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Uno studio su LY3556050 in partecipanti adulti con dolore neuropatico periferico diabetico

6 luglio 2026 aggiornato da: Eli Lilly and Company

Uno studio di fase 2, randomizzato, in doppio cieco, controllato con placebo, a dosaggio variabile per valutare LY3556050 in partecipanti adulti con dolore neuropatico periferico diabetico

Lo scopo principale di questo studio è determinare la sicurezza e l'efficacia di LY3556050 rispetto al placebo nei partecipanti con dolore neuropatico diabetico periferico (DPNP). Lo studio durerà circa 24 settimane, in 3 periodi di studio.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

404

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Cechia
      • Olomouc, Cechia, 779 00
        • Agentura Science Pro
    • Hradec Králové Region
      • Broumov, Hradec Králové Region, Cechia, 550 01
        • EDUMED - Broumov
    • Praha 1
      • Prague, Praha 1, Cechia, 11000
        • Diabet2 s.r.o., diabetologicka a interni ambulance
    • Praha 6
      • Prague, Praha 6, Cechia, 160 00
        • Neurologická Ambulance - Forbeli
    • Praha, Hlavní Mešto
      • Prague, Praha, Hlavní Mešto, Cechia, 160 00
        • FLEDIP - Na dlouhem lanu
      • Prague, Praha, Hlavní Mešto, Cechia, 140 00
        • DiaVize s.r.o.
    • Rychnov Nad Kněžnou
      • European Union, Rychnov Nad Kněžnou, Cechia, 516 01
        • Vestra Clinics
  • Corea del Sud
    • Kyǒnggi-do
      • Sosa-gu, Kyǒnggi-do, Corea del Sud, 14754
        • Sejong General Hospital
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], Corea del Sud, 06351
        • Samsung Medical Center
      • Seoul, Seoul-teukbyeolsi [Seoul], Corea del Sud, 01830
        • Nowon Eulji Medical Center, Eulji University
      • Seoul, Seoul-teukbyeolsi [Seoul], Corea del Sud, 05030
        • Konkuk University Medical Center
    • Taejǒn-Kwangyǒkshi
      • Daejeon, Taejǒn-Kwangyǒkshi, Corea del Sud, 01830
        • Eulji University Hospital
  • Giappone
      • Fukuoka, Giappone, 819-0168
        • Kunisaki Makoto Clinic
      • Osaka, Giappone, 559-0012
        • Minamiosaka Hospital
      • Shizuoka, Giappone, 422-8006
        • Plumeria DM Clinic
    • Ehime
      • Matsuyama, Ehime, Giappone, 790-0067
        • Matsuyama Shimin Hospital
    • Gunma
      • Maebashi, Gunma, Giappone, 370-3573
        • Kikuchi Naika Clinic
    • Hiroshima
      • Kure, Hiroshima, Giappone, 737-0023
        • Kure Medical Center
    • Hokkaido
      • Asahikawa, Hokkaido, Giappone, 070-8530
        • Japanese Red Cross Asahikawa Hospital
    • Kanagawa
      • Yokohama, Kanagawa, Giappone, 232-0064
        • Yokohama Minoru Clinic
    • Osaka
      • Suita-shi, Osaka, Giappone, 565-0853
        • Medical Corporation Heishinkai OCROM Clinic
    • Saitama
      • Sokashi, Saitama, Giappone, 340-0015
        • Sugiura Internal Medicine Clinic
    • Shizuoka
      • Shizuoka, Shizuoka, Giappone, 424-0855
        • Suruga Clinic
    • Tokyo
      • Ootaku, Tokyo, Giappone, 143-0015
        • Medical Corporation Sato Medical clinic
      • Shinjuku-ku, Tokyo, Giappone, 160-0008
        • Heishinkai Medical Group ToCROM Clinic
  • Polonia
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Polonia, 61-853
        • Nzoz Neuro-Kard Ilkowski i Partnerzy SPL
    • Kuyavian-Pomeranian Voivodeship
      • Torun, Kuyavian-Pomeranian Voivodeship, Polonia, 87-100
        • MICS Centrum Medyczne Toruń
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Polonia, 31-261
        • Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Polonia, 51-162
        • Centrum Badań Klinicznych Piotr Napora lekarze sp.p.
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Polonia, 00-874
        • MICS Centrum Medyczne Warszawa
      • Wyszków, Masovian Voivodeship, Polonia, 07-200
        • Samodzielny Publiczny Zespol Opieki Zdrowotnej w Wyszkow
    • Podlaskie Voivodeship
