[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04941599":3,"trial-entities:NCT04941599":105,"trial-summary:NCT04941599":109},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":43,"secondary_outcomes":48,"sex":55,"minimum_age":56,"maximum_age":57,"healthy_volunteers":58,"eligibility_criteria":59,"std_ages":81,"locations":84,"central_contacts":93,"overall_officials":99,"references":103,"see_also_links":104},"NCT04941599","201575","2-Hydroxybenzylamine (2-HOBA) to Reduce HDL Modification and Improve HDL Function in Familial Hypercholesterolemia (FH)","RECRUITING","2027-12-31","2026-08","2026-08-07","2024-02-14","Vanderbilt University Medical Center","OTHER",true,"The Investigators will test the hypothesis that 2-HOBA will reduce modification of HDL and LDL and improve HDL function in humans with heterozygous FH. The Investigators plan to first study subjects with Familial Hypercholesterolemia (FH), treating them with 750 mg of 2-HOBA or placebo every 8 hours for 6 weeks.",null,[18],"Familial Hypercholesterolemia",[18,20,21,22,23],"HDL","LDL","2-HOBA","HDL Function","INTERVENTIONAL","PREVENTION",[27],"PHASE2",{"count":29,"type":30},72,"ESTIMATED",[32,39],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":38},"DRUG","2-Hydroxybenzylamine","2-Hydroxybenzylamine (2-HOBA) 250 mg three tabs TID (po) for 6 weeks.",[37],"2-Hydroxybenzylamine (2-HOBA)",[22],{"type":13,"name":40,"description":41,"armGroupLabels":42},"Placebo","Placebo 250 mg three tabs TID (po) for 6 weeks.",[40],[44],{"measure":45,"description":46,"timeFrame":47},"2-HOBA increases HDL cholesterol efflux capacity.","Change in HDL cholesterol efflux capacity will be measured by macrophage cholesterol efflux assay.","Baseline to week 6",[49,52],{"measure":50,"description":51,"timeFrame":47},"2-HOBA reduces modification of HDL by Isolevuglandin (Iso-LG).","Measurement of the Iso-LG-lysine lactam by mass spectrometry.",{"measure":53,"description":54,"timeFrame":47},"2-HOBA reduces modification of HDL by malondialdehyde (MDA).","Measurement of dilysyl-MDA cross-links by mass spectrometry.","ALL","18 Years","69 Years",false,{"inclusion":60,"exclusion":62,"raw_text":80},[61],"Individuals with heterozygous Familial Hypercholesterolemia.",[63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79],"Myocardial infarction or stroke within the last 6 months","unstable angina, symptoms of angina within the last 3 months","NYHA class III or IV heart failure or LVEF \\\u003C 30%","poorly controlled hypertension: SBP \\> 180 mm Hg or DBP \\> 110 mm Hg,","pregnancy,","evidence of a previous acute coronary syndrome,","current smokers,","individuals with Type 2 Diabetes Mellitus, obesity (BMI \\> 30),","hypertriglyceridemia (fasting TG \\> 250 mg\u002Fdl),","renal insufficiency (Cr \\> 1.8),","hepatic disease (aspartate aminotransferase(AST) or alanine aminotransferase (ALT) \\> 2x ULN),","hypothyroidism,","nephrotic syndrome,","rheumatoid arthritis,","systemic lupus erythematosus,","AIDS or HIV","history of malignancy of any organ in last 5 years.","Inclusion Criteria:\n\n* Individuals with heterozygous Familial Hypercholesterolemia.\n\nExclusion Criteria:\n\n* Myocardial infarction or stroke within the last 6 months\n* unstable angina, symptoms of angina within the last 3 months\n* NYHA class III or IV heart failure or LVEF \\\u003C 30%\n* poorly controlled hypertension: SBP \\> 180 mm Hg or DBP \\> 110 mm Hg,\n* pregnancy,\n* evidence of a previous acute coronary syndrome,\n* current smokers,\n* individuals with Type 2 Diabetes Mellitus, obesity (BMI \\> 30),\n* hypertriglyceridemia (fasting TG \\> 250 mg\u002Fdl),\n* renal insufficiency (Cr \\> 1.8),\n* hepatic disease (aspartate aminotransferase(AST) or alanine aminotransferase (ALT) \\> 2x ULN),\n* hypothyroidism,\n* nephrotic syndrome,\n* rheumatoid arthritis,\n* systemic lupus erythematosus,\n* AIDS or HIV\n* history of malignancy of any organ in last 5 years.",[82,83],"ADULT","OLDER_ADULT",[85],{"facility":12,"status":7,"city":86,"state":87,"zip":88,"country":89,"geoPoint":90},"Nashville","Tennessee","37212","United States",{"lat":91,"lon":92},36.16589,-86.78444,[94],{"name":95,"role":96,"phone":97,"email":98},"Anca Ifrim, RN","CONTACT","6155224210","anca.ifrim@vumc.org",[100],{"name":101,"affiliation":12,"role":102},"MacRae F. Linton, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":106,"biomarkers":108},[107],"Hyperlipoproteinemia, Type IIa",[],{"nct_id":4,"found":14,"summary":110,"prompt_version":120},{"design":111,"status":112,"heading":113,"summary":114,"follow_up":115,"word_count":116,"commitments":117,"compensation":118,"drugs_mentioned":119},"This is an interventional study, meaning participants will receive either the study drug or a placebo. It plans to enroll 72 participants.","completed","2-Hydroxybenzylamine (2-HOBA) for Familial Hypercholesterolemia (FH)","This study is testing a drug called 2-Hydroxybenzylamine (2-HOBA) to see if it can improve how \"good\" cholesterol (HDL) works in people with Familial Hypercholesterolemia (FH). FH is a genetic condition that causes very high cholesterol levels. Researchers believe 2-HOBA might help reduce changes to HDL and LDL cholesterol and make HDL more effective. You could be eligible if you have heterozygous FH, are between 18 and 69 years old, and don't have certain heart conditions or uncontrolled high blood pressure. The main goal is to see if 2-HOBA increases HDL's ability to remove cholesterol from the body. The current recruitment status is unclear, but the study plans to enroll 72 participants.","The primary endpoint is measured from baseline to week 6.",112,"Participants will take 2-Hydroxybenzylamine (2-HOBA) or a placebo three times a day by mouth for 6 weeks.","Not stated in the trial record.",[34],"v2"]