The news: Eli Lilly plans to file for global regulatory approval of its first weight loss pill following positive results in a second key trial. People with both obesity and type 2 diabetes lost an average 10.5% of their weight and significantly improved blood sugar levels.

Lilly will submit global applications, including to the FDA in the US, by the end of the year. If approved, its orforglipron pill could be available as soon as next year.

Why it matters: The new study adds to Lilly’s initial orforglipron results reported earlier this month, in which people with obesity lost about 12% of their weight. People who have both obesity and type 2 diabetes typically have more difficulty losing weight than patients only with obesity.

Lilly’s GLP-1 oral medication is the second GLP-1 weight loss pill being submitted for approval.

• Novo Nordisk filed an application in May for oral semaglutide after its study showed 15% weight loss in patients with obesity.
• Another oral GLP-1 contender, Viking Therapeutics, recently reported a midstage study that showed patients with obesity lost up to 12.2% of their body weight after 13 weeks. However, Viking still needs to complete phase 3 studies before it can apply for approval.

Zooming out: Lilly and Novo already market GLP-1 injectables for weight loss Zepbound and Wegovy, respectively. Injectable effectiveness rates are higher than oral with studies, showing 20% and higher body weight loss—but the shots cost $1,000 per month or more.

• Lilly and Novo offer the drugs on their D2C platforms at discounted cash-pay prices starting at $349.
• Novo partnered with GoodRx last week to extend its discounted $499 price to local pharmacies.
• Lilly and Novo manage telehealth partnerships with Ro, WeightWatchers, and LifeMD to sell their branded GLP-1s. However, the drugmakers cancelled deals with other telehealth providers including Hims & Hers (Novo) and Noom (Lilly) after those companies refused to stop selling compounded GLP-1s.

Our take: GLP-1s pills faced investor disappointment over weight loss results that fell short of injectables. However, with around 100 million US adults with obesity, the next-gen pills are an opportunity for marketers to rethink how the more convenient, no-needle options can fit patients’ needs.

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