Monday, July 15, 2024

Diabetes Treatment Advances: FDA Expands Fractyl Endoscopy Trial to Include Untreated Patients

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Diabetes treatment has progressed with the US Food and Drug Administration (FDA) approving an expansion of Fractyl Health’s REVITALIZE-1 clinical study. Originally focused on patients with type 2 diabetes (T2D) using insulin and up to three non-insulin drugs, including GLP-1-based therapies, the trial will now include patients whose diabetes has been inadequately controlled or untreated. This significant expansion aims to explore the broader potential of Fractyl’s endoscopic device in addressing the symptoms and progression of T2D.

The REVITALIZE-1 trial (NCT04419779) investigates the efficacy of Fractyl’s endoscopic device, designed to treat obesity and type 2 diabetes by relining the duodenum. The initial trial parameters limited participation to those already on specific diabetes medications. However, with the FDA’s approval, the trial will now also include patients whose diabetes remains uncontrolled or untreated, potentially broadening the scope and impact of the study.

Diabetes Treatment Breakthrough: Fractyl CEO Harith Rajagopalan Highlights Expansion of REVITALIZE-1 Trial

Harith Rajagopalan, co-founder and CEO of Fractyl, expressed enthusiasm about the trial’s expansion. “We are excited about the expansion of the protocol for REVITALIZE-1 because we believe Revita holds unique potential for tackling disease progression and prevention in the huge public health crisis that is T2D,” said Rajagopalan. He emphasized that Revita aims to enhance glucose regulation and slow down or halt the progression of T2D, potentially representing a paradigm shift in diabetes treatment.

In conjunction with the expanded REVITALIZE-1 trial, Fractyl Health is launching the REMAIN-1 trial. This randomized, double-blind trial will compare the effects of the Revita device in patients who have lost at least 15% of their total body weight on tirzepatide therapy against a sham therapy.

The first cohort of patients is expected to begin treatment in the third quarter of 2024, with a mid-point data analysis anticipated in the second quarter of 2025. The primary goal of REMAIN-1 is to demonstrate a percentage change in body weight from baseline to week 24. Secondary endpoints aim to show that most patients treated with Revita maintain clinically significant weight loss even after discontinuing tirzepatide.


Diabetes Care Innovation: Fractyl CEO Rajagopalan Discusses Potential Impact of REMAIN-1 Trial on GLP-1 Therapy Users

Rajagopalan highlighted the potential impact of the REMAIN-1 trial: “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.”

The expanded REVITALIZE-1 trial is part of a broader trend in innovative diabetes treatment devices. Tandem Diabetes Care recently shared positive data from a user satisfaction and wearability survey for its automated insulin delivery system, Tandem Mobi, indicating high levels of patient satisfaction.

Similarly, Medtronic published favorable results from a trial of its MiniMed 780G automated insulin delivery system at the American Diabetes Association (ADA) meeting in Orlando, Florida. These advancements highlight the rapid evolution of diabetes management technologies, offering patients more effective and user-friendly options.

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The FDA’s decision to expand the REVITALIZE-1 trial underscores the growing recognition of the need for innovative approaches to manage and treat type 2 diabetes. By including patients with inadequately controlled or untreated diabetes, the trial aims to provide comprehensive data on the device’s efficacy across a broader patient population. This could lead to significant advancements in how diabetes is managed, particularly for those who have struggled to control their condition with existing treatments.

The expansion of the REVITALIZE-1 trial represents a critical step forward in the fight against type 2 diabetes. With the inclusion of patients whose diabetes has gone uncontrolled or untreated, Fractyl Health’s endoscopic device has the potential to address a significant unmet need in diabetes management. Combined with the launch of the REMAIN-1 trial, Fractyl Health is poised to make substantial contributions to the field of diabetes treatment, offering new hope to millions of patients worldwide. As advancements in diabetes treatment devices continue, the future looks promising for more effective and sustainable management of this chronic condition.


Resource: Medical Device Network, June 25, 2024

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