Concord

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

Researchers are evaluating insulin icodec, a once-weekly insulin injection, compared to insulin glargine, a once-daily injection, in adults with type 1 diabetes. The study aims to see how well weekly insulin icodec controls blood sugar levels compared to daily insulin glargine when both are combined with insulin aspart. This phase 3 study will last about 26 weeks, or roughly 8.5 months. Participants will receive either insulin icodec or insulin glargine, both given as subcutaneous injections. All participants will also use insulin aspart as a subcutaneous injection. The study compares these two insulin regimens to assess their effects on blood sugar control over the 26-week period. During the study, researchers will monitor changes in glycosylated hemoglobin (HbA1c) from the start of the study to week 26. Participants will follow the study protocol including self-measured plasma glucose profiles. Safety and efficacy will be evaluated throughout the treatment period to understand the impact of the insulin regimens on blood sugar control and participant health.

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

Researchers are conducting a multi-center, global, randomized, double-blind, placebo-controlled Phase 2b trial to evaluate the effectiveness, safety, and tolerability of IMVT-1402 in adults with Graves' disease who remain hyperthyroid despite antithyroid drug treatment. The study focuses on participants aged 18 to 75 years who have this diagnosis and are still experiencing hyperthyroidism. Participants will receive either IMVT-1402 or a placebo for 26 weeks. The study includes two dosing regimens of IMVT-1402: Dose 1 administered for 26 weeks and Dose 2 also administered for 26 weeks. The placebo group will receive treatment for the same duration. The treatments are given as drugs, and the study is designed to keep both participants and researchers unaware of which treatment is assigned. During the study, researchers will monitor participants to see how many achieve normal thyroid function (euthyroid) and remain off antithyroid drugs by Week 26. Participants will be assessed regularly to evaluate safety, tolerability, and treatment effects. The involvement includes following the assigned treatment and attending scheduled visits for evaluations. The total participation time corresponds with the 26-week treatment period.

Researchers are evaluating the safety and effectiveness of Armour Thyroid compared to synthetic T4 treatment in adults with primary hypothyroidism who are currently stable on synthetic T4. The study focuses on assessing how well patients respond to dose conversion from synthetic T4 therapy to Armour Thyroid. This trial is conducted as a Phase 2/3 multicenter, double-blind, randomized, active-controlled study. Participants receive either Armour Thyroid in oral capsule or tablet form or synthetic T4 capsules. They must have been on a stable dose of synthetic T4 for at least 12 months before screening, with a dose of at least 25 mcg daily. The study compares both treatments over time to evaluate efficacy and safety in maintaining thyroid function. During the study, researchers monitor thyroid-stimulating hormone (TSH) levels to measure treatment response at week 55. They also track any adverse events related to the treatments for up to approximately 90 weeks. Participants undergo regular assessments to ensure safety and effectiveness throughout the study period.

Researchers are evaluating a multi-level intervention aimed at improving household food insecurity and blood sugar control in Latino adults with type 2 diabetes. The study, called ADELANTE, seeks to find out if weekly healthy food deliveries combined with an intensive lifestyle program called Vida Sana can better improve blood sugar levels compared to usual care. It also examines effects on food insecurity, dietary habits, and mental well-being, as well as the potential for applying this approach in primary care settings. Participants and up to two household members are randomly assigned to one of two groups: one receives 12 weeks of weekly healthy food box deliveries plus a 12-month Vida Sana lifestyle intervention delivered remotely, while the other group waits 6 months to receive the food boxes but does not get Vida Sana initially. The Vida Sana program includes 23 group sessions over a year, focusing on moderate calorie reduction, increased physical activity like brisk walking, and behavior changes supported by a health coach. Food boxes contain seasonal produce and whole grain foods designed to supplement household food and encourage trying new fiber-rich options. Participants will be monitored for blood sugar control (HbA1c) over 12 months, with assessments at baseline through 12 months. The study includes questionnaires and follow-up measures completed remotely, with ongoing support from health coaches. Food deliveries are scaled to household size and supplemented with personalized coaching during the Vida Sana sessions. The total involvement spans 12 months, with initial and delayed food delivery phases to compare effects of combined versus food-only interventions.

