m\^2 (both inclusive) at screening. * Considered to be generally healthy 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
* Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * Any contraindications for the use of the oral contraception used in the study according to the Microgynon Product Information. * Use of prescription medicinal products or non-prescription drugs including any herbal medicine known to interfere with the metabolic CYP pathways, such as hypericum (St. John's Wort), ginseng, garlic, milk thistle, and echinaceae, within 14 days before screening. Exceptions are routine vitamins, occasional use of acetaminophen, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation. * 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. * Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The area under the ethinylestradiol plasma concentration time curve at steady state | Day 8 and Day 193 | Measured as hours picograms per milliliter (h\*pg/mL). |
| The area under the levonorgestrel plasma concentration time curve at steady state | Day 8 and Day 193 | Measured as hours picograms per milliliter (h\*pg/mL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum ethinylestradiol plasma concentration at steady state | Day 8 and Day 193 | Measured as picograms per milliliter (pg/mL). |
| Maximum levonorgestrel plasma concentration at steady state | Day 8 and Day 193 | Measured as picograms per milliliter (pg/mL). |
| The area under the ethinylestradiol plasma concentration time curve at steady state | Day 8 and Day 135 | Measured as hours picograms per milliliter (h\*pg/mL). |
| The area under the levonorgestrel plasma concentration time curve at steady state | Day 8 and Day 135 | Measured as hours picograms per milliliter (h\*pg/mL). |
| Cmax,para, maximum acetaminophen plasma concentration following a standardised meal | Day 1 and Day 186 | Measured as micrograms per milliliter (μg/mL). |
| Cmax,LN,SS, maximum levonorgestrel plasma concentration at steady state | Day 8 and Day 135 | Measured as picograms per milliliter (pg/mL). |
| AUC1 area under the acetaminophen concentration-time curve following a standardised meal | Day 1 and Day 186 | Measured as hours micro grams per milliliter (h\*μg/mL). |
| AUC2 area under the acetaminophen concentration-time curve following a standardised meal | Day 1 and Day 186 | Measured as hours micro grams per milliliter (h\*μg/mL). |
| AUC4 area under the acetaminophen concentration-time curve following a standardised meal | Day 1 and Day 128 | Measured as hours micro grams per milliliter (h\*μg/mL). |
| Cmax,EE,SS, maximum ethinylestradiol plasma concentration at steady state | Day 8 and Day 135 | Measured as picograms per milliliter (pg/mL). |
| AUC3 area under the acetaminophen concentration-time curve following a standardised meal | Day 1 and Day 128 | Measured as hours micro grams per milliliter (h\*μg/mL). |
Countries
Canada
Outcome results
None listed