Sufferers switched from weekly to month-to-month upkeep dosing of an experimental Pfizer anti-obesity drug achieved a mean placebo-adjusted weight lack of as much as 12.3% in a mid-stage examine. Outcomes that contribute to the argument for providing sufferers much less frequent injections of this GLP-1 drug.

The Part 2b examine has two main objectives: to show that the investigational drug, PF-08653944, can obtain weight reduction and preserve efficacy when sufferers change to month-to-month dosing, and to show that switching to a quadruple equal month-to-month dose maintains favorable tolerability and security.

4 doses of the drug, PF-08653944, had been evaluated within the 64-week examine, which enrolled overweight or obese members with out sort 2 diabetes. The trial was designed with two titration steps and weekly dosing till week 12, adopted by month-to-month upkeep dosing. In preliminary outcomes reported Tuesday, Pfizer mentioned weight discount for all 4 doses was superior to placebo at week 28. No plateau was noticed at this level, suggesting sufferers will proceed to reduce weight because the examine continues for 64 weeks.

Even inside the context of preliminary outcomes, there may be restricted information to investigate. Pfizer solely reported outcomes for 2 of the 4 arms of the PF’3944 examine, the low- and intermediate-monthly dosing regimens. The corporate mentioned these are the doses deliberate for inclusion in Part 3 testing. The placebo-adjusted weight lack of 12.3% reported at 28 weeks was for the imply dose of 4.8 mg; the low dose group of three.2 mg confirmed a placebo-adjusted weight lack of 10%.

As for the gastrointestinal issues which have a class-wide impact and trigger many sufferers to cease taking GLP-1 medication, Pfizer mentioned these occasions had been gentle or reasonable. No a couple of case of extreme nausea or vomiting was noticed in any dose group and there have been no circumstances of extreme diarrhea. Pfizer mentioned detailed outcomes will probably be introduced in June on the American Diabetes Affiliation’s scientific session assembly. However based mostly on the preliminary information, Pfizer can safely check a better dose in Part 3. The deliberate pivotal check of PF’3944 will embrace a excessive month-to-month dose of 9.6 mg, which is the equal of the two.4 mg weekly dose being investigated in an ongoing Part 3 trial.

PF’3944 (previously MET-097i) was Metsera’s most superior drug candidate, which Pfizer acquired for $10 billion final fall after a protracted bidding struggle with Novo Nordisk. This peptide has been developed with expertise that offers the molecule an extended half-life, permitting for an extended dosing interval in comparison with presently accessible GLP-1 agonists, administered as weekly injections.

In a analysis word, Leerink Companions analyst David Risinger famous that Pfizer didn’t disclose both absolutely the weight reduction for the examine drug or the placebo response. However he mentioned the info seems “considerably inferior” to that of Eli Lilly’s weekly injectable GLP-1 and GIP agonist, Zepbound. Regardless of all of the caveats of comparisons between research, Part 3 outcomes for Zepbound confirmed a placebo-adjusted weight lack of 13% at 28 weeks.

Pfizer’s weight problems pipeline consists of medication that focus on the amylin and GIP receptors. Shortly after the Metsera acquisition closed, Pfizer licensed the rights to an oral GLP-1 drug candidate from YaoPharma. Plans for this pipeline embrace greater than 20 trials this yr, testing these medication as monotherapies and in combos. PF’3944 alone will probably be evaluated in 10 Part 3 research.

The Part 2b readout of PF’3944 coincided with Pfizer’s launch of full-year 2025 monetary outcomes. Within the convention name to debate the outcomes, Chief Scientific Officer Chris Boshoff mentioned the long-acting GLP-1 agonist is the muse for Pfizer’s weight problems portfolio.

“We’re able to implement a complete Part 3 program for ‘3944, concentrating on potential approvals from 2028 onwards,” he mentioned. “And we’re pursuing differentiated mixture approaches with earlier-stage brokers which have the potential to offer higher alternative to deal with the various unmet wants of sufferers.”

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