Amgen’s (AMGN) late-stage weight-loss drug MariTide is getting ready to enter the final stages of testing as the company enrolls patients in its phase 3 trial.
The company announced Monday that it has resolved some investors’ safety and tolerability concerns about the drug. Rather than jumping from a low to high dose, Amgen will now get patients to the highest dose through a three-step dose escalation, starting at 21 mg and ending at 350 mg doses.
Amgen is one of several companies discussing GLP-1s at this week’s American Diabetes Conference in Chicago. The company revealed the full data of its phase 2 data, showing 20% weight loss in obese individuals and 17% in those who also have Type 2 diabetes.
Investors and physicians alike are closely watching how MariTide performs, as both sides wait to see if it will become a popular option among patients. If the drug is eventually approved by the FDA, it would become the first monthly, or potentially quarterly, injectable weight-loss drug.
Read more about Amgen’s stock moves and today’s market action.
Investors have been unimpressed by the 20% weight loss for patients, compared to market leader Eli Lilly’s (LLY) Zepbound at up to 24%. In addition, some analysts worried about the safety profile when Amgen first released data, in November 2024, sending the stock down more than 30% that day.
Jefferies analysts said in a note to clients Monday that they were “surprisingly bullish” on Amgen’s drug because the monthly dosing and ability to tolerate the drug’s side effects were “attractive” for patients.
“AMGN remains debated by investors, but we still get pretty good feedback from docs on the differentiated profile,” the analysts wrote.
But Amgen maintains that MariTide’s weight-loss potential could be higher, since the patients observed in clinical trials didn’t plateau at the end of 52 weeks. The company is following up with longer-term observations and the potential to use MariTide quarterly, rather than monthly.
That is key to the doctors’ interest in MariTide, the analysts said. Meanwhile, investors feel that Lilly and competitor Novo Nordisk (NVO), with its Wegovy, have a solid hold on the injectable market, and there is little room for new players.
Jay Bradner, executive vice president of research and development at Amgen, told Yahoo Finance that he expects the drug to be a competitive offering in the marketplace.
“This marketplace is quite large, and is expected to sub-segment as medicines with different properties emerge,” Bradner said.
“We will never reach … the segment of the population that loves injecting themselves,” he said. “Because a feature of MariTide is this chance for … much less frequently administered medicine.”
Anjalee Khemlani is the senior health reporter at Yahoo Finance, covering all things pharma, insurance, care services, digital health, PBMs, and health policy and politics. That includes GLP-1s, of course. Follow Anjalee as AnjKhem on social media platforms X, LinkedIn, and Bluesky @AnjKhem.