About this trial
The purpose of this study is to evaluate the efficacy, safety, and tolerability of Suzetrigine in participants with pain associated with diabetic peripheral neuropathy (DPN).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Body weight greater than or equal to (≥)45 kilogram (kg)
Body mass index (BMI) ≥18 to less than (<) 40 kilogram per meter square (kg/m²)
Diagnosis of diabetes mellitus type 1 or type 2 and with glycosylated hemoglobin A1c (HbA1c) ≤9% and the presence of bilateral pain in lower extremities due to DPN for at least 1 year
Weekly average of daily NPRS score ≥4 and less than or equal to (≤) 9 with limited variation in the 7-day Baseline Period
Disqualifiers
More than 3 missing daily NPRS scores during the 7-day Baseline Period
Received Journavx within 30 days of study drug dosing
Any sensory abnormality (excluding DPN) as pre-specified in the protocol
Trial design
Parallel
Treatments tested in this trial
Suzetrigine
DrugTablets for oral administration
Placebo (matched to SUZ)
DrugPlacebo matched to SUZ for oral administration.
Treatment groups
Trial outcomes
Primary outcomes
Change From Baseline in the Weekly Average of Daily Pain Intensity on the Numeric Pain Rating Scale (NPRS) at Week 12 Compared to Placebo
Secondary outcomes
Change From Baseline in the Medical Outcomes Study 36-item Short-form Health Status (SF-36v2) Physical Component Summary (PCS) Score at Week 12 Compared to Placebo (Pooled with data from Study VX24-548-110)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.