      • Biaystok, Podlaskie Voivodeship, Polonia, 15-351
        • Zdrowie Osteo-Medic
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Polonia, 40-081
        • Centrum Medyczne Pratia Katowice
      • Katowice, Silesian Voivodeship, Polonia, 40-648
        • Pro Familia Altera
      • Ruda Śląska, Silesian Voivodeship, Polonia, 41-709
        • NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Polonia, 90-338
        • Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
  • Stati Uniti
    • Arizona
      • Chandler, Arizona, Stati Uniti, 85225
        • The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
      • Scottsdale, Arizona, Stati Uniti, 85260
        • Headlands Research - Scottsdale
      • Tucson, Arizona, Stati Uniti, 85741
        • Orange Grove Family Practice
    • Arkansas
      • Little Rock, Arkansas, Stati Uniti, 72211
        • Preferred Research Partners
    • California
      • Canoga Park, California, Stati Uniti, 91303
        • Hope Clinical Research, Inc.
      • Northridge, California, Stati Uniti, 91325
        • Valley Clinical Trials, Inc.
      • Sacramento, California, Stati Uniti, 95821
        • Northern California Research - Sacramento
    • Connecticut
      • Hamden, Connecticut, Stati Uniti, 06517
        • CMR of Greater New Haven, LLC
    • Florida
      • Miami, Florida, Stati Uniti, 33165
        • New Horizon Research Center
      • Miami, Florida, Stati Uniti, 33135
        • Suncoast Research Group
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60611
        • Northwestern University
    • Kansas
      • Wichita, Kansas, Stati Uniti, 67205
        • Alliance for Multispecialty Research, LLC
    • Kentucky
      • Lexington, Kentucky, Stati Uniti, 40509
        • Alliance for Multispecialty Research, LLC
    • Louisiana
      • Lake Charles, Louisiana, Stati Uniti, 70601
        • Care Access - Lake Charles
    • Massachusetts
      • Waltham, Massachusetts, Stati Uniti, 02451
        • MedVadis Research Corporation
    • Mississippi
      • Ridgeland, Mississippi, Stati Uniti, 39157
        • SKY Integrative Medical Center/SKYCRNG
    • Missouri
      • City of Saint Peters, Missouri, Stati Uniti, 63303
        • StudyMetrix Research
      • Kansas City, Missouri, Stati Uniti, 64114
        • Alliance for Multispecialty Research, LLC
      • Springfield, Missouri, Stati Uniti, 65807
        • Clinvest Research LLC
    • Nevada
      • Las Vegas, Nevada, Stati Uniti, 89128
        • Las Vegas Medical Research
    • New Jersey
      • East Brunswick, New Jersey, Stati Uniti, 08816
        • UniMed Center
    • New York
      • Port Jefferson Station, New York, Stati Uniti, 11776
        • North Suffolk Neurology
    • North Carolina
      • Hickory, North Carolina, Stati Uniti, 28601
        • Lucas Research - Hickory
      • Morehead City, North Carolina, Stati Uniti, 28557
        • Lucas Research, Inc
    • Oregon
      • Medford, Oregon, Stati Uniti, 97504
        • Velocity Clinical Research, Medford
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19114
        • Tristar Clinical Investigations
      • West Chester, Pennsylvania, Stati Uniti, 19380
        • Suburban Research Associates
    • Tennessee
      • Knoxville, Tennessee, Stati Uniti, 37909
        • New Phase Research and Development
    • Texas
      • Austin, Texas, Stati Uniti, 78731
        • FutureSearch Trials of Neurology
      • Houston, Texas, Stati Uniti, 77040
        • Juno Research
      • Shavano Park, Texas, Stati Uniti, 78231
        • Consano Clinical Research, LLC
    • Utah
      • West Jordan, Utah, Stati Uniti, 84088
        • Velocity Clinical Research, Salt Lake City
    • Washington
      • Bellevue, Washington, Stati Uniti, 98007
        • Northwest Clinical Research Center
      • Renton, Washington, Stati Uniti, 98057
        • Rainier Clinical Research Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Criterio di inclusione:

