How UBT251 works with birth control pills in women who are overweight or obese

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional trial to evaluate the safety and potential effects of UBT251 when taken with oral contraceptives and after an acetaminophen dose in women with overweight or obesity who cannot become pregnant. Eligible participants are generally healthy aside from overweight/obesity and have BMI 27.0 to 39.9 kg/m^2, age 18–65, and weight ≥60 kg. The study will monitor safety, tolerability, and preliminary pharmacodynamic interactions with birth control medications. The intervention arms include UBT251, an oral contraceptive, and acetaminophen as a comparative or supportive measure. Lead sponsor is Novo Nordisk A/S, with sites at Altasciences Clinical Company, Inc in Montreal, Quebec.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Female (sex assigned at birth) of NCBP.
* Age 18-65 years (both inclusive) at the time of signing the informed consent.
* Body mass index (BMI) between 27.0-39.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
* Body weight \>= 60.0 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.
* Treatment with any compound containing glucagon-like peptide 1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), or glucagon (GCG) receptor agonism within 90 days before screening.
* Any contraindications for the use of the oral contraception used in the study according to the PORTIA 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 cytochrome P450 (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 it's running

• Altasciences Clinical Company, Inc
  Montreal, Quebec, Canada Recruiting

Study contacts

• Study coordinator: Novo Nordisk
• Email: clinicaltrials@novonordisk.com
• Phone: (+1) 866-867-7178

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.