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NCT Number: NCT07525791

A Research Study Looking Into How NNC0662-0419 Works With Birth Control Pills and Emptying of the Stomach in Women Not Able to Become Pregnant With Excess Body Weight

The purpose of this clinical study is to find out if NNC0662-0419 is safe and effective to be taken together with other medicines, like birth control pills, and emptying of the stomach in women not able to become pregnant living with overweight or obesity. There are 3 study treatments in this study, participants will get all of the treatments, NNC0662-0419 the treatment being tested, Altavera a type of birth control pill, Acetaminophen a common type of mild painkiller.

Recruiting

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Key information

Age range

18 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences Clinical Kansas, Inc.

Overland Park, Kansas, 66212, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female (sex assigned at birth) of non-childbearing potential.
  • Age 18-64 years (both inclusive) at the time of signing the informed consent.
  • Body weight more than or equal to (≥) 60.0 kilogram (kg).
  • Considered to be generally healthy, except for overweight or obesity, 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

  • Known or suspected hypersensitivity to study intervention(s) or related products.
  • Use of any medication containing glucagon-like peptide 1 (GLP-1), glucose-dependent insulinotropic peptide (GIP), or amylin receptor agonism before screening.
  • Any contraindications for the use of the oral contraception used in the study according to the Altavera Product Information.
  • Use of hormone replacement therapy within 28 days before screening or intention to initiate treatment with hormone replacement therapy during the study.
  • Use of prescription medicinal products or non-prescription drugs, including any herbal medicine known to interfere with the metabolic CYP pathways, such as perikon (St. John's Wort), within 14 days (or within 5 half-lives of the medicinal product, whichever is longest) of screening, with the exception of use of routine vitamins (vitamins used within a normal dose reference interval), occasional use of acetaminophen, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation.
  • Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, or as judged by the investigator.
  • 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.

Treatment and study plan

NNC0662-0419

Drug

Once-weekly subcutaneous NNC0662-0419 will be administered using a pen injector

Oral contraceptive

Drug

An oral contraceptive Altavera [levonorgestrel (LN) 0.15 milligram (mg) and ethinyl estradiol (EE) 0.03 mg] will be administered orally.

Acetaminophen

Drug

A single dose of acetaminophen will be administered orally.

Primary outcomes

  1. Area under curve (AUC) 0-24 h, EE, steady state (SS): The area under the EE plasma concentration-time curve (pre-dose to 24 hours post-dose)

    Time frame: Day 8 and 1 day after last NNC0662-0419 dose

    Measured as picograms per milliliter (h*pg/mL)

  2. AUC0-24h, LN, SS: The area under the LN plasma concentration-time curve (pre-dose to 24 hours post-dose)

    Time frame: Day 8 and 1 day after last NNC0662-0419 dose

    Measured as h*pg/mL

Secondary outcomes

  1. Maximum concentration (Cmax), EE, SS: Maximum observed EE plasma concentration (pre-dose to 24 hours post-dose)

    Time frame: Day 8 and 1 day after last NNC0662-0419 dose

    Measured as pg/mL

  2. Cmax, LN, SS: Maximum observed LN plasma concentration (pre-dose to 24 hours post-dose)

    Time frame: Day 8 and 1 day after last NNC0662-0419 dose

    Measured as pg/mL

  3. AUC0-60min, para: The area under the paracetamol plasma concentration-time curve (pre-dose to 60 minutes post-dose) following a standardised meal

    Time frame: Day 1 and 1 day after 3rd NNC0662-0419 dose on highest dose step

    Measured as microgram per milliliter (h*μg/mL)

  4. AUC0-300min, para: The area under the paracetamol plasma concentration-time curve (pre-dose to 300 minutes post-dose) following a standardised meal

    Time frame: Day 1 and 1 day after 3rd NNC0662-0419 dose on highest dose step

    Measured as h*μg/mL

  5. Cmax, para; Maximum observed paracetamol plasma concentration (pre-dose to 300 minutes post-dose) following a standardised meal

    Time frame: Day 1 and 1 day after 3rd NNC0662-0419 dose on highest dose step

    Measured as μg/mL

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

An Investigation of the Effect of NNC0662-0419 on Pharmacokinetics of an Oral Combination Contraceptive (Ethinylestradiol and Levonorgestrel) and Gastric Emptying in Women of Non-childbearing Potential With Overweight or Obesity

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 13, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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