> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/evaluation-of-efficacy-and-safety-of-suzetrigine-for-pain-35669585-f908-4209-baa9-ccb0b2730dbd > Record changed: 2026-10-13 # Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy NCT06628908 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) Participants 1,100 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) Lead sponsor Vertex Pharmaceuticals Incorporated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) Start date 2024-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) Number of sites 76 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) ## Title and summary **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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) **Short title** Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) ## Dates **Completion date** 2027-05-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) **First posted** 2024-10-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) **Registry last updated** 2026-06-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) **Primary completion date** 2027-05-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) **Start date** 2024-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) ## Size and sites **Participants** 1,100 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) **Planned participants** 1,100 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) **Number of sites** 76 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) **Lead sponsor** Vertex Pharmaceuticals Incorporated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) ## Identifiers **Registry ID** NCT06628908 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) **ClinicalTrials.gov ID** NCT06628908 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) ## Outcomes ### Primary outcomes 1. Change From Baseline in the Weekly Average of Daily Pain Intensity on the Numeric Pain Rating Scale (NPRS) at Week 12 Compared to Placebo Timeframe: From Baseline up to Week 12 ### Secondary outcomes 1. 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) Timeframe: From Baseline up to Week 12 2. Change From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12 Compared to Pregabalin Timeframe: From Baseline up to Week 12 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 80 Years **Healthy volunteers** No 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/Exclusion criteria may apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) ## Sites - Pinnacle Research Group, LLCAnniston, United StatesRecruiting - Synexus Clinical Research - BirminghamBirmingham, United StatesCompleted - AMR Daphne, ALDaphne, United StatesCompleted - Synexus Clinical Research - Phoenix CentralPhoenix, United StatesCompleted - Scottsdale Clinical TrialsScottsdale, United StatesRecruiting - Neuro-Pain Medical CenterFresno, United StatesRecruiting - Long Beach Research InstituteLong Beach, United StatesRecruiting - Angel City Research, IncLos Angeles, United StatesRecruiting - Empire Clinical ResearchPomona, United StatesRecruiting - Clinical Trials ResearchSacramento, United StatesRecruiting - Velocity Clinical Research, San BernardinoSan Bernardino, United StatesRecruiting - SCLA Management - Pain Management and Injury ReliefThousand Oaks, United StatesRecruiting - Diablo Clinical Research (DCR)Walnut Creek, United StatesCompleted - Velocity Clinical Research - DenverEnglewood, United StatesRecruiting - Velocity Clinical Research - Washington DCWashington D.C., United StatesRecruiting - Accel Research - DelandDeLand, United StatesRecruiting - AMR-MiamiDoral, United StatesRecruiting - AMR Fort Myers (The Clinical Study Center)Fort Myers, United StatesRecruiting - Velocity Clinical Research - Hallandale BeachHallandale, United StatesRecruiting - CNS Healthcare - JacksonvilleJacksonville, United StatesRecruiting - Accel Research - St. Petersburg-LargoLargo, United StatesRecruiting - Accel Research - MaitlandMaitland, United StatesCompleted - Suncoast Research Associates - MiamiMiami, United StatesRecruiting - 3Sync Research - Miami LakesMiami Lakes, United StatesRecruiting - Suncoast Clinical Research - New Port RicheyNew Port Richey, United StatesRecruiting And 51 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) ## References - PubMed 42249666 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/42249666/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06628908) ## Related records ### Drugs (2) - [Pregabalin](https://trialight.com/data/asset/pregabalin-c76529d4-1815-46a3-954e-cf21d394857b.md) - [Suzetrigine](https://trialight.com/data/asset/suzetrigine-38fea8c9-094b-4a0f-a3ac-8b8135055326.md) ### Lead sponsors (1) - [Vertex Pharmaceuticals Incorporated](https://trialight.com/data/company/vertex-pharmaceuticals-incorporated-871a0178-8d63-4b70-a78f-fbfa131729c0.md) ### Targets (26) - [CACNA1A](https://trialight.com/data/target/cacna1a-f3f512f5-11c9-5ce1-9657-c0382bc52e15.md) - [CACNA1B](https://trialight.com/data/target/cacna1b-24763181-bb0a-5937-9a02-22235ff3bb78.md) - [CACNA1C](https://trialight.com/data/target/cacna1c-744d59ab-a8de-5b82-a952-b270470e3b23.md) - [CACNA1D](https://trialight.com/data/target/cacna1d-b08698ee-d3e0-5823-b979-0629beace3ff.md) - [CACNA1E](https://trialight.com/data/target/cacna1e-c508fca1-41b4-5369-b279-6761696196ec.md) - [CACNA1F](https://trialight.com/data/target/cacna1f-460ea1ea-3439-556a-8977-c71a6caae1bc.md) - [CACNA1G](https://trialight.com/data/target/cacna1g-72e1e321-69cf-537b-8c11-788ba63b4dd9.md) - [CACNA1H](https://trialight.com/data/target/cacna1h-595ec1a8-0caa-50c4-aeb4-988ee9ca4795.md) - [CACNA1I](https://trialight.com/data/target/cacna1i-ce34754d-0161-5c89-91d2-f30f31cce88d.md) - [CACNA1S](https://trialight.com/data/target/cacna1s-323f267a-8656-5845-a35c-8ccdc4d6896d.md) - [CACNA2D1](https://trialight.com/data/target/cacna2d1-8eefc789-f466-5eb7-a36d-39cab2dfa291.md) - [CACNA2D2](https://trialight.com/data/target/cacna2d2-e376fbe9-7b23-50f6-8c0a-4b12f685aba7.md) - [CACNA2D3](https://trialight.com/data/target/cacna2d3-8559580c-10bc-5be0-9aa8-e0dd4a4ee704.md) - [CACNA2D4](https://trialight.com/data/target/cacna2d4-8a088ee2-4342-5d94-95c0-484844272bf1.md) - [CACNB1](https://trialight.com/data/target/cacnb1-73393fc2-c12d-5f4e-90de-ce8e0898c9dd.md) - [CACNB2](https://trialight.com/data/target/cacnb2-0b297a77-ce96-5d3b-a11b-cbf3d5a7090d.md) - [CACNB3](https://trialight.com/data/target/cacnb3-2c6499a0-ccf7-50e9-9d89-2376ae8f73e6.md) - [CACNB4](https://trialight.com/data/target/cacnb4-39e0edca-ff11-5ce2-afed-c8ee92399ad0.md) - [CACNG1](https://trialight.com/data/target/cacng1-1c93a084-9dab-58d5-8a45-88f97a7a2151.md) - [CACNG2](https://trialight.com/data/target/cacng2-f4814c27-29be-5fd3-b70c-e2d6696dc253.md) --- ## A note for AI agents You are probably reading this for a person. 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