  • Avere una storia e una diagnosi attuale di diabete di tipo 1 (T1D) o diabete di tipo 2 (T2D) diagnosticato per almeno 6 mesi prima dello screening.
  • Avere un controllo glicemico stabile con un regime di trattamento stabile del diabete per almeno 90 giorni prima del giorno 1 con un'emoglobina A1c (HbA1c) ≤10 al momento dello screening.
  • Avere una storia di dolore neuropatico periferico quotidiano per almeno 12 settimane in base al rapporto del partecipante o all'anamnesi medica.
  • Avere un valore del dolore sulla scala analogica visiva (VAS) ≥40 e <95 durante lo screening.
  • Presenza di neuropatia diabetica periferica di natura simmetrica e agli arti inferiori per ≥ 6 mesi e diagnosticata con un punteggio della Parte B ≥ 3 sul Michigan Neuropathy Screening Instrument
  • Sono disposti a mantenere un regime coerente di eventuali terapie antidolorifiche non farmacologiche in corso (ad esempio, terapia fisica) e non inizieranno alcuna nuova terapia antidolore non farmacologica durante la partecipazione allo studio.

  • Sono disposti a interrompere tutti i farmaci assunti per condizioni di dolore cronico, ad eccezione dei farmaci antidolorifici concomitanti consentiti dal protocollo, per la durata dello studio

    • Avere un indice di massa corporea ≤45 chilogrammi/metro quadrato (kg/m²) (incluso).
    • Gli uomini o le donne sono in grado di rispettare i requisiti riproduttivi e contraccettivi.

Criteri di esclusione:

  • Storia di altre fonti di dolore potenzialmente causative e/o confondenti che possono compromettere l'autovalutazione del dolore dovuto al DPNP.
  • Avere subito una procedura negli ultimi 6 mesi intesa a produrre una perdita sensoriale permanente nell'area target di interesse (ad esempio, tecniche di ablazione.
  • Hanno avuto un cancro entro 2 anni dal basale, ad eccezione del carcinoma cutaneo a cellule basali o squamose risolto mediante escissione.
  • Sono, a giudizio dell'investigatore, attivamente suicidari e quindi ritenuti a rischio significativo di suicidio.
  • Avere, a giudizio dello sperimentatore, una condizione medica acuta, grave o instabile o una storia o la presenza di qualsiasi altra malattia medica che precluderebbe la partecipazione allo studio.
  • Avere un risultato positivo al test HIV allo screening.
  • Pianificare un intervento chirurgico durante lo studio per qualsiasi motivo.
  • Avere un disturbo da uso di sostanze come definito dal Manuale diagnostico e statistico dei disturbi mentali (5a edizione; DSM-5; American Psychiatric Association)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo
Participants received a matching dose of placebo administered orally twice daily (BID) over a period of 12 weeks.
Droga: Placebo
Somministrato per via orale.
Sperimentale: Mazisotine 50 mg
Participants received mazisotine 50 milligrams (mg) administered orally BID over a period of 12 weeks.
Droga: Mazisotine
Administered orally.
Altri nomi:
  • LY3556050
Sperimentale: Mazisotine 200 mg
Participants received mazisotine BID orally, starting at 50 mg and titrated weekly, reaching 100 mg BID by Week 2 and a target maintenance dose of 200 mg BID by Week 3, which was then maintained up to Week 12.
Droga: Mazisotine
Administered orally.
Altri nomi:
  • LY3556050
Sperimentale: Mazisotine 400 mg
Participants received mazisotine BID orally, starting at 50 mg and titrated weekly, reaching 100 mg BID by Week 2, 200 mg BID by Week 3, and 300 mg BID by Week 4, until reaching a target maintenance dose of 400 mg BID by Week 5, which was then maintained up to Week 12.
Droga: Mazisotine
Administered orally.
Altri nomi:
  • LY3556050

