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Clinical trials for Subtilisin

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    20 result(s) found for: Subtilisin. Displaying page 1 of 1.
    EudraCT Number: 2014-004856-68 Sponsor Protocol Number: CB8025-21427 Start Date*: 2015-04-29
    Sponsor Name:CymaBay Therapeutics, Inc.
    Full Title: A 12-week, open-label, dose-escalating, phase 2 study to evaluate the effects of MBX-8025 in patients with Homozygous Familial Hypercholesterolemia (HoFH)
    Medical condition: Homozygous Familial Hypercholesterolemia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed) NL (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2020-002755-38 Sponsor Protocol Number: CKJX839C12302 Start Date*: 2020-12-30
    Sponsor Name:Novartis Pharma AG
    Full Title: Two part (double-blind) inclisiran versus placebo [Year 1] followed by open-label inclisiran [Year 2] randomized multicentre study to evaluate safety, tolerability, and efficacy of inclisiran in ad...
    Medical condition: Homozygous Familial Hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10057080 Homozygous familial hypercholesterolemia LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SI (Completed) GR (Completed) NL (Completed) FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-001109-29 Sponsor Protocol Number: CKJX839D12304 Start Date*: 2022-12-06
    Sponsor Name:Novartis Pharma AG
    Full Title: A Double-blind, Randomized, Placebo- and Active-Comparator Controlled Study to Evaluate the Efficacy of Inclisiran as Monotherapy in Patients with Primary Hypercholesterolemia Not Receiving Lipid-L...
    Medical condition: Primary Hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10077965 Primary hypercholesterolaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-001544-30 Sponsor Protocol Number: 20101154 Start Date*: 2011-08-03
    Sponsor Name:Amgen Inc
    Full Title: A Randomized, Placebo and Ezetimibe Controlled, Dose-ranging Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C in Hypercholesterolemic Subjects With a 10 Year Framingham Risk Score of...
    Medical condition: Hypercholesterolaemia
    Disease: Version SOC Term Classification Code Term Level
    14.0 10027433 - Metabolism and nutrition disorders 10020603 Hypercholesterolaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2011-001528-39 Sponsor Protocol Number: 20090158 Start Date*: 2011-07-13
    Sponsor Name:Amgen Inc
    Full Title: "A Double-blind, Radomized, Placebo-comtrolled, Multicenter Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C in Subjects with Heterozygous Familial Hypercholesterolemia"
    Medical condition: Heterozygous familial hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    13.1 10010331 - Congenital, familial and genetic disorders 10057099 Heterozygous familial hypercholesterolaemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) GB (Completed) DE (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2021-005064-22 Sponsor Protocol Number: TA-8995-301 Start Date*: 2022-09-22
    Sponsor Name:NewAmsterdam Pharma B.V.
    Full Title: Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies (BROOKLYN): A Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Partici...
    Medical condition: dyslipidemia heterozygous familial hypercholesterolemia (HeFH)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004848 10020049 High cholesterol LLT
    20.0 100000004850 10057079 Heterozygous familial hypercholesterolemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) NL (Completed) CZ (Completed) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-003485-11 Sponsor Protocol Number: 1002-043 Start Date*: 2017-02-16
    Sponsor Name:Esperion Therapeutics Inc.,
    Full Title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Effects of Bempedoic Acid (ETC-1002) on the Occurrence of Major Cardiovascular Events in Patients with, or at high risk for, Cardi...
    Medical condition: Patients with, or at high risk for, cardiovascular disease (CVD) who are statin intolerant.
