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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06292013




Registration number
NCT06292013
Ethics application status
Date submitted
27/02/2024
Date registered
4/03/2024

Titles & IDs
Public title
A Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) - ACCLAIM-Lp(a)
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) Who Have Established Atherosclerotic Cardiovascular Disease or Are at Risk for a First Cardiovascular Event - ACCLAIM-Lp(a)
Secondary ID [1] 0 0
J3L-MC-EZEF
Secondary ID [2] 0 0
18812
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atherosclerotic Cardiovascular Disease (ASCVD) 0 0
Elevated Lp(a) 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 - Lepodisiran Sodium
Treatment: Drugs - Placebo

Experimental: Lepodisiran Sodium - Lepodisiran sodium administered subcutaneously (SC).

Placebo comparator: Placebo - Placebo administered SC.


Treatment: Drugs: Lepodisiran Sodium
Administered SC

Treatment: Drugs: Placebo
Administered SC
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 4.5 Years)
Secondary outcome [1] 0 0
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 of the Component of MACE-3 Composite Endpoint
Timepoint [2] 0 0
Baseline up to End of Study (About 4.5 Years)
Secondary outcome [3] 0 0
Time to First Occurrence of Fatal or Non-Fatal Myocardial Infarction
Timepoint [3] 0 0
Baseline up to End of Study (About 4.5 Years)
Secondary outcome [4] 0 0
Time to Cardiovascular Death
Timepoint [4] 0 0
Baseline up to End of Study (About 4.5 Years)
Secondary outcome [5] 0 0
Time to Occurrence of All-Cause Death
Timepoint [5] 0 0
Baseline up to End of Study (About 4.5 Years)
Secondary outcome [6] 0 0
Time to First Occurrence of Any Component of the MACE-4 Composite Endpoint (In the Population with Established ASCVD and CV Event, or Revascularization)
Timepoint [6] 0 0
Baseline up to End of Study (About 4.5 Years)
Secondary outcome [7] 0 0
Time to First Occurrence of any Component of the MACE-4 Composite Endpoint (In the Population At Risk for First CV event)
Timepoint [7] 0 0
Baseline up to End of Study (About 4.5 Years)
Secondary outcome [8] 0 0
Time to First Occurrence of any Component of the MACE-4 Composite Endpoint (In the Population with Lp(a) = 200 nmol/L)
Timepoint [8] 0 0
Baseline up to End of Study (About 4.5 Years)
Secondary outcome [9] 0 0
Time to First Occurrence of Any Component of MACE-3 + MALE Composite Endpoint
Timepoint [9] 0 0
Baseline up to End of Study (About 4.5 Years)
Secondary outcome [10] 0 0
Time to First Occurrence of Any Component of Coronary MACE-3 Composite Endpoint
Timepoint [10] 0 0
Baseline up to End of Study (About 4.5 Years)

Eligibility
Key inclusion criteria
* Have Lipoprotein(a) [Lp(a)] =175 nanomoles per liter (nmol/L).
* Meet criteria of either 2a or 2b:

2a: Individuals 18 years of age or older with established atherosclerotic cardiovascular disease (ASCVD) with an event or revascularization.

2b: Individuals 55 years of age or older who are at risk for a first cardiovascular (CV) event and either: Documented coronary artery disease (CAD), carotid stenosis, or peripheral artery disease (PAD) without history of event or revascularization; known familial hypercholesteremia; or a combination 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 had a major cardiovascular event or surgery, such as myocardial infarction (MI), stroke or coronary or peripheral revascularization, < 90 days before screening.
* Have uncontrolled hypertension
* Have New York Heart Association class IV heart failure.
* Have lipoprotein apheresis within 90 days of screening, or planned lipoprotein apheresis during the study.
* Have severe renal failure, defined as

