Trials
CLEAR Outcomes: Bempedoic acid effects on major CV outcomes (NCT02993406)
Study title/design: CLEAR Outcomes: Bempedoic acid effects on major CV outcomes (NCT02993406) Trial NCT02993406 (Completed). Aim To determine if bempedoic acid decreases cardiovascular (CV) events in participants with or at high risk of CV disease who are statin intolerant. Study design Phase 3 randomised, double-blind,…
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CLEAR Harmony Open Label Extension: Long term safety and tolerability of bempedoic acid (NCT03067441)
Study title/design: CLEAR Harmony Open Label Extension: Long term safety and tolerability of bempedoic acid (NCT03067441) Trial NCT03067441 (Completed) Aim To determine if bempedoic acid (ETC-1002) is safe and well tolerated in patients at high cardiovascular (CV) risk with elevated LDL-C not adequately controlled by…
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CLEAR Harmony: Long term safety and tolerability of bempedoic acid in patients with hyperlipidaemia and high CV risk (NCT02666664)
Study title/design: CLEAR Harmony: Long term safety and tolerability of bempedoic acid in patients with hyperlipidaemia and high CV risk (NCT02666664) Trial NCT02666664 (Completed). Aim To determine if bempedoic acid (ETC-1002) is safe and well tolerated in patients at high cardiovascular (CV) risk with elevated…
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CLEAR Wisdom: Long term efficacy of bempedoic acid in patients with hyperlipidaemia and high CV risk (NCT02991118)
Study title/design: CLEAR Wisdom: Long term efficacy of bempedoic acid in patients with hyperlipidaemia and high CV risk (NCT02991118) Trial NCT0299118 (Completed). Aim To determine if bempedoic acid (ETC-1002) is effective in patients at high cardiovascular (CV) risk with elevated LDL-C not adequately controlled by…
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CLEAR Serenity: Bempedoic acid in patients with hyperlipidaemia and statin intolerance (NCT02988115)
Study title/design: CLEAR Serenity: Bempedoic acid in patients with hyperlipidaemia and statin intolerance (NCT02988115) Trial NCT02988115 (Completed). Aim To determine if bempedoic acid (ETC-1002) is effective and safe in patients with elevated LDL-C who are statin intolerant. Study design Phase 3 randomised, double-blind, placebo-controlled study…
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CORALreef Outcomes: enlicitide decanoate (MK-0616) in patients at high cardiovascular risk (NCT06008756)
Study title/design: CORALreef Outcomes: enlicitide decanoate (MK-0616) in patients at high cardiovascular risk (NCT06008756) Trial NCT06008756/MK-0616-015 (Recruiting). Estimated primary completion: 29 November 2029. Estimated study completion: 29 November 2029. Aim To evaluate the efficacy of enlicitide decanoate (MK-0616) compared to placebo in increasing the time…
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CORALreef HeFH: enlicitide decanoate (MK-0616) in adults with familial hypercholesterolaemia (CORALreef HeFH, NCT05952869)
Study title/design: CORALreef HeFH: enlicitide decanoate (MK-0616) in adults with familial hypercholesterolaemia (CORALreef HeFH, NCT05952869) Trial NCT05952869/MK-0616-017 (Active, not recruiting). Estimated primary completion: 28 April 2025. Estimated study completion: 28 April 2025. Aim To evaluate the efficacy, safety and tolerability of enlicitide decanoate (MK-0616) in…
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CORALreef Lipids: enlicitide decanoate (MK-0616) in hypercholesterolaemia (NCT059528456)
Study title/design: CORALreef Lipids: enlicitide decanoate (MK-0616) in hypercholesterolaemia (NCT059528456) Trial NCT059528456/MK-0616-013 (Active, not recruiting). Estimated primary completion: 15 August 2025. Estimated study completion: 15 August 2025. Aim To evaluate the efficacy, safety and tolerability of enlicitide decanoate (MK-0616) in lowering LDL-C in adults with…
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Efficacy and safety of enlicitide decanoate (MK-0616) in hypercholesterolaemia (NCT05261126)
Study title/design: Efficacy and safety of enlicitide decanoate (MK-0616) in hypercholesterolaemia (NCT05261126) Trial NCT05261126/MK-0616-008 (Completed) Aim To assess the efficacy and safety of enlicitide decanoate (MK-0616) in lowering LDL-C in adults with hypercholesterolaemia Study design Phase 2b, randomised, double-blind, placebo-controlled study of oral MK-0616 6…
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A study of VERVE-102 in patients with familial hypercholesterolaemia or premature coronary artery disease (NCT06164730)
Trial NCT06164730 (Recruiting) Estimated primary completion: August 2026 Estimated study completion: August 2026 Aim To evaluate the safety and pharmacodynamic profile of VERVE-102 in patients with familial hypercholesterolaemia or premature coronary artery disease (CAD). Study design Phase 1b, open label, single ascending dose escalation study…
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Long term efficacy and safety of lerodalcibep (LIB003) in patients with HoFH, HeFH or high risk for CVD requiring further LDL-C reduction (LIBerate-OLE, NCT04798430)
