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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07157774




Registration number
NCT07157774
Ethics application status
Date submitted
28/08/2025
Date registered
5/09/2025
Date last updated
5/09/2025

Titles & IDs
Public title
Assessing the Impact of Muvalaplin on Major Cardiovascular Events in Adults With Elevated Lipoprotein(a)
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Effect of Muvalaplin on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) Who Have Had a Prior Atherosclerotic Cardiovascular Event or Are at Risk for a First Atherosclerotic Cardiovascular Event
Secondary ID [1] 0 0
2025-521067-13-00
Secondary ID [2] 0 0
27269
Universal Trial Number (UTN)
Trial acronym
MOVE-Lp(a)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elevated Lp(a) 0 0
Atherosclerotic Cardiovascular Disease (ASCVD) 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Muvalaplin
Treatment: Drugs - Placebo

Experimental: Muvalaplin - Participants will receive muvalaplin orally.

Placebo comparator: Placebo - Participants will receive placebo orally.


Treatment: Drugs: Muvalaplin
Administered orally

Treatment: Drugs: Placebo
Administered orally

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to First Occurrence of Any Component of the Major Adverse Cardiac Event (MACE)-4 Composite Endpoint
Timepoint [1] 0 0
Baseline up to End of Study (About 5.25 Years)
Secondary outcome [1] 0 0
Percent Change from Baseline in Lipoprotein(a) (Lp(a)) at Week 4
Timepoint [1] 0 0
Baseline, Week 4
Secondary outcome [2] 0 0
Time to First Occurrence of Any Component of the MACE-3 Composite Endpoint
Timepoint [2] 0 0
Baseline up to End of Study (About 5.25 Years)
Secondary outcome [3] 0 0
Time to First Occurrence of Any Component of the Modified MACE-3 Composite Endpoint
Timepoint [3] 0 0
Baseline up to End of Study (About 5.25 Years)
Secondary outcome [4] 0 0
Time to First Occurrence of Any Component of the Coronary MACE-3 Composite Endpoint
Timepoint [4] 0 0
Baseline up to End of Study (About 5.25 Years)
Secondary outcome [5] 0 0
Time to First Occurrence of Any Component of MACE-3 + Major Adverse Limb Event (MALE) Composite Endpoint
Timepoint [5] 0 0
Baseline up to End of Study (About 5.25 Years)
Secondary outcome [6] 0 0
Time to Occurrence of All-Cause Mortality
Timepoint [6] 0 0
Baseline up to End of Study (About 5.25 Years)
Secondary outcome [7] 0 0
Time to First Occurrence of Each Individual Component of the MACE-4 Composite Endpoint
Timepoint [7] 0 0
Baseline up to End of Study (About 5.25 Years)
Secondary outcome [8] 0 0
Change from Baseline to Each Annual Visit for Health-Care Resource Utilization (HCRU)
Timepoint [8] 0 0
Baseline up to End of Study (About 5.25 Years)
Secondary outcome [9] 0 0
Pharmacokinetics (PK): Trough Concentration at Steady State (C-trough, ss) of Muvalaplin
Timepoint [9] 0 0
Predose through Week 96

Eligibility
Key inclusion criteria
* Have Lp(a) =175 nanomoles per liter (nmol/L)
* Meet one of the following criteria:

* Have had a prior atherosclerotic cardiovascular disease (ASCVD) event (such as heart attack, stroke, or procedure to restore blood flow to the heart or other parts of the body) within 10 years prior to screening
* Are at risk for a first ASCVD event, defined as one or more of the following:

