Pfizer has reported detailed Phase IIb results for its investigational monthly glucagon-like peptide-1 receptor agonist (GLP-1 RA) peptide, berobenatide (PF’3944), in the treatment of obesity and type 2 diabetes (T2D).
The studies aimed to identify optimal doses for Phase III and test dose escalation schemes, advancing the monthly GLP-1 RA berobenatide clinical trial programme.
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The Phase IIb VESPER-1, VESPER-2 and VESPER-3 studies examined both weekly and monthly dosing in adults with obesity or overweight, with and without T2D.
Data demonstrated proof-of-concept for berobenatide as a potential first-in-class monthly GLP-1 RA peptide capable of producing competitive weight loss outcomes.
The studies also reported favourable tolerability for berobenatide, with low gastrointestinal adverse events and low discontinuation rates even under rapid dose escalation protocols without the option to step down.
The first public clinical experience with the top weekly berobenatide dose was highlighted.
A 32-week exploratory extension (Part B) of the VESPER-1 study showed a non-placebo-adjusted weight loss of 15.9% at week 60, with no plateau observed, in participants who escalated to 2.4mg weekly.
VESPER-1 evaluated once-weekly usage in adults with obesity or overweight, including assessment of durability and transitions from weekly to less frequent dosing.
Pfizer chief internal medicine officer Jim List said: “In Phase IIb studies, berobenatide delivered continuous, uninterrupted weight loss at all doses selected for Phase III, while preserving a tolerable profile as people transitioned from a weekly to a monthly maintenance dose.
“These data highlight the potential for berobenatide to be the first approved monthly GLP-1 RA peptide and support our extensive Phase III programme that includes ten studies for chronic weight management and obesity-related comorbidities.”
Additional data from VESPER-3 (monthly dosing, without T2D) and VESPER-2 (weekly dosing, with T2D) were presented, with VESPER-2 showing a 2.2% reduction in HbA1c at week 28 with berobenatide, versus a 0.2% reduction in the placebo group.
The pivotal VESPER-6 Phase III study of berobenatide’s monthly maintenance dosing is currently enrolling, as is SOLIS-1, which studies an ultra-long-acting amylin analogue (PF’3945) as monotherapy and in combination with berobenatide.
Pfizer plans to conduct more than 20 trials for obesity and related comorbidities by 2026. This includes ten Phase III trials for berobenatide, covering chronic weight management and related conditions such as knee osteoarthritis and obstructive sleep apnoea, and studies in combination with various nutrient-stimulated hormone peptides.
Last month, Pfizer reported positive results from its Phase II trial evaluating the 25-valent pneumococcal conjugate vaccine candidate, PF-07872412 (25vPnC), in infants.
