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NCT Number: NCT07710729

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences Clinical Company, Inc

Montreal, Quebec, H3P 3P1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

UBT251

Drug

Administered subcutaneously.

Oral contraceptive

Drug

Administered orally.

Acetaminophen

Drug

Administered orally.

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. Cmax,EE,SS: Maximum EE plasma concentration at steady state

    Time frame: From pre-dose on Day 8 up to 157 days

    Measured in picograms per millilitre (pg/mL).

  2. Cmax,LN,SS: Maximum LN plasma concentration at steady state

    Time frame: From pre-dose on Day 8 up to 157 days

    Measured in pg/mL.

  3. AUC,para: The area under the acetaminophen plasma concentration-time curve

    Time frame: From pre-dose on Day 1 up to 150 days

    Measured in hour microgram per millilitre (h*μg/mL).

  4. Cmax,para: Maximum observed acetaminophen plasma concentration

    Time frame: From pre-dose on Day 1 up to 150 days

    Measured in microgram per millilitre (μg/mL).

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 17, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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