The success of drugs such as Ozempic, Wegovy, and Zepbound has sparked a race among pharmaceutical labs worldwide. These medications are based on compounds originally developed for type 2 diabetes but have taken off as weight loss treatments.
Orforglipron. U.S. drugmaker Eli Lilly announced that its new treatment, orforglipron, has completed the third phase of clinical trials. According to the company, it’s the first drug in its class to pass this test—the first oral small-molecule GLP-1 receptor agonist that can be taken without restrictions on food or water intake.
GLP-1 agonist. Orforglipron, like semaglutide—the compound behind Ozempic and Wegovy—is a glucagon-like peptide-1 (GLP-1) receptor agonist. It mimics a hormone our bodies produce. GLP-1 is a peptide released when we eat that sends signals to two different recipients for two distinct purposes.
One signal goes to the pancreas, prompting insulin secretion to help metabolize sugar. That’s why GLP-1 drugs are used to treat type 2 diabetes. The other signal is sent to the brain, where it triggers a feeling of fullness.
ACHIEVE. The ACHIEVE-1 study, part of the broader ACHIEVE program, evaluated the safety and efficacy of orforglipron compared to a placebo in adults with type 2 diabetes and inadequate glycemic control. The trial also tested different doses.
After 40 weeks, researchers observed a satisfactory difference in average blood glucose levels between the experimental and control groups. The study also reported a reduction in body mass among those who took the drug.
“We are pleased to see that our latest incretin medicine meets our expectations for safety and tolerability, glucose control and weight loss, and we look forward to additional data readouts later this year,” Lilly chair and CEO David Ricks said. “As a convenient once-daily pill, orforglipron may provide a new option and, if approved, could be readily manufactured and launched at scale for use by people around the world,” he added.
Full trial results will be presented at the ADA Scientific Sessions and published in a peer-reviewed journal.
Adverse effects. One of the most critical aspects of clinical trials is identifying potential side effects to determine whether the benefits outweigh the risks. In this case, adverse effects were similar to those seen in treatments like Ozempic.
The most common side effects were gastrointestinal and described as “generally mild to moderate in severity,” including diarrhea, nausea, vomiting, dyspepsia (indigestion), and constipation. Investigators noted no liver safety concerns.
Passing the third phase of clinical trials marks an important step toward the drug reaching pharmacies, but it doesn’t guarantee immediate approval. Regulatory authorities such as the FDA must still grant final approval.
Image | Michał Parzuchowski (Unsplash)
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