According to a Sept. 16 press release, three separate doses of the new drug (6 mg, 12 mg, and 36 mg) demonstrated “significant improvements” in body weight reduction compared to a placebo at 72 weeks. “Obesity is a complex, global health challenge — and patients need treatment options that are both effective and easy to integrate into everyday life,” Sean Wharton, M.D., director at Wharton Medical Clinic and lead investigator, said in the release.
Wharton continued, “In this Phase 3 study, orforglipron demonstrated strong efficacy results and safety consistent with the GLP-1 class, reinforcing its potential as a first-line treatment in primary care. Additionally, orforglipron could help reduce known markers of cardiovascular risk associated with obesity and support meaningful improvements in public health.”
Notably, the highest dose of the new drug lowered A1C more than Novo Nordisk’s drug, semaglutide, bringing it down by 1.9 percentage points compared to 1.5 percentage points. Similarly, the new drug worked better for weight loss, with a 8.2% reduction, compared to 5.3%.
According to the release, the company is advancing the drug toward regulatory submissions. It said it anticipates it will be submitted for treatment of type two diabetes next year. However, experts say the new drug could be fast tracked under the Food and Drug Administration’s (FDA) new Commissioner’s National Priority Voucher Pilot Program. The standard review takes 10 months, but under the pilot program, it could be available in two.
“People living with obesity have broad and varied needs — whether it’s improving weight, A1C, lipids, blood pressure, or other health markers that primary care physicians routinely address with their patients,” said Kenneth Custer, Ph.D., executive vice president and president of Lilly Cardiometabolic Health.
Custer continued, “We’re encouraged to see orforglipron improve many of these areas in ATTAIN-1. As a convenient, once-daily pill that can be scaled globally, orforglipron could be ideally suited for early adoption in primary care — where proactive intervention has the potential to lead to meaningful, long-term health improvements.”