* Documented coronary artery disease (CAD), carotid stenosis, or peripheral artery disease (PAD) without a history of ASCVD event
* A high coronary artery calcium (CAC) score
* Reduced kidney function with diabetes
* Combination(s) of high risk factors
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have experienced a major cardiovascular event or surgery, such as heart attack, stroke, or procedure to restore blood flow to the heart or other parts of the body, within 90 days prior to screening or occurring between screening and randomization
* Are planning or expected to undergo a procedure to restore blood flow in the arteries or a major heart surgery during the study
* Have uncontrolled high blood pressure
* Have New York Heart Association (NYHA) class III or IV heart failure
* Have undergone a procedure to remove cholesterol from the blood within 90 days of screening, or have a planned procedure during the study
* Have severe kidney impairment
* Have had cancer within 5 years prior to screening

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [2] 0 0
Barwon Health - Geelong
Recruitment hospital [3] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [4] 0 0
Sydney Cardiometabolic Centre - Liverpool
Recruitment hospital [5] 0 0
Advara HeartCare - Milton - Milton
Recruitment hospital [6] 0 0
Latrobe Regional Health - Traralgon
Recruitment postcode(s) [1] 0 0
4029 - Brisbane
Recruitment postcode(s) [2] 0 0
3220 - Geelong
Recruitment postcode(s) [3] 0 0
7000 - Hobart
Recruitment postcode(s) [4] 0 0
2170 - Liverpool
Recruitment postcode(s) [5] 0 0
4064 - Milton
Recruitment postcode(s) [6] 0 0
3844 - Traralgon
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Italy
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Florence
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Genova
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Milan
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Italy
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Padua
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Italy
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Palermo
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Italy
State/province [227] 0 0
Perugia
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Italy
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Pisa
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Italy
State/province [229] 0 0
Rome
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Japan
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Akita
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Japan
State/province [231] 0 0
Amagasaki
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Japan
State/province [232] 0 0
Bunkyo
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Japan
State/province [233] 0 0
Chuoku
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Japan
State/province [234] 0 0
Fujisawa
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Japan
State/province [235] 0 0
Fukuoka
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Japan
State/province [236] 0 0
Gifu
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Japan
State/province [237] 0 0
Hachioji-shi
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Japan
State/province [238] 0 0
Hakodate
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Japan
State/province [239] 0 0
Hiroshima
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Japan
State/province [240] 0 0
Ichikawa
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Japan
State/province [241] 0 0
Inzai
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Japan
State/province [242] 0 0
Itabashiku
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Japan