* Estimated glomerular rate (eGFR) <15 milliliters per minute per 1.73 meters squared (mL/min/1.73m2) at screening Visit 1, or ongoing dialysis.
* Have a diagnosis of active nephrotic syndrome, or urine albumin-creatinine ratio (UACR) of =5000 mg/g at screening Visit 1.
* Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease, or any of these laboratory results as determined by the central laboratory at 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
5/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2029
Actual
Sample size
Target
12500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Paratus Clinical Research Canberra - Bruce
Recruitment hospital [2] 0 0
Paratus Clinical Research Western Sydney - Blacktown
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Emeritus Research - Botany
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Northern Beaches Clinical Research - Brookvale
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Paratus Clinical Research Central Coast - Kanwal
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Liverpool Hospital - Liverpool
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The AIM Centre / Hunter Diabetes Centre - Merewether
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AusTrials - St. Leonards - Sydney
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Royal Brisbane and Women's Hospital - Brisbane
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Core Research Group - Brisbane
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Heart of Australia - Brisbane
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Cholesterol Care - Brisbane
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Paratus Clinical Research Brisbane - Herston
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Logan Hospital - Meadowbrook
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Mount Isa Base Hospital - Mount Isa
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The Townsville Hospital - Townsville
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Fusion Clinical Research - Adelaide
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Nightingale Research - Adelaide
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Adelaide Cardiology - Adelaide
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Emeritus Research - Camberwell
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Victorian Heart Hospital - Clayton
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Barwon Health - Geelong
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Austin Health - Repatriation Hospital - Heidelberg West
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AusTrials - Sunshine - Melbourne
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Advara HeartCare - Mulgrave - Mulgrave
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Advara HeartCare Joondalup - Joondalup
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Clinitrials - Perth
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Royal Perth Hospital - Perth
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2617 - Bruce
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2148 - Blacktown
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2019 - Botany
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2100 - Brookvale
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2259 - Kanwal
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2170 - Liverpool
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2291 - Merewether
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2065 - Sydney
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4029 - Brisbane
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4064 - Brisbane
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4068 - Brisbane
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4102 - Brisbane
