Heterozygous Familial Hypercholesterolemia
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CLINICAL_TRIALS trial_result · 2026-07-17Clinical Trial Results: A Clinical Study in Children With Heterozygous Familial Hypercholesterolemia (HeFH) Aged 6 to 17 Treated Once Daily With Bempedoic Acid Oral Dosing (CLEAR Path 1) [Phase 2]
Phase 2 clinical trial in children aged 6 to 17 with heterozygous familial hypercholesterolemia evaluating once-daily bempedoic acid (CLEAR …
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CLINICAL_TRIALS research · 2026-04-23Clinical Trial Update: A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029) [Phase 2, Phase 3]
Recruiting update for MK-0616 (Enlicitide Decanoate), an oral PCSK9 inhibitor, studied in children and adolescents with heterozygous familia…
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CLINICAL_TRIALS research · 2026-04-16Clinical Trial Update: Inclisiran (Leqvio®) in Patients With Atherosclerotic Vascular Disease and/or Heterozygous Familial Hypercholesterolemia Treated in Spain: the INSPIRE Study
Clinical trial update for Inclisiran (Leqvio) in patients with atherosclerotic vascular disease or heterozygous familial hypercholesterolemi…
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CLINICAL_TRIALS trial_result · 2026-04-08Clinical Trial Update: Long-term Follow-up of Participants Dosed With an Investigational Gene Editing Therapy for Cardiovascular Disease
Verve Therapeutics reports long-term follow-up data from participants treated with its investigational gene-editing therapy for cardiovascul…
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CLINICAL_TRIALS research · 2026-04-01Clinical Trial Update: A Study of VERVE-102 in Patients With Familial Hypercholesterolemia or Premature Coronary Artery Disease [Phase 1]
A Phase 1 clinical trial update for VERVE-102 in patients with heterozygous familial hypercholesterolemia or premature coronary artery disea…
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CLINICAL_TRIALS trial_result · 2026-03-19Clinical Trial Update: A Study to Evaluate the SYH2053 Injection in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) [Phase 3]
A Phase 3 study to evaluate SYH2053 Injection in patients with heterozygous familial hypercholesterolemia. The trial status is not yet recru…
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CLINICAL_TRIALS trial_result · 2026-03-17Clinical Trial Update: Early-phase Study of ART002g1 Injection in HeFH: Safety, Tolerability and Preliminary Efficacy [EARLY_Phase 1]
This document reports an early-phase (Phase 1) study of ART002g1 injection for heterozygous familial hypercholesterolemia, focusing on safet…
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CLINICAL_TRIALS research · 2026-03-13Clinical Trial Update: The ORIGIN-FH Study [NA]
The ORIGIN-FH clinical trial is currently recruiting to study familial hypercholesterolemia, including heterozygous and homozygous forms.
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CLINICAL_TRIALS research · 2026-03-04Clinical Trial Update: QLC7401 in Participants With Heterozygous Familial Hypercholesterolemia (HeFH) [Phase 3]
Phase 3 clinical trial update for QLC7401 in adults with heterozygous familial hypercholesterolemia; the study status is not yet recruiting.
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CLINICAL_TRIALS other · 2026-02-23Clinical Trial Update: "Detection and Follow-up of Coronary Lesions in HeFH (DESTINY-FH Study)" [NA]
Clinical trial update for the DESTINY-FH study on detection and follow-up of coronary lesions in heterozygous familial hypercholesterolemia;…
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CLINICAL_TRIALS trial_result · 2026-01-16Clinical Trial Update: A Phase III Study to Assess the Effect of AZD0780 on LDL-C in Patients With HeFH [Phase 3]
This document reports a Phase III clinical trial evaluating AZD0780's effect on LDL-C in patients with heterozygous familial hypercholestero…
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CLINICAL_TRIALS trial_result · 2025-12-23Clinical Trial Update: Study of MGL-3196 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) [Phase 2]
MGL-3196 (resmetirom), developed by Madrigal, completed a Phase 2 trial in patients with heterozygous familial hypercholesterolemia, with re…
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FDA label_change · 2025-11-21FDA Approved: NEXLIZET — Supplemental Application (Esperion Therapeutics, Inc.)
