How NNC0662-0419 interacts with birth control and stomach emptying in women with overweight or obesity who cannot become pregnant
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
This test will see if taking NNC0662-0419 together with birth control pills changes stomach emptying and is safe for women with overweight or obesity who cannot become pregnant.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | Female |
| Sponsor | Novo Nordisk A/S Industry-sponsored |
| Locations | 1 site (Overland Park, Kansas) |
| Trial ID | NCT07525791 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1 interventional study in which participants receive three treatments: the investigational drug NNC0662-0419, the oral contraceptive Altavera, and acetaminophen used as a probe for gastric emptying. Each participant will receive all study treatments under controlled conditions with timed dosing and clinic monitoring. Investigators will collect blood samples for pharmacokinetics, monitor vital signs, ECGs and laboratory safety tests, and measure acetaminophen absorption to infer effects on gastric emptying. The goal is to characterize safety and any drug–drug or gastric emptying interactions in women with overweight or obesity who are not of childbearing potential.
Who should consider this trial
Good fit: Women (sex assigned at birth) aged 18–64 who are non-childbearing potential, weigh at least 60 kg, are generally healthy apart from overweight or obesity, and have no contraindications to the study oral contraceptive are ideal candidates.
Not a fit: People who can become pregnant, men, those currently using GLP‑1/GIP or amylin agonists, or anyone with contraindications to the oral contraceptive are unlikely to be eligible and would not benefit from participating.
Why it matters
Potential benefit: If successful, the study could show whether NNC0662-0419 can be used safely with oral contraceptives and clarify any effects on stomach emptying, informing safer prescribing for women with overweight or obesity.
How similar studies have performed: Similar pharmacokinetic and gastric emptying interaction studies have been performed with other weight-loss agents and oral contraceptives, so the methodology is established even though NNC0662-0419 itself is new.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Overland Park, Kansas
- Altasciences Clinical Kansas, Inc. — Overland Park, Kansas, United States (Recruiting)
Study contacts
- Study coordinator: Novo Nordisk
- Email: clinicaltrials@novonordisk.com
- Phone: (+1) 866-867-7178
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.