Ultralong-Acting GLP-1 Berobenatide Shows Robust Weight Loss in Phase 2b Trials

Pfizer’s berobenatide, an ultralong-acting GLP-1 receptor agonist, demonstrated substantial weight loss in phase 2b trials for adults with obesity or overweight, with and without type 2 diabetes. According to data presented at the American Diabetes Association Scientific Sessions, the drug supports both weekly and monthly dosing schedules and is currently moving into phase 3 testing.

How does berobenatide impact weight loss and blood sugar?

In the VESPER-2 study, which focused on adults with type 2 diabetes and obesity or overweight, Ildiko Lingvay, MD, MPH, MSCS, reported dose-dependent weight decreases of up to 10.2%. The highest dose also led to a reduction in HbA1c of up to 2.2%.

For participants without diabetes in the VESPER-1 open-label extension, John B. Buse, MD, PhD, noted continued weight loss with monthly dosing. At 60 weeks, the highest dose of 4.8 mg monthly resulted in a 15% weight loss from baseline.

The VESPER-3 study examined the switch from weekly to monthly intervals. Buse reported that body weight decreased by up to 12.3% at 28 weeks with the highest dose, with no evidence of a plateau at that stage.

Did You Know? Berobenatide is a terminally lipidated 41 amino acid peptide with a half-life of 15.5 days, a structure that enables its potential for monthly administration.

Why is a monthly GLP-1 option significant?

Louis J. Aronne, MD, FACP, FTOS, DABOM, stated that berobenatide could be the first approved monthly GLP-1 receptor agonist peptide. He emphasized that its classification as a biologic is important given current issues with compounding.

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Aronne noted that clinicians and patients need more options that work in different ways. This is particularly important for individuals who do not respond to currently available highly effective medications.

Regarding safety, researchers found that tolerability is consistent with the overall GLP-1 class. Lingvay reported that gastrointestinal events, such as nausea and vomiting, were mostly mild or moderate, with 88% of participants experiencing no or mild events.

Expert Insight: Samantha Carter observes that moving from weekly to monthly dosing could significantly alter patient adherence patterns. By reducing the frequency of injections, this approach may lower the treatment burden for those managing chronic obesity.

What happens next for berobenatide?

Pfizer has 10 ongoing and planned phase 3 trials to address overweight, obesity, and associated comorbidities. The data from the phase 2b studies will inform the dosing used in these larger programs.

Donna H. Ryan, MD, suggested that upcoming phase 3 data may answer unresolved questions. These include whether higher doses translate to greater weight loss and the drug’s efficacy in improving metabolic and cardiovascular risk factors.

Future results could also clarify the effects of berobenatide on disease modification and provide more detail on gastrointestinal tolerability during monthly dosing.

Frequently Asked Questions

What is berobenatide?
It is a fully biased, long-acting injectable GLP-1 receptor agonist developed by Pfizer to reduce body weight in people with overweight or obesity.

How is berobenatide administered?
Research shows that both weekly and monthly dosing intervals are feasible and well tolerated.

What are the common side effects?
Consistent with the GLP-1 class, side effects are primarily gastrointestinal, including nausea, vomiting, diarrhea, and constipation, which are mostly mild or moderate.

Would a monthly injection make you more likely to stick with a weight management program?