A Research Study Looking at How the Compound NNC0487-0111 Works With Birth Control Pills and Affects Emptying of the Stomach in Women Not Able to Become Pregnant
NCT Number: NCT06461039
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Obesity
Interventions: DRUG: NNC0487-0111 A|DRUG: NNC0487-0111 C|DRUG: Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC)|DRUG: Acetaminophen - 500 mg/15 ml
Sponsor: Novo Nordisk A/S
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-14
Completion Date: 2025-04-07
Locations: Altasciences Clinical Company, Inc, Montreal, Quebec, H3P 3P1, Canada

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.

Primary Outcome Measures: The area under the ethinylestradiol plasma concentration time curve at steady state, Measured as hours picograms per milliliter (h\*pg/mL)., Day 8 and Day 193|The area under the levonorgestrel plasma concentration time curve at steady state, Measured as hours picograms per milliliter (h\*pg/mL)., Day 8 and Day 193
Secondary Outcome Measures: Maximum ethinylestradiol plasma concentration at steady state, Measured as picograms per milliliter (pg/mL)., Day 8 and Day 193|Maximum levonorgestrel plasma concentration at steady state, Measured as picograms per milliliter (pg/mL)., Day 8 and Day 193|The area under the ethinylestradiol plasma concentration time curve at steady state, Measured as hours picograms per milliliter (h\*pg/mL)., Day 8 and Day 135|The area under the levonorgestrel plasma concentration time curve at steady state, Measured as hours picograms per milliliter (h\*pg/mL)., Day 8 and Day 135|Cmax,EE,SS, maximum ethinylestradiol plasma concentration at steady state, Measured as picograms per milliliter (pg/mL)., Day 8 and Day 135|Cmax,LN,SS, maximum levonorgestrel plasma concentration at steady state, Measured as picograms per milliliter (pg/mL)., Day 8 and Day 135|AUC1 area under the acetaminophen concentration-time curve following a standardised meal, Measured as hours micro grams per milliliter (h\*μg/mL)., Day 1 and Day 186|AUC2 area under the acetaminophen concentration-time curve following a standardised meal, Measured as hours micro grams per milliliter (h\*μg/mL)., Day 1 and Day 186|Cmax,para, maximum acetaminophen plasma concentration following a standardised meal, Measured as micrograms per milliliter (μg/mL)., Day 1 and Day 186|AUC3 area under the acetaminophen concentration-time curve following a standardised meal, Measured as hours micro grams per milliliter (h\*μg/mL)., Day 1 and Day 128|AUC4 area under the acetaminophen concentration-time curve following a standardised meal, Measured as hours micro grams per milliliter (h\*μg/mL)., Day 1 and Day 128|Cmax,para, maximum acetaminophen plasma concentration following a standardised meal, Measured as micrograms per milliliter (μg/mL)., Day 1 and Day 128