    Disease: Version SOC Term Classification Code Term Level
    20.1 10007541 - Cardiac disorders 10007648 Cardiovascular disease, unspecified LLT
    20.0 10007541 - Cardiac disorders 10007649 Cardiovascular disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) NL (Completed) LV (Completed) LT (Completed) GB (GB - no longer in EU/EEA) DK (Completed) DE (Completed) HU (Completed) BG (Completed) CZ (Completed) PL (Completed) ES (Completed) HR (Completed) BE (Completed) AT (Completed) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2022-001876-32 Sponsor Protocol Number: SLN360-002 Start Date*: 2023-04-14
    Sponsor Name:Silence Therapeutics plc
    Full Title: A multi-centre, randomised, double-blind placebo-controlled, Phase 2 study to investigate efficacy, safety and tolerability of SLN360 in participants with elevated lipoprotein(a) at high risk of at...
    Medical condition: elevated lipoprotein (a) and high risk of atherosclerotic cardiovascular disease (ASCVD) events
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004866 10051615 Atherosclerotic cardiovascular disease LLT
    20.0 10022891 - Investigations 10054009 Lipoprotein (a) increased PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) NL (Completed) SK (Completed) DK (Completed) CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-005399-40 Sponsor Protocol Number: 20110233 Start Date*: 2012-03-09
    Sponsor Name:Amgen Inc
    Full Title: A two part, Phase 2/3 Study to Assess the Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia Part A - Open-label, Single-arm, Multicenter Pilot...
    Medical condition: Homozygous familial hypercholesterolaemia
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004850 10057100 Homozygous familial hypercholesterolaemia LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) CZ (Completed) ES (Completed) IT (Completed) NL (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-001517-32 Sponsor Protocol Number: K-877-201 Start Date*: 2013-10-02
    Sponsor Name:Kowa Research Europe
    Full Title: A dose finding study to assess the safety and efficacy of K-877 in patients with statin-controlled LDL-C but abnormal lipid levels
    Medical condition: dyslipidemia (eg hyperlipidaemia, hypertriglyceridaemia)
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004861 10020667 Hyperlipidemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) GB (Completed) HU (Completed) DE (Completed) CZ (Completed) NL (Completed) DK (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2020-004390-44 Sponsor Protocol Number: LIB003-004 Start Date*: 2021-09-08
    Sponsor Name:LIB Therapeutics, LLC
    Full Title: Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Heterozygous Familial Hypercholesterolemia Patients on Stable Lipid-Lowering T...
    Medical condition: Heterozygous Familial Hypercholesterolemia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-003611-62 Sponsor Protocol Number: LIB003-003 Start Date*: 2020-03-20
    Sponsor Name:LIB Therapeutics, LLC
    Full Title: Randomized, Open-Label, Cross-Over, Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 with Evolocumab in Homozygous Familial Hypercholesterolemia Patients on Stable Lipid-Lowering Therapy.
    Medical condition: Homozygous Familial Hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10057080 Homozygous familial hypercholesterolemia LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-005989-34 Sponsor Protocol Number: 034B20 Start Date*: 2022-08-31
    Sponsor Name:Aphaia Pharma AG
    Full Title: A Phase II, randomized, double-blind, placebo-controlled, parallel-group proof-of-concept study to evaluate efficacy and safety of distal jejunal-release dextrose (Aphaia technology, AT) in obese s...
    Medical condition: Obesity with/without associated endocrine and/or metabolic conditions and/or hypertension and/or NASH and/or NAFL with/without fibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10029883 Obesity PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-001527-20 Sponsor Protocol Number: 20101155 - TIMI 57 Start Date*: 2011-09-20
    Sponsor Name:Amgen Inc
    Full Title: TIMI 57 - A Double-Blind, Randomized, Placebo-controlled, Multicenter, Dose-ranging Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C in Combination with HMG-CoA Reductase Inhibitors ...
    Medical condition: Hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    13.1 10027433 - Metabolism and nutrition disorders 10020603 Hypercholesterolaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2021-005065-40 Sponsor Protocol Number: TA-8995-302 Start Date*: 2022-05-13
    Sponsor Name:NewAmsterdam Pharma B.V.
    Full Title: Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies (BROADWAY): A Placebo-Controlled, Double-Blind, Randomized Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participant...
