18 and older, any sex, with Diabetic Peripheral Neuropathy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
To Evaluate the Efficacy of Intramuscular Administration of Engensis on Reducing Pain in Participants With Painful Diabetic Peripheral Neuropathy in the Feet and Lower Legs as Compared to PlaceboPrimary· From the 7 days prior to the Day 0 Visit (Study VMDN-003-2, NCT04469270), Day 270, to the 7 days prior to the Day 365 Visit in the intent-to-treat population
Change in the means of the Average Daily Pain Scores from the full Brief Pain Inventory for Diabetic Peripheral Neuropathy from the 7 days prior to the Day 0 Visit (Study VMDN-003-2) to the 7 days prior to the Day 365 Visit in the intent-to-treat population. The mean of the Average Daily Pain Scores are used for the primary endpoint recorded in the 7 days prior to the Days 270 and 365/ET Visits. The Brief Pain Inventory for Diabetic Peripheral Neuropathy scale is a 0 to 10 point scale with 10 being Pain as bad as you can imagine.
The mean of at least 5 daily pain scores recorded for Question
Change from Baseline to Day 270
Group
Value
95% CI
Engensis
-2.27
± 2.083
Placebo
-2.62
± 2.087
Change from Baseline to 7 Days prior to the Day 365 visit
Group
Value
95% CI
Engensis
-2.53
± 2.173
Placebo
-2.78
± 2.126
To Evaluate the Efficacy of IM Administration of Engensis on the Worst Pain in Participants With Painful Diabetic Peripheral Neuropathy in the Feet and Lower Legs as Compared to PlaceboSecondary· From the 7 days prior to the Day 0 Visit (Study VMDN-003-2) to the 7 days prior to the Day 365 Visit for Engensis compared to Placebo
Change in the means of the Worst Pain Scores from the full Brief Pain Inventory for Diabetic Peripheral Neuropathy from the 7 days prior to Day 0 Visit (Study VMDN-003-2), to Day 270, and 7 days prior to the Day 365 Visit for Engensis compared to Placebo. The Brief Pain Inventory for Diabetic Peripheral Neuropathy scale is a 0 to 10 point scale with 10 being Pain as bad as you can imagine.
The mean of at least 5 worst daily pain scores recorded for Question 3 of the Brief Pain Inventory for Diabetic Peripheral Neuropathy in the electronic diary during the 7 days prior to the Visits on Days 27
Change from Baseline to Day 270
Group
Value
95% CI
Engensis
-2.50
± 2.376
Placebo
-2.94
± 2.664
Change from Baseline to Day 365
Group
Value
95% CI
Engensis
-2.65
± 2.485
Placebo
-3.19
± 2.454
To Evaluate the Safety of IM Administration of Engensis in the Number of Participants With Painful DPN in the Feet and Lower Legs as Compared to PlaceboSecondary· From Day 0 Visit (Study VMDN-003-2) to the Day 365 Visit
Number of participants with adverse events and serious adverse events for Engensis compared to Placebo, including the number of participants with clinically significant laboratory values for Engensis compared to Placebo
Group
Value
95% CI
Engensis
16
Placebo
22
To Evaluate the Efficacy of Administration of Engensis on Reducing Pain in Participants With Painful Diabetic Peripheral Neuropathy in the Feet and Lower LegsSecondary· From the 7 days prior to the Day 0 Visit (Study VMDN-003-2), to the 7 days prior to the Day 270 Visit, and 7 days prior to the Day 365 Visit
Proportion of Responders (≥ 50% reduction in the Average Daily Pain Scores from the full Brief Pain Inventory for Diabetic Peripheral Neuropathy) from the 7 days prior to the Day 0 Visit (Study VMDN-003-2) to the 7 days prior to the Day 270 Visit and the 7 days prior to the Day 365 Visit for Engensis compared to Placebo.
Responders with ≥50% reduction by Day 270
Group
Value
95% CI
Engensis
17
Placebo
27
Responders with ≥50% reduction by Day 365
Group
Value
95% CI
Engensis
16
Placebo
27
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events that started after the Day 180 Visit (Day 180 Visit date +1 day), and recorded up to the end of the study visit, Day 365..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
To evaluate the durability of efficacy and long-term safety of intramuscular administration of Engensis or Placebo that was administered in the double-blind, randomized, VMDN-003-2 Placebo-controlled Phase 3 Study.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT05176093 — A 6-Month Extension Study to Assess the Long-Term Safety of Engensis in Amyotrophic Lateral Sclerosis
· Phase 2
· completed
NCT04632225 — Safety of Engensis in Participants With Amyotrophic Lateral Sclerosis
· Phase 2
· completed
NCT04469270 — Study to Assess Safety and Efficacy of Engensis in Painful Diabetic Peripheral Neuropathy
· Phase 3
· completed
Other recruiting trials for Diabetic Peripheral Neuropathy
Currently open trials in the same condition.
NCT07380880 — Comparison of Proprioceptive Neuromuscular Training and Sensory Re-education in Patients With Diabetic Peripheral Neurop
· NA
· recruiting
NCT06591780 — Innovative Multi-Variable Biofeedback for Improving Gait Performance in Individuals With Diabetic Peripheral Neuropathy
· NA
· recruiting
NCT07036796 — Effect of Melatonin in Patients With Diabetic Peripheral Neuropathy
· Phase 2
· recruiting
NCT07085130 — The Effect of Hand and Foot Exercises Combined With Cold Application or Virtual Reality on Diabetic Neuropathy
· NA
· active not recruiting
NCT06483620 — Cross-cultural Adaptation and Validity of the Arabic-translated NEUROPATHY-SPECIFIC QUALITY OF LIFE Questionnaire
· recruiting
Other Helixmith Co., Ltd. trials
Trials by the same sponsor.
NCT05176093 — A 6-Month Extension Study to Assess the Long-Term Safety of Engensis in Amyotrophic Lateral Sclerosis
· Phase 2
· completed
NCT05552625 — The Efficacy and Safety of TADIOS as an Adjuvant Therapy in Patients Diagnosed With Mild to Moderate COVID-19
· Phase 2, PHASE3
· withdrawn
NCT04632225 — Safety of Engensis in Participants With Amyotrophic Lateral Sclerosis
· Phase 2
· completed
NCT04469270 — Study to Assess Safety and Efficacy of Engensis in Painful Diabetic Peripheral Neuropathy
· Phase 3
· completed
NCT05361031 — The Safety and Tolerability of Engensis (VM202) in Patients With Charcot-Marie-Tooth Disease Subtype 1A (CMT1A)
· Phase 1, PHASE2
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Helixmith Co., Ltd.
Last refreshed: 9 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04873232.