How UBT251 Changes Levels of Midazolam, Caffeine, and Warfarin in People with Overweight or Obesity

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 Phase 1 trial will enroll adults aged 18 to 65 with BMI 27.0 to 39.9 kg/m^2 who are generally healthy aside from overweight or obesity. Participants will receive UBT251 together with a cocktail of warfarin, caffeine, and midazolam to see how the drug affects blood levels of these medicines and to assess safety. The study is conducted at Altasciences Clinical LA in Cypress, California, sponsored by Novo Nordisk A/S. Primary goals focus on pharmacokinetics and initial safety in the target population. The trial is interventional and involves single- or multiple-dose exposure under close monitoring.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female (sex assigned at birth, inclusive of all gender identities).
* Age 18-65 years (both inclusive) at the time of signing the informed consent.
* 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 marketed product containing compounds with glucagon-like peptide 1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), or glucagon (GCG) receptor agonism within 90 days before screening.
* 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), ginseng, garlic, milk thistle, and echinaceae, 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, or topical medication not reaching systemic circulation.
* Any contraindications for the use of caffeine, midazolam, and warfarin used in the study according to Vivarin®, Midazolam®, and warfarin sodium product information.
* 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 LA, Inc.
  Cypress, California, United States 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.