    Medical condition: dyslipidemia heterozygous familial hypercholesterolemia (HeFH) atherosclerotic cardiovascular disease (ASCVD)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004848 10020049 High cholesterol LLT
    20.0 100000004850 10057079 Heterozygous familial hypercholesterolemia LLT
    26.0 100000004866 10051615 Atherosclerotic cardiovascular disease LLT
    20.0 100000004866 10076622 Atherosclerotic plaque LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) DK (Completed) CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-001529-26 Sponsor Protocol Number: 20090159 Start Date*: 2011-07-15
    Sponsor Name:Amgen Inc
    Full Title: A Randomized, Multicenter Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C, Compared with Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-Co...
    Medical condition: Hypercholesterolaemia
    Disease: Version SOC Term Classification Code Term Level
    13.1 10027433 - Metabolism and nutrition disorders 10020603 Hypercholesterolaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) BE (Completed) SE (Completed) DK (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2021-002871-20 Sponsor Protocol Number: LIB003-012 Start Date*: 2022-04-21
    Sponsor Name:LIB Therapeutics, LLC
    Full Title: Randomized, Open Label, Phase 3 Study to Evaluate the Efficacy and Safety of Lerodalcibep (LIB003) compared to Inclisiran in Patients With Cardiovascular Disease, or at High Risk for Cardiovascula...
    Medical condition: Patients with atherosclerotic cardiovascular (CV) disease (ASCVD) or high risk of ASCVD who need additional LDL-C reduction
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004849 10007648 Cardiovascular disease, unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) NO (Completed) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-002873-24 Sponsor Protocol Number: RM-493-035 Start Date*: 2022-05-16
    Sponsor Name:Rhythm Pharmaceuticals Inc.
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study: 5 Independent Sub-studies of Setmelanotide in Patients with POMC, PCSK1, LEPR, SRC1, SH2B1, and PCSK1 N221D Gene Defects in the Melano...
    Medical condition: Specific Gene Defects in the Melanocortin-4 Receptor Pathway, responsible for improper functions of certain messenger materials in the body. E.g Melanocyte-Stimulating Hormone (MSH)
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) ES (Ongoing) DE (Trial now transitioned) GR (Trial now transitioned) NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-004597-65 Sponsor Protocol Number: RM-493-037 Start Date*: 2022-10-20
    Sponsor Name:Rhythm Pharmaceuticals, Inc.
    Full Title: A Phase 3, Randomized, Double-Blind Trial of Two Formulations of Setmelanotide (Daily and Weekly) with a Crossover to Open-Label Once Weekly Setmelanotide in Patients with Specific Gene Defects in ...
    Medical condition: Treatment of obesity associated with genetic defects upstream of the MC4 receptor in the leptin-melanocortin pathway. Diseases that are the result of genetic defects affecting the MC4R pathway, con...
    Disease: Version SOC Term Classification Code Term Level
    23.0 10010331 - Congenital, familial and genetic disorders 10084105 Leptin receptor deficiency PT
    23.0 10010331 - Congenital, familial and genetic disorders 10083937 Pro-opiomelanocortin deficiency PT
    20.1 10010331 - Congenital, familial and genetic disorders 10048680 Bardet-Biedl syndrome LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2019-002278-30 Sponsor Protocol Number: APH-19 Start Date*: 2020-08-12
    Sponsor Name:Amryt Pharmaceuticals DAC
    Full Title: Phase III, single-arm, open-label, international, multi-centre study to evaluate the efficacy and safety of lomitapide in paediatric patients with Homozygous Familial Hypercholesterolaemia (HoFH) o...
    Medical condition: Homozygous familial hypercholesterolaemia (HoFH). A rare and life-threatening inherited disorder of lipid metabolism with an estimated prevalence of 1 per 160,000 to 300,000 in the European populat...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10057100 Homozygous familial hypercholesterolaemia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed)
    Trial results: View results
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