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 women with overweight or obesity. The study examines how UBT251 interacts with common medications like birth control tablets and acetaminophen to understand its effects on the body. Women who cannot become pregnant, have a body mass index (BMI) between 27 and 39.9, and are generally healthy except for being overweight may be suitable candidates for this trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that UBT251 is generally safe and well-tolerated by participants. The most common side effects involved the stomach and digestive system, such as mild nausea or diarrhea. These effects were mostly mild and temporary. This suggests that UBT251 is likely safe for humans, which is encouraging for those considering joining a trial. While all medications can have side effects, data indicates that UBT251's effects are usually not severe.12345
Why are researchers excited about this trial's treatments?
Most treatments for obesity involve lifestyle changes, medications like orlistat, or potentially surgery. But UBT251 offers something different by being administered through a subcutaneous injection, which is a novel delivery method for obesity management. Researchers are excited because this treatment involves dose escalation to reach a maintenance level, possibly allowing for more precise control of the treatment's effects. Additionally, the trial's inclusion of an oral contraceptive and acetaminophen aims to evaluate the pharmacokinetics and gastric emptying, respectively, providing comprehensive insights into how UBT251 interacts with other substances in the body. This could lead to a more tailored and effective approach to managing obesity.
What evidence suggests that this trial's treatments could be effective for obesity?
Studies have shown that UBT251, one of the treatments tested in this trial, can help individuals with obesity or who are overweight lose a significant amount of weight. In one study, participants lost up to 19.7% of their body weight in 24 weeks. This result is impressive compared to other treatments. For example, semaglutide, a well-known weight loss drug, demonstrated a 4.8% weight loss in similar studies. Based on this research, UBT251 appears to be a promising option for managing weight.24567
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 women with overweight or obesity who cannot become pregnant. Participants should be generally healthy aside from their weight and able to take birth control pills.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Oral contraceptive and acetaminophen are administered to establish baseline pharmacokinetics
Treatment
UBT251 is administered by subcutaneous injection with dose escalation to a maintenance treatment level
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Oral contraceptive
- UBT251
Trial Overview
The study tests how safe and effective UBT251 is when taken with birth control pills, and also looks at how it affects stomach emptying using acetaminophen as a marker. All participants receive these medicines.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
UBT251 will be administered by subcutaneous injection during the treatment period with dose escalation to a maintenance treatment level.
An oral contraceptive will be administered during baseline and treatment assessment periods to evaluate the effect of UBT251 on oral contraceptive pharmacokinetics.
A single dose of acetaminophen will be administered with a standardised meal during baseline and treatment assessment periods to evaluate gastric emptying
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
1.
hcplive.com
hcplive.com/view/ubt251-a-triple-agonist-delivers-up-to-19-7-mean-weight-loss-in-phase-2-trialUBT251, A Triple Agonist, Delivers Up To 19.7% Mean ...
In a phase 2 trial in Chinese people with overweight or obesity, UBT251 led to mean weight loss of up to 19.7% (-17.5 kg) after 24 weeks.
2.
biopharminternational.com
biopharminternational.com/view/ubt251-phase-ii-data-intensify-triple-agonist-competition-in-diabetesUBT251 Phase II Data Intensify Triple-Agonist Competition ...
What were the study results? ... The therapy also showed a mean body weight reduction of up to 9.8%, compared to 4.8% with semaglutide and 1.4% ...
NCT07395687 | A Research Study on How Well Different ...
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.
4.
clinicaltrialsarena.com
clinicaltrialsarena.com/news/novo-nordisk-partnered-drug-shows-19-7-weight-loss-in-phase-ii-trial/Novo Nordisk-partnered drug shows 19.7% weight loss in ...
From a baseline mean body weight of 92.2kg, the highest mean weight loss observed for people treated with UBT251 was 19.7% compared to 2.0% in ...
5.
patientcareonline.com
patientcareonline.com/view/phase-2-trial-ubt251-triple-agonist-achieves-19-7-weight-loss-at-24-weeksPhase 2 Trial: UBT251 Triple Agonist Achieves 19.7% ...
UBT251 led to up to 19.7% mean weight loss at 24 weeks vs 2.0% with placebo in adults with overweight or obesity.
6.
biopharminternational.com
biopharminternational.com/view/novo-nordisk-phase-ii-data-validate-triple-agonist-metabolic-targeting-approachNovo Nordisk Phase II Data Validate Triple-Agonist ...
Once-weekly UBT251 achieved up to 19.7% mean body-weight reduction at 24 weeks versus 2.0% with placebo in a randomized, double-blind, placebo- ...
7.
ml-eu.globenewswire.com
ml-eu.globenewswire.com/Resource/Download/659d5fe3-c8ca-431d-aa66-233c6fd83261Triple agonist UBT251 delivers up to 19.7% mean weight ...
UBT251 appeared to have a safe and well-tolerated profile consistent with incretin- based therapies. from that trial is expected in 2027.
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