Gene therapy shot aimed at diabetic nerve pain put to the test

NCT ID NCT02427464

Completed Symptom relief Sponsor: Helixmith Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Nov 01, 2025 · Last updated Jun 19, 2026 · Updated 38 times

Summary

This study tested whether a gene therapy called VM202 could safely reduce pain in people with diabetic peripheral neuropathy. Over 500 adults with type 1 or type 2 diabetes received either VM202 injections or a placebo in their legs. The main goal was to see if the treatment lowered average daily pain scores over 90 days, while also monitoring for side effects.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

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Locations

Arizona Research Center

Phoenix, Arizona, 85023, United States
Associated Neurologists of Southern Connecticut, PC

Fairfield, Connecticut, 06824, United States
Center for Clinical Research

San Francisco, California, 94115, United States
Clinical Research of West Florida

Tampa, Florida, 33603, United States
Clinical Trials, Inc.

Little Rock, Arkansas, 72205, United States
Columbia University Medical Center Department of Neurology

New York, New York, 10032, United States
Compass Research, LLC

Orlando, Florida, 32806, United States
Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States
EVMS (Eastern Virginia Medical School)

Norfolk, Virginia, 23510, United States
Innovative Research of West Florida

Clearwater, Florida, 33756, United States
Martin Foot and Ankle

York, Pennsylvania, 17402, United States
Nerve and Muscle Center of Texas

Houston, Texas, 77030, United States
Neurological Research Institute

Santa Monica, California, 90404, United States
Northern California Research

Sacramento, California, 95821, United States
Northwestern University

Chicago, Illinois, 60611, United States
Rainier Clinical Research Center, Inc.

Renton, Washington, 98057, United States
Raleigh Neurology Associates, P.A.

Raleigh, North Carolina, 27607, United States
Richard S. Cherlin, MD

Los Gatos, California, 95032, United States
The Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States
UF Health College of Med, Jacksonville

Jacksonville, Florida, 32207, United States
University of Florida McKnight Brain Institute

Gainesville, Florida, 32611, United States
University of Kansas Medical Center Research Institute

Kansas City, Kansas, 66160, United States
University of Minnesota

Minneapolis, Minnesota, 55455, United States
University of Utah -Neurology

Salt Lake City, Utah, 84132, United States
Western Washington Medical Group

Everett, Washington, 98208, United States

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

Engensis (VM202) gene therapy

What this could lead to

If successful, this gene therapy could provide a new way to reduce chronic nerve pain in people with diabetes, potentially offering longer-lasting relief than current medications.

What could go wrong

This is a Phase 3 trial, but results may not show a clear benefit over placebo. Gene therapies can have unexpected side effects, and the pain relief might be modest or temporary.

Conditions

The condition(s) this trial relates to.

diabetic neuropathy Pain peripheral nervous system disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

DIABETIC NEUROPATHY, PAINFUL PAINFUL DIABETIC NEUROPATHY PAINFUL DIABETIC NEUROPATHY