Rocky Mount

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 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 investigating the effects of QCZ484 in patients with mild to moderate hypertension. This Phase 2b, multicenter, randomized, double-blind, placebo-controlled study aims to evaluate the efficacy, safety, and pharmacodynamics of QCZ484 compared to a placebo, using various doses administered subcutaneously every 6 months. Participants will receive multiple doses of QCZ484 or a saline placebo through subcutaneous injections over a 12-month treatment period. The study will carefully test different dose levels to identify the optimal dosing strategy for patients with hypertension. Throughout the study, participants will be monitored for changes in their mean 24-hour systolic blood pressure measured by ambulatory blood pressure monitoring at baseline and after 3 months. Safety and tolerability will also be assessed, including regular laboratory tests and clinical evaluations. The trial includes detailed assessments to ensure participants understand and comply with study procedures during the entire duration.

Researchers are evaluating the effects of dalcetrapib, a cholesterol ester transfer protein inhibitor, on cardiovascular risk in people who have recently been hospitalized for acute coronary syndrome (ACS) and have a specific genetic profile (AA genotype). This phase 3, placebo-controlled, randomized, double-blind study focuses on adults aged 45 years and older. Participants must be clinically stable and managed according to guidelines for low-density lipoprotein cholesterol (LDL-C). The study aims to measure the time to the first occurrence of any fatal or non-fatal myocardial infarction over an average follow-up of 30 months. Participants will be randomly assigned to receive either dalcetrapib 300 mg tablets or matching placebo tablets. The study includes a genetic screening phase to confirm the presence of the AA genotype using a specific genotype assay test. Screening and enrollment may start during hospitalization or after discharge, with randomization required within 12 weeks of the ACS event. Follow-up visits will be conducted virtually when possible every 3 months or as clinic visits until the study ends. If a participant stops the study medication early, assessments for study endpoints will continue every 3 months. Throughout the study, participants will undergo medical history reviews, genetic testing, and regular assessments to monitor cardiovascular events. Researchers will collect data on myocardial infarction occurrences as the primary outcome. Safety and adherence will be monitored through scheduled visits, and the study will continue until about 200 participants have experienced a primary event or until a planned interim analysis determines stopping. The total participation duration varies based on event occurrence but involves ongoing follow-up every 3 months after randomization.

Researchers are evaluating a test called the ctDNA MRD test to detect molecular residual disease in people with high-risk, early breast cancer who are planning to receive chemotherapy. This study aims to validate if this blood and tissue test can help predict cancer recurrence after neoadjuvant therapy, which is treatment given before surgery. Participants will be followed for up to 5.5 years to observe outcomes related to cancer recurrence and tissue sample quality. Participants will provide blood and tissue samples for the ctDNA MRD test. The study is for those with invasive breast cancer scheduled for neoadjuvant chemotherapy and requires availability of leftover tissue from initial biopsies. The test involves collecting 34 cc of blood for each research draw and using tissue from the breast or lymph nodes to create a personalized assay. This study does not involve any experimental drug but focuses on diagnostic sample collection and testing. During the study, participants will be monitored for up to 5.5 years, including evaluations of biopsy tissue quality and tracking distant recurrence-free intervals over 6 years. Researchers will collect clinical information, blood, and tissue samples to assess molecular residual disease. The primary outcomes include the rate of evaluable biopsy tissue over 3 years and the length of time participants remain free from distant cancer recurrence over 6 years. Participants must be able to comply with study procedures and provide required samples throughout the follow-up period.

Researchers are evaluating Matrion14 (LifeNet Health, Inc.), a specialized placental membrane product, as a treatment for diabetic foot ulcers compared to standard wound care. Matrion is made from donated human birth tissue, including amniotic, chorionic, and trophoblast layers. It is carefully processed to be acellular and sterile, making it suitable for surgical use in healing wounds. Participants receive either the Matrion graft applied weekly to the cleaned wound, followed by conventional care such as dressing and off-loading, or they receive standard wound dressing materials with moist therapy and appropriate gauze coverings. Dressings are maintained for about 5 to 9 days before being changed, and off-loading to reduce pressure on the wound is required for both groups. During the study, participants will have their wounds regularly assessed over 12 weeks to measure healing progress. Researchers will monitor the wound condition, infection status, and overall safety. Participants must comply with dressing changes, off-loading, and study visits. The study evaluates wound healing effectiveness and safety of the treatments in adults aged 21 to 80 with diabetic foot ulcers.