FDA approved a supplemental application for NEXLIZET (bempedoic acid and ezetimibe) to update/expand its labeling.
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CLINICAL_TRIALS trial_result · 2025-08-08Clinical Trial Update: A Clinical Study in Children With Heterozygous Familial Hypercholesterolemia (HeFH) Aged 6 to 17 Treated Once Daily With Bempedoic Acid Oral Dosing (CLEAR Path 1) [Phase 2]
A Phase 2 pediatric trial evaluating once-daily oral bempedoic acid in children aged 6 to 17 with heterozygous familial hypercholesterolemia…
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CLINICAL_TRIALS trial_result · 2025-05-08Clinical Trial Update: A Study of VERVE-101 in Patients With Familial Hypercholesterolemia and Cardiovascular Disease [Phase 1]
Phase 1 trial update reporting completion of the study of VERVE-101 in patients with heterozygous familial hypercholesterolemia and cardiova…
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FDA approval · 2025-04-22FDA Approved: COLESEVELAM HYDROCHLORIDE — Supplemental Application (Bionpharma Inc.)
FDA approved a supplemental application for Colesevelam hydrochloride (generic) submitted by Bionpharma Inc., effectively granting approval …
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CLINICAL_TRIALS trial_result · 2025-02-06Clinical Trial Update: A Study on Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia [Phase 3]
A Phase 3 study evaluating the efficacy and safety of HST101 in Chinese patients with hypercholesterolemia and related dyslipidemias; the tr…
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CLINICAL_TRIALS research · 2025-02-06Clinical Trial Update: Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia
A recruiting clinical trial assessing the prevalence of steatotic liver disease with metabolic dysfunction in patients with heterozygous fam…
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FDA approval · 2024-03-29FDA Approved: EZETIMIBE — Supplemental Application (Quallent Pharmaceuticals Health LLC)
The FDA approved a supplemental application for ezetimibe filed by Quallent Pharmaceuticals Health LLC. This confirms approval of a new or m…
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CLINICAL_TRIALS trial_result · 2024-03-18Clinical Trial Update: A Study to Evaluate the Efficacy and Safety of JS002 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH). [Phase 3]
Phase 3 trial updating efficacy and safety of JS002 in patients with heterozygous familial hypercholesterolemia has completed.
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FDA approval · 2024-03-12FDA Approved: ROSUVASTATIN — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA supplemental approval has been granted for rosuvastatin from Camber Pharmaceuticals, indicating an approved supplemental application for…
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FDA approval · 2024-03-08FDA Approved: PRALUENT — Supplemental Application (Regeneron Pharmaceuticals, Inc.)
FDA approved Regeneron's supplemental application for PRALUENT (alirocumab), confirming expanded regulatory authorization.
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CLINICAL_TRIALS trial_result · 2023-12-11Clinical Trial Update: Study to Assess the Efficacy and Safety of LIB003 in HeFH Patients on Oral Lipid Therapy Needing Further LDL-C Reduction [Phase 3]
Phase 3 trial assessing LIB003 for further LDL-C reduction in adults with heterozygous familial hypercholesterolemia; study completed.
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CLINICAL_TRIALS trial_result · 2023-08-09Clinical Trial Update: Safety and Efficacy of IBI306 in HeFH Patients [Phase 3]
Phase 3 trial update on IBI306 in patients with heterozygous familial hypercholesterolemia assessing safety and efficacy.
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CLINICAL_TRIALS trial_result · 2023-05-10Clinical Trial Update: Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C [Phase 2]
This Phase 2 study evaluated the efficacy and safety of Inclisiran in Japanese participants at high cardiovascular risk with elevated LDL-C.…