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

August 21, 2026 updated by: Novo Nordisk A/S

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3P 3P1
        • Recruiting
        • Altasciences Clinical Company, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: UBT251
UBT251 will be administered by subcutaneous injection during the treatment period with dose escalation to a maintenance treatment level.
Drug: UBT251
Administered subcutaneously.
Experimental: Oral Contraceptive (ethinylestradiol [EE] and levonorgestrel [LN])
An oral contraceptive will be administered during baseline and treatment assessment periods to evaluate the effect of UBT251 on oral contraceptive pharmacokinetics.
Drug: Oral contraceptive
Administered orally.
Experimental: Acetaminophen (equivalent to paracetamol [para])
A single dose of acetaminophen will be administered with a standardised meal during baseline and treatment assessment periods to evaluate gastric emptying
Drug: Acetaminophen
Administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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
Time Frame: From pre-dose on Day 8 up to 157 days
Measured in h*pg/mL.
From pre-dose on Day 8 up to 157 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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
Measured in pg/mL.
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
Measured in hour microgram per millilitre (h*μg/mL).
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
Measured in microgram per millilitre (μg/mL).
From pre-dose on Day 1 up to 150 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2026

Primary Completion (Estimated)

April 27, 2027

Study Completion (Estimated)

April 27, 2027

Study Registration Dates

First Submitted

July 13, 2026

First Submitted That Met QC Criteria

July 13, 2026

First Posted (Actual)

July 17, 2026

Study Record Updates

Last Update Posted (Actual)

August 25, 2026

Last Update Submitted That Met QC Criteria

August 21, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9559-8619
  • U1111-1332-9333 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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