Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
ID07395687

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

Led by Novo Nordisk A/S · Updated on 2026-04-21

333

Participants Needed

3

Research Sites

5 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the safety and effectiveness of UBT251 for people living with overweight or obesity. This clinical trial is a phase 2 study that compares different doses of UBT251 against a placebo, which contains no active medicine. The goal is to understand how UBT251 affects body weight and tolerability in adults with these conditions. Participants will be randomly assigned to receive various doses of UBT251 or a placebo, all given as injections under the skin of the abdomen. The study includes multiple parts where participants receive different dose levels, with some receiving a single dose and others multiple doses. Placebo injections are designed to look like UBT251 to maintain study blinding. During the trial, participants will be monitored for treatment-emergent adverse events and changes in body weight over several weeks. Blood samples will be taken to measure UBT251 levels in the body. The study involves regular visits for assessments including physical exams, vital signs, and lab tests, extending up to 33 weeks. Researchers will track safety, tolerability, and how the drug moves through the body to evaluate outcomes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female (sex at birth)
  • For Part C: Japanese, Chinese, or non-Asian participants with both parents of matching descent
  • Age at informed consent: 18-55 years for Part A and Part C; 18-65 years for Part B
  • Body mass index (BMI) at screening: 27.0-39.9 kg/m² for Part A; 30.0-50.0 kg/m² for Part B; 24-34.9 kg/m² for Part C
  • Eligible based on medical history, physical exam, vital signs, ECG, and lab tests as judged by the investigator
Not Eligible

You will not qualify if you...

  • Known or suspected allergy to study drug or related products
  • Use of medications containing GLP-1, GIP, or glucagon receptor agonists within 90 days before screening
  • Any condition or unwillingness that may risk safety or protocol compliance as judged by the investigator

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 28 weeks

Participants receive subcutaneous injections of UBT251 or placebo at multiple dose levels to assess safety, tolerability, and efficacy for overweight or obesity.

Regular visits during treatment period

Follow-up

Duration - Up to 5 weeks after treatment

Participants are monitored for safety and treatment effects after completing the treatment phase.

1 to 2 visits

Trial Site Locations

Total: 3 locations

1

Altasciences Clinical LA, Inc.

Cypress, California, United States, 90630

Actively Recruiting

2

Altasciences Clinical Kansas, Inc.

Overland Park, Kansas, United States, 66212

Actively Recruiting

3

Altasciences Clinical Company, Inc

Montreal, Quebec, Canada, H3P 3P1

Actively Recruiting

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Research Team

N

Novo Nordisk

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

11

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