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

NCT06461039 | Completed Phase 1 FDA Drug

• 2 other identifiers: NN9487-7612U1111-1300-3685
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Maximum ethinylestradiol plasma concentration at steady state

  Day 8 and Day 193

• Maximum levonorgestrel plasma concentration at steady state

  Day 8 and Day 193

• The area under the ethinylestradiol plasma concentration time curve at steady state

  Day 8 and Day 135

• The area under the levonorgestrel plasma concentration time curve at steady state

  Day 8 and Day 135

• Cmax,EE,SS, maximum ethinylestradiol plasma concentration at steady state

  Day 8 and Day 135

Study Arms (1)

NNC0487-0111

EXPERIMENTAL

Participants will receive oral dosing of NNC0487-0111 and gradually will escalate from dose 1 to dose 2. The oral NNC0487-0111 treatment will be followed by s.c. NNC0487-0111 treatment with dose escalating from dose 3 to dose 4.

Drug: NNC0487-0111 A; Drug: NNC0487-0111 C; Drug: Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC); Drug: Acetaminophen - 500 mg/15 ml

Interventions

NNC0487-0111 A DRUG

NNC0487-0111 A will be administered subcutaneously.

NNC0487-0111

NNC0487-0111 C DRUG

NNC0487-0111 C will be taken orally.

NNC0487-0111

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

Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC) will be taken orally.

NNC0487-0111

Acetaminophen - 500 mg/15 ml DRUG

Acetaminophen - 500 mg/15 ml will be taken orally.

NNC0487-0111

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Altasciences Clinical Company, Inc

Montreal, Quebec, H3P 3P1, Canada

Location

MeSH Terms

Conditions

Obesity

Interventions

Levonorgestrel; Ethinyl Estradiol; Contraceptive Agents; Acetaminophen

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Norpregnatrienes; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 14, 2024
• Study Start: June 14, 2024
• Primary Completion: March 16, 2025
• Study Completion: April 4, 2025
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)