40 Participants NeededMy employer runs this trial

UBT251 for Obesity

Age: 18+
Sex: Female
Trial Phase: Phase 1
Sponsor: Novo Nordisk A/S
Must be taking: Birth control
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 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?

CT

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

I was assigned female at birth and am not of childbearing potential.
I am between 18 and 65 years old.
Body mass index (BMI) between 27.0-39.9 kg/m^2 (both inclusive) at screening with overweight due to excess adipose tissue as judged by the investigator
See 2 more

Exclusion Criteria

I have not used GLP-1, GIP, or glucagon receptor drugs in the last 90 days.
I do not have any medical reasons preventing me from using oral contraception.
I have used or plan to use hormone replacement therapy recently.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Oral contraceptive and acetaminophen are administered to establish baseline pharmacokinetics

1 week

Treatment

UBT251 is administered by subcutaneous injection with dose escalation to a maintenance treatment level

22 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: UBT251Experimental Treatment1 Intervention
Group II: Oral Contraceptive (ethinylestradiol [EE] and levonorgestrel [LN])Experimental Treatment1 Intervention
Group III: Acetaminophen (equivalent to paracetamol [para])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.

UBT251 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.

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 ...

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 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- ...

Triple 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.