Berobenatide for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called berobenatide to determine its effectiveness in helping people maintain weight loss. It targets adults who have already lost weight using semaglutide or tirzepatide, medications that aid in weight management. The study aims to assess the safety and effectiveness of berobenatide for these individuals. People with diabetes or certain thyroid or pancreas conditions are not eligible. Participants will engage in the study for about 11 months. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the development of a potentially groundbreaking treatment.
Do I need to stop my current medications to join the trial?
You will need to continue taking semaglutide or tirzepatide, as the study is for people who are already using these medications for weight management.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that semaglutide and tirzepatide are generally safe for treating obesity. The most common side effects involve the digestive system, such as nausea and diarrhea, occurring more frequently with tirzepatide. However, serious side effects remain rare. Both drugs have undergone studies for long-term use and are considered safer than older weight-loss treatments. Although some reports of eye problems exist, they are less common.
For berobenatide, less information is available as it remains under testing. It passed earlier safety checks, but further research is necessary to confirm its safety.12345Why do researchers think this study treatment might be promising?
Berobenatide is unique because it targets obesity with a novel mechanism of action that differs from current standard treatments like Semaglutide and Tirzepatide. Unlike these treatments, which generally work by mimicking hormones that regulate insulin and appetite, Berobenatide is designed to work through a different biological pathway, potentially offering a new approach to managing obesity. Researchers are excited about Berobenatide because it could provide an alternative for patients who don't respond well to existing medications, expanding the options for effective obesity management.
What evidence suggests that this trial's treatments could be effective for obesity?
Research has shown that berobenatide, which participants in this trial may receive, may aid in weight loss. One study found that participants lost up to 12.3% of their body weight after 28 weeks of treatment. Another study reported a similar weight loss of about 16% over 32 weeks. In this trial, other participants will receive semaglutide or tirzepatide, both of which have demonstrated significant weight loss results. Specifically, semaglutide led to weight reductions of up to 21.6%, while tirzepatide resulted in weight loss ranging from 15% to nearly 21%. These treatments have proven effective for many individuals dealing with obesity.678910
Who Is on the Research Team?
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, do not have diabetes, and have already lost weight using semaglutide or tirzepatide. Participants should be generally healthy aside from their weight condition.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Berobenatide or continue with Semaglutide/Tirzepatide by subcutaneous injection
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Berobenatide
- Semaglutide
- Tirzepatide
Trial Overview
The study tests whether switching to a new monthly medicine called berobenatide helps people keep weight off after losing it with semaglutide or tirzepatide. The study lasts about 11 months.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive Berobenatide by Subcutaneous Injection.
Participants will receive Semaglutide or Tirzepatide by Subcutaneous Injection.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University
Citations
Robust Phase 2b Efficacy and Favorable Tolerability ...
Results from a 32-week exploratory extension (Part B) of the Phase 2b VESPER-1 study showed a non-placebo-adjusted weight loss of 15.9%* with no ...
2.
adameetingnews.org
adameetingnews.org/ultra-long-acting-glp-1-ra-improves-weight-loss-in-individuals-with-and-without-type-2-diabetes/Ultra-long-acting GLP-1 RA improves weight loss in ...
After 28 weeks, berobenatide demonstrated placebo-adjusted weight loss of up to 12.3% with the 4.8 mg monthly dose. Notably, weight loss ...
Berobenatide weight loss benefit maintained in shift to ...
At week 28, patients had lost more weight with all four berobenatide regimens than with placebo (P < .001), with placebo-adjusted weight loss of up to 12.3% of ...
Detailed data show Pfizer's monthly obesity drug continues ...
berobenatide helped patients with obesity and. After 28 weeks of weekly injections, those on the highest dose lost 10.2% of their body weight ...
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 ...
Efficacy and Safety of Tirzepatide and Semaglutide for Obesity ...
Gastrointestinal adverse events were the most common, occurring more frequently with tirzepatide, while serious events were rare.
Review Comparative safety and side effects of semaglutide ...
Ophthalmic safety profile Semaglutide and Tirzepatide have been linked to ocular complications in both large clinical trials and smaller observational reports.
Indirect comparative efficacy and safety of tirzepatide vs ...
The safety profiles showed that tirzepatide and GLP-1 RAs were associated with more GI AEs than placebo; however, there were no significant ...
Semaglutide and Tirzepatide for Obesity: Effectiveness and ...
Safety profile of semaglutide … 3-year efficacy and safety data evaluating tirzepatide in participants with prediabetes status.
Efficacy and safety of tirzepatide for weight loss in patients ...
This meta-analysis aims to evaluate efficacy and safety of tirzepatide for weight loss, including its dose-response relationship and adverse ...
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