Shares of the drugmaker rose 2.4% to $712 in premarket trading.
The once-daily pill also helped 75% of patients who received the highest dose of orforglipron lower their A1C level – a measure of blood sugar over time – to at or below 6.5%, Lilly said, which is below the American Diabetes Association’s target of less than 7% for most adults.
Orforglipron is a small-molecule pill that is easier to manufacture and package than wildly popular injectable drugs for obesity, such as Lilly’s Zepbound and Novo Nordisk’s rival treatment Wegovy, which are peptide mimics of the appetite-controlling GLP-1 hormone.
Lilly views the pill as a promising alternative to injections that can be made at “extraordinary scale,” said Kenneth Custer, president of the cardiometabolic health division for the Indianapolis-based drugmaker.
In the 72-week study of more than 1,600 overweight or obese adults with type 2 diabetes, those who received the 36-milligram highest dose of orforglipron on average shed 10.5% of their weight, or about 23 pounds (10.43 kg), versus 2.2% for those who received a placebo, achieving the main goal of the trial. Patients on the lowest 6 mg dose of the Lilly drug lost 5.5% of their weight. Custer said overweight and obese patients with type 2 diabetes are typically more resistant to weight loss than those without the condition. With data from this trial in hand, Lilly said it now has the full clinical package needed to start filing for approvals of orforglipron with various regulators.
When asked if Lilly would consider seeking a priority review voucher, which can cut the FDA’s decision time for a new drug application to six months from the standard 10, Custer said “all options are on the table.”
Topline data from orforglipron’s earlier late-stage study in overweight or obese adults without diabetes showed 12.4% average weight loss. Analysts had hoped it would match Wegovy’s 14.9% over 68 weeks from 2021, with some expecting the pill to exceed that.
The rate of nausea in the latest trial for high-dose patients was 36.4%, while 23.1% experienced vomiting, compared with 8.4% and 3.8%, respectively, for the placebo group. That was similar to the earlier study’s 33.7% nausea and 24% vomiting rates, which contributed to the share selloff.
In the latest results, just over 10% of the high-dose patients dropped out of the trial due to adverse side effects. As with the prior trial, no liver safety issues were seen, Lilly said.
Zepbound and Wegovy dominate a weight-loss market that is projected by some analysts to generate $150 billion a year by the early 2030s.
The U.S. Food and Drug Administration is reviewing a high-dose oral Wegovy for possible approval this year. Novo says it delivered 15% weight loss in a late-stage trial.
Lilly said the latest trial also showed orforglipron improved heart-risk markers, lowering cholesterol, triglycerides, and blood pressure, across all doses.
Wegovy has been approved to reduce the risk of major heart problems, and Lilly this month released data showing the heart-protective qualities of diabetes treatment Mounjaro, which has the same main ingredient as Zepbound.
Heart disease approvals would greatly enhance the likelihood of insurance coverage for weight-loss drugs.
