OverweightPhase 1NCT07710729
A Research Study Looking Into How UBT251 Works With Birth Control Tablets and Emptying of the Stomach in Women With Excess Body Weight Not Able to Become Pregnant
A Phase 1 study testing UBT251, Oral contraceptive and Acetaminophen in people with Overweight and Obesity, run by Novo Nordisk A/S at 1 site in Canada.
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 birth control tablets, and emptying of the stomach in women not able to become pregnant living with overweight or obesity Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- UBT251, Oral contraceptive and Acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 17 Jul 2026to 27 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female (sex assigned at birth) of NCBP.
- Age 18-65 years (both inclusive) at the time of signing the informed consent.
- Body mass index (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 compound containing glucagon-like peptide 1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), or glucagon (GCG) receptor agonism within 90 days before screening.
- Any contraindications for the use of the oral contraception used in the study according to the PORTIA Product Information.
- Use of hormone replacement therapy within 28 days before screening or intention to initiate treatment with hormone replacement therapy during the study.
- Use of prescription medicinal products or non-prescription drugs, including any herbal medicine known to interfere with the metabolic cytochrome P450 (CYP) pathways, such as perikon (St. John's Wort), 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 and acetylsalicylic acid, or topical medication not reaching systemic circulation.
- 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.
Canada1 site, 1 recruiting
- Recruiting
Altasciences Clinical Company, Inc
Montreal, Quebec, H3P 3P1
About this study
Official title: A Single-Centre, Open-Label Study of the Effect of UBT251 on Pharmacokinetics of an Oral Combination Contraceptive (Ethinylestradiol and Levonorgestrel) and Gastric Emptying in Women of Non-Childbearing Potential 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 birth control tablets, and emptying of the stomach in women not able to become pregnant living with overweight or obesity
- Conditions
- Overweight, Obesity
- Being tested
- UBT251, Oral contraceptive, Acetaminophen
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UBT251Drug
Administered subcutaneously.
Oral contraceptiveDrug
Administered orally.
AcetaminophenDrug
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| UBT251 | Experimental | UBT251 will be administered by subcutaneous injection during the treatment period with dose escalation to a maintenance treatment level. Receives: Drug: UBT251 |
| Oral Contraceptive (ethinylestradiol [EE] and levonorgestrel [LN]) | Experimental | An oral contraceptive will be administered during baseline and treatment assessment periods to evaluate the effect of UBT251 on oral contraceptive pharmacokinetics. Receives: Drug: Oral contraceptive |
| Acetaminophen (equivalent to paracetamol [para]) | Experimental | A single dose of acetaminophen will be administered with a standardised meal during baseline and treatment assessment periods to evaluate gastric emptying Receives: Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC,EE,SS: The area under the EE plasma concentration time curve during a dosing interval at steady state
Measured in hours picograms per millilitre (h*pg/mL).
Measured: From pre-dose on Day 8 up to 157 days
AUC ,LN,SS: The area under the LN plasma concentration time curve during a dosing interval at steady state
Measured in h*pg/mL.
Measured: From pre-dose on Day 8 up to 157 days
Secondary outcomes (4)
Cmax,EE,SS: Maximum EE plasma concentration at steady state
Measured in picograms per millilitre (pg/mL).
Measured: From pre-dose on Day 8 up to 157 days
Cmax,LN,SS: Maximum LN plasma concentration at steady state
Measured in pg/mL.
Measured: From pre-dose on Day 8 up to 157 days
AUC,para: The area under the acetaminophen plasma concentration-time curve
Measured in hour microgram per millilitre (h*μg/mL).
Measured: From pre-dose on Day 1 up to 150 days
Cmax,para: Maximum observed acetaminophen plasma concentration
Measured in microgram per millilitre (μg/mL).
Measured: From pre-dose on Day 1 up to 150 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 start17 Jul 2026
- Primary completion27 Apr 2027 (estimated)
- Study completion27 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- 40 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
- NCT07710729
- Sponsor's protocol ID
- NN9559-8619
- Other IDs
- U1111-1332-9333
- Status last verified
- Aug 2026
- First submitted
- 13 Jul 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Centre, Open-Label Study of the Effect of UBT251 on Pharmacokinetics of an Oral Combination Contraceptive (Ethinylestradiol and Levonorgestrel) and Gastric Emptying in Women of Non-Childbearing Potential With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07710729
- Acronym / sponsor ID
- NN9559-8619
- Conditions
- Overweight, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2026 (actual)
- Primary completion
- 27 Apr 2027 (estimated)
- Study completion
- 27 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 birth control tablets, and emptying of the stomach in women not able to become pregnant living with overweight or obesity
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| UBT251 | Experimental | Drug: UBT251UBT251 will be administered by subcutaneous injection during the treatment period with dose escalation to a maintenance treatment level. |
| Oral Contraceptive (ethinylestradiol [EE] and levonorgestrel [LN]) | Experimental | Drug: Oral contraceptiveAn oral contraceptive will be administered during baseline and treatment assessment periods to evaluate the effect of UBT251 on oral contraceptive pharmacokinetics. |
| Acetaminophen (equivalent to paracetamol [para]) | Experimental | Drug: AcetaminophenA single dose of acetaminophen will be administered with a standardised meal during baseline and treatment assessment periods to evaluate gastric emptying |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female (sex assigned at birth) of NCBP.
- Age 18-65 years (both inclusive) at the time of signing the informed consent.
- Body mass index (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 (7 listed)
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Treatment with any compound containing glucagon-like peptide 1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), or glucagon (GCG) receptor agonism within 90 days before screening.
- Any contraindications for the use of the oral contraception used in the study according to the PORTIA Product Information.
- Use of hormone replacement therapy within 28 days before screening or intention to initiate treatment with hormone replacement therapy during the study.
- Use of prescription medicinal products or non-prescription drugs, including any herbal medicine known to interfere with the metabolic cytochrome P450 (CYP) pathways, such as perikon (St. John's Wort), 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 and acetylsalicylic acid, or topical medication not reaching systemic circulation.
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 |
| Oral contraceptiveAdministered orally. | Drug | Oral Contraceptive (ethinylestradiol [EE] and levonorgestrel [LN]) |
| AcetaminophenAdministered orally. | Drug | Acetaminophen (equivalent to paracetamol [para]) |
Primary outcome
AUC,EE,SS: The area under the EE plasma concentration time curve during a dosing interval at steady state
Time frame: From pre-dose on Day 8 up to 157 days
Measured in hours picograms per millilitre (h*pg/mL).
AUC ,LN,SS: The area under the LN plasma concentration time curve during a dosing interval at steady state
Time frame: From pre-dose on Day 8 up to 157 days
Measured in h*pg/mL.
4 secondary outcomes
Cmax,EE,SS: Maximum EE plasma concentration at steady state
Time frame: From pre-dose on Day 8 up to 157 days
Cmax,LN,SS: Maximum LN plasma concentration at steady state
Time frame: From pre-dose on Day 8 up to 157 days
AUC,para: The area under the acetaminophen plasma concentration-time curve
Time frame: From pre-dose on Day 1 up to 150 days
Cmax,para: Maximum observed acetaminophen plasma concentration
Time frame: From pre-dose on Day 1 up to 150 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 25 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, Oral contraceptive and Acetaminophen in people with Overweight and Obesity, run by Novo Nordisk A/S at 1 site in Canada.
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 7 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 25 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 Canada. 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?
AUC,EE,SS: The area under the EE plasma concentration time curve during a dosing interval at steady state (time frame: From pre-dose on Day 8 up to 157 days). The study lists 2 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 25 Aug 2026.