The weight loss was surprising, says Rajagopalan. Ozempic and Wegovy are injected into the fatty tissue of the thighs, waist, or upper arm. From there, it enters the bloodstream, where it somehow communicates with the brain. Since Fractyl’s gene therapy is delivered directly to the pancreas, company scientists didn’t expect to see significant weight loss.
To deliver the therapy to the pancreas, the company developed an endoscopic procedure that involves threading a thin needle attached to a catheter that travels down the throat and into the GI tract. Fractyl scientists tested the procedure for safety in 50 pigs, which have a pancreas that’s anatomically similar to that of humans.
In addition to producing insulin, the pancreas makes digestive enzymes that help break down food. But when it becomes inflamed—a condition called pancreatitis—these enzymes can attack the pancreas instead. Pancreatitis can be short-lived or chronic, the latter causing permanent damage to the organ. Maria Escobar Vasco, an endocrinologist and diabetes expert at UT Health San Antonio, says the idea of a one-time gene therapy is intriguing, but more testing will be needed. “The question is, how safe is it? I don’t think we know yet,” she says. The company is aiming to begin an initial human trial by the end of 2024, so those answers are still a few years away..