State/province [243] 0 0
Izumo
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Japan
State/province [244] 0 0
Kagoshima
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Japan
State/province [245] 0 0
Kamakura
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Japan
State/province [246] 0 0
Kanazawa
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Japan
State/province [247] 0 0
Kawasaki
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Japan
State/province [248] 0 0
Kobe
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Japan
State/province [249] 0 0
Kumamoto
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Japan
State/province [250] 0 0
Kusatsu
Country [251] 0 0
Japan
State/province [251] 0 0
Meguro-ku
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Japan
State/province [252] 0 0
Minoh
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Japan
State/province [253] 0 0
Mito
Country [254] 0 0
Japan
State/province [254] 0 0
Miyazaki
Country [255] 0 0
Japan
State/province [255] 0 0
Morioka
Country [256] 0 0
Japan
State/province [256] 0 0
Nagasaki
Country [257] 0 0
Japan
State/province [257] 0 0
Nagoya
Country [258] 0 0
Japan
State/province [258] 0 0
Naka
Country [259] 0 0
Japan
State/province [259] 0 0
Narita
Country [260] 0 0
Japan
State/province [260] 0 0
Nerima-ku
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Japan
State/province [261] 0 0
Okayama
Country [262] 0 0
Japan
State/province [262] 0 0
Osaka
Country [263] 0 0
Japan
State/province [263] 0 0
Oita
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Japan
State/province [264] 0 0
Osaki
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Japan
State/province [265] 0 0
Ota-ku
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Japan
State/province [266] 0 0
Sapporo
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Japan
State/province [267] 0 0
Shibukawa
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Japan
State/province [268] 0 0
Shinjuku-ku
Country [269] 0 0
Japan
State/province [269] 0 0
Shunan
Country [270] 0 0
Japan
State/province [270] 0 0
Suita
Country [271] 0 0
Japan
State/province [271] 0 0
Takamatsu
Country [272] 0 0
Japan
State/province [272] 0 0
Takatsuki
Country [273] 0 0
Japan
State/province [273] 0 0
Tokyo
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Japan
State/province [274] 0 0
Toshimaku
Country [275] 0 0
Japan
State/province [275] 0 0
Tsuchiura
Country [276] 0 0
Japan
State/province [276] 0 0
Yamato-shi
Country [277] 0 0
Japan
State/province [277] 0 0
Yokohama
Country [278] 0 0
Japan
State/province [278] 0 0
Yokosuka
Country [279] 0 0
Mexico
State/province [279] 0 0
Actopan
Country [280] 0 0
Mexico
State/province [280] 0 0
Aguascalientes
Country [281] 0 0
Mexico
State/province [281] 0 0
Chihuahua City
Country [282] 0 0
Mexico
State/province [282] 0 0
Ciudad Madero
Country [283] 0 0
Mexico
State/province [283] 0 0
Cuernavaca
Country [284] 0 0
Mexico
State/province [284] 0 0
Culiacán
Country [285] 0 0
Mexico
State/province [285] 0 0
Guadalajara
Country [286] 0 0
Mexico
State/province [286] 0 0
Hermosillo
Country [287] 0 0
Mexico
State/province [287] 0 0
León
Country [288] 0 0
Mexico
State/province [288] 0 0
Mazatlán
Country [289] 0 0
Mexico
State/province [289] 0 0
Metepec
Country [290] 0 0
Mexico
State/province [290] 0 0
Mexicali
Country [291] 0 0
Mexico
State/province [291] 0 0
Mexico
Country [292] 0 0
Mexico
State/province [292] 0 0
Mexico City
Country [293] 0 0
Mexico
State/province [293] 0 0
Mérida
Country [294] 0 0
Mexico
State/province [294] 0 0
Monterrey
Country [295] 0 0
Mexico
State/province [295] 0 0
Morelia
Country [296] 0 0
Mexico
State/province [296] 0 0
