Actively Recruiting
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
Eligibility Criteria
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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