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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
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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