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En studie av LY3556050 hos vuxna deltagare med diabetisk perifer neuropatisk smärta

6 juli 2026 uppdaterad av: Eli Lilly and Company

En fas 2, randomiserad, dubbelblind, placebokontrollerad, dosvarierande studie för att utvärdera LY3556050 hos vuxna deltagare med diabetisk perifer neuropatisk smärta

Huvudsyftet med denna studie är att fastställa säkerheten och effekten av LY3556050 jämfört med placebo hos deltagare med diabetisk perifer neuropatisk smärta (DPNP). Studien kommer att pågå i cirka 24 veckor, över 3 studieperioder.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

404

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inklusionskriterier:

  • Ha en historia och aktuell diagnos av typ 1-diabetes (T1D) eller typ 2-diabetes (T2D) diagnostiserad i minst 6 månader före screening.
  • Ha en stabil glykemisk kontroll på stabil diabetesbehandlingsregim i minst 90 dagar före dag 1 med ett hemoglobin A1c (HbA1c) ≤10 vid tidpunkten för screening.
  • Ha en historia av daglig perifer neuropatisk smärta i minst 12 veckor baserat på deltagarrapport eller medicinsk historia.
  • Ha ett smärtvärde på visuell analog skala (VAS) ≥40 och <95 under screening.
  • Ha närvaro av diabetisk perifer neuropati av symmetrisk karaktär och i nedre extremiteter i ≥6 månader och diagnostiserad med en poäng på del B ≥3 på Michigan Neuropathy Screening Instrument
  • Är villiga att upprätthålla en konsekvent regim av alla pågående icke-farmakologiska smärtlindrande terapier (till exempel sjukgymnastik) och kommer inte att påbörja några nya icke-farmakologiska smärtlindrande terapier under studiedeltagandet.

  • Är villiga att avbryta alla mediciner som tas för kroniska smärttillstånd, förutom tillåten samtidig smärtmedicinering som tillåts enligt protokoll, under studiens varaktighet

    • Har ett body mass index ≤45 kilogram/kvadratmeter (kg/m²) (inklusive).
    • Är män eller kvinnor i stånd att följa reproduktions- och preventivmedelskrav.

Exklusions kriterier:

  • Historik om andra potentiellt orsakande och/eller förvirrande smärtkällor som kan försämra självbedömningen av smärta på grund av DPNP.
  • Har haft en procedur under de senaste 6 månaderna avsedd att producera permanent sensorisk förlust i målområdet av intresse (till exempel ablationstekniker.
  • Har haft cancer inom 2 år efter baslinjen, förutom kutan basalcellscancer eller skivepitelcancer som lösts genom excision.
  • Är, enligt utredarens bedömning, aktivt självmordsbenägen och bedöms därför löpa betydande risk för självmord.
  • Har, enligt utredarens bedömning, ett akut, allvarligt eller instabilt medicinskt tillstånd eller en historia eller närvaro av någon annan medicinsk sjukdom som skulle hindra studiedeltagande.
  • Har ett positivt HIV-testresultat vid screening.
  • Ha en operation planerad under studien av någon anledning.
  • Har en missbruksstörning enligt definitionen i Diagnostic and Statistical Manual of Mental Disorders (5:e upplagan; DSM-5; American Psychiatric Association)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: Placebo
Participants received a matching dose of placebo administered orally twice daily (BID) over a period of 12 weeks.
Läkemedel: Placebo
Administreras oralt.
Experimentell: Mazisotine 50 mg
Participants received mazisotine 50 milligrams (mg) administered orally BID over a period of 12 weeks.
Läkemedel: Mazisotine
Administered orally.
Andra namn:
  • LY3556050
Experimentell: 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.
Läkemedel: Mazisotine
Administered orally.
Andra namn:
  • LY3556050
Experimentell: 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.
Läkemedel: Mazisotine
Administered orally.
Andra namn:
  • LY3556050

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Mean Change From Baseline in Worst Pain Intensity (WPI) as Measured by Weekly Average of Numeric Rating Scale (NRS)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Eli Lilly and Company

Utredare

  • Studierektor: 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 och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

5 oktober 2023

Primärt slutförande (Faktisk)

11 juni 2025

Avslutad studie (Faktisk)

11 juni 2025

Studieregistreringsdatum

Först inskickad

3 oktober 2023

Först inskickad som uppfyllde QC-kriterierna

3 oktober 2023

Första postat (Faktisk)

10 oktober 2023

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

30 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Anonymiserad individuell patientnivådata kommer att tillhandahållas i en säker åtkomstmiljö efter godkännande av ett forskningsförslag och ett undertecknat datadelningsavtal.

Tidsram för IPD-delning

Data finns tillgängliga 6 månader efter den primära publiceringen och godkännandet av indikationen som studerats i USA och Europeiska unionen (EU), beroende på vilket som inträffar senare. Data kommer att vara tillgängliga på obestämd tid för begäran.

Kriterier för IPD Sharing Access

Ett forskningsförslag måste godkännas av en oberoende granskningspanel och forskare måste underteckna ett datadelningsavtal.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • CSR

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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