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An open label, long term, safety and tolerability extension to a randomized, double-blind, placebo controlled study of LCQ908 in subjects with Familial Chylomicronemia Syndrome

The purpose of this study is to determine long-term safety and tolerability, and continued efficacy in lowering triglycerides of LCQ908 in subjects FCS.

Open-Label Extension Study of EFC12492, R727-CL-1112, EFC12732 and LTS11717 Studies to Assess the Long-Term Safety and Efficacy of Alirocumab in Patients with Heterozygous Familial Hypercholesterolemia

Primary objective* To assess the long-term safety of alirocumab when added to currently available lipid-modifying drug therapy in patients with heterozygous familial hypercholesterolemia (heFH) who have completed one of the following studies:…

Effect of IVF culture medium on health of IVF children

The primary objective is to elucidate whether there is a difference in the outcome of health parameters between IVF children who as an embryo were cultured in two different culture media. As secondary objectives we will investigate how the health…

Multicenter, Controlled, Open-Label Extension (OLE) Study To Assess the Long-Term Safety and Efficacy of AMG 145 (study 20110110)

Primary: Longterm safety and tolerability of AMG 145.Secondary: Longterm efficacy of AMG 145.

Enzyme substitution in exocrine pancreatic insufficiency; Self administration against a fixed dose regimen.

To assess the difference in efficacy of pancreatic enzymes in a self-dosage regimen after extensive patient-education in comparison to the standard treatment for patients with EPI.

Pharmacokinetic drug interaction study between rAltegraVIr and ATORvastatin (AVIATOR).

Primary objective:To assess the effect of multiple dose atorvastatin on the steady state pharmacokinetics of raltegravir and vice versa by intrasubject comparison in healthy subjects.• The comparison of steady state raltegravir (400 mg BID for 7…

Short- term effects of a single bout of moderate physical activity on liver fat content and validation of ultrasonography method after exercise

In this study we will examine the short-term effects of a single bout of physical activity on liver fat content. Research question: What are the short- term effects of a single bout of moderate physical activity on liver fat content? Can the…

Short- term effects of a single bout of moderate physical activity on liver fat content

In this study we will examine the short-term effects of a single bout of physical activity on liver fat content. Research question: What are the short- term effects of a single bout of moderate physical activity on liver fat content?

A 12-week, open-label, dose-escalating, phase 2 study to evaluate the effects of MBX-8025 in patients with Homozygous Familial Hypercholesterolemia (HoFH) (study CB8025-21427)

Primary: To evaluate the effect of MBX-8025 on LDL-C.Secondary: To evaluate the effects of MBX-8025 on other lipid parametersTo evaluate the safety and tolerability of MBX-8025.To evaluate steady-state trough plasma levels of MBX-8025 and its…

A Multicenter, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of Evolocumab

To characterize the safety and tolerability of long-term administration of evolocumab in subjects with known coronary artery disease andhypercholesterolemia.

A 12-week, open-label, dose-escalating, phase 2 study to evaluate the effects of MBX-8025 in patients with Homozygous Familial Hypercholesterolemia (HoFH) (study CB8025-21427)

Primary:To evaluate the effect of MBX-8025 on LDL-C.Secondary:To evaluate the effects of MBX-8025 on other lipid parameters. To evaluate the safety and tolerability of MBX-8025. To evaluate steady-state trough plasma levels of MBX-8025 and its…

AN OPEN-LABEL, SINGLE-ARM, PROOF-OF-CONCEPT STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SINGLE AND MULTIPLE DOSES OF REGN1500 IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA

Please refer to protocol, section 1.2 "Rationale"

A three-part, open-label, randomized (Part 1) and fixed-sequence (Part 2 and Part 3) study to compare the pharmacokinetics of different ESB1609 Form A formulations to that of ESB1609 Form B (Part 1) and to investigate the effect of CYP2C9 inhibition and induction on the single dose pharmacokinetics of ESB1609 Form A (Part 2 and Part 3).

Part 1:Primary objective:• To evaluate the PK profile of a single oral dose of ESB1609 jetmilled Form A in plasma and compare this profile with the PK profile of ESB1609 monohydrate Form B with 30% SLS.• To compare the PK profile of different…

Role of brown fat and skeletal muscle in post-prandial clearance of triglycerides during and after cold exposure

1. To examine the effect of cold on post-prandial triglyceride metabolism using a standardized meal test during and after cold exposure 2. To examine the relationship between cold-induced brown adipose tissue activity and the changes in…

A Three-Part, Single-Arm, Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Evinacumab in Pediatric Patients with Homozygous Familial Hypercholesterolemia

PrimaryThe primary objective for Part A of the study is to assess the pharmacokinetics (PK) of evinacumab in pediatric patients with homozygous familial hypercholesterolemia (HoFH).The primary objective for Part B of the study is to demonstrate a…

A long term extension trial of the Phase III lipid-lowering trials to assess the effect of long term dosing of inclisiran given as subcutaneous injections in subjects with high cardiovascular risk and elevated LDL-C (ORION-8)

The primary objectives are to evaluate:-The effect of inclisiran treatment on the proportion of subjects achieving prespecified low densitylipoprotein cholesterol (LDL-C) targets at end of study (EOS)-The safety and tolerability profile of long term…

A Phase 2 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of ARO-APOC3 in Adults with Dyslipidemia

This study has been transitioned to CTIS with ID 2024-511331-96-00 check the CTIS register for the current data. Primary Objective• To evaluate the safety and efficacy of long-term treatment with ARO-APOC3 in adults with dyslipidemia.

The Clock thickens:
Morning or evening training for the treatment of NAFLD?

The aim of the study is to identify the effect of exercise timing on NAFLD. Additionally, we aim to increase the understanding of the exercise-related modulation of the metabolic and inflammatory processes causing NAFLD, including insulin resistance…

An Open-Label Extension Study of AKCEA-APOCIII-LRX Administered Subcutaneously to Patients with Familial Chylomicronemia Syndrome (FCS)

This study has been transitioned to CTIS with ID 2023-509029-29-00 check the CTIS register for the current data. In this study, we look at how safe the new medicinal product ISIS 678354 is for the treatment of FCS. And how well it works.

A Long-term Follow-up Study to Evaluate the Safety and Efficacy of RGX-501

The primary study objective is long-term safety of RGX-501 and secondarily evaluation of the long-term effects of RGX-501 on LDL-C and other lipid parameters.