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

NCT07710729 | Not Yet Recruiting Phase 1

• 2 other identifiers: NN9559-8619U1111-1332-9333
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  From pre-dose on Day 8 up to 157 days

Secondary Outcomes (4)

• Cmax,EE,SS: Maximum EE plasma concentration at steady state

  From pre-dose on Day 8 up to 157 days

• Cmax,LN,SS: Maximum LN plasma concentration at steady state

  From pre-dose on Day 8 up to 157 days

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

  From pre-dose on Day 1 up to 150 days

• Cmax,para: Maximum observed acetaminophen plasma concentration

  From pre-dose on Day 1 up to 150 days

Study Arms (3)

UBT251

EXPERIMENTAL

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

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.

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

Drug: Acetaminophen

Interventions

UBT251 DRUG

Administered subcutaneously.

UBT251

Acetaminophen DRUG

Administered orally.

Acetaminophen (equivalent to paracetamol [para])

Oral contraceptive DRUG

Administered orally.

Oral Contraceptive (ethinylestradiol [EE] and levonorgestrel [LN])

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Altasciences Clinical Company, Inc

Montreal, Quebec, H3P 3P1, Canada

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Contraceptives, Oral; Acetaminophen

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 17, 2026
• Study Start: July 17, 2026
• Primary Completion (Estimated): April 27, 2027
• Study Completion (Estimated): April 27, 2027
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)