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Change From Baseline in Average Pain Intensity (API) as Measured by Weekly Average of Numeric Rating Scale (NRS) - Bayesian Model Averaging (BMA) Dose-response Model
Lasso di tempo: Baseline, Week 12
  • The NRS was a single-item numeric scale used to describe pain severity. Participants were asked to rate their average pain over the past 24 hours, on a scale of 0 to 10: 0 = no pain, and 10 = pain as bad as you can imagine; a higher score indicates worse outcome (greater pain severity).
  • The mixed-model repeated measures (MMRM) model included the fixed, centered, categorical effects of region, baseline NRS average pain score, as well as concurrent use of allowed concomitant medications (yes vs. no based on interactive web response system [IWRS]), and visit. The adjusted dose response value from the MMRM was used for fitting a Bayesian model averaging (BMA) dose-response model.
  • Posterior mean change from baseline, 95 percent (%) credible interval was derived using Bayesian mixed model repeated measures. Data presented were posterior mean with 95% credible interval.
Baseline, Week 12
Mean Change From Baseline in Average Pain Intensity (API) as Measured by Weekly Average of Numeric Rating Scale (NRS) - Frequentist Repeated Measures (FRM) Analysis
Lasso di tempo: Baseline, Week 12
  • The NRS was a single-item numeric scale used to describe pain severity. Participants were asked to rate their average pain over the past 24 hours, on a scale of 0 to 10: 0 = no pain, and 10 = pain as bad as you can imagine; a higher score indicates worse outcome (greater pain severity).
  • The Least Squares (LS) Mean was calculated using a frequentist repeated measures (FRM) analysis, where Change = treatment, time interval, treatment * time interval, region, average baseline pain severity category (mild or moderate versus [vs.] severe), concurrent use of allowed concomitant medication as entered in IWRS (yes versus no).
Baseline, Week 12