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4010 - Herston
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4131 - Meadowbrook
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4825 - Mount Isa
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4814 - Townsville
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5000 - Adelaide
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5068 - Adelaide
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3124 - Camberwell
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3168 - Clayton
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3220 - Geelong
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3081 - Heidelberg West
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3021 - Melbourne
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3170 - Mulgrave
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6027 - Joondalup
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6000 - Perth
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Hungary
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Debrecen
Country [181] 0 0
India
State/province [181] 0 0
Chhattisgarh
Country [182] 0 0
India
State/province [182] 0 0
Delhi
Country [183] 0 0
India
State/province [183] 0 0
Karnataka
Country [184] 0 0
India
State/province [184] 0 0
Kerala
Country [185] 0 0
India
State/province [185] 0 0
Maharashtra
Country [186] 0 0
India
State/province [186] 0 0
Rajasthan
Country [187] 0 0
India
State/province [187] 0 0
Uttar Pradesh
Country [188] 0 0
India
State/province [188] 0 0
Uttarakhand
Country [189] 0 0
Israel
State/province [189] 0 0
HaDarom
Country [190] 0 0
Israel
State/province [190] 0 0
HaMerkaz
Country [191] 0 0
Israel
State/province [191] 0 0
HaTsafon
Country [192] 0 0
Israel
State/province [192] 0 0
Tell Abib
Country [193] 0 0
Israel
State/province [193] 0 0
Yerushalayim
Country [194] 0 0
Israel
State/province [194] 0 0
?eifa
Country [195] 0 0
Italy
State/province [195] 0 0
Emilia-Romagna
Country [196] 0 0
Italy
State/province [196] 0 0
Lazio
Country [197] 0 0
Italy
State/province [197] 0 0
Liguria
Country [198] 0 0
Italy
State/province [198] 0 0
Milano
Country [199] 0 0
Italy
State/province [199] 0 0
Modena
Country [200] 0 0
Italy
State/province [200] 0 0
Toscana
Country [201] 0 0
Italy
State/province [201] 0 0
Veneto
Country [202] 0 0
Italy
State/province [202] 0 0
Bologna
Country [203] 0 0
Italy
State/province [203] 0 0
Perugia
Country [204] 0 0
Japan
State/province [204] 0 0
Aichi
Country [205] 0 0
Japan
State/province [205] 0 0
Chiba
Country [206] 0 0
Japan
State/province [206] 0 0
Fukuoka
Country [207] 0 0
Japan
State/province [207] 0 0
Hiroshima
Country [208] 0 0
Japan
State/province [208] 0 0
Hokkaido
Country [209] 0 0
Japan
State/province [209] 0 0
Hyogo
Country [210] 0 0
Japan
State/province [210] 0 0
Ibaraki
Country [211] 0 0
Japan
State/province [211] 0 0
Ishikawa
Country [212] 0 0
Japan
State/province [212] 0 0
Iwate
Country [213] 0 0
Japan
State/province [213] 0 0
Kagawa
Country [214] 0 0
Japan
State/province [214] 0 0
Kanagawa
Country [215] 0 0
Japan
State/province [215] 0 0
Miyagi
Country [216] 0 0
Japan
State/province [216] 0 0
Miyazaki
Country [217] 0 0
Japan
State/province [217] 0 0
Nagano
Country [218] 0 0
Japan
State/province [218] 0 0
Niigata
Country [219] 0 0
Japan
State/province [219] 0 0
Okayama
Country [220] 0 0
Japan
State/province [220] 0 0
Osaka
Country [221] 0 0
Japan
State/province [221] 0 0
Shizuoka
Country [222] 0 0
Japan
State/province [222] 0 0
Tochigi
Country [223] 0 0
Japan
State/province [223] 0 0
Tokyo
Country [224] 0 0
Japan
State/province [224] 0 0
Toyama
Country [225] 0 0
Japan
State/province [225] 0 0
Yamaguchi
Country [226] 0 0
Japan
State/province [226] 0 0
Yamanashi
Country [227] 0 0
Japan
State/province [227] 0 0
Kagoshima
