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← All trials/NCT07710729

Not yet recruitingPhase 1

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 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

Lead sponsor

Novo Nordisk A/S

Asset

UBT251

Subcutaneous · GLP-1 / GIP / glucagon triple

Listed sites

1

Recruiting sites

-

Estimated enrollment

40

Study population

Obesity / overweight

Eligibility highlights

BMI 27-39.9FemaleHealthy volunteers

Primary endpoint

-

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07710729
Org study IDNN9559-8619
Secondary IDU1111-1332-9333World Health Organization (WHO)

Timeline

Milestones

Study first posted2026-07-17actual
Study start2026-07-17estimated
Last update posted2026-07-17actual
Primary completion2027-04-27estimated
Study completion2027-04-27estimated

Assets

Investigational agents

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexFemale
Healthy volunteersAccepted

Inclusion criteria

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.

Exclusion criteria

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.

Endpoints (0)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

No endpoints recorded for this trial.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.