UBT251 for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a new treatment called UBT251 is safe and effective for individuals who are overweight or have obesity. Participants will receive either UBT251 or a placebo, which resembles the treatment but contains no active medicine, assigned randomly. This trial may suit those living with obesity or overweight due to excess body fat. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important research.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have taken any products with GLP-1, GIP, or glucagon receptor agonists within 90 days before screening.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that UBT251 is generally well-tolerated in earlier studies. Reports from ongoing trials have not indicated any major safety concerns. Researchers have tested this treatment in individuals with overweight or obesity to assess its safety. Although some side effects are possible with any treatment, serious issues have not been commonly reported with UBT251. This suggests it might be a safe option for many, though individual experiences can vary. Always consult a healthcare provider to understand what this might mean personally.12345
Why do researchers think this study treatment might be promising for obesity?
Researchers are excited about UBT251 for obesity because it offers a novel approach compared to traditional methods like lifestyle modifications, medications such as orlistat and phentermine, or bariatric surgery. Unlike these options, UBT251 is administered subcutaneously and is designed to target specific pathways involved in weight regulation, which could potentially lead to more effective weight loss. Additionally, the ability to administer UBT251 at multiple dose levels provides flexibility in tailoring treatment to individual needs, offering hope for better patient outcomes.
What evidence suggests that UBT251 might be an effective treatment for obesity?
Research has shown that UBT251 offers promising results for weight loss in individuals who are overweight or have obesity. One study found that participants taking UBT251 lost an average of 15.1% of their body weight. This significant reduction suggests that UBT251 may effectively help lower body weight. The treatment targets several pathways in the body to aid weight loss. Although more research is needed, these initial findings are encouraging for those seeking to manage their weight. Participants in this trial will receive randomized doses of UBT251 or a placebo, enabling a comprehensive evaluation of its effectiveness.23467
Who Is on the Research Team?
Clinical Transparency (dept. 2834)
Principal Investigator
Novo Nordisk A/S
Are You a Good Fit for This Trial?
This trial is for adults with overweight or obesity, defined by specific body mass index (BMI) ranges: 27.0-39.9 kg/m^2 for Part A, 30.0-50.0 kg/m^2 for Part B, and 24-34.9 kg/m^2 for Part C of the study. Participants must be aged between 18 to 65 years depending on the part of the study they are in and have a heritage background as specified (Japanese descent for Japanese participants, Chinese descent for Chinese participants, non-Asian descent otherwise).Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive UBT251 or placebo subcutaneously across multiple dose levels
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- UBT251
Trial Overview
The trial is testing UBT251's safety and effectiveness against obesity compared to a placebo (no active medicine). Participants will randomly receive either UBT251 or placebo without knowing which one they're getting.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Placebo Group
Participants will be randomized to receive dose level 3 subcutaneously.
Participants will be randomized to receive dose level 2 subcutaneously.
Participants will be randomized to receive dose level 1 subcutaneously.
Participants will be randomized to receive a single dose level subcutaneously.
Participants will be randomized to receive 2 dose levels subcutaneously.
Participants will be randomized to receive multiple dose levels subcutaneously.
Participants will be randomized to receive multiple dose levels subcutaneously.
Participants will be randomized to receive multiple dose levels subcutaneously.
Participants will be randomized to receive multiple dose levels subcutaneously.
Participants will receive placebo matched to UBT251 subcutaneously.
Participants will receive placebo matching one of the UBT251 arms subcutaneously.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novo Nordisk A/S
Lead Sponsor
Lars Fruergaard Jørgensen
Novo Nordisk A/S
Chief Executive Officer since 2017
MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark
Martin Holst Lange
Novo Nordisk A/S
Chief Medical Officer since 2021
MD from University of Copenhagen
Citations
A Research Study on How Well Different Doses of the ...
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.
Novo bets on 'triple-G' obesity drug from China in pursuit of ...
UBT251 recently entered a Phase II trial in people with overweight or obesity in China, having shown an average weight loss of 15.1% from ...
Triple Agonism Based Therapies for Obesity - PMC - NIH
Retatrutide leads to 24.2% mean WL at the highest dose after 48 weeks in people with obesity, with no evidence of plateau and up to 26% of ...
4.
theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/NVO/pressreleases/284612/novo-nordisk-expands-obesity-pipeline-with-new-phase-2-trial-for-ubt251/Novo Nordisk Expands Obesity Pipeline With New Phase 2 ...
The Novo Nordisk A/S study “A Study Investigating Safety, Tolerability and Efficacy of UBT251 in Participants Living With Overweight or Obesity” ...
5.
pharmexec.com
pharmexec.com/view/novo-nordisk-united-laboratories-exclusive-license-agreement-triple-receptor-agonistNovo Nordisk, The United Laboratories Ink Exclusive ...
The study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple subcutaneous (SC) injections of UBT251 in ...
UBT251 Injection Phase II Study (Overweight or Obesity)
A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the ...
The United Laboratories and Novo Nordisk announce ...
To date, UBT251 has been approved for clinical trials in China in adult type 2 diabetes, overweight or obesity, metabolic dysfunction-associated ...
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