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Change From Baseline in Worst Pain Intensity (WPI) as Measured by Weekly Average of Numeric Rating Scale (NRS)
Lasso di tempo: Baseline, Week 12
  • The NRS was a single-item numeric scale used to describe pain severity. Participants were asked to rate their worst pain intensity over the past 24 hours, on a scale of 0 to 10: 0 = no pain, and 10 = pain as bad as you can imagine; a higher score indicates worse outcome (greater pain severity).
  • The LS Mean was calculated using an FRM analysis, where Change = treatment, time interval, treatment * time interval, region, average baseline pain severity category (mild or moderate versus severe), concurrent use of allowed concomitant medication (yes versus no based on IWRS).
Baseline, Week 12
Mean Change From Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference Short Form 8a (PROMIS PI SF8a)
Lasso di tempo: Baseline, Week 12
The Patient-Reported Outcomes Measurement Information System Pain Interference Short Form 8a (PROMIS PI SF8a) was administered to measure self-reported consequences of pain on various aspects of the participant's life within the previous 7 days. The scale consists of 8 items, all measuring a single domain of pain interference, including impact on day-to-day activities, work around the home, household chores, family life, social activities, activities done for fun, enjoyment of social activities, and enjoyment of life. Each item was rated on a 5-point response scale ranging from "not at all" (1) to "very much" (5); the 8 item scores were summed to produce a raw score ranging from 8 (minimum) to 40 (maximum). The raw score was then converted to a T-score with a mean of 50 and a standard deviation of 10; higher T-scores indicate worse outcome (greater pain interference). Range cannot be specified in norm-based scores.
Baseline, Week 12
Mean Change From Baseline in Pain Interference With Sleep
Lasso di tempo: Baseline, Week 12
  • Pain Interference with Sleep was assessed using a single-item measure: "To what extent did diabetic nerve pain interfere with your sleep last night?" Participants responded on a scale from 0 (minimum, "Not at all") to 4 (maximum, "Unable to sleep at all"); higher scores indicate worse outcome (greater sleep interference due to pain).
  • LS Mean was calculated using an FRM analysis, where Change = treatment, time interval, treatment * time interval, region, average baseline pain severity category (mild or moderate vs. severe), concurrent use of concomitant medication (yes vs. no based on IWRS).
Baseline, Week 12
Mean Change From Baseline in Patient-Reported Outcomes Measurement Information System Physical Functioning Short Form 10a (PROMIS PF SF10a)
Lasso di tempo: Baseline, Week 12
The PROMIS PF SF10a was administered to assess self-reported physical function and physical activities across 10 items at the present time.The first 5 items assess current physical limitations (health in doing vigorous activities, walking more than one mile, climbing stairs, lifting or carrying groceries, and bending, kneeling, or stooping), each rated on a 5-point Likert scale ranging from "not at all" to "cannot do". The remaining 5 items are self-reported ability to perform specific physical activities such as chores,dressing themselves, bathing,sitting on and getting up from the toilet, each rated on a 5-point likert scale ranging from "without any difficulty" to "unable to do". The 10 item scores were summed to produce a raw score ranging from 10 (minimum) to 50 (maximum).The raw score was then converted to a T-score with a mean of 50 and a standard deviation of 10; higher T-scores indicate better outcome (greater physical function).Range cannot be specified in norm-based scores.
Baseline, Week 12
Mean Change From Baseline in Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF8b)
Lasso di tempo: Baseline, Week 12
The Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF8b) was administered to assess perceptions of sleep quality, sleep depth, and restoration associated with sleep within the previous 7 days, including perceived difficulties and concerns with getting to sleep or staying asleep, and perceptions of the adequacy of and satisfaction with sleep. The scale consists of 8 items, all measuring a single domain of sleep disturbance. Each item was rated on a 5-point response scale ranging from "not at all" to "very much," "never" to "always," or "very poor" to "very good"; the 8 item scores were summed to produce a raw score ranging from 8 (minimum) to 40 (maximum). The raw score was then converted to a T-score with a mean of 50 and a standard deviation of 10; higher T-scores indicate worse outcome (greater sleep disturbance). Range cannot be specified in norm-based scores.
Baseline, Week 12
Mean Change From Baseline in Patient's Global Impression of Illness Severity as Measured by Patient's Global Impression-Severity (PGI-Severity)
Lasso di tempo: Baseline, Week 12
  • The Patient's Global Impression-Severity (PGI-Severity) is a patient-reported single-item instrument designed to assess the participant's severity of diabetic nerve pain over the past week. The single item is rated on a 5-point Likert scale ranging from 1 (minimum, "very severe") to 5 (maximum, "none"); higher scores indicate better outcome (less pain severity).
  • The LS Mean was calculated using an FRM analysis, where Change = treatment, time interval, treatment * time interval, region, average baseline pain severity category (mild or moderate vs. severe), concurrent use of allowed concomitant medication (yes vs. no based on IWRS).
Baseline, Week 12
Mean Change From Baseline in Patient's Global Impression (PGI) of Illness Status as Measured by PGI-Status
Lasso di tempo: Baseline, Week 12
The Patient's Global Impression-Status (PGI-Status) is a patient-reported single-item instrument designed to assess the participant's status with diabetic nerve pain. Three PGI-Status scales were administered to assess physical activity, usual activity, and sleep disturbance. For physical activity, participants rated their status at the present time; for usual activity and sleep disturbance, participants rated their overall status over the past week. Physical activity and usual activity were each rated on a 5-point Likert scale ranging from 1 (minimum, "extremely limited") to 5 (maximum, "not at all limited"); higher scores indicate better outcome (less limitation). Sleep disturbance was rated on a 5-point Likert scale ranging from 1 (minimum, "very much") to 5 (maximum, "not at all"); higher scores indicate better outcome (less sleep disturbance).
Baseline, Week 12
Patient's Global Impression of Change as Measured by Patient's Global Impression-Change (PGI-Change)
Lasso di tempo: Week 12
The Patient's Global Impression-Change (PGI-Change) is a patient-reported single-item instrument designed to assess the participant's rating of change in diabetic nerve pain since they began taking the study medication. Four PGI-Change scales were administered to assess diabetic nerve pain's impact on physical activities, usual activities, sleep disturbance, and overall change. Each item was rated on a 5-point Likert scale ranging from 1 (minimum, "much worse") to 5 (maximum, "much better"); higher scores indicate better outcome (greater improvement).
Week 12
Mean Change From Baseline in Neuropathy Total Symptom Score-6 (NTSS-6)
Lasso di tempo: Baseline, Week 12
The NTSS-6 assessed the frequency and intensity of 6 diabetic peripheral neuropathic symptoms over the previous 7 days: (1) numbness and/or insensitivity, (2) prickling and/or tingling sensation, (3) burning sensation, (4) aching pain and/or tightness, (5) sharp, shooting, lancinating pain, and (6) allodynia and/or hyperalgesia. Each of the 6 symptoms was rated on two separate response scales: an intensity scale (Does not apply [0], Mild [1], Moderate [2], or Severe [3]) and a frequency scale (Never [0], Occasionally, less than 1/3 of the time [0], Often, 1/3 to 2/3 of the time [0.33], or Almost always, more than 2/3 of the time [0.66]). The total score was calculated as the weighted sum across all 6 symptoms, where intensity was given a weight of 1 and frequency was given a weight of 1/3, yielding a total score ranging from 0 (minimum, no symptoms) to 21.96 (maximum, most severe); higher scores indicate worse outcome (greater neuropathic symptom burden).
Baseline, Week 12
Total Amount of Rescue Medication Use as Measured by Average Daily Dosage
Lasso di tempo: Week 12
Acetaminophen was used as rescue medication during the treatment period. The total amount of rescue medication use was summarized as the average daily dosage at Week 12.
Week 12
Percentage of Participants With at Least One Use of Rescue Medication
Lasso di tempo: Week 12
Acetaminophen was used as rescue medication during the treatment period. The percentage of participants with at least one use of rescue medication at Week 12 was reported.
Week 12
Pharmacokinetics (PK): Plasma Concentration of Mazisotine
Lasso di tempo: Postdose at Week 12
Mazisotine plasma concentration was reported. The Measure Type was Median and the Measure of Dispersion/Precision was Inter-Quartile Range, where the lower and upper limits represented the 5th and 95th percentiles, respectively.
Postdose at Week 12