Country [228] 0 0
Japan
State/province [228] 0 0
Kumamoto
Country [229] 0 0
Japan
State/province [229] 0 0
Kyoto
Country [230] 0 0
Japan
State/province [230] 0 0
Saga
Country [231] 0 0
Japan
State/province [231] 0 0
Saitama
Country [232] 0 0
Korea, Republic of
State/province [232] 0 0
Incheon-gwangyeoksi [Incheon]
Country [233] 0 0
Korea, Republic of
State/province [233] 0 0
Kang-won-do
Country [234] 0 0
Korea, Republic of
State/province [234] 0 0
Kwangju-Kwangyokshi
Country [235] 0 0
Korea, Republic of
State/province [235] 0 0
Kyonggi-do
Country [236] 0 0
Korea, Republic of
State/province [236] 0 0
Seoul-teukbyeolsi [Seoul]
Country [237] 0 0
Korea, Republic of
State/province [237] 0 0
Taegu-Kwangyokshi
Country [238] 0 0
Korea, Republic of
State/province [238] 0 0
Taejon-Kwangyokshi
Country [239] 0 0
Korea, Republic of
State/province [239] 0 0
Ulsan-Kwangyokshi
Country [240] 0 0
Mexico
State/province [240] 0 0
Baja California
Country [241] 0 0
Mexico
State/province [241] 0 0
Distrito Federal
Country [242] 0 0
Mexico
State/province [242] 0 0
Guanajuato
Country [243] 0 0
Mexico
State/province [243] 0 0
Jalisco
Country [244] 0 0
Mexico
State/province [244] 0 0
Michoacán
Country [245] 0 0
Mexico
State/province [245] 0 0
Morelos
Country [246] 0 0
Mexico
State/province [246] 0 0
Nuevo León
Country [247] 0 0
Mexico
State/province [247] 0 0
Oaxaca
Country [248] 0 0
Mexico
State/province [248] 0 0
Sinaloa
Country [249] 0 0
Mexico
State/province [249] 0 0
Sonora
Country [250] 0 0
Mexico
State/province [250] 0 0
Veracruz
Country [251] 0 0
Mexico
State/province [251] 0 0
Yucatán
Country [252] 0 0
Mexico
State/province [252] 0 0
Aguascalientes
Country [253] 0 0
Mexico
State/province [253] 0 0
Chihuahua
Country [254] 0 0
Mexico
State/province [254] 0 0
Durango
Country [255] 0 0
Mexico
State/province [255] 0 0
Querétaro
Country [256] 0 0
Mexico
State/province [256] 0 0
San Luis Potosí
Country [257] 0 0
Netherlands
State/province [257] 0 0
Fryslân
Country [258] 0 0
Netherlands
State/province [258] 0 0
Gelderland
Country [259] 0 0
Netherlands
State/province [259] 0 0
Limburg
Country [260] 0 0
Netherlands
State/province [260] 0 0
Noord-Brabant
Country [261] 0 0
Netherlands
State/province [261] 0 0
Noord-Holland
Country [262] 0 0
Netherlands
State/province [262] 0 0
Overijssel
Country [263] 0 0
Netherlands
State/province [263] 0 0
Utrecht
Country [264] 0 0
Netherlands
State/province [264] 0 0
Zeeland
Country [265] 0 0
Netherlands
State/province [265] 0 0
Zuid-Holland
Country [266] 0 0
Netherlands
State/province [266] 0 0
Groningen
Country [267] 0 0
Poland
State/province [267] 0 0
Dolnoslaskie
Country [268] 0 0
Poland
State/province [268] 0 0
Kujawsko-pomorskie
Country [269] 0 0
Poland
State/province [269] 0 0
Lubelskie
Country [270] 0 0
Poland
State/province [270] 0 0
Lubuskie
Country [271] 0 0
Poland
State/province [271] 0 0
Mazowieckie
Country [272] 0 0
Poland
State/province [272] 0 0
Malopolskie
Country [273] 0 0
Poland
State/province [273] 0 0
Opolskie
Country [274] 0 0
Poland
State/province [274] 0 0
Podkarpackie
Country [275] 0 0
Poland
State/province [275] 0 0
Podlaskie
Country [276] 0 0
Poland
State/province [276] 0 0
Pomorskie
Country [277] 0 0
Poland
State/province [277] 0 0
Warminsko-mazurskie
Country [278] 0 0
Poland
State/province [278] 0 0
Wielkopolskie
Country [279] 0 0
Poland
State/province [279] 0 0
Lódzkie
Country [280] 0 0
Poland
State/province [280] 0 0
Slaskie
Country [281] 0 0
Puerto Rico
State/province [281] 0 0
Bayamón
Country [282] 0 0
Puerto Rico
State/province [282] 0 0
San Juan
Country [283] 0 0
Romania
State/province [283] 0 0
Bucure?ti
Country [284] 0 0
Romania
State/province [284] 0 0
Buzau
Country [285] 0 0
Romania
State/province [285] 0 0
Dolj
Country [286] 0 0
Romania
State/province [286] 0 0
Maramure?
Country [287] 0 0
Romania
State/province [287] 0 0
Mure?
