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Researchers are evaluating the effect of baxdrostat combined with dapagliflozin compared to baxdrostat with placebo on reducing albuminuria in people with chronic kidney disease (CKD) and high blood pressure. This Phase IIb, randomized, multicenter, double-blind study includes adults aged 18 years and older, with or without type 2 diabetes and regardless of current SGLT2 inhibitor treatment. The study aims to assess both the impact on albuminuria and the safety of these treatments. Participants will be randomly assigned to receive either baxdrostat with dapagliflozin or baxdrostat with a matching placebo. The study includes an optional pre-screening period to assess kidney function and other health markers, and those on SGLT2 inhibitors will undergo a washout before starting treatment. Randomization will consider diabetes status to ensure balanced groups. During the study, participants will be monitored up to 12 weeks to measure changes in albuminuria, specifically urinary albumin-to-creatinine ratio (UACR). Safety and other health parameters will also be assessed through blood tests and blood pressure measurements. The study ends when the last participant completes their final visit and procedures, ensuring thorough data collection on treatment effects and safety.

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 effects of CST-3056 on symptoms and signs of neurogenic orthostatic hypotension (nOH) in adults aged 18 to 85. This Phase 2 study focuses on subjects with nOH caused by Parkinson's disease or pure autonomic failure. Participants must have orthostatic hypotension confirmed by specific blood pressure changes and symptom assessments, and those using related medications must stop them prior to screening and dosing. The study involves a single-blind dose-ranging design where participants receive once-daily oral doses of CST-3056 or placebo over five days. Dosing occurs on Days 1 through 4 and a fifth day to determine the individual's optimal dose based on blood pressure and safety observations. Participants discontinue certain medications before beginning treatment and are closely monitored for safety and tolerability during the dosing period. Participants will undergo assessments of standing systolic blood pressure at baseline and hourly up to four hours after dosing on Days 1 to 4. Follow-up includes a phone call 3 to 7 days after discharge to check health status and record any adverse events. The study tracks changes in orthostatic blood pressure and symptom responses to evaluate CST-3056's effects in this population.

Researchers are evaluating the effectiveness and safety of eloralintide compared to a placebo for reducing body weight in adults who have overweight or obesity along with type 2 diabetes. This Phase 3, randomized, double-blind study focuses on participants who have been on stable treatment for their type 2 diabetes and aims to provide detailed information on body weight changes over time. Participants will receive either eloralintide or a placebo administered by subcutaneous injection once weekly. The study lasts about 75 weeks, including treatment and follow-up periods. The goal is to monitor the changes in body weight from the beginning of the study through week 64. During the study, participants will undergo various assessments to track body weight and overall health. Researchers will collect data on weight changes and monitor safety throughout the study period. The main outcome measured is the percentage change in body weight from baseline to week 64, ensuring close observation of participants' responses to the treatment.

This research aims to evaluate the safety, tolerability, and pharmacokinetics of ORX142 in healthy adults, including those aged 18 to 80 years. The study is conducted in multiple parts to assess single and multiple ascending doses of ORX142, including effects in healthy older adults and acutely sleep-deprived healthy subjects. It is a Phase 1, randomized, double-blind, placebo-controlled trial designed to understand how the drug behaves in the body and its safety profile across different conditions. Participants receive ORX142 tablets or placebo tablets under various dosing schedules. The study includes single ascending doses, multiple ascending doses, and assessments under fasted and fed states. Specific parts focus on healthy adults aged 18 to 55, older adults aged 60 to 80, and a crossover study in acutely sleep-deprived adults, with careful monitoring during each dosing period. During the study, participants are closely observed from enrollment through a follow-up visit 13 days after discharge. Researchers monitor the incidence and severity of any treatment-emergent adverse events, along with pharmacokinetic and pharmacodynamic responses. The comprehensive safety and tolerability assessments help determine how well participants tolerate the medication and understand its effects over time.

Researchers are evaluating the safety, tolerability, and effectiveness of VLS-01 buccal film (VLS-01-BU) as a short-term treatment for adults with treatment resistant Major Depressive Disorder (TRD). This Phase 2, multicenter, double-blind, randomized, placebo-controlled trial aims to compare antidepressant effects of VLS-01-BU against placebo, focusing on the onset and durability of these effects. About 142 participants with TRD will be randomly assigned in equal groups to receive two doses of either VLS-01-BU or placebo via buccal transmucosal administration, spaced two weeks apart. Following this placebo-controlled period, symptoms will be monitored for 12 weeks. Then, all participants will be re-randomized to receive a single additional double-blind dose of VLS-01-BU at one of two dose strengths during a non-placebo-controlled treatment phase. Safety and efficacy will be assessed two weeks after the third dose. Participants will be closely monitored throughout the study, including during the 12-week follow-up after the second dose and after the final treatment. Researchers will measure changes in depression severity using the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to Day 29. Safety evaluations and tolerability assessments will also be conducted to understand the effects and duration of VLS-01-BU treatment.

