Lipid Metabolism Disorder

Noncommunicable diseases like type 2 diabetes and cardiovascular disease cause more deaths worldwide than any other conditions, with a growing impact especially in low- and middle-income countries. Cardiovascular disease CVD is a leading cause of death globally, and its prevalence is rising despite awareness efforts. Diet and nutrition are important factors influencing these diseases, and this research explores the role of a traditional Chinese medicine nutritional drink in supporting cardiovascular health. The study evaluates the effects of the Perfect Heartio drink, a nutritional supplement made from diluted herbal extracts traditionally used in Chinese medicine. Participants will consume 15 grams of the drink twice daily for 12 weeks while their compliance is monitored. This intervention is being studied to assess its potential in improving heart and blood vessel function by measuring various cardiovascular health indicators. Participants will be assessed at the start and at weeks 4, 8, and 12 for lipid profiles, heart inflammation, heart injury, and heart remodeling. Quality of life and self-perceived health status will also be evaluated over these timepoints. The study includes healthy adults aged 18 and above who agree to follow the intervention plan and attend follow-up visits. Monitoring throughout the study will help researchers understand the drinks impact on cardiovascular health markers over the 12-week period.

Researchers are evaluating an AI-assisted digital health tool called the Smart family doctor to improve control of hypertension, diabetes, and dyslipidemia in adults who have undergone coronary artery bypass grafting CABG or percutaneous coronary intervention PCI. This study uses a randomized controlled design involving about 536 participants across 5-10 hospitals. Participants must be adults aged 18 or older with a history of CABG or PCI and the specified conditions. Participants in the experimental group will use the AI-assisted Smart family doctor app that provides personalized health education, targeted guidance on managing blood pressure, blood sugar, medication adherence, exercise, and smoking cessation. They will also receive tailored reminders and can report self-measured health data for feedback. Both groups receive weekly 3-hour health management guidance from health managers, and participants will wear a smart band daily for health data collection during the 6-month study period. Throughout the study, participants will be assessed for control rates of hypertension, diabetes, and hyperlipidemia at 6 months. Additional measures include blood pressure, cholesterol levels, blood glucose, physical activity, quality of life, psychological status, and cognitive function. The study monitors health data continuously via smart bands and collects self-reports and clinical assessments to evaluate the interventions impact over the 6 months.

Researchers are evaluating the PILI Aina project to improve the management of common diet-related cardiometabolic diseases like type 2 diabetes, hypertension, dyslipidemias, and obesity among Native Hawaiian adults. This project aims to reduce risk factors for new diet-related illnesses by promoting traditional Native Hawaiian diets and improving social cohesion. The study focuses on adapting and testing an evidence-based multilevel intervention called PILI Aina to optimize its effectiveness and sustainability. The study involves a community-level component called Ai Pono, which includes quarterly hands-on cooking demonstrations and cultural lessons held over five years, for a total of 36 events. Each 2-hour event features cooking demonstrations, tastings, and education about the cultural importance of traditional foods like sweet potato, breadfruit, and kalo. These lessons aim to improve family and community eating environments and social cohesion. Attendance is limited to 30 people per event, with priority given to new participants after the first lesson. Participants will be surveyed at each event to assess their reactions, fruit and vegetable intake, confidence in healthy eating, and feelings of community support. Additionally, random samples of households in participating homesteads will be surveyed annually to measure family environment, nutrition environment, social cohesion, diet self-efficacy, food literacy, and social support. These assessments will occur at baseline and yearly for four years, helping researchers evaluate the impact and sustainability of the intervention over time.

Researchers are evaluating the effects of 2-Hydroxybenzylamine 2-HOBA on people with heterozygous Familial Hypercholesterolemia FH. The study aims to test whether 2-HOBA can reduce harmful modification of HDL and LDL cholesterol and improve HDL function. This phase 2 trial is focused on prevention and involves a randomized, placebo-controlled design with quadruple masking to ensure objective results. Participants receive either 750 mg of 2-HOBA given as three 250 mg capsules three times daily or a placebo for six weeks. The study compares these two groups in parallel to assess the impact of 2-HOBA on cholesterol modification and function. The treatment period lasts six weeks, during which participants take the assigned capsules orally. Throughout the study, participants undergo assessments to measure HDL cholesterol efflux capacity and the extent of HDL modification by specific agents like Isolevuglandin and malondialdehyde. These measurements are taken from baseline through week 6. Researchers monitor participants health and safety, with the total involvement lasting at least the six-week treatment period. The trial is sponsored by Vanderbilt University Medical Center and continues through the end of 2027.

Researchers are conducting a Phase III clinical trial to study the effects of Bempedoic Acid Tablets in adults with primary hyperlipidemia whose condition is not adequately controlled by statins. The study aims to assess the drugs effectiveness, tolerability, and safety in this patient group. It is sponsored by Gan & Lee Pharmaceuticals and involves a randomized, double-blind design to compare treatments. Participants will be randomly assigned to receive either the Bempedoic Acid Tablet or a placebo, both administered once daily by mouth. The treatment period focuses on a 12-week timeframe to evaluate changes in cholesterol levels. The study includes assessments of LDL-C and total cholesterol levels as key measures, alongside monitoring for any adverse events throughout the trial. During the study, participants will undergo evaluations at baseline and at week 12 to measure cholesterol changes. Safety will be monitored through reports of adverse and serious adverse events up to week 13. The trial requires informed consent and adherence to contraception guidelines for participants of reproductive potential. The total participation length spans at least 13 weeks, including treatment and safety follow-up.

