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En undersøgelse af LY3556050 hos voksne deltagere med diabetiske perifere neuropatiske smerter

6. juli 2026 opdateret af: Eli Lilly and Company

En fase 2, randomiseret, dobbeltblindet, placebokontrolleret, dosisvarierende undersøgelse til evaluering af LY3556050 hos voksne deltagere med diabetiske perifere neuropatiske smerter

Hovedformålet med denne undersøgelse er at bestemme sikkerheden og effektiviteten af ​​LY3556050 versus placebo hos deltagere med diabetisk perifer neuropatisk smerte (DPNP). Undersøgelsen varer cirka 24 uger fordelt på 3 studieperioder.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

404

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Arizona
      • Chandler, Arizona, Forenede Stater, 85225
        • The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
      • Scottsdale, Arizona, Forenede Stater, 85260
        • Headlands Research - Scottsdale
      • Tucson, Arizona, Forenede Stater, 85741
        • Orange Grove Family Practice
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72211
        • Preferred Research Partners
    • California
      • Canoga Park, California, Forenede Stater, 91303
        • Hope Clinical Research, Inc.
      • Northridge, California, Forenede Stater, 91325
        • Valley Clinical Trials, Inc.
      • Sacramento, California, Forenede Stater, 95821
        • Northern California Research - Sacramento
    • Connecticut
      • Hamden, Connecticut, Forenede Stater, 06517
        • CMR of Greater New Haven, LLC
    • Florida
      • Miami, Florida, Forenede Stater, 33165
        • New Horizon Research Center
      • Miami, Florida, Forenede Stater, 33135
        • Suncoast Research Group
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern University
    • Kansas
      • Wichita, Kansas, Forenede Stater, 67205
        • Alliance for Multispecialty Research, LLC
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40509
        • Alliance for Multispecialty Research, LLC
    • Louisiana
      • Lake Charles, Louisiana, Forenede Stater, 70601
        • Care Access - Lake Charles
    • Massachusetts
      • Waltham, Massachusetts, Forenede Stater, 02451
        • MedVadis Research Corporation
    • Mississippi
      • Ridgeland, Mississippi, Forenede Stater, 39157
        • SKY Integrative Medical Center/SKYCRNG
    • Missouri
      • City of Saint Peters, Missouri, Forenede Stater, 63303
        • StudyMetrix Research
      • Kansas City, Missouri, Forenede Stater, 64114
        • Alliance for Multispecialty Research, LLC
      • Springfield, Missouri, Forenede Stater, 65807
        • Clinvest Research LLC
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Las Vegas Medical Research
    • New Jersey
      • East Brunswick, New Jersey, Forenede Stater, 08816
        • UniMed Center
    • New York
      • Port Jefferson Station, New York, Forenede Stater, 11776
        • North Suffolk Neurology
    • North Carolina
      • Hickory, North Carolina, Forenede Stater, 28601
        • Lucas Research - Hickory
      • Morehead City, North Carolina, Forenede Stater, 28557
        • Lucas Research, Inc
    • Oregon
      • Medford, Oregon, Forenede Stater, 97504
        • Velocity Clinical Research, Medford
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19114
        • Tristar Clinical Investigations
      • West Chester, Pennsylvania, Forenede Stater, 19380
        • Suburban Research Associates
    • Tennessee
      • Knoxville, Tennessee, Forenede Stater, 37909
        • New Phase Research and Development
    • Texas
      • Austin, Texas, Forenede Stater, 78731
        • FutureSearch Trials of Neurology
      • Houston, Texas, Forenede Stater, 77040
        • Juno Research
      • Shavano Park, Texas, Forenede Stater, 78231
        • Consano Clinical Research, LLC
    • Utah
      • West Jordan, Utah, Forenede Stater, 84088
        • Velocity Clinical Research, Salt Lake City
    • Washington
      • Bellevue, Washington, Forenede Stater, 98007
        • Northwest Clinical Research Center
      • Renton, Washington, Forenede 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
  • Sydkorea
    • Kyǒnggi-do
      • Sosa-gu, Kyǒnggi-do, Sydkorea, 14754
        • Sejong General Hospital
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], Sydkorea, 06351
        • Samsung Medical Center
      • Seoul, Seoul-teukbyeolsi [Seoul], Sydkorea, 01830
        • Nowon Eulji Medical Center, Eulji University
      • Seoul, Seoul-teukbyeolsi [Seoul], Sydkorea, 05030
        • Konkuk University Medical Center
    • Taejǒn-Kwangyǒkshi
      • Daejeon, Taejǒn-Kwangyǒkshi, Sydkorea, 01830
        • Eulji University Hospital
  • Tjekkiet
      • Olomouc, Tjekkiet, 779 00
        • Agentura Science Pro
    • Hradec Králové Region
      • Broumov, Hradec Králové Region, Tjekkiet, 550 01
        • EDUMED - Broumov
    • Praha 1
      • Prague, Praha 1, Tjekkiet, 11000
        • Diabet2 s.r.o., diabetologicka a interni ambulance
    • Praha 6
      • Prague, Praha 6, Tjekkiet, 160 00
        • Neurologická Ambulance - Forbeli
    • Praha, Hlavní Mešto
      • Prague, Praha, Hlavní Mešto, Tjekkiet, 160 00
        • FLEDIP - Na dlouhem lanu
      • Prague, Praha, Hlavní Mešto, Tjekkiet, 140 00
        • DiaVize s.r.o.
    • Rychnov Nad Kněžnou
      • European Union, Rychnov Nad Kněžnou, Tjekkiet, 516 01
        • Vestra Clinics

