Eatontown

Researchers are evaluating the effects of combining baxdrostat with dapagliflozin versus baxdrostat with a placebo on albuminuria in adults with chronic kidney disease CKD and high blood pressure. This Phase IIb, randomized, multicenter, double-blind study includes participants aged 18 and older, with or without type 2 diabetes and with or without prior SGLT2 inhibitor treatment. The goal is to understand how these treatments affect kidney function and safety in this population. Participants will be randomly assigned to receive either a daily dose of baxdrostat combined with dapagliflozin or baxdrostat with a placebo matching dapagliflozin. Before randomization, some participants may go through an optional pre-screening and a washout period if they are currently taking an SGLT2 inhibitor. The study includes stratification based on diabetes status to balance groups. Throughout the study, participants will undergo assessments including measurements of urine albumin-to-creatinine ratio UACR to evaluate changes in albuminuria from baseline over up to 12 weeks. Safety and other health parameters such as blood pressure, potassium, and sodium levels will also be monitored. Study completion is defined by finishing all scheduled procedures, and the study continues until the last participant completes their last visit globally.

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

Researchers are evaluating the effects of CST-3056 on symptoms and signs of neurogenic orthostatic hypotension nOH, a condition that causes a significant drop in blood pressure upon standing. This Phase 2 study focuses on people diagnosed with symptomatic orthostatic hypotension due to Parkinsons disease or pure autonomic failure. The study aims to better understand how CST-3056 impacts standing blood pressure and orthostatic symptoms in these subjects. Participants will receive single oral doses of CST-3056 once daily for five days, including an optimal dose day determined from earlier doses based on standing blood pressure and tolerability. The study also includes a placebo group receiving a single dose on one day. Subjects must discontinue other treatments using alpha-1 adrenergic receptor agonists for at least one day before key assessments and dosing. The dosing is conducted in a single-blind, sequential manner. During the study, participants will be closely monitored for changes in standing and seated blood pressure, orthostatic symptom severity using the Orthostatic Hypotension Symptom Assessment OHSA, and responses to head-up tilt table testing. Follow-up occurs 3 to 7 days after discharge via telephone to review health status and report any adverse events. The total study duration per participant includes screening, treatment over five days, and a safety follow-up call after discharge.

Researchers are evaluating the efficacy and safety of eloralintide compared with placebo for reducing body weight in adults with overweight or obesity who also have type 2 diabetes. This phase 3 study is designed to assess the treatments effects over a course of about 75 weeks, aiming to provide insights into managing weight in this population. Participants are randomly assigned to receive one of several doses of eloralintide or a placebo, all administered by weekly subcutaneous injections