Researchers are evaluating the effect of muvalaplin on reducing cardiovascular risk in adults with elevated lipoprotein(a) levels who either have atherosclerotic cardiovascular disease or are at risk for a heart attack or stroke. This Phase 3, randomized, double-blind, placebo-controlled study focuses on adults with high Lp(a) levels and prior or potential cardiovascular events. The study aims to assess the time to the first major adverse cardiovascular event over about 5.25 years. Participants will be randomly assigned to receive either muvalaplin or a placebo, both administered orally. The study includes individuals with Lp(a) levels of at least 175 nanomoles per liter who have had a prior cardiovascular event within 10 years or are at risk for a first event due to conditions such as coronary artery disease, carotid stenosis, peripheral artery disease, high coronary artery calcium score, reduced kidney function with diabetes, or other high-risk factors. The treatment period lasts through the study duration, with close monitoring. During the study, participants will be regularly evaluated to track the occurrence of major adverse cardiovascular events, including heart attacks and strokes. Safety assessments will monitor blood pressure, kidney function, and heart failure status among other health indicators. The primary outcome measures the time to the first major cardiovascular event from baseline up to the end of the study, which spans approximately 5.25 years.

Researchers are evaluating the safety and effectiveness of Cardiac Contractility Modulation (CCM) therapy in people with heart failure who have a left ventricular ejection fraction (LVEF) between 40% and 70%. This clinical trial is prospective, multi-center, randomized, quadruple-blind, and sham-controlled, aiming to assess CCM therapy delivered through the OPTIMIZER Smart Mini System. The study is divided into two parts: Part I focuses on safety and effectiveness based on functional capacity and health status, while Part II focuses on clinical outcome data. Participants will have the OPTIMIZER Smart Mini System implanted and then be randomized in a 2:1 ratio to either have CCM therapy turned ON or OFF for the first 18 months, during which the trial is blinded. CCM therapy is programmed to deliver seven one-hour treatment phases evenly spaced over 24 hours. After 18 months, participants initially assigned to the CCM OFF (sham) group will have the therapy turned ON. Subjects enrolled in Part I will continue to be followed through Part II to contribute data for safety and effectiveness evaluation. Throughout the study, participants will undergo various assessments including the 6-minute walk test and the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score to measure changes in functional capacity and health status at 6 months. Safety will be monitored by tracking device- or procedure-related complications up to 12 months. The study also measures a composite of mortality, morbidity, and health status outcomes over an 18-month period. Follow-up and monitoring continue throughout the study duration to capture these outcomes and ensure participant safety.

Researchers are collecting blood and tissue samples from people with and without cancer to study and evaluate tests that could help detect cancer early. The goal is to create a blinded reference set of samples to validate blood-based tests for early detection of multiple types of cancer, including leukemia, lymphoma, breast, lung, and others. The study also aims to assess how well these tests perform at the time of initial cancer diagnosis, considering different tumor types and cancer stages. Participants complete a baseline questionnaire and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also provide tissue samples at these times. The study includes patients aged 40 to 75 years, with cancer diagnoses at various stages or individuals without cancer. Special procedures are in place for patients with high suspicion of certain cancers before confirmation. During the study, researchers collect detailed information through questionnaires, blood draws, and tissue sampling to analyze test accuracy. Participants are monitored for up to one year after registration to follow outcomes. The primary measure is providing this blinded set of blood samples to help validate future cancer detection tests, supporting research that could improve early diagnosis and treatment.

Researchers are evaluating the safety and effectiveness of the Aortix System, a circulatory support device, compared to standard medical therapy for patients hospitalized with acute decompensated heart failure (ADHF) who have diuretic resistance and persistent fluid congestion despite usual treatment. This study includes adults aged 21 and older, regardless of heart ejection fraction, and involves both a randomized group and an advanced heart failure registry group. The study aims to enroll up to 320 subjects at multiple sites in the United States and internationally. Participants in the randomized portion will be assigned to receive either the Aortix device or standard care medical management. The Aortix device is intended to assist circulation in patients resistant to diuretic therapy. The advanced heart failure registry will include patients who need improved kidney function before receiving advanced therapies like heart transplant or LVAD, and all registry patients will receive the Aortix device. The study involves monitoring patients while hospitalized and after device placement or medical treatment. Participants will be evaluated through clinical assessments, imaging, laboratory tests, and monitoring of heart failure symptoms and kidney function. The primary outcomes measured include safety events related to the device or procedure within 30 days and the effectiveness based on fluid loss, survival, and freedom from heart failure hospital readmission or therapy escalation over 30 days. Follow-up visits and assessments will be conducted to track participants' response to treatment and overall health status during the study period.