Ongoing Clinical Trials for Metabolic Syndrome
Two clinical trials are currently underway to study new approaches for managing metabolic syndrome and its associated cardiovascular risks. These studies are testing different medications to see how they might help improve metabolic health and prevent complications in people with this condition.
Clinical trial locations
- Finland
- Spain
Study on Dulaglutide for Preventing Diabetes in Patients with Metabolic Syndrome Awaiting Kidney Transplantation
This trial, conducted in Spain, focuses on patients who are waiting for a kidney transplant and have metabolic syndrome. The study examines whether treatment with dulaglutide, marketed as Trulicity, can help reverse metabolic syndrome and prevent the development of diabetes in these patients.
Main inclusion criteria: To participate, patients must be at least 18 years old and on the kidney transplant waiting list. They must have metabolic syndrome, which means having at least three of the following conditions: prediabetes with fasting blood sugar between 100-126 mg/dL, a body mass index of 27 or higher, high triglycerides of 150 mg/dL or higher, or a large waist circumference measuring greater than 101.6 cm for men or 88.9 cm for women. Women who can become pregnant must use effective birth control during the study.
Main exclusion criteria: Patients who do not have metabolic syndrome or are not on the kidney transplant waiting list cannot participate. Those who do not meet at least two of the key criteria such as prediabetes, abdominal obesity, high triglycerides, or abnormal lipid levels are excluded. Patients unwilling or unable to follow the treatment plan for 3 to 6 months, or those considered part of a vulnerable population, are also not eligible.
Study focus: The trial aims to determine whether dulaglutide can reverse metabolic syndrome over a treatment period of up to six months. Participants receive weekly injections of the medication or a placebo. Researchers evaluate changes in metabolic indicators at three and six months, monitoring blood sugar levels, body weight, insulin sensitivity, and any side effects such as nausea, diarrhea, or headaches. The study is expected to conclude by December 31, 2026.
Investigational drug: Dulaglutide belongs to a class of medications called GLP-1 receptor agonists. These medications work by mimicking a natural hormone that stimulates insulin release, helping to lower blood sugar levels. The trial uses a 0.75 mg dose administered once weekly through a pre-filled pen injection.
Study on the Effects of Roxadustat and Placebo on Cardiovascular Risk Factors and Metabolic Syndrome in Patients
This trial, taking place in Finland, investigates how roxadustat, marketed as Evrenzo, affects heart health and metabolism in people with cardiovascular risk factors and metabolic syndrome. The study examines the medication’s impact on glucose and fat metabolism, as well as overall cardiovascular function.
Main inclusion criteria: Participants must have a body mass index over 20 kg/m² and weigh less than 100 kg. They need to be in good general health as confirmed by medical history, laboratory tests, physical examination, and a 12-lead ECG test that records the heart’s electrical activity. Both men and women can participate, and individuals should not be from a vulnerable population.
Main exclusion criteria: The study excludes patients with a history of heart disease or stroke, uncontrolled high blood pressure, severe liver disease, kidney disease requiring dialysis, or active cancer. Those who have had major surgery within the last three months, have uncontrolled diabetes, are pregnant or breastfeeding, have a known allergy to the study medication, or are currently enrolled in another clinical trial cannot participate.
Study focus: Over an eight-week period, participants receive either roxadustat or a placebo in the form of oral tablets. Researchers monitor various health parameters including cholesterol levels, insulin resistance, glucose tolerance, body composition, blood pressure, and muscle blood flow. The trial assesses how roxadustat influences factors related to heart health and metabolism. The study is expected to conclude by the end of 2025.
Investigational drug: Roxadustat is a medication that works by stimulating the body to produce more red blood cells, which can improve oxygen delivery throughout the body. This may potentially influence metabolic processes and help manage blood sugar levels and fat in the body, as well as improve heart function. In this trial, it is being tested in a 70 mg tablet form taken orally.
Summary
These two ongoing clinical trials represent different approaches to managing metabolic syndrome and its complications. The Spanish trial specifically targets kidney transplant candidates, testing whether preventing diabetes before transplantation is possible through medication. The Finnish study takes a broader approach, examining how improving oxygen delivery in the body might affect metabolic and cardiovascular health.
Both trials are investigating medications that work through different mechanisms. The GLP-1 receptor agonist dulaglutide directly affects blood sugar regulation, while roxadustat takes an indirect approach by increasing red blood cell production. The studies are expected to provide valuable insights into new treatment strategies for people living with metabolic syndrome and those at risk of developing cardiovascular disease.
