Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy

A Phase 3, Randomized, Double-blind, Placebo- and Active-Controlled Study of the Efficacy and Safety of Suzetrigine in Subjects With Pain Associated With Diabetic Peripheral Neuropathy

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06628908

Enrollment

1100

Registered

2024-10-08

Start date

2024-10-01

Completion date

2027-05-31

Last updated

2026-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Peripheral Neuropathic Pain

Brief summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of Suzetrigine (SUZ) in participants with pain associated with diabetic peripheral neuropathy (DPN).

Interventions

DRUGSuzetrigine

Tablets for oral administration.

DRUGPlacebo (matched to SUZ)

Placebo matched to SUZ for oral administration.

DRUGPregabalin

Capsules for oral administration.

DRUGPlacebo (matched to Pregabalin)

Placebo matched to Pregabalin for oral administration.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: * Body weight greater than or equal to (≥) 45 kilogram (kg) * Body mass index (BMI) ≥18.0 to less than (\<) 40.0 kilogram per meter square (kg/m\^2) * Diagnosis of diabetes mellitus type 1 or type 2 by glycosylated hemoglobin A1c (HbA1c) ≤9% and the presence of bilateral pain in lower extremities due to DPN * Weekly average of daily NPRS score ≥4 and less than or equal to (≤) 9 with limited variation in the 7-day Baseline Period Key

Exclusion criteria

* More than 3 missing daily NPRS scores during the 7-day Baseline Period * Any sensory abnormality (excluding DPN) as pre-specified in the protocol Other protocol defined Inclusion/

Design outcomes

Primary

Measure	Time frame
Change From Baseline in the Weekly Average of Daily Pain Intensity on the Numeric Pain Rating Scale (NPRS) at Week 12 Compared to Placebo	From Baseline up to Week 12

Secondary

Measure	Time frame
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 VX24-548-111)	From Baseline up to Week 12
Change From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12 Compared to Pregabalin	From Baseline up to Week 12

Countries

United States

Contacts

CONTACTMedical Information

medicalinfo@vrtx.com617-341-6777

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026