144 Participants NeededMy employer runs this trial

Berobenatide 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 berobenatide to evaluate its safety and effectiveness for individuals with overweight or obesity. The study will assess the efficacy of different delivery systems for this medication. Participants must visit the study site multiple times during the trial. It suits adults with a BMI between 27 and 45 who weigh more than 110 pounds. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, providing participants the opportunity to be among the first to receive this new treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that berobenatide, a treatment being tested for obesity, has promising safety results from earlier studies. These studies found that adults who are overweight or have obesity generally tolerate berobenatide well. Serious side effects were uncommon, with most participants experiencing only mild, manageable side effects.

The treatment remains in the early stages of testing, with researchers primarily focused on understanding its safety in humans. However, evidence from earlier studies provides some reassurance about its safety.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about berobenatide for obesity because it offers a novel approach compared to current treatments like lifestyle changes, medications such as orlistat, or surgery. Unlike existing treatments that primarily focus on reducing fat absorption or appetite, berobenatide might target specific pathways related to metabolism and energy expenditure. Additionally, this treatment is administered subcutaneously using innovative delivery systems, potentially enhancing its effectiveness and patient compliance. If successful, berobenatide could offer a new, efficient option for those struggling with obesity.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that berobenatide may aid in weight loss. One study found that participants lost an average of 12.3% of their body weight after 28 weeks with a specific dose. Another study reported a similar weight loss of about 15.9% over 32 weeks, with no signs of the weight loss stopping. These results suggest that berobenatide could be effective for individuals struggling with obesity. However, it's important to note that these findings come from earlier studies, and more research is needed to confirm its efficacy and safety. Participants in this trial will receive different delivery systems of berobenatide to further evaluate its effectiveness and safety.678910

Who Is on the Research Team?

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for adults who are overweight or have obesity. Participants should generally be healthy aside from their weight and able to attend several clinic visits during the study.

Inclusion Criteria

BMI of 27-45 kg/m2 and a total body weight greater than 50 kg (110 lb)
I am 18 years old or older.

Exclusion Criteria

History of other chronic disorders
I am not pregnant, breastfeeding, or planning to become pregnant during the study.
I or a close family member have had medullary thyroid cancer or MEN2.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of berobenatide using different delivery systems

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Berobenatide

Trial Overview

The study is testing how different forms of a medicine called Berobenatide are absorbed into the blood after a single dose in adults with overweight or obesity. Various delivery methods will be compared.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Treatment 4Experimental Treatment1 Intervention
Group II: Treatment 3Experimental Treatment1 Intervention
Group III: Treatment 2Experimental Treatment1 Intervention
Group IV: Treatment 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

Robust Phase 2b Efficacy and Favorable Tolerability ...

Phase 2b VESPER-1 study showed a non-placebo-adjusted weight loss of 15.9%* with no plateau observed at 32 weeks on berobenatide

Clinical Trial for Obesity, Overweight and/or ...

The purpose of this clinical study is to learn about the effects and safety of berobenatide (PF-08653944). This may help people with overweight or obesity ...

Recent Studies on the Effectiveness and Safety of Anti-Obesity ...

Clinical evidence suggests that phentermine provides clinically meaningful short-term weight reduction, with higher doses producing greater early improvements, ...

#ADA26: Pfizer's monthly shot shows effect on obesity, ...

Pfizer's berobenatide shows up to 10.2% weight loss and 2.2% blood sugar reduction in Phase 2b trial in patients with obesity and type 2 ...

Ultra-Long-Acting Injectable GLP-1 RA Shows Promise for ...

After 28 weeks of treatment, berobenatide demonstrated placebo-adjusted weight loss of up to 12.3% with the 4.8 mg monthly dose. The safety and ...

Robust Phase 2b Efficacy and Favorable Tolerability ...

In addition, data from the Phase 2b VESPER-2 study, which evaluated weekly dosing of berobenatide in adults with obesity or overweight and type ...

Pfizer Reports Strong Berobenatide Phase 2b Results for ...

Pfizer's ADA 2026 data for berobenatide (PF‑07976016) strengthen the case for what could become the first monthly GLP‑1 RA peptide for obesity.

Berobenatide - Drug Targets, Indications, Patents

SAFETY OF ONCE-MONTHLY BEROBENATIDE IN ADULTS WITH OBSTRUCTIVE SLEEP APNEA AND OVERWEIGHT OR OBESITY … substantial reductions in mean body weight of 11.3%

Researchers to share VESPER phase 2 clinical trial data

Both VESPER-1 and VESPER-3 are investigating berobenatide in adults with obesity or overweight with a comorbidity without diabetes. VESPER-1 ...

Clinical Trial for Obesity and Overweight.

The purpose of this study is to learn whether berobenatide (PF-08653944) is safe and effective for adults in China who are overweight or obese.