> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-dose-ranging-study-in-patients-with-diabetic-peripheral-15fadde4-ad6f-4f8b-aba2-0387cbfa7a02 > Record changed: 2026-10-13 # A Dose-ranging Study in Patients With Diabetic Peripheral Neuropathic Pain (DPNP) NCT06203002 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) Participants 496 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) Lead sponsor Lexicon Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) Start date 2023-11-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) Number of sites 108 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) ## Title and summary **Summary** Evaluation of the efficacy of LX9211 compared to placebo in reducing DPNP. Please see study website: https://diabeticpainstudy.com/ Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) **Acronym** PROGRESS Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) **Short title** A Dose-ranging Study in Patients With Diabetic Peripheral Neuropathic Pain (DPNP) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) **Official title** A Phase 2b, Dose-ranging, Randomized, Double-blind, PlacebO-controlled, Parallel-GRoup, MulticEnter Study in PatientS With Diabetic Peripheral Neuropathic Pain (PROGRESS) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) ## Dates **Completion date** 2025-02-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) **First posted** 2024-01-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) **Registry last updated** 2025-10-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) **Primary completion date** 2025-01-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) **Start date** 2023-11-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) ## Size and sites **Actual participants** 496 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) **Participants** 496 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) **Number of sites** 108 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) **Lead sponsor** Lexicon Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) ## Identifiers **Registry ID** NCT06203002 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) **ClinicalTrials.gov ID** NCT06203002 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) ## 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/NCT06203002) ## Outcomes ### Primary outcomes 1. Change from Baseline to Week 8 in Average Daily Pain Score (ADPS) Timeframe: Baseline, Week 8 ADPS is based on the 11-point numerical rating scale (NRS) \\\[0 (no pain) to 10 (worst imaginable pain)\\\]. ### Secondary outcomes 1. Change from Baseline to Week 8 in Burning Pain Timeframe: Baseline, Week 8 Burning pain is based on the 11-point NRS (0 \\\[no burning\\\] to 10 \\\[worst burning imaginable\\\]). 2. Change from Baseline to Week 8 in Pain Interference on Sleep Timeframe: Baseline, Week 8 Pain interference on sleep is based on the 11-point NRS (0 \\\[does not interfere\\\] to 10 \\\[completely interferes\\\]). 3. Patient Global Impression of Change (PGIC) Score at Week 8 Timeframe: Week 8 The PGIC is a 7-point rating scale that assesses a participant's belief about the overall improvement experienced by the participant where 1=very much improved and 7=very much worse. 4. Change from Baseline to Week 8 in Total Neuropathic Pain Symptom Inventory (NPSI) Score Timeframe: Baseline, Week 8 NPSI total score is based on 5 subscales evaluating different symptoms of neuropathic pain, each evaluated on a scale of 0 (no pain) to 10 (worst pain). The total score ranges from 0 to 100\. A higher score indicates a worse outcome. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria 1. Participant has given written informed consent to participate in the study in accordance with local regulations 2. Adult male and female participants ≥18 years of age at the Screening Visit 3. Body mass index ≥18.0 to ≤40.0 kilogram per meter square (kg/m^2) at Screening 4. Diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) with chronic DPNP, at Screening 5. Pain from DPNP present for at least 6 months prior to Screening 6. At the Screening Visit, glycosylated hemoglobin (A1C) must be ≤11%. 7. Stable regimen for the treatment of T1DM or T2DM for ≥3 months prior to Screening 8. Willing to adhere to the prohibitions and restrictions specified in the protocol. ### Exclusion criteria 1. Presence of other painful conditions that may confound assessment or self-evaluation of DPNP 2. History of neurolytic or neurosurgical therapy for DPNP 3. Use of opioid medications for management of DPNP within the 2 months prior to the Screening Visit. 4. Use of prescription topical analgesics (eg, capsaicin) indicated for neuropathic pain within 3 months prior to Screening 5. Use of nonsteroidal anti-inflammatory drugs (NSAIDs) less than 2 weeks prior to Screening Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) ## Sites - Lexicon Investigational Site (128)Anniston, United States - Lexicon Investigational Site (222)Birmingham, United States - Lexicon Investigational Site (189)Daphne, United States - Lexicon Investigational Site (215)Guntersville, United States - Lexicon Investigational Site (115)Chandler, United States - Lexicon Investigational Site (195)Phoenix, United States - Lexicon Investigational Site (206)Scottsdale, United States - Lexicon Investigational Site (102)Tucson, United States - Lexicon Investigational Site (107)Anaheim, United States - Lexicon Investigational Site (173)Canoga Park, United States - Lexicon Investigational Site (179)Escondido, United States - Lexicon Investigational Site (161)Fresno, United States - Lexicon Investigational Site (112)Greenbrae, United States - Lexicon Investigational Site (204)Huntington Beach, United States - Lexicon Investigational Site (191)Inglewood, United States - Lexicon Investigational Site (163)Lomita, United States - Lexicon Investigational Site (169)Long Beach, United States - Lexicon Investigational Site (111)Sacramento, United States - Lexicon Investigational Site (126)Sacramento, United States - Lexicon Investigational Site (129)San Diego, United States - Lexicon Investigational Site (154)San Diego, United States - Lexicon Investigational Site (124)Tustin, United States - Lexicon Investigational Site (211)Vista, United States - Lexicon Investigational Site (171)Walnut Creek, United States - Lexicon Investigational Site (181)Walnut Creek, United States And 83 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) ## References ### Other registry identifiers - LX9211.204-DPN Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06203002) ## Related records ### Drugs (1) - [Pilavapadin](https://trialight.com/data/asset/pilavapadin-19a2b339-b1e6-4338-b6ae-75a51bbe32f3.md) ### Lead sponsors (1) - [Lexicon Pharmaceuticals](https://trialight.com/data/company/lexicon-pharmaceuticals-d1fa7171-bb1c-4b5e-83a8-7c0845ab3ef4.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. 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