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En studie av LY3556050 hos voksne deltakere med diabetisk perifer nevropatisk smerte

6. juli 2026 oppdatert av: Eli Lilly and Company

En fase 2, randomisert, dobbeltblind, placebokontrollert, dose-varierende studie for å evaluere LY3556050 hos voksne deltakere med diabetisk perifer nevropatisk smerte

Hovedformålet med denne studien er å bestemme sikkerheten og effekten av LY3556050 versus placebo hos deltakere med diabetisk perifer nevropatisk smerte (DPNP). Studiet vil vare i omtrent 24 uker, over 3 studieperioder.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

404

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  • Ha en historie og nåværende diagnose av type 1 diabetes (T1D) eller type 2 diabetes (T2D) diagnostisert i minst 6 måneder før screening.
  • Ha en stabil glykemisk kontroll på stabilt diabetesbehandlingsregime i minst 90 dager før dag 1 med hemoglobin A1c (HbA1c) ≤10 på tidspunktet for screening.
  • Ha en historie med daglig perifer nevropatisk smerte i minst 12 uker basert på deltakerrapport eller sykehistorie.
  • Ha en visuell analog skala (VAS) smerteverdi ≥40 og <95 under screening.
  • Har tilstedeværelse av diabetisk perifer nevropati av symmetrisk natur og i nedre ekstremiteter i ≥6 måneder og diagnostisert med en score på del B ≥3 på Michigan Neuropathy Screening Instrument
  • Er villige til å opprettholde et konsistent regime med alle pågående ikke-farmakologisk smertelindrende terapier (for eksempel fysioterapi) og vil ikke starte noen nye ikke-farmakologiske smertestillende terapier under studiedeltakelsen.

  • Er villig til å seponere alle medisiner tatt for kroniske smertetilstander, unntatt tillatt samtidig smertestillende medisin som er tillatt i henhold til protokollen, for varigheten av studien

    • Ha en kroppsmasseindeks ≤45 kilogram/kvadratmeter (kg/m²) (inkludert).
    • Er menn eller kvinner i stand til å overholde reproduktive og prevensjonsmessige krav.

Ekskluderingskriterier:

  • Anamnese med andre potensielt forårsakende og/eller forvirrende smertekilder som kan svekke selvevaluering av smerte på grunn av DPNP.
  • Har hatt en prosedyre i løpet av de siste 6 månedene ment å gi permanent sansetap i målområdet av interesse (for eksempel ablasjonsteknikker.
  • Har hatt kreft innen 2 år etter baseline, bortsett fra kutan basalcelle eller plateepitelkarsinom løst ved eksisjon.
  • Er, etter etterforskerens vurdering, aktivt suicidal og anses derfor å ha betydelig risiko for selvmord.
  • Har etter etterforskerens vurdering en akutt, alvorlig eller ustabil medisinsk tilstand eller en historie eller tilstedeværelse av andre medisinske sykdommer som vil utelukke studiedeltakelse.
  • Ha et positivt HIV-testresultat ved screening.
  • Planlegg en operasjon under studien uansett årsak.
  • Har en rusforstyrrelse som definert av Diagnostic and Statistical Manual of Mental Disorders (5. utgave; DSM-5; American Psychiatric Association)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo
Participants received a matching dose of placebo administered orally twice daily (BID) over a period of 12 weeks.
Legemiddel: Placebo
Administrert oralt.
Eksperimentell: Mazisotine 50 mg
Participants received mazisotine 50 milligrams (mg) administered orally BID over a period of 12 weeks.
Legemiddel: Mazisotine
Administered orally.
Andre navn:
  • LY3556050
Eksperimentell: 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.
Legemiddel: Mazisotine
Administered orally.
Andre navn:
  • LY3556050
Eksperimentell: 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.
Legemiddel: Mazisotine
Administered orally.
Andre navn:
  • LY3556050

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mean Change From Baseline in Worst Pain Intensity (WPI) as Measured by Weekly Average of Numeric Rating Scale (NRS)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Eli Lilly and Company

Etterforskere

  • Studieleder: 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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. oktober 2023

Primær fullføring (Faktiske)

11. juni 2025

Studiet fullført (Faktiske)

11. juni 2025

Datoer for studieregistrering

Først innsendt

3. oktober 2023

Først innsendt som oppfylte QC-kriteriene

3. oktober 2023

Først lagt ut (Faktiske)

10. oktober 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Anonymiserte individuelle pasientnivådata vil bli gitt i et sikkert tilgangsmiljø ved godkjenning av et forskningsforslag og en signert datadelingsavtale.

IPD-delingstidsramme

Data er tilgjengelig 6 måneder etter den primære publisering og godkjenning av indikasjonen studert i USA og EU (EU), avhengig av hva som er senere. Data vil være tilgjengelig på ubestemt tid for forespørsel.

Tilgangskriterier for IPD-deling

Et forskningsforslag må godkjennes av et uavhengig granskningspanel og forskere må signere en datadelingsavtale.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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