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NCT Number: NCT07395687

A Research Study on How Well Different Doses of the Medicine UBT251 Help People Living With Overweight or Obesity

The purpose of this clinical study is to find out if UBT251 is safe and effective for treating people who are living with overweight or obesity. Participants will get either UBT251 (the treatment being tested) or Placebo (a treatment that has no active medicine in it), which treatment participants get is decided by chance.

Recruiting

Interested in participating?

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Altasciences Clinical Company, Inc, Montreal, Quebec, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female (sex at birth).
  • For Part C: Japanese, Chinese or non-Asian participants (all self-reported):
  • For Japanese participants: both parents of Japanese descent.
  • For Chinese participants: both parents of Chinese descent.
  • For non-Asian participants: both parents of non-Asian descent (non-Asian is defined as of countries outside of Asia).
  • Age at the time of signing the informed consent:
  • For Part A: 18-55 years (both inclusive)
  • For Part B: 18-65 years (both inclusive)
  • For Part C: 18-55 years (both inclusive).
  • BMI at screening (overweight and obesity should be due to excess adipose tissue, as judged by the investigator):
  • For Part A: 27.0-39.9 kilogram per meter square (kg/m^2) (both inclusive)
  • For Part B: 30.0-50.0 kg/m^2 (both inclusive)
  • For Part C: 24-34.9 kg/m^2 (both inclusive)
  • Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG), 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 marketed product containing compounds with glucagon-like peptide 1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP) or glucagon receptor agonism within 90 days before screening.
  • Any condition, unwillingness or inability, which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol.

Treatment and study plan

UBT251

Drug

UBT251 injection will be administered subcutaneously in a lifted fold of the abdominal skin.

Placebo

Drug

Placebo matched to UBT251 injection will be administered subcutaneously in a lifted fold of the abdominal skin.

Primary outcomes

  1. Part A - Number of treatment emergent adverse events (TEAEs)

    Time frame: From baseline (week 0) to end of study (week 33)

    Measured as Number of events.

  2. Part B - Relative change in body weight

    Time frame: From baseline (week 0) to end of treatment (week 28)

    Measured as percentage of body weight.

  3. Part C- AUC; the area under the UBT251 plasma concentration time curve

    Time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 43)

    Measured as hour*nanomoles per liter (h*nmol/L)

Secondary outcomes

  1. Part A - Relative change in body weight

    Time frame: From baseline (week 0) to end of treatment (week 28)

    Measured as percentage of body weight.

  2. Part A - Change in body weight

    Time frame: From baseline (week 0) to end of treatment (week 28)

    Measured as kilogram (kg).

  3. Part A - AUC; the area under the UBT251 plasma concentration-time curve

    Time frame: From pre-dose on day 1 to end of study (week 33)

    Measured as h*nmol/L

  4. Part A - Cmax; the maximum plasma concentration of UBT251

    Time frame: From pre-dose on day 1 to end of study (week 33)

    Measured as nanomole per liter (nmol/L)

  5. Part B - Change in body weight

    Time frame: From baseline (week 0) to end of treatment (week 28)

    Measured as kg.

  6. Part B - Change in waist circumference

    Time frame: From baseline (week 0) to end of treatment (week 28)

    Measured as centimetre (cm).

  7. Part B - Number of TEAEs

    Time frame: From baseline (week 0) to end of study (week 33)

    Measured as number of events

  8. Part C - Cmax; the maximum plasma concentration of UBT251

    Time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 43)

    Measured as nmol/L

  9. Part C - Number of treatment-emergent adverse events (TEAEs)

    Time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 43)

    Measured as number of events.

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 Study Investigating Safety, Tolerability and Efficacy of UBT251 in Participants Living With Overweight or Obesity

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 9, 2026
Registry last updated
Apr 21, 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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