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Har en historie og aktuel diagnose af type 1-diabetes (T1D) eller type 2-diabetes (T2D) diagnosticeret i mindst 6 måneder før screening.
  • Hav en stabil glykæmisk kontrol på et stabilt diabetesbehandlingsregime i mindst 90 dage før dag 1 med et hæmoglobin A1c (HbA1c) ≤10 på tidspunktet for screening.
  • Har en historie med daglige perifere neuropatiske smerter i mindst 12 uger baseret på deltagerrapport eller sygehistorie.
  • Har en visuel analog skala (VAS) smerteværdi ≥40 og <95 under screening.
  • Har tilstedeværelse af diabetisk perifer neuropati af symmetrisk karakter og i nedre ekstremiteter i ≥6 måneder og diagnosticeret med en score på del B ≥3 på Michigan Neuropathy Screening Instrument
  • Er villige til at opretholde et konsekvent regime af enhver igangværende ikke-farmakologisk smertelindrende behandling (f.eks. fysioterapi) og vil ikke påbegynde nye ikke-farmakologiske smertelindrende behandlinger under studiedeltagelsen.

  • Er villig til at seponere al medicin, der tages for kroniske smertetilstande, undtagen tilladt samtidig smertestillende medicin, der er tilladt i henhold til protokol, i hele undersøgelsens varighed

    • Har et kropsmasseindeks ≤45 kilogram/kvadratmeter (kg/m²) (inklusive).
    • Er mænd eller kvinder i stand til at overholde reproduktive og præventionsmæssige krav.

Ekskluderingskriterier:

  • Anamnese med andre potentielt forårsagende og/eller forvirrende kilder til smerte, der kan forringe selvevaluering af smerte på grund af DPNP.
  • Har haft en procedure inden for de seneste 6 måneder, der har til formål at fremkalde permanent sensorisk tab i målområdet af interesse (f.eks. ablationsteknikker.
  • Har haft kræft inden for 2 år efter baseline, bortset fra kutan basalcelle- eller pladecellekarcinom, der er løst ved excision.
  • Er efter efterforskerens vurdering aktivt selvmordstruet og vurderes derfor at være i betydelig risiko for selvmord.
  • Har efter investigators vurdering en akut, alvorlig eller ustabil medicinsk tilstand eller en historie eller tilstedeværelse af enhver anden medicinsk sygdom, der ville udelukke undersøgelsesdeltagelse.
  • Få et positivt HIV-testresultat ved screening.
  • Få en operation planlagt under undersøgelsen af ​​en eller anden grund.
  • Har en stofmisbrugsforstyrrelse som defineret af Diagnostic and Statistical Manual of Mental Disorders (5. udgave; DSM-5; American Psychiatric Association)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Participants received a matching dose of placebo administered orally twice daily (BID) over a period of 12 weeks.
Medicin: Placebo
Indgives oralt.
Eksperimentel: Mazisotine 50 mg
Participants received mazisotine 50 milligrams (mg) administered orally BID over a period of 12 weeks.
Medicin: Mazisotine
Administered orally.
Andre navne:
  • LY3556050
Eksperimentel: 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.
Medicin: Mazisotine
Administered orally.
Andre navne:
  • LY3556050
Eksperimentel: 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.
Medicin: Mazisotine
Administered orally.
Andre navne:
  • LY3556050

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Eli Lilly and Company

Efterforskere

  • 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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. oktober 2023

Primær færdiggørelse (Faktiske)

11. juni 2025

Studieafslutning (Faktiske)

11. juni 2025

Datoer for studieregistrering

Først indsendt

3. oktober 2023

Først indsendt, der opfyldte QC-kriterier

3. oktober 2023

Først opslået (Faktiske)

10. oktober 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Anonymiserede individuelle data på patientniveau vil blive leveret i et sikkert adgangsmiljø efter godkendelse af et forskningsforslag og en underskrevet datadelingsaftale.

IPD-delingstidsramme

Data er tilgængelige 6 måneder efter den primære offentliggørelse og godkendelse af den undersøgte indikation i USA og Den Europæiske Union (EU), alt efter hvad der er senere. Data vil være tilgængelige på ubestemt tid for anmodning.

IPD-delingsadgangskriterier

Et forskningsforslag skal godkendes af et uafhængigt bedømmelsespanel, og forskere skal underskrive en datadelingsaftale.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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