San Luis Potosí City
Country [297] 0 0
Mexico
State/province [297] 0 0
San Nicolás de los Garza
Country [298] 0 0
Mexico
State/province [298] 0 0
San Pedro Garza García
Country [299] 0 0
Mexico
State/province [299] 0 0
Tijuana
Country [300] 0 0
Mexico
State/province [300] 0 0
Tlalpan
Country [301] 0 0
Mexico
State/province [301] 0 0
Veracruz
Country [302] 0 0
Mexico
State/province [302] 0 0
Villahermosa
Country [303] 0 0
Mexico
State/province [303] 0 0
Xalapa
Country [304] 0 0
Netherlands
State/province [304] 0 0
Alkmaar
Country [305] 0 0
Netherlands
State/province [305] 0 0
Almere Stad
Country [306] 0 0
Netherlands
State/province [306] 0 0
Amersfoort
Country [307] 0 0
Netherlands
State/province [307] 0 0
Amsterdam
Country [308] 0 0
Netherlands
State/province [308] 0 0
Arnhem
Country [309] 0 0
Netherlands
State/province [309] 0 0
Assen
Country [310] 0 0
Netherlands
State/province [310] 0 0
Born
Country [311] 0 0
Netherlands
State/province [311] 0 0
Ede
Country [312] 0 0
Netherlands
State/province [312] 0 0
Hilversum
Country [313] 0 0
Netherlands
State/province [313] 0 0
Hoogeveen
Country [314] 0 0
Netherlands
State/province [314] 0 0
Leiden
Country [315] 0 0
Netherlands
State/province [315] 0 0
Nijmegen
Country [316] 0 0
Netherlands
State/province [316] 0 0
Roosendaal
Country [317] 0 0
Netherlands
State/province [317] 0 0
Rotterdam
Country [318] 0 0
Netherlands
State/province [318] 0 0
Utrecht
Country [319] 0 0
Netherlands
State/province [319] 0 0
Zwijndrecht
Country [320] 0 0
Poland
State/province [320] 0 0
Bielsko-Biala
Country [321] 0 0
Poland
State/province [321] 0 0
Bydgoszcz
Country [322] 0 0
Poland
State/province [322] 0 0
Debica
Country [323] 0 0
Poland
State/province [323] 0 0
Elblag
Country [324] 0 0
Poland
State/province [324] 0 0
Grudziadz
Country [325] 0 0
Poland
State/province [325] 0 0
Katowice
Country [326] 0 0
Poland
State/province [326] 0 0
Komorniki
Country [327] 0 0
Poland
State/province [327] 0 0
Krakow
Country [328] 0 0
Poland
State/province [328] 0 0
Leszno
Country [329] 0 0
Poland
State/province [329] 0 0
Lodz
Country [330] 0 0
Poland
State/province [330] 0 0
Lublin
Country [331] 0 0
Poland
State/province [331] 0 0
Piotrkow Trybunalski
Country [332] 0 0
Poland
State/province [332] 0 0
Tarnów
Country [333] 0 0
Poland
State/province [333] 0 0
Warsaw
Country [334] 0 0
Poland
State/province [334] 0 0
Wroclaw
Country [335] 0 0
Romania
State/province [335] 0 0
Baia Mare
Country [336] 0 0
Romania
State/province [336] 0 0
Balotesti
Country [337] 0 0
Romania
State/province [337] 0 0
Brasov
Country [338] 0 0
Romania
State/province [338] 0 0
Bucharest
Country [339] 0 0
Romania
State/province [339] 0 0
Buzau
Country [340] 0 0
Romania
State/province [340] 0 0
Gala?i
Country [341] 0 0
Romania
State/province [341] 0 0
Oradea
Country [342] 0 0
Romania
State/province [342] 0 0
Satu Mare
Country [343] 0 0
Romania
State/province [343] 0 0
Sibiu
Country [344] 0 0
Romania
State/province [344] 0 0
Târgu Mures
Country [345] 0 0
Romania
State/province [345] 0 0
Tg.Mures
Country [346] 0 0
Romania
State/province [346] 0 0
Timi?oara
Country [347] 0 0
Slovakia
State/province [347] 0 0
Bratislava
Country [348] 0 0
Slovakia
State/province [348] 0 0
Dunajská Streda
Country [349] 0 0
Slovakia
State/province [349] 0 0
Galanta
Country [350] 0 0
Slovakia
State/province [350] 0 0
Košice
Country [351] 0 0
Slovakia
State/province [351] 0 0
Malacky
Country [352] 0 0
Slovakia
State/province [352] 0 0
Michalovce
Country [353] 0 0
Slovakia
State/province [353] 0 0
Pieštany
Country [354] 0 0
Slovakia
State/province [354] 0 0
Rimavská Sobota
Country [355] 0 0
Slovakia
State/province [355] 0 0
Spišská Nová Ves
Country [356] 0 0
Slovakia
State/province [356] 0 0
