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

Last updated: May 7, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

1

Condition

Obesity

Diabetes Prevention

Treatment

NNC0487-0111 C

Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC)

Acetaminophen - 500 mg/15 ml

Clinical Study ID

NCT06461039
NN9487-7612
U1111-1300-3685
  • Ages 18-65
  • Female

Study 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.

Eligibility Criteria

Inclusion

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, physicalexamination, and the results of vital signs, electrocardiogram and clinicallaboratory tests performed during the screening visit, as judged by theinvestigator.

Exclusion

Exclusion Criteria:

  • Any disorder, unwillingness or inability which in the investigator's opinion mightjeopardise participant's safety or compliance with the protocol.

  • Any contraindications for the use of the oral contraception used in the studyaccording to the Microgynon Product Information.

  • Use of prescription medicinal products or non-prescription drugs including anyherbal medicine known to interfere with the metabolic CYP pathways, such ashypericum (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 affectingabsorption of trial products (e.g. subtotal and total gastrectomy, sleevegastrectomy, gastric bypass surgery) or current presence of gastrointestinalimplant.

  • Presence of clinically significant gastrointestinal disorders potentially affectingabsorption of drugs or nutrients, as judged by the investigator.

Study Design

Total Participants: 43
Treatment Group(s): 4
Primary Treatment: NNC0487-0111 C
Phase: 1
Study Start date:
June 14, 2024
Estimated Completion Date:
April 04, 2025

Connect with a study center

  • Altasciences Clinical Company, Inc

    Montreal, Quebec H3P 3P1
    Canada

    Site Not Available

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