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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06461039
• Other study ID #: NN9487-7612
• Secondary ID: U1111-1300-3685
• Status: Recruiting
• Phase: Phase 1
• Start date: June 14, 2024
• Est. completion date: April 7, 2025

Study information

• Verified date: June 2024
• Source: Novo Nordisk A/S
• Contact: Novo Nordisk
• Phone: (+1) 866-867-7178
• Email: clinicaltrials[@]novonordisk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 7, 2025
• Est. primary completion date: March 17, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

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

Locations

Country	Name	City	State
Canada	Altasciences Clinical Company, Inc	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Maximum ethinylestradiol plasma concentration at steady state	Measured as picograms per milliliter (pg/mL).	Day 8 and Day 193
Secondary	Maximum levonorgestrel plasma concentration at steady state	Measured as picograms per milliliter (pg/mL).	Day 8 and Day 193
Secondary	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
Secondary	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
Secondary	Cmax,EE,SS, maximum ethinylestradiol plasma concentration at steady state	Measured as picograms per milliliter (pg/mL).	Day 8 and Day 135
Secondary	Cmax,LN,SS, maximum levonorgestrel plasma concentration at steady state	Measured as picograms per milliliter (pg/mL).	Day 8 and Day 135
Secondary	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
Secondary	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
Secondary	Cmax,para, maximum acetaminophen plasma concentration following a standardised meal	Measured as micrograms per milliliter (µg/mL).	Day 1 and Day 186
Secondary	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
Secondary	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
Secondary	Cmax,para, maximum acetaminophen plasma concentration following a standardised meal	Measured as micrograms per milliliter (µg/mL).	Day 1 and Day 128