Country [288] 0 0
Romania
State/province [288] 0 0
Timi?
Country [289] 0 0
Romania
State/province [289] 0 0
Brasov
Country [290] 0 0
Romania
State/province [290] 0 0
Gala?i
Country [291] 0 0
Romania
State/province [291] 0 0
Ia?i
Country [292] 0 0
Romania
State/province [292] 0 0
Satu Mare
Country [293] 0 0
Romania
State/province [293] 0 0
Sibiu
Country [294] 0 0
Slovakia
State/province [294] 0 0
Banskobystrický Kraj
Country [295] 0 0
Slovakia
State/province [295] 0 0
Bratislavský Kraj
Country [296] 0 0
Slovakia
State/province [296] 0 0
Košický Kraj
Country [297] 0 0
Slovakia
State/province [297] 0 0
Nitriansky Kraj
Country [298] 0 0
Slovakia
State/province [298] 0 0
Prešovský Kraj
Country [299] 0 0
Slovakia
State/province [299] 0 0
Trnavský Kraj
Country [300] 0 0
Slovakia
State/province [300] 0 0
Žilinský Kraj
Country [301] 0 0
Spain
State/province [301] 0 0
A Coruña [La Coruña]
Country [302] 0 0
Spain
State/province [302] 0 0
Alicante
Country [303] 0 0
Spain
State/province [303] 0 0
Andalucía
Country [304] 0 0
Spain
State/province [304] 0 0
Asturias
Country [305] 0 0
Spain
State/province [305] 0 0
Balears [Baleares]
Country [306] 0 0
Spain
State/province [306] 0 0
Barcelona [Barcelona]
Country [307] 0 0
Spain
State/province [307] 0 0
Cantabria
Country [308] 0 0
Spain
State/province [308] 0 0
Catalunya [Cataluña]
Country [309] 0 0
Spain
State/province [309] 0 0
Cádiz
Country [310] 0 0
Spain
State/province [310] 0 0
Galicia [Galicia]
Country [311] 0 0
Spain
State/province [311] 0 0
Girona [Gerona]
Country [312] 0 0
Spain
State/province [312] 0 0
Las Palmas
Country [313] 0 0
Spain
State/province [313] 0 0
Madrid, Comunidad De
Country [314] 0 0
Spain
State/province [314] 0 0
Madrid
Country [315] 0 0
Spain
State/province [315] 0 0
Murcia, Región De
Country [316] 0 0
Spain
State/province [316] 0 0
Sevilla
Country [317] 0 0
Spain
State/province [317] 0 0
Tarragona [Tarragona]
Country [318] 0 0
Spain
State/province [318] 0 0
Valenciana, Comunitat
Country [319] 0 0
Spain
State/province [319] 0 0
València
Country [320] 0 0
Spain
State/province [320] 0 0
Huelva
Country [321] 0 0
Spain
State/province [321] 0 0
Jaén
Country [322] 0 0
Spain
State/province [322] 0 0
Salamanca
Country [323] 0 0
Spain
State/province [323] 0 0
Segovia
Country [324] 0 0
Spain
State/province [324] 0 0
Zaragoza
Country [325] 0 0
Taiwan
State/province [325] 0 0
Changhua
Country [326] 0 0
Taiwan
State/province [326] 0 0
Kaohsiung
Country [327] 0 0
Taiwan
State/province [327] 0 0
Taichung
Country [328] 0 0
Taiwan
State/province [328] 0 0
Tainan
Country [329] 0 0
Taiwan
State/province [329] 0 0
Taipei
Country [330] 0 0
Taiwan
State/province [330] 0 0
Yilan
Country [331] 0 0
Taiwan
State/province [331] 0 0
New Taipei
Country [332] 0 0
Taiwan
State/province [332] 0 0
Taoyuan
Country [333] 0 0
United Kingdom
State/province [333] 0 0
Bristol, City Of
Country [334] 0 0
United Kingdom
State/province [334] 0 0
Devon
Country [335] 0 0
United Kingdom
State/province [335] 0 0
England
Country [336] 0 0
United Kingdom
State/province [336] 0 0
Hertfordshire
Country [337] 0 0
United Kingdom
State/province [337] 0 0
Kingston Upon Hull
Country [338] 0 0
United Kingdom
State/province [338] 0 0
Lancashire
Country [339] 0 0
United Kingdom
State/province [339] 0 0
Manchester
Country [340] 0 0
United Kingdom
State/province [340] 0 0
Scotland
Country [341] 0 0
United Kingdom
State/province [341] 0 0
Tyne And Wear
Country [342] 0 0
United Kingdom
State/province [342] 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
1-877-CTLILLY (1-877-285-4559) or 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
317-615-4559
Fax 0 0
Email 0 0
[email protected]
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: http://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.


Results not provided in https://clinicaltrials.gov/study/NCT06292013