CClinicalTrials.gg
Sign In
RecruitingNCT07710768Updated Aug 18, 2026

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

A Phase 1 interventional study of UBT251 and Cocktail (Warfarin/Caffeine/Midazolam) in Obesity and Overweight, sponsored by Novo Nordisk A/S. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-18.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 2 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
44
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity
  • Overweight
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 44 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    UBT251

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

    Drug: UBT251

  • 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.

    Drug: Cocktail (Warfarin/Caffeine/Midazolam)

Interventions

  • DrugUBT251

    Administered subcutaneously.

  • DrugCocktail (Warfarin/Caffeine/Midazolam)

    Administered orally.

06

What researchers measure

Primary outcomes

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

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

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

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

    Measured in ng\*h/mL.

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

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

    Measured in ng\*h/mL.

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

Secondary outcomes

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

    Measured in nanogram per millilitre (ng/mL).

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

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

    Measured in ng/mL.

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

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

    Measured in ng/mL.

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

07

Study locations

1 of 1 sites recruiting
  • Altasciences Clinical LA, Inc.
    Cypress, California 90630, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07710768
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Jul 17, 2026
Start date
Jul 15, 2026
Primary completion
Apr 7, 2027 (estimated)
Completion
Apr 7, 2027 (estimated)
Last update
Aug 18, 2026

Study contacts

Novo Nordisk
Contact
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Clinical Transparency (dept. 2834)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Obesity→

Other studies from this sponsor

Novo Nordisk A/S

Start the discussion