- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01618916
A Study of LY3015014 in Otherwise Healthy Participants With High Low-density Lipoprotein (LDL) Cholesterol
22. februar 2019 opdateret af: Eli Lilly and Company
A Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3015014 in Japanese and Non-Japanese Subjects With Elevated LDL-C
This is a phase 1 study in otherwise healthy participants with high LDL cholesterol.
Following multiple doses of LY3015014, the safety and tolerability of the drug, how the body handles the drug, and the drug's effect on the body will be evaluated.
Participants will participate in the study for approximately 3 months not including screening.
Screening is required within 42 days prior to the start of the study.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
51
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96814
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Texas
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Dallas, Texas, Forenede Stater, 75247
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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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
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Participants must be healthy males or females without childbearing potential as determined by medical history and physical examination, including first-generation Japanese participants
- Have body mass indexes of 18 to 35 kilograms per meter square (kg/m^2), inclusive, at screening
- Have screening low-density lipoprotein cholesterol (LDL-C) of between 100 and 180 milligrams per deciliter (mg/dL), inclusive
Exclusion Criteria:
- Have known allergies to compounds related to LY3015014 or any components of the formulation or known clinically significant hypersensitivity to biologic agents
- Have a history of atopy, significant allergies to humanized monoclonal antibodies, clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions [including but not limited to erythema multiforme major, linear immunoglobulin (Ig)A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis)
- Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, of constituting a risk when taking the study medication, or of interfering with the interpretation of data
- Have received any vaccine(s) within 1 month of LY3015014 dosing or intend to do so during the study
- Have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) prior to dosing
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 1.0 milligrams per kilogram (mg/kg) LY3015014 Every 2 Weeks
1.0 mg/kg LY3015014 given subcutaneously (SC) once every 2 weeks for 29 days.
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Administreret SC
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Eksperimentel: 1.0 mg/kg LY3015014 Every 4 Weeks
1.0 mg/kg LY3015014 given SC once every 4 weeks for 29 days.
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Administreret SC
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Eksperimentel: 3.0 mg/kg LY3015014 Every 2 Weeks
3.0 mg/kg LY3015014 given SC once every 2 weeks for 29 days.
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Administreret SC
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Eksperimentel: 3.0 mg/kg LY3015014 Every 4 Weeks
3.0 mg/kg LY3015014 given SC once every 4 weeks for 29 days.
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Administreret SC
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Placebo komparator: Placebo Every 2 Weeks
Saline injection (to match LY3015014) given SC once every 2 weeks for 29 days.
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Administreret SC
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Placebo komparator: Placebo Every 4 Weeks
Saline injection (to match LY3015014) given SC once every 4 weeks for 29 days.
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Administreret SC
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants With 1 or More Drug Related Treatment-Emergent Adverse Events (TEAEs) or Any Serious AEs (SAEs)
Tidsramme: Baseline through study completion (up to Day 127)
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TEAEs were defined as SAEs and other non-serious AEs that occurred or worsened after study treatment.
A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events section of this report.
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Baseline through study completion (up to Day 127)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3015014
Tidsramme: First Dose (Day 1) and Last Dose (Day 29): Predose, 4 Hours and 24 Hours Postdose
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The Cmax following the first dose and last dose of LY3015014 is reported.
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First Dose (Day 1) and Last Dose (Day 29): Predose, 4 Hours and 24 Hours Postdose
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PK: Area Under the Concentration Curve of LY3015014 During 1 Dosing Interval (AUC[0-tau])
Tidsramme: First Dose (Day 1) and Last Dose (Day 29): Predose, 4 Hours and 24 Hours Postdose
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The AUC(0-tau) following the first dose and last dose of LY3015014 is reported.
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First Dose (Day 1) and Last Dose (Day 29): Predose, 4 Hours and 24 Hours Postdose
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PK: Time of Maximum Concentration (Tmax) of LY3015014
Tidsramme: First Dose: Predose (Day 1) up to Week 4 postdose and Last Dose: predose (Day 29) up to Week 14 postdose
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The tmax following the first dose and last dose of LY3015014 is reported.
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First Dose: Predose (Day 1) up to Week 4 postdose and Last Dose: predose (Day 29) up to Week 14 postdose
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Percent Change From Baseline to Days 43, 57, and 127 in LDL-C
Tidsramme: Baseline, Day 43, Day 57, and Day 127
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Percent change from baseline in LDL-C was calculated as Least Squares (LS) mean using mixed effect model repeated measures (MMRM) analysis adjusted for baseline measurement, treatment, day after dosing, and treatment by day interaction.
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Baseline, Day 43, Day 57, and Day 127
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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
1. juni 2012
Primær færdiggørelse (Faktiske)
1. februar 2013
Studieafslutning (Faktiske)
1. februar 2013
Datoer for studieregistrering
Først indsendt
11. juni 2012
Først indsendt, der opfyldte QC-kriterier
11. juni 2012
Først opslået (Skøn)
13. juni 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. marts 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. februar 2019
Sidst verificeret
1. februar 2019
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 14354
- I5S-EW-EFJB (Anden identifikator: Eli Lilly and Company)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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