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RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe different doses of UBT251 are and how well they work for adults with overweight or obesity. Participants will get either UBT251 or a placebo, which has no active medicine. The treatment is chosen by chance.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Male or female, based on sex at birth.
  • Part A: Age 18–55 and BMI 27.0–39.9. BMI is a measure based on height and weight.
  • Part B: Age 18–65 and BMI 30.0–50.0.
  • Part C: Age 18–55 and BMI 24.0–34.9.
  • For Part C, you must report being Japanese, Chinese, or non-Asian. Both parents must have the same listed background. Non-Asian means from countries outside Asia.
  • The study doctor must judge that your extra weight is due to extra body fat.
  • The study doctor must find you eligible after reviewing your health history, exam, vital signs, heart tracing (ECG), and lab tests.

Who can't join

  • A known or suspected allergy to the study treatments or related products.
  • Use of a marketed medicine that activates GLP-1, GIP, or glucagon receptors within 90 days before screening. These medicines act on certain hormone signals in the body.
  • Any health issue, unwillingness, or inability to follow study rules that the study doctor thinks could affect your safety or participation.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Male or female (sex at birth). 2. 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). 3. Age at the time of signing the informed consent: 1. For Part A: 18-55 years (both inclusive) 2. For Part B: 18-65 years (both inclusive) 3. For Part C: 18-55 years (both inclusive). 4. BMI at screening (overweight and obesity should be due to excess adipose tissue, as judged by the investigator): 1. For Part A: 27.0-39.9 kilogram per meter square (kg/m\^2) (both inclusive) 2. For Part B: 30.0-50.0 kg/m\^2 (both inclusive) 3. For Part C: 24-34.9 kg/m\^2 (both inclusive) 5. 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: 1. Known or suspected hypersensitivity to study intervention(s) or related products. 2. 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. 3. Any condition, unwillingness or inability, which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol.

Study sites (2)

CA

KS