Hypercholesterolemia

CLINICAL_TRIALS trial_result · 2024-10-23

Clinical Trial Update: Trial to Evaluate Efficacy and Safety of LIB003 and Inclisiran in High-risk CVD Patients [Phase 3]

Phase 3 trial evaluating LIB003 in combination with Inclisiran for efficacy and safety in high-risk cardiovascular disease patients has comp…

CLINICAL_TRIALS trial_result · 2024-10-23

Clinical Trial Update: A Study of Enlicitide Chloride (MK-0616) in Healthy Participants and Participants Taking Statins (MK-0616-012) [Phase 1]

Phase 1 clinical trial update for Enlicitide Chloride (MK-0616) in healthy participants and those on statins (MK-0616-012); the study has co…

CLINICAL_TRIALS research · 2024-10-22

Clinical Trial Update: Long-term Efficacy and Safety of OLE LIB003 in HoFH, HeFH, and High-risk CVD Patients Requiring Further LDL-C Reduction [Phase 3]

Phase 3 open-label extension evaluating long-term efficacy and safety of LIB003 in patients with homozygous and heterozygous familial hyperc…

CLINICAL_TRIALS trial_result · 2024-10-21

Clinical Trial Update: Unravelling the Impact of Diet on Cardiovascular Health in Treated Heterozygous Familial Hypercholesterolemia. [NA]

The clinical trial investigating how diet affects cardiovascular health in individuals with treated heterozygous familial hypercholesterolem…

CLINICAL_TRIALS trial_result · 2024-10-18

Clinical Trial Update: A Study to Evaluate the Efficacy and Safety of BR1017A and BR1017B Combination Therapy in Essential Hypertension Patients With Primary Hypercholesterolemia [Phase 3]

A Phase 3 clinical trial evaluating the efficacy and safety of BR1017A and BR1017B in essential hypertension with primary hypercholesterolem…

FDA approval · 2024-10-15

FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Glenmark Pharmaceutials Inc., USA)

FDA approved a supplemental application for rosuvastatin calcium from Glenmark Pharmaceuticals, confirming regulatory approval of this gener…

FDA approval · 2024-10-11

FDA Approved: COLESEVELAM HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

The FDA approved a supplemental application for Colesevelam hydrochloride from Amneal Pharmaceuticals of New York LLC.

CLINICAL_TRIALS trial_result · 2024-10-10

Clinical Trial Update: Adult Subjects With Elevated Low-Density Lipoprotein-Cholesterol to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects [Phase 1]

This clinical trial update reports a Phase 1 study in adults with elevated LDL-cholesterol to evaluate the safety, tolerability, pharmacokin…

CLINICAL_TRIALS trial_result · 2024-09-27

Clinical Trial Update: A Dose-Finding Study in Japanese Patients to Evaluate the Effect of Obicetrapib as an Adjunct to Stable Statin Therapy. [Phase 2]

A Phase 2 dose-finding study in Japanese patients evaluated obicetrapib as an adjunct to stable statin therapy for dyslipidemia/hypercholest…

FDA approval · 2024-09-23

FDA Approved: EZETIMIBE — Supplemental Application (Sandoz Inc)

The FDA approved a supplemental application for ezetimibe submitted by Sandoz Inc, updating the approved ezetimibe product.

CLINICAL_TRIALS research · 2024-09-19

Clinical Trial Update: A Real-world Study to Assess the Characteristics and Long-term Effectiveness of Inclisiran in Chinese Adult Patients

This completed real-world study evaluates the characteristics and long-term effectiveness of Inclisiran in Chinese adults with hypercholeste…

CLINICAL_TRIALS trial_result · 2024-09-19

Clinical Trial Update: A Study of MK-0616 in Healthy Adult Participants (MK-0616-009) [Phase 1]

Phase 1 clinical trial update for MK-0616 in healthy adult participants. The study lists hypercholesterolemia as the associated condition an…

CLINICAL_TRIALS research · 2024-09-19

Clinical Trial Update: Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia [Phase 3]

A Phase 3 clinical trial is evaluating JS002 as monotherapy for primary hypercholesterolemia and mixed dyslipidemia. The study is currently …

CLINICAL_TRIALS trial_result · 2024-09-19

Clinical Trial Update: Kefir Cholesterol Lowering Pilot Study [NA]

A completed pilot clinical trial sponsored by the University of Alberta assessed whether kefir can lower cholesterol in adults with hypercho…

CLINICAL_TRIALS trial_result · 2024-08-30

Clinical Trial Update: The Effect of Progressive Resistance Exercise Training (PRET) on CVRF in Adults With ID. [NA]

This clinical trial update reports a completed study examining the effect of progressive resistance exercise training on cardiovascular risk…

CLINICAL_TRIALS trial_result · 2024-08-23

Clinical Trial Update: A Study of MK0653A (Ezetimibe (+) Simvastatin) in Patients With Hypercholesterolemia (0653A-038) [Phase 3]

Phase 3 clinical trial update for MK0653A (ezetimibe plus simvastatin) in hypercholesterolemia; the study status is completed.

CLINICAL_TRIALS trial_result · 2024-08-23

Clinical Trial Update: U of A/ U of M Beans and Peas Health Claim Project [NA]

A completed clinical trial update from the University of Alberta and University of Manitoba on a beans and peas health claim project investi…

CLINICAL_TRIALS research · 2024-08-23

Clinical Trial Update: Extra Virgin Olive Oil Supplementation in Pregnancies With Increased Cholesterol Levels [NA]

Clinical trial update on extra virgin olive oil supplementation in pregnancies with high cholesterol; the study is not yet recruiting.

FDA approval · 2024-08-20

FDA Approved: PITAVASTATIN — Original Application (Amneal Pharmaceuticals LLC)

FDA approved Amneal Pharmaceuticals LLC's original application for pitavastatin (generic), authorizing its manufacture and sale as a statin …

FDA approval · 2024-08-16

FDA Approved: COLESTIPOL HYDROCHLORIDE — Original Application (Edenbridge Pharmaceuticals LLC.)

FDA approved the original application for colestipol hydrochloride from Edenbridge Pharmaceuticals LLC, a generic product. The drug is used …