The GENESIS clinical study aims to map HLA genetic variation in the Greek population and evaluate possible correlations with selected underlying diseases. It is a multicenter, prospective, non-interventional clinical study targeting 12,000 subjects over an anticipated duration of 36 months, with the goal of creating a pilot HLA map for medical research and possible clinical applications. Each subject will complete one visit at a participating site and provide demographic information, including date of birth, gender, race, ancestry, height, and weight, as well as information about smoking or vaping, alcohol consumption, arterial blood pressure, diagnosed diseases, and current treatments. Recent clinical laboratory results from up to 12 months before sample collection may also be collected when available, including blood count, metabolic, liver enzyme, and biochemical parameters. Two buccal swabs will be collected from each subject for DNA extraction and HLA genotyping analysis. Selected DNA samples will also undergo low-pass whole genome sequencing to further investigate associations between the HLA region and autoimmune diseases. After the analysis is completed, an individualized ancestry report will be securely available to study subjects if they elect to access it.

Researchers are studying a trial medicine called MK-7262 to lower the level of Lipoproteina or Lpa in the blood. This trial also looks at another medicine named enlicitide, which lowers low-density lipoprotein cholesterol LDL-C. The study aims to find out if taking MK-7262 alone or together with enlicitide works better than a placebo in lowering Lpa and LDL-C levels. The safety and tolerability of these medicines are also being evaluated. Participants will be randomly assigned to one of four groups. One group will take both MK-7262 and enlicitide placebos, the second will take enlicitide with an MK-7262 placebo, the third will take MK-7262 with an enlicitide placebo, and the fourth will take both MK-7262 and enlicitide. All treatments are oral tablets taken once daily for about 12 weeks. During the study, participants will have their Lpa and LDL-C levels measured at baseline and at weeks 8 and 12 to assess changes. Researchers will monitor any adverse events and whether participants stop treatment due to side effects, with safety observed for up to approximately 20 weeks. The study also tracks other related outcomes like percentages of participants reaching specific Lpa levels. Overall participation lasts up to about 12 weeks of treatment plus follow-up.

Researchers are evaluating the effects of Diaberine, a berberine-based nutraceutical, on blood sugar regulation and metabolism in adults with metabolism disorder. This randomized, triple-blind, placebo-controlled trial will study 80 participants aged 18 to 70 over 24 weeks to assess how well this dietary supplement may aid in these health areas. Participants will be randomly assigned to one of two groups. One group will take Diaberine capsules containing Vitamin B12, berberine, magnesium citrate, cinnamon bark extract, chromium, and other ingredients three times daily, 15 minutes before meals. The other group will take placebo capsules with similar appearance but without the active ingredients. Both treatments will continue for 24 weeks with regular monitoring. During the study, participants will have their blood sugar regulation and metabolism measured at baseline, week 12, and week 24. Additionally, quality of life and weight changes will be tracked at multiple points throughout the 24 weeks. Participants will be monitored through questionnaires, blood tests, and weight assessments to evaluate the supplements effects and tolerance over time.

This research aims to evaluate the effects of EDP167, a small interfering RNA drug targeting the angiopoietin-like 3 protein ANGPTL3, in adults with Homozygous Familial Hypercholesterolemia HoFH, a genetic condition causing very high cholesterol levels. By inhibiting ANGPTL3, EDP167 may help manage lipid levels in these patients. The study is a phase II, dose-exploration trial designed to assess the drugs safety, effectiveness, and how it behaves in the body pharmacokinetics and pharmacodynamics. Participants will be randomly assigned to receive either 200 mg or 300 mg doses of EDP167 through subcutaneous injections. The main study phase includes a screening period and 24 weeks of treatment, with injections given on Day 1 and Week 12. After this, those who complete the main phase may enter a 6-month extension phase receiving injections at Month 0 and Month 3, followed by a 6-month follow-up to further monitor effects and safety. Throughout the study, participants will have their cholesterol levels and other lipid markers regularly measured, including LDL-C, triglycerides, total cholesterol, and ANGPTL3 levels. Safety and immune response to the drug will also be assessed. Participants are monitored to observe changes from baseline up to 6 months after treatment during the extension phase. The total participation duration includes initial screening, treatment periods, and follow-up visits to evaluate both short- and longer-term study outcomes.

Researchers are studying the effects of MAR001 on adults with high triglycerides and remnant cholesterol. This phase 2, randomized, double-blind, placebo-controlled trial aims to compare MAR001 with a placebo to see how it changes triglyceride levels after eating a mixed meal. The study focuses on the postprandial after eating state in adults aged 18 to 75 years with elevated triglycerides and remnant cholesterol. Participants receive either MAR001 or a matching placebo through subcutaneous injections. The treatment period lasts 12 weeks, during which researchers measure changes in triglycerides and remnant cholesterol levels after a mixed meal. The study uses a quadruple-blind design, meaning participants, care providers, investigators, and outcomes assessors do not know who receives MAR001 or placebo. During the study, participants will have fasting triglyceride tests at screening and regular assessments throughout the 12 weeks. Researchers will track the area under the curve and peak plasma concentrations of triglycerides and remnant cholesterol after meals to evaluate treatment effects. Participants must maintain stable diets and medication regimens during the trial. Safety and adherence will be monitored with ongoing assessments to understand the impact of MAR001 compared to placebo.