Vranov nad Toplou
Country [357] 0 0
South Korea
State/province [357] 0 0
Daegu
Country [358] 0 0
South Korea
State/province [358] 0 0
Gwangju
Country [359] 0 0
South Korea
State/province [359] 0 0
Namdong-gu
Country [360] 0 0
South Korea
State/province [360] 0 0
Seongnam
Country [361] 0 0
South Korea
State/province [361] 0 0
Seoul
Country [362] 0 0
South Korea
State/province [362] 0 0
Suwon
Country [363] 0 0
South Korea
State/province [363] 0 0
Ulsan
Country [364] 0 0
Spain
State/province [364] 0 0
A Coruña
Country [365] 0 0
Spain
State/province [365] 0 0
Barcelona
Country [366] 0 0
Spain
State/province [366] 0 0
Centelles
Country [367] 0 0
Spain
State/province [367] 0 0
Córdoba
Country [368] 0 0
Spain
State/province [368] 0 0
Ferrol
Country [369] 0 0
Spain
State/province [369] 0 0
Granada
Country [370] 0 0
Spain
State/province [370] 0 0
Huelva
Country [371] 0 0
Spain
State/province [371] 0 0
Jaén
Country [372] 0 0
Spain
State/province [372] 0 0
L'Hospitalet de Llobregat
Country [373] 0 0
Spain
State/province [373] 0 0
Las Palmas de Gran Canaria
Country [374] 0 0
Spain
State/province [374] 0 0
León
Country [375] 0 0
Spain
State/province [375] 0 0
Madrid
Country [376] 0 0
Spain
State/province [376] 0 0
Málaga
Country [377] 0 0
Spain
State/province [377] 0 0
Palma
Country [378] 0 0
Spain
State/province [378] 0 0
Pontevedra
Country [379] 0 0
Spain
State/province [379] 0 0
Pozuelo de Alarcón
Country [380] 0 0
Spain
State/province [380] 0 0
Reus
Country [381] 0 0
Spain
State/province [381] 0 0
Sanlúcar de Barrameda
Country [382] 0 0
Spain
State/province [382] 0 0
Santander
Country [383] 0 0
Spain
State/province [383] 0 0
Santiago de Compostela
Country [384] 0 0
Spain
State/province [384] 0 0
Segovia
Country [385] 0 0
Spain
State/province [385] 0 0
Seville
Country [386] 0 0
Spain
State/province [386] 0 0
Toledo
Country [387] 0 0
Spain
State/province [387] 0 0
Valencia
Country [388] 0 0
Spain
State/province [388] 0 0
Valladolid
Country [389] 0 0
Spain
State/province [389] 0 0
Villamartín
Country [390] 0 0
Spain
State/province [390] 0 0
Zaragoza
Country [391] 0 0
Taiwan
State/province [391] 0 0
Kaohsiung City
Country [392] 0 0
Taiwan
State/province [392] 0 0
Kaohsiung Niao Sung Dist
Country [393] 0 0
Taiwan
State/province [393] 0 0
Tainan City
Country [394] 0 0
Taiwan
State/province [394] 0 0
Taipei
Country [395] 0 0
Taiwan
State/province [395] 0 0
Taoyuan District
Country [396] 0 0
United Kingdom
State/province [396] 0 0
Belfast
Country [397] 0 0
United Kingdom
State/province [397] 0 0
Blackpool
Country [398] 0 0
United Kingdom
State/province [398] 0 0
Bodelwyddan
Country [399] 0 0
United Kingdom
State/province [399] 0 0
Bradford-on-Avon
Country [400] 0 0
United Kingdom
State/province [400] 0 0
Bristol
Country [401] 0 0
United Kingdom
State/province [401] 0 0
Glasgow
Country [402] 0 0
United Kingdom
State/province [402] 0 0
High Wycombe
Country [403] 0 0
United Kingdom
State/province [403] 0 0
Hounslow
Country [404] 0 0
United Kingdom
State/province [404] 0 0
Inverness
Country [405] 0 0
United Kingdom
State/province [405] 0 0
Liskeard
Country [406] 0 0
United Kingdom
State/province [406] 0 0
London
Country [407] 0 0
United Kingdom
State/province [407] 0 0
Poole
Country [408] 0 0
United Kingdom
State/province [408] 0 0
Preston
Country [409] 0 0
United Kingdom
State/province [409] 0 0
Rochdale
Country [410] 0 0
United Kingdom
State/province [410] 0 0
Sheffield
Country [411] 0 0
United Kingdom
State/province [411] 0 0
Stockton-on-Tees
Country [412] 0 0
United Kingdom
State/province [412] 0 0
Torpoint
Country [413] 0 0
United Kingdom
State/province [413] 0 0
West Bromwich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.