Pfizer (PFE.US) ultra-long-lasting weight loss treatment achieves positive top-line results and will launch phase 3 trials

The Zhitong Finance App learned that on February 3, Pfizer (PFE.US) announced that its ultra-long-acting injectable GLP-1 receptor agonist (RA), PF'3944 (MET-097i), achieved positive top-line results in the 2b phase VESPER-3 study. The study assessed a monthly maintenance dosing regimen for adult patients who are obese or overweight without type 2 diabetes.

PF'3944 is an ultra-long-acting, fully biased GLP-1 receptor agonist. It is a pipeline obtained by Pfizer through its recent acquisition of Metsera, and has the potential to be injected once a month. It is currently being developed as a weekly (QW) monotherapy and monthly treatment plan, and joint use with various peptide drugs is being explored, including the insulin analog PF-08653945 (PF'3945; MET-233i) and the glucose-dependent insulin-stimulating polypeptide receptor (GIPR) agonist PF-08654696 (MET-034i).

The results showed that in the 28th week of treatment, the weight of patients in group 1 and group 3 decreased by 10% and 12.3%, respectively, compared to the placebo group. These data showed that after switching to the monthly dose, the patient's weight loss was steady and continuous. There was no plateau period at week 28, and it is expected that the weight loss will continue until week 64.

During week 28, PF'3944 also maintained good and favorable safety characteristics, consistent with those of GLP-1RA drugs. Adverse events (TEAEs) observed during gastrointestinal treatment were mainly mild or moderate. There was only 1 case of severe nausea or vomiting and no severe diarrhea in all dose groups. In groups 1 and 3, 5 patients stopped treatment during the weekly phase due to adverse events (AEs), and 5 patients stopped treatment during the monthly phase due to AEs. There were no cases of discontinuation of treatment due to AES in the placebo group.

Following the recent acquisition of Metsera and reaching an exclusive global cooperation and licensing agreement with Yaopharma, Pfizer has now established a diverse pipeline of clinical-stage obesity drug candidates, covering injectable and oral medications targeting GLP-1 receptors, as well as GIPR agonists and antagonists, and amylopectin analogs. Pfizer plans to advance large-scale obesity development projects and is expected to launch more than 20 clinical trials in 2026. These include 10 Phase 3 studies of PF'3944: the Phase 3 critical VESPER-4 study that has been initiated to evaluate weekly use of PF'3944 in obese or overweight people without type 2 diabetes; the planned Phase 3 VESPER-5 study to assess weekly use of PF '3944 for obese or overweight people with type 2 diabetes; the planned Phase 3 PER-VES6 study evaluating PF'3944 for obese or overweight people once a month; and at least 7 other planned phase 3 studies to cover comorbidities and improve patients Treatment options and accessibility.