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Revita German Real-World Registry: First 14 participants continue to demonstrate sustained improvements in blood glucose and weight

Six-month follow-up data from Fractyl Health’s Revita German Real-World Registry has reported that he first 14 consented registry participants have now completed at least six months of post-Revita follow up. At baseline, prior to Revita, these participants were a median age of 62 years, had a median body weight of 111 kg and advanced T2D with an average of 14 years since diagnosis. Despite using up to three different glucose lowering medications, participants’ T2D remained uncontrolled with a median baseline HbA1c of 9.2%.

These 14 participants underwent Revita and experienced an average total body weight loss of 8.1% at six months after the procedure, with generally sustained or improved weight loss from month one to month six. These real-world findings further support the potential of Revita for durable maintenance of weight loss.

Fasting blood glucose also improved after the procedure, falling from a baseline median of 153 to 116 mg/dL at six months, and HbA1c improved from a median of 9.2 to 7.6%, reflecting better glucose control, despite all patients stabilising or reducing the number of glucose-lowering medications. No device or procedure-related serious adverse events have been reported to date.

First 14 participants with at least six months of follow up continue to demonstrate sustained improvements in blood glucose and weight with reduction in T2D medication utilization after a single Revita treatment. There were no device- or procedure-related serious adverse events have been observed to date in any registry participant.

Professor Stephan Martin, Director of the West German Diabetes Center of Excellence offering Revita combined with dietary and lifestyle support in Düsseldorf, Germany recently presented the Revita registry study three-month follow-up results at the German Diabetes Association (DDG) annual meeting,

“Early results from our real-world registry suggest that patients who undergo Revita can experience significant improvement in blood sugar, reduction in body weight, and stabilization or reduction of medication burden,” said Timothy Kieffer, Chief Scientific Officer at Fractyl Health. “These results are particularly impressive considering that most patients in the registry have been struggling with advanced T2D and inadequate control despite treatment with standard-of-care polypharmacy for many years. In particular, the maintenance of body weight loss through 6 months of follow up is a promising indicator for our ongoing clinical development program in weight maintenance through our Remain-1 pivotal study.”

To date, 26 of the 33 participants treated with Revita in Germany have consented to participate in the Revita Registry. Periodic updates on the Revita Registry and real-world clinical outcomes for patients in Germany undergoing Revita treatment will be shared as the study continues to expand and enrol.

Fractyl Health’s lead product candidate, Revita, is based on the company’s insights surrounding the potential role of the gut in obesity and T2D. Revita is designed to remodel the duodenal lining via hydrothermal ablation (i.e., duodenal mucosal resurfacing) to edit abnormal intestinal nutrient sensing and signalling mechanisms that are a potential root cause of metabolic disease.

Revita has received a CE mark in Europe and, in January 2022, received reimbursement authorization through NUB in Germany for the treatment of T2D. In the United States, Revita is for investigational use only under US law. A pivotal study of Revita in patients with inadequately controlled T2D despite multiple medicines and insulin, called Revitalize-1, is currently enrolling in the United States and Europe. A pivotal study of Revita in patients with obesity after discontinuation of GLP-1 based drugs, called Remain-1, is anticipated to initiate in the second half of 2024.


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