NCT06461039

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

Investigation of the Effect of NNC0487-0111 on Pharmacokinetics of an Oral Combination Contraceptive (Ethinylestradiol and Levonorgestrel) and Gastric Emptying in Females of Non-childbearing Potential

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	NNC0487-0111 A	NNC0487-0111 A will be administered subcutaneously.
DRUG	NNC0487-0111 C	NNC0487-0111 C will be taken orally.
DRUG	Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC)	Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC) will be taken orally.
DRUG	Acetaminophen - 500 mg/15 ml	Acetaminophen - 500 mg/15 ml will be taken orally.

Timeline

• Start date: 2024-06-14
• Primary completion: 2025-03-16
• Completion: 2025-04-04
• First posted: 2024-06-14
• Last updated: 2025-05-08

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study