Recruiting
Phase 1

UBT251 with Birth Control

Sponsor:

Novo Nordisk A/S

Code:

NCT07710729

Conditions

Overweight

Obesity

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

UBT251

Oral contraceptive

Acetaminophen

Study Details

Brief 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

Conditions

Overweight

Obesity

Study ID

NCT07710729

Start date

Jul 17, 2026

Status verified date

Aug, 2026

Completion date

Apr 27, 2027

Anticipated

Primary completion date

Apr 27, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: UBT251

UBT251 will be administered by subcutaneous injection during the treatment period with dose escalation to a maintenance treatment level.

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.

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

Interventions

UBT251

Administered subcutaneously.

Oral contraceptive

Administered orally.

Acetaminophen

Administered orally.

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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Novo Nordisk

(+1) 866-867-7178clinicaltrials@novonordisk.com

Locations

Altasciences Clinical Company, Inc

Recruiting

Montreal, Quebec, Canada, H3P 3P1

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2026-08-25.