A Research Study on How UBT251 Affects Levels of Midazolam, Caffeine and Warfarin in the Blood of Participants With Excess Body Weight

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNovo Nordisk A/S

About this trial

The purpose of this clinical study is to find out if UBT251 is safe and effective to be taken together with medicines, like midazolam, caffeine and warfarin in participants living with overweight or obesity.

Eligibility criteria

Qualifiers

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/m² (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.

Body weight >=60.0 kg.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • UBT251
  • Cocktail (Warfarin/Caffeine/Midazolam)

Treatment groups

44 Participants
are divided into 2 treatment groups

Sponsors and collaborators