ObesityPhase 1NCT07710768
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 study testing UBT251 and Cocktail (Warfarin/Caffeine/Midazolam) in people with Obesity and Overweight, run by Novo Nordisk A/S at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- UBT251 and Cocktail (Warfarin/Caffeine/Midazolam)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2026to 7 Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Altasciences Clinical LA, Inc.
Cypress, California, 90630
About this study
Official 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
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
- Being tested
- UBT251, Cocktail (Warfarin/Caffeine/Midazolam)
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UBT251Drug
Administered subcutaneously.
Cocktail (Warfarin/Caffeine/Midazolam)Drug
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| UBT251 | Experimental | UBT251 will be administered subcutaneously with gradual dose escalation during the study. Receives: Drug: UBT251 |
| Cocktail (Warfarin/Caffeine/Midazolam) | Experimental | 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. Receives: Drug: Cocktail (Warfarin/Caffeine/Midazolam) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured in ng*h/mL.
Measured: 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
Measured in ng*h/mL.
Measured: From pre-dose on Day 1 up to 156 days
Secondary outcomes (3)
Cmax,s-warfarin: The maximum observed plasma s-warfarin concentration after single dose
Measured in nanogram per millilitre (ng/mL).
Measured: From pre-dose on Day 1 up to 156 days
Cmax,caffeine: The maximum observed plasma caffeine concentration after single dose
Measured in ng/mL.
Measured: From pre-dose on Day 1 up to 156 days
Cmax,midazolam: The maximum observed plasma midazolam concentration after single dose
Measured in ng/mL.
Measured: From pre-dose on Day 1 up to 156 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start15 Jul 2026
- Primary completion7 Apr 2027 (estimated)
- Study completion7 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710768
- Sponsor's protocol ID
- NN9559-8621
- Other IDs
- U1111-1332-5554
- Status last verified
- Aug 2026
- First submitted
- 13 Jul 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07710768
- Acronym / sponsor ID
- NN9559-8621
- Conditions
- Obesity, Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 7 Apr 2027 (estimated)
- Study completion
- 7 Apr 2027 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UBT251 | Experimental | Drug: UBT251UBT251 will be administered subcutaneously with gradual dose escalation during the study. |
| Cocktail (Warfarin/Caffeine/Midazolam) | Experimental | Drug: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UBT251Administered subcutaneously. | Drug | UBT251 |
| Cocktail (Warfarin/Caffeine/Midazolam)Administered orally. | Drug | Cocktail (Warfarin/Caffeine/Midazolam) |
Primary outcome
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).
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.
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.
3 secondary outcomes
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
Cmax,caffeine: The maximum observed plasma caffeine concentration after single dose
Time frame: From pre-dose on Day 1 up to 156 days
Cmax,midazolam: The maximum observed plasma midazolam concentration after single dose
Time frame: From pre-dose on Day 1 up to 156 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UBT251 and Cocktail (Warfarin/Caffeine/Midazolam) in people with Obesity and Overweight, run by Novo Nordisk A/S at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.