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NCT Number: NCT07710768

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences Clinical LA, Inc.

Cypress, California, 90630, United States

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

UBT251

Drug

Administered subcutaneously.

Cocktail (Warfarin/Caffeine/Midazolam)

Drug

Administered orally.

Primary outcomes

  1. AUC0-∞,s-warfarin: The area under the plasma s-warfarin concentration-time curve extrapolated to infinity after single dose

    Time frame: From pre-dose on Day 1 up to 156 days

    Measured in nanogram hour per millilitre (ng*h/mL).

  2. AUC0-∞,caffeine : The area under the plasma caffeine concentration-time curve extrapolated to infinity after single dose

    Time frame: From pre-dose on Day 1 up to 156 days

    Measured in ng*h/mL.

  3. AUC0-∞,midazolam: The area under the midazolam concentration-time curve extrapolated to infinity after single dose

    Time frame: From pre-dose on Day 1 up to 156 days

    Measured in ng*h/mL.

Secondary outcomes

  1. Cmax,s-warfarin: The maximum observed plasma s-warfarin concentration after single dose

    Time frame: From pre-dose on Day 1 up to 156 days

    Measured in nanogram per millilitre (ng/mL).

  2. Cmax,caffeine: The maximum observed plasma caffeine concentration after single dose

    Time frame: From pre-dose on Day 1 up to 156 days

    Measured in ng/mL.

  3. Cmax,midazolam: The maximum observed plasma midazolam concentration after single dose

    Time frame: From pre-dose on Day 1 up to 156 days

    Measured in ng/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 Open-label, Single-sequence, Crossover Study Investigating the Influence of UBT251 on Pharmacokinetics of Index Substrates for Cytochrome P450 Enzymes in Participants With Overweight or Obesity

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 17, 2026
Registry last updated
Jul 17, 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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