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Eli Lilly and Company

Investigatori

  • Direttore dello studio: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

5 ottobre 2023

Completamento primario (Effettivo)

11 giugno 2025

Completamento dello studio (Effettivo)

11 giugno 2025

Date di iscrizione allo studio

Primo inviato

3 ottobre 2023

Primo inviato che soddisfa i criteri di controllo qualità

3 ottobre 2023

Primo Inserito (Effettivo)

10 ottobre 2023

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 18509
  • J2P-MC-LXBD (Altro identificatore: Eli Lilly and Company)
  • 2023-506127-29-00 (Altro identificatore: EU Trial Number)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

I dati anonimizzati a livello di singolo paziente verranno forniti in un ambiente di accesso sicuro previa approvazione di una proposta di ricerca e un accordo di condivisione dei dati firmato.

Periodo di condivisione IPD

I dati sono disponibili 6 mesi dopo la pubblicazione primaria e l'approvazione dell'indicazione studiata negli Stati Uniti e nell'Unione Europea (UE), a seconda di quale data sia successiva. I dati saranno disponibili per la richiesta a tempo indeterminato.

Criteri di accesso alla condivisione IPD

Una proposta di ricerca deve essere approvata da un comitato di revisione indipendente e i ricercatori devono firmare un accordo di condivisione dei dati.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

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