Pfizer advances weight-loss pill. What are the side effects?
Pfizer has announced the selection of a preferred once-daily modified release formulation for danuglipron, an oral GLP-1 receptor agonist, based on results from an ongoing pharmacokinetic study, reports Kazinform.
A Kazinform correspondent contacted Pfizer, and the company emphasised it is too early to speculate on regulatory approvals and availability. It is also unclear which countries will be included in the initial distribution of this weight-loss pill, and whether Kazakhstan will be among them.
Pfizer's commitment to obesity treatment
Pfizer plans to conduct dose optimization studies in the latter half of 2024 to evaluate multiple doses of this preferred formulation, aiming to inform future registration-enabling studies.
Mikael Dolsten, Chief Scientific Officer and President of Pfizer Research and Development, highlighted the company's commitment to addressing obesity, noting danuglipron's potential to offer a competitive profile in the oral GLP-1 space.
“Following a thorough analysis of our previous Phase 2b data and trial design, we believe that with the preferred modified release formulation and future trial design optimization, we can advance a competitive oral GLP-1 molecule into registration enabling studies, with the goal of addressing the present and persistent medical needs of people living with obesity,” Dolsten stated.
The ongoing open-label, randomised study is assessing the pharmacokinetics and safety of immediate- and modified-release formulations of danuglipron in healthy adults. Preliminary results support once-daily dosing with a safety profile consistent with previous studies, showing no liver enzyme elevations among more than 1,400 participants.
Previous weight-loss pills and their development
Several weight-loss pills have been developed over the years, each with varying degrees of success and controversy:
● Orlistat (Xenical): Developed by Roche in Switzerland, Orlistat works by inhibiting fat absorption in the gut. However, it can cause gastrointestinal side effects such as oily stools and flatulence.
● Lorcaserin (Belviq): Developed by Arena Pharmaceuticals in the United States, Lorcaserin was approved by the FDA but was later withdrawn from the market due to concerns about cancer risks.
● Phentermine/Topiramate (Qsymia): Developed by Vivus, Inc., also in the United States, this combination drug reduces appetite but can cause side effects like increased heart rate and birth defects if taken during pregnancy.
● Semaglutide (Wegovy): Developed by Novo Nordisk in Denmark, this GLP-1 receptor agonist has shown significant promise in promoting weight loss but must be carefully monitored for side effects like gastrointestinal issues and potential thyroid tumours.
These examples underscore the critical need for safe, effective, and accessible weight-loss solutions, highlighting the significance of Pfizer's ongoing development of danuglipron.
Liposuction tragedies in Kazakhstan and Russia
People seeking weight loss often turn to extreme measures, sometimes with tragic outcomes. In Kazakhstan, a woman died after undergoing liposuction in a private clinic in Almaty. The procedure, meant to remove excess fat, resulted in complications that led to her untimely death. Similarly, in Russia, a mother lost her life following a body liposuction procedure at a clinic. Her family claims she was pressured into the surgery while recovering from a facelift, highlighting the potential dangers and ethical concerns in cosmetic surgery practices.
Pfizer's next steps
Pfizer plans to conduct dose optimization studies in the second half of 2024, evaluating multiple doses of the preferred modified release formulation to inform the registration enabling studies. This advancement follows encouraging results from an ongoing pharmacokinetic study, indicating a pharmacokinetic profile supportive of once-daily dosing.
About Danuglipron
Danuglipron (PF-06882961) is an investigational oral GLP-1 receptor agonist developed by Pfizer, aimed at regulating blood sugar levels and promoting weight loss through increased insulin release and slower food digestion. It is not yet approved by health authorities.
Broader implications and expectations
The implications of developing an effective, once-daily weight-loss pill are significant, considering the global obesity epidemic. According to Pfizer, danuglipron could become a major player in the market, competing with other GLP-1 receptor agonists. However, the path to approval and widespread use involves rigorous testing and regulatory hurdles.
The company stated that their commitment to developing danuglipron aligns with their broader goal of addressing chronic diseases through innovative treatments. If successful, danuglipron could potentially transform the landscape of obesity treatment, providing a convenient oral option compared to injectable therapies currently dominating the market.
About Pfizer
Pfizer is dedicated to applying science and global resources to deliver therapies that improve and extend lives. With a focus on quality, safety, and value, Pfizer develops innovative medicines and vaccines, working across markets to promote wellness, prevention, and treatments for challenging diseases.
