Procedure Promises Maintaining Weight Post-Ozempic

Revita, a procedure restoring the lining of the part of the small intestine, promises to help maintain weight after discontinuing Ozempic and similar drugs.

Revita, developed by Fractyl Health, is an outpatient endoscopic procedure that involves resurfacing the mucosal lining of the duodenum, the first part of the small intestine located just after the stomach. Duodenum is responsible for breaking down food into absorbable nutrients.

Revita targets the duodenal lining, which can become thickened by high-fat and high-sugar diets, making it hard for the body to maintain a healthy metabolism and blood glucose levels, according to Fractyl's press release.

The company says that by resurfacing and reversing the pathology of the duodenal lining, Revita could become the first disease-modifying therapy to target the root cause of obesity and type 2 diabetes.

In June, the U.S. Food and Drug Administration (FDA) granted Revita a breakthrough device designation for maintaining weight loss after discontinuation of GLP-1 drugs.

GLP-1s, short for glucagon-like peptide-1 receptor agonists, are highly effective type 2 diabetes and obesity drugs that help people lose up to 15% to 20% of body weight. The medications work by mimicking the GLP-1 hormone, which helps control insulin and blood glucose levels and reduce appetite.

The designation was granted after an analysis of previous studies in type 2 diabetes patients, which showed durable weight maintenance following a single Revita procedure.

"If successful and approved, Revita may offer a reliable 'off-ramp' to the millions of people currently taking GLP-1 therapies, potentially providing durable weight maintenance without having to continue taking these medications," said Harith Rajagopalan, M.D., Ph.D., co-founder and Chief Executive Officer of Fractyl, in a statement.

GLP-1s are also costly and associated with severe adverse events, such as stomach paralysis and pancreatitis, leading to high discontinuation rates when used for obesity treatment.

A recent study discovered that more than half of patients (52.9%) discontinued the drug after 140 days. Two years after the prescription, 85% of patients discontinued the drug.

Moreover, there is evidence suggesting that weight loss on GLP-1s may return as soon as one year after coming off the drug.

Hope for diabetes patients

In June, Fractyl Health announced that it would accelerate the study of the Revita device, expanding eligibility to patients with type 2 diabetes who are inadequately controlled on any glucose-lowering agent.

The company says Revita may hold potential for tackling disease progression and prevention, as the diabetes crisis is only deepening.

Rajagopalan said, "For patients currently managing type 2 diabetes with medications and/or insulin, Revita aims to enhance glucose regulation and halt or slow down the disease's advancement, representing a paradigm shift in the way in which we treat these patients."