Researchers are evaluating the long-term safety of INZ-701, a recombinant fusion protein designed as a potential treatment for patients with ENPP1 Deficiency or ABCC6 Deficiency. These conditions involve gene mutations that affect mineralization processes in the body. This open-label study, known as the ADAPT Study (INZ701-304), focuses on patients who have previously received INZ-701 in an earlier clinical trial and wish to continue treatment. Participants will undergo a 30-day screening period followed by an open-label treatment phase where all will receive once-weekly subcutaneous injections of INZ-701. Treatment will continue until the drug becomes commercially available in their region or until the sponsor discontinues its development. After the treatment phase, participants will have a safety follow-up visit approximately 30 days after their last study visit. During the study, researchers will closely monitor participants for treatment-emergent adverse events and the presence of anti-drug antibodies over a long-term period of up to six years. Participants will be assessed through safety evaluations, pharmacokinetic and pharmacodynamic testing, and other clinical measures. The study aims to gather comprehensive data on the safety and immune response to INZ-701 during extended use.

Researchers are evaluating the AK+ Guard21212121 software as a medical device designed to detect moderate to severe hyperkalemia (high serum potassium levels of 6.5 mmol/L or greater) in adults with chronic kidney disease (CKD), specifically stages III-IV. The study aims to assess the diagnostic accuracy of this software in an outpatient setting and its usability and compliance when used for remote daily monitoring over four weeks. The software uses artificial intelligence to analyze Lead I electrocardiogram (ECG) data from various devices, including standard 12-lead ECGs and consumer wearables like the Apple Watch. The study has two main parts: Arm 2A focuses on outpatient diagnostic accuracy by measuring sensitivity, specificity, and other performance metrics of AK+ Guard21212121 using ECG data alongside outpatient serum potassium tests. It also evaluates the software's compatibility with different ECG devices and system reliability. Arm 2B involves remote patient monitoring, where participants use the software daily for up to four weeks on compatible iPhones. This arm assesses participant compliance, user experience through surveys like the System Usability Scale and Net Promoter Score, and technical performance in a real-world, unsupervised environment. Participants will attend outpatient visits for ECG and blood potassium testing and then may continue with daily remote monitoring if eligible. Researchers will track the accuracy of hyperkalemia detection, participant adherence to daily ECG recordings, and overall usability of the software. Measurements include diagnostic test results at baseline, daily compliance rates, user satisfaction scores, and system reliability metrics over the study period. The study excludes those with certain heart devices, conduction abnormalities, or recent treatments affecting potassium levels. Total participation involves outpatient assessment and up to four weeks of remote monitoring.

An open-label study designed to evaluate the long-term safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and clinical effects of subcutaneous (SC) administration of CTI-1601, also known as nomlabofusp, in subjects with Friedreich's ataxia (FRDA). The objectives of this study are: * To evaluate the safety and PK of long-term subcutaneous (SC) administration of CTI-1601 in subjects with FRDA * To evaluate the PD and clinical effects of long-term subcutaneous (SC) administration of CTI-1601 in subjects with FRDA on: * Tissue FXN concentrations * Clinical evaluations of FRDA * Gene expression and select lipids

This research aims to study a new approach to treating opioid use disorder (OUD) by testing a vaccine targeted against oxycodone called Oxy(Gly)4-sKLH. OUD is a serious problem, and while current medications like methadone and buprenorphine exist, relapse rates remain high. The goal of this trial is to evaluate the safety, antibody production, and ability of the vaccine to reduce the pleasurable effects of opioids in adults with OUD, particularly those who use heroin or fentanyl intranasally. This is a Phase 1a/1b trial conducted at multiple sites, though one site is currently paused due to regulatory reasons. Participants will receive either a low dose or high dose of the Oxy(Gly)4-sKLH vaccine or a placebo, injected into the deltoid muscle. Immunizations occur at Weeks 0, 3, 6, and 18. The study includes several phases: a Screening Phase (Weeks -6 to -2), an Outpatient Study Visit Phase (Weeks 0 to 21), three Laboratory Sessions (Weeks -1, 7, and 19), and an Extended Follow-Up Phase (Weeks 23, 30, 34, 38, and 42). The vaccine is combined with an aluminum adjuvant to support the immune response. Participants will be involved in scheduled visits, dosing, laboratory tests, and assessments over about 42 weeks. Researchers will monitor treatment-emergent side effects, antibody responses over time, and the vaccine's impact on subjective opioid effects during testing sessions. Safety and long-term immune response will be closely followed, and participants must comply with study procedures to complete the trial.