Recruiting
Phase 1

UBT251 with Midazolam, Caffeine, Warfarin

Sponsor:

Novo Nordisk A/S

Code:

NCT07710768

Conditions

Obesity

Overweight

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

UBT251

Cocktail (Warfarin/Caffeine/Midazolam)

Study Details

Brief summary:

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.

Conditions

Obesity

Overweight

Study ID

NCT07710768

Start date

Jul 15, 2026

Status verified date

Aug, 2026

Completion date

Apr 7, 2027

Anticipated

Primary completion date

Apr 7, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

44 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: UBT251

UBT251 will be administered subcutaneously with gradual dose escalation during the study.

experimental: Cocktail (Warfarin/Caffeine/Midazolam)

A cocktail containing warfarin, caffeine, and midazolam will be administered at predefined study visits to evaluate the effect of UBT251 on the pharmacokinetics of CYP enzyme substrates.

Interventions

UBT251

Administered subcutaneously.

Cocktail (Warfarin/Caffeine/Midazolam)

Administered orally.

Primary outcome measure

  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Novo Nordisk

(+1) 866-867-7178clinicaltrials@novonordisk.com

Locations

Altasciences Clinical LA, Inc.

Recruiting

Cypress, California, United States, 90630

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2026-08-18.