Researchers are evaluating the effectiveness of a dehydrated human placental tissue product called Amnion-Intermediate-Chorion (AIC) combined with standard care versus standard care alone in healing diabetic foot ulcers. Diabetic foot ulcers affect up to 15% of people with diabetes and are challenging to treat because they often do not respond well to standard treatments and may become infected. The study aims to see if AIC can improve wound closure compared to standard care by helping rebuild the skin's dermis layer. Participants will receive either standard of care treatment alone or standard of care plus the AIC product. Standard care involves cleaning the wound, removing damaged tissue, reducing pressure on the ulcer, and maintaining moisture balance to promote healing. The AIC product is a dehydrated human placental tissue allograft containing amnion and chorion layers to support skin repair. The study is a randomized, multicenter Phase 4 trial comparing these two approaches in adults with diabetic foot ulcers. During the study, participants will be monitored for up to 12 weeks to measure how many ulcers fully close. Researchers will assess wound healing progress, including wound size and closure status. Participants must attend study visits and follow off-loading instructions to reduce pressure on the ulcer. Safety and treatment effectiveness will be tracked throughout the trial to understand the benefits of adding AIC to standard care for diabetic foot ulcers.

Researchers are evaluating the effects of baxdrostat combined with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with systolic blood pressure of at least 130 mmHg at screening, and at least one additional risk factor for heart failure. This Phase III randomized, placebo-controlled, event-driven study aims to determine if the combination reduces the risk of heart failure events or cardiovascular death, with follow-up lasting up to 38 months. Participants who meet screening criteria but are not currently treated with SGLT2 inhibitors or have been treated for less than 4 weeks will enter a run-in period receiving dapagliflozin 10 mg once daily for 4 to 6 weeks before randomization. The study involves random assignment to either baxdrostat plus dapagliflozin or placebo plus dapagliflozin. Site visits occur at approximately 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months. Participants discontinuing the blinded study drug may continue open-label dapagliflozin, with ongoing visits and data collection as per protocol. Participants will undergo an optional pre-screening period without site visits or consent to help identify eligibility, followed by up to 14 days of formal screening after informed consent. Researchers will monitor heart failure events and cardiovascular deaths as primary outcomes. Safety and adherence will be tracked throughout the study, including during any premature discontinuation of blinded treatment. The study will conclude when a predetermined number of secondary endpoint events have occurred, with continued follow-up as needed.

Researchers are evaluating the effectiveness and safety of sacituzumab govitecan-hziy (SG) combined with pembrolizumab compared to the treatment chosen by a doctor, which may be pembrolizumab alone or pembrolizumab with capecitabine. This study focuses on patients with triple negative breast cancer who still have invasive cancer remaining after surgery and pre-surgical treatment. The study is a phase 3, randomized, open-label trial designed to assess outcomes in this patient group. Participants receive sacituzumab govitecan-hziy and pembrolizumab through intravenous infusion as the experimental treatment. The comparison group receives the physician's choice of treatment, which involves either pembrolizumab alone intravenously or pembrolizumab combined with oral capecitabine tablets. Both treatment options follow surgery and prior therapy, targeting residual invasive disease. Throughout the study, participants are monitored up to 60 months to measure invasive disease-free survival, which indicates the time without cancer recurrence or progression. Researchers will track treatment safety and effectiveness through regular assessments. The study involves tissue sample submissions from before and after neoadjuvant therapy and surgery, performance status evaluations, organ function tests, and recovery status from surgery and radiotherapy.

Researchers are evaluating high-dose vitamin D supplementation as a treatment for bone loss caused by androgen-deprivation therapy (ADT) in men with prostate cancer stages I to IVA. This phase III trial aims to see if vitamin D helps keep bones strong, reduces the number of falls, lowers fatigue, and improves quality of life in these patients. The study focuses on men aged 50 years or older who are undergoing or starting ADT. Participants are randomly assigned to one of two groups: one receives high-dose vitamin D orally once a week for 52 weeks, and the other receives a placebo with the same schedule. Both groups undergo blood collection and dual-energy x-ray absorptiometry (DXA) scans to measure bone mineral density (BMD) at the total hip, femoral neck, distal radius, and lumbar spine at the start and during the study. Additional assessments include questionnaires on falls, fractures, quality of life, pain, fatigue, sleep, and daily activities. Throughout the 52-week study, participants provide blood samples and complete DXA scans to monitor changes in bone density. Researchers evaluate the reduction in bone loss at various sites, track falls and fractures, and assess quality of life and symptoms reported by patients. Safety and adherence are monitored to understand the effects of vitamin D supplementation during ADT treatment in prostate cancer patients.