Study title/design Long term efficacy and safety of lerodalcibep (LIB003) in patients with HoFH, HeFH or high risk for CVD requiring further LDL-C reduction (LIBerate-OLE, NCT04798430) Trial NCT04798430/LIB003-007 (Enrolling by invitation). Estimated primary completion: October 30 2024. Estimated study completion: December 31 2024. Aim To…
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Trial to evaluate efficacy and safety of lerodalcibep (LIB003) and inclisiran in high risk CVD patients (LIBerate-VI) (NCT05004675)
Study title/design Trial to evaluate efficacy and safety of lerodalcibep (LIB003) and inclisiran in high risk CVD patients (LIBerate-VI) (NCT05004675) Trial NCT05004675/LIB003-012 (Active, not recruiting). Estimated primary completion: 30 May 2024. Estimated study completion: 30 July 2024. Aim To compare LDL-C reductions with lerodalcibep 300…
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Study of efficacy and safety of lerodalcibep (LIB003) in patients with CVD on statins requiring additional LDL-C reduction (LIBerate-CVD) (NCT04797247)
Study title/design Study of efficacy and safety of lerodalcibep (LIB003) in patients with CVD on statins requiring additional LDL-C reduction (LIBerate-CVD) (NCT04797247) Trial NCT04797247/LIB003-005 (Completed) Aim To assess LDL-C reductions at week 52 with monthly (Q4W) dosing of lerodalcibep 300 mg s.c. compared to placebo…
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Study to assess the efficacy and safety of lerodalcibep (LIB003) in patients with HeFH on oral lipid therapy needing further LDL-C reduction (LIBerate-FH) (NCT04797104)
Study title/design Study to assess the efficacy and safety of lerodalcibep (LIB003) in patients with HeFH on oral lipid therapy needing further LDL-C reduction (LIBerate-FH) (NCT04797104) Trial NCT04797104/LIB003-004 (Completed) Aim To assess LDL-C reductions at week 24 and the mean of weeks 22 and 24…
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Study of long term efficacy and safety of lerodalcibep (LIB003) in patients with CVD or high risk for CVD needing further LDL-C Reduction (LIBerate-HR, NCT04806893)
Study title/design Study of long term efficacy and safety of lerodalcibep (LIB003) in patients with CVD or at high risk of CVD needing further LDL-C reduction (LIBerate-HR, NCT04806893) Trial NCT04806893/LIB003-006 (Completed) Aim To assess LDL-C reductions at week 52 with lerodalcibep 300 mg s.c. every…
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Phase 3 study to evaluate the efficacy and safety of lerodalcibep (LIB003) with evolocumab in HoFH (NCT04034485)
Study title/design Phase 3 study to evaluate the efficacy and safety of lerodalcibep (LIB003) with evolocumab in HoFH (NCT04034485) Trial CT04034485/LIB003-003 (Completed) Aim To compare the safety, tolerability and LDL-C response after 24 weeks of LIB003 300 mg s.c every 4 weeks with evolocumab 420…
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Trial to evaluate efficacy and safety of lerodalcibep (LIB003), evolocumab and alirocumab in patients at high risk CVD (LIBerate-H2H) (NCT04790513)
Study title/design Trial to evaluate efficacy and safety of lerodalcibep (LIB003), evolocumab and alirocumab in patients at high risk CVD (LIBerate-H2H) (NCT04790513) Trial NCT04790513/LIB003-011 (Completed). Aim To compare LDL-C reductions at week 12 of monthly lerodalcibep 300 mg s.c., evolocumab 420 mg s.c., and alirocumab…
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Open label extension to evaluate the longer term efficacy of lerodalcibep (LIB003) (NCT03847974)
Study title/design Open label extension to evaluate the longer term efficacy of lerodalcibep (LIB003) (NCT03847974) Trial NCT03847974 (Completed) Aim To assess the longer term safety, tolerability and LDL-C lowering efficacy of LIB003 administered every 4 weeks, after 52 weeks. Study Design Open label Phase 2b…
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Study to evaluate efficacy and safety of LIB003 in patients on lipid-lowering therapy needing additional LDL-C reduction (NCT03549260)
Study title/design Study to evaluate efficacy and safety of LIB003 in patients on lipid-lowering therapy needing additional LDL-C reduction (NCT03549260) Trial NCT03549260/LIB003-002 (Completed) Aim To assess the LDL-C lowering efficacy of different doses of LIB003 administered every 4 weeks in participants on stable statin and/or…
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A Study of VERVE-101 in Patients With Familial Hypercholesterolemia and Cardiovascular Disease (Heart-1)
Trial A Study of VERVE-101 in Patients With Familial Hypercholesterolemia and Cardiovascular Disease ClinicalTrials.gov Identifier: NCT05398029 (Active, not recruiting) Recruitment initiated July 2022 Estimated primary completion: December 2024 Estimated study completion: December 2024 Enrolment paused in April 2024 due to laboratory abnormalities Aim To evaluate…
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