44 Participants NeededMy employer runs this trial

UBT251 for Obesity

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called UBT251 to determine its safety and effectiveness for individuals who are overweight or have obesity. Participants will receive UBT251 along with common medications like midazolam, caffeine, and warfarin to study drug interactions. Individuals with a body mass index (BMI) between 27 and 39.9 who are generally healthy, aside from being overweight or obese, may qualify for this trial. As a Phase 1 trial, the research aims to understand how UBT251 works in people, providing participants the opportunity to be among the first to receive this new treatment.

Is there any evidence suggesting that UBT251 is likely to be safe for humans?

Research has shown that UBT251 is generally safe and well-tolerated. In earlier studies, most participants experienced only mild side effects. The most common side effects were stomach-related, such as nausea or an upset stomach, and were mild for most individuals. This indicates that UBT251 has demonstrated a good safety record so far, making it a promising option for further study.12345

Why are researchers excited about this trial's treatments?

UBT251 is unique because it is administered subcutaneously with a gradual dose escalation, offering a novel delivery method for obesity treatment. Unlike current standard treatments like diet plans, exercise, or medications such as orlistat and phentermine, UBT251 introduces a new approach by potentially influencing weight management through a different mechanism. Researchers are excited about this treatment because it may offer a more targeted and potentially more effective option for individuals struggling with obesity. Additionally, the study examines how UBT251 interacts with other substances, providing insights into its broader effects on metabolism and drug interactions.

What evidence suggests that UBT251 might be an effective treatment for obesity?

Research has shown that UBT251, which participants in this trial may receive, yields promising results for weight loss. In one study, participants lost an average of up to 19.7% of their body weight over 24 weeks, while those on a placebo lost only 2.0%. The treatment was also safe and well-tolerated. These findings suggest that UBT251 could effectively manage weight. Another arm of this trial will administer a cocktail containing warfarin, caffeine, and midazolam to evaluate UBT251's effect on the pharmacokinetics of CYP enzyme substrates.12346

Who Is on the Research Team?

CT

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

This trial is for adults who are overweight or have obesity. Participants should generally be in good health aside from their weight and able to take the study medicines as directed.

Inclusion Criteria

My sex assigned at birth is male or female.
Considered generally healthy except for overweight or obesity based on medical history, physical examination, vital signs, ECG, and clinical laboratory tests at screening as judged by the investigator
I am between 18 and 65 years old.
See 2 more

Exclusion Criteria

I do not have any medical reasons to avoid caffeine, midazolam, or warfarin.
Known or suspected hypersensitivity to study intervention(s) or related products
I have had major stomach surgery or have a device in my digestive tract.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

UBT251 is administered subcutaneously with gradual dose escalation, alongside a cocktail of warfarin, caffeine, and midazolam to evaluate pharmacokinetics

22 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • UBT251

Trial Overview

The study tests how a new drug, UBT251, affects the levels of three common substances—midazolam, caffeine, and warfarin—in the blood when taken together by people with excess body weight.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: UBT251Experimental Treatment1 Intervention
Group II: Cocktail (Warfarin/Caffeine/Midazolam)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials
1,578
Recruited
3,813,000+
Lars Fruergaard Jørgensen profile image

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 profile image

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

Citations

UBT251, 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.

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.

Phase 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.

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 ...

Novo Nordisk Phase II Data Validate Triple-Agonist ...

UBT251 achieved up to 19.7% mean body-weight reduction at 24 weeks versus 2.0% with placebo in a randomized, double-blind, placebo-controlled ...

UBT-251 - Drug Targets, Indications, Patents

Efficacy and Safety of UBT251 Injection in Obese Participants With Moderate-to-severe Obstructive Sleep Apnea (OSA) Not on Positive Airway Pressure (PAP)