NCT04146896

Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy (DPN)

Completed Phase 2 Results posted Last updated 28 April 2023

What this trial tests

Phase 2 trial testing NYX-2925 50 mg in Diabetic Peripheral Neuropathic Pain in 228 participants. Completed in 23 February 2022.

Timeline

12 November 2019

Primary endpoint
23 February 2022

23 February 2022

Quick facts

Lead sponsor	Aptinyx
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	228
Start date	12 November 2019
Primary completion	23 February 2022
Estimated completion	23 February 2022
Sites	35 locations across United States

Drugs / interventions tested

• NYX-2925 50 mg — full drug profile →
• Placebo

Conditions studied

• Diabetic Peripheral Neuropathic Pain — all drugs for Diabetic Peripheral Neuropathic Pain →

Sponsor

Aptinyx — full company profile →

Who can join

Adults 18 to 75, any sex, with Diabetic Peripheral Neuropathic Pain. 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.

Pain Intensity Numeric Rating Scale (NRS) Score Primary · Week 12

Change from baseline in the weekly mean of the daily Numeric Rating Scale (NRS) score assessing average pain intensity related to DPN in the past 24 hours. In the NRS, a participant selects a whole number (0 to 10) that best indicates the intensity of his/her pain, where 0 represents no pain and 10 represents worst pain imaginable.

Group	Value	95% CI
NYX-2925	-2.01	± 1.821
Placebo	-2.27	± 2.102

Daily Sleep Interference Scale (DSIS) Score Secondary · Week 12

Change from baseline in the weekly mean of the Daily Sleep Interference Scale (DSIS) scores. The DSIS asks participants to ''Select the number that best describes how much your pain has interfered with your sleep during the past 24 hours.'' Response options for the DSIS range from 0 (did not interfere with sleep) to 10 (completely interfered with sleep/unable to sleep due to pain).

Group	Value	95% CI
NYX-2925	-2.11	± 1.903
Placebo	-2.39	± 2.344

Patient Global Impression of Change (PGI-C) Secondary · Week 12

Number of subjects 'much improved' or 'very much improved' on Patient Global Impression of Change (PGI-C)

Group	Value	95% CI
NYX-2925	38
Placebo	40

Number of Subjects Achieving ≥30% Pain Reduction Secondary · Week 12

Number of subjects achieving ≥30% pain reduction from baseline in the weekly mean NRS average pain intensity related to DPN

Group	Value	95% CI
NYX-2925	51
Placebo	52

Number of Subjects Achieving ≥50% Reduction Secondary · Week 12

Number of subjects achieving ≥50% reduction from baseline in the weekly mean NRS average pain intensity related to DPN

Group	Value	95% CI
NYX-2925	29
Placebo	35

Norfolk Quality of Life Questionnaire - Diabetic Neuropathy (QOL-DN) Score Secondary · Week 12

Change from baseline in the Norfolk Quality of Life Questionnaire - Diabetic Neuropathy (QOL-DN) score. The QOL-DN is a 47 item subject reported questionnaire. Scores range from 0-126, and lower scores indicate improved quality of life.

Group	Value	95% CI
NYX-2925	-15.3	± 17.91
Placebo	-16.7	± 21.14

Use of Rescue Medication Secondary · Week 12

Number of subjects using rescue medication

Group	Value	95% CI
NYX-2925	100
Placebo	97

Adverse events — posted to ClinicalTrials.gov

Time frame: Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event.. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

NYX-2925

Serious: 1/114 (1%)

Deaths: 0/114

Placebo

Serious: 6/114 (5%)

Deaths: 2/114

Serious adverse events (8 terms)

Reaction	System	NYX-2925	Placebo
Acute Coronary Syndrome	Cardiac disorders	—	—
Non Cardiac Acute Chest Pain	General disorders	—	—
Gastrointestinal Bleeding	Gastrointestinal disorders	—	—
Unstable Angina	Cardiac disorders	—	—
Chronic kidney disease exacerbation	Renal and urinary disorders	—	—
Acute myocardial infarction	Cardiac disorders	—	—
COVID-19 pneumonia	Infections and infestations	—	—
Worsening of coronary artery disease	Cardiac disorders	—	—

Other adverse events (4 terms — click to expand)

Reaction	System	NYX-2925	Placebo
Diarrhea	Gastrointestinal disorders	—	—
Headache	Nervous system disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—

Most-reported serious reactions: Acute Coronary Syndrome, Non Cardiac Acute Chest Pain, Gastrointestinal Bleeding, Unstable Angina, Chronic kidney disease exacerbation, Acute myocardial infarction, COVID-19 pneumonia, Worsening of coronary artery disease.

Data from ClinicalTrials.gov NCT04146896 adverse events section.

Sponsor's own description

To evaluate the efficacy of NYX-2925 versus placebo in treating the neuropathic pain associated with diabetic peripheral neuropathy.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Diabetic neuropathy: cutting-edge research and future directions.
   Yang Y, Zhao B, Wang Y, Lan H, et al · · 2025 · cited 61× · PMID 40274830 · DOI 10.1038/s41392-025-02175-1
2. Potential novel therapeutic strategies for neuropathic pain.
   Du Z, Zhang J, Han X, Yu W, et al · · 2023 · cited 15× · PMID 37152429 · DOI 10.3389/fnmol.2023.1138798
3. Innovative strategies for diabetic peripheral neuropathy: From clinical management to emerging bioengineering solutions.
   He Z, Diao J, Hamel FG, Duan B. · · 2026 · PMID 41737633 · DOI 10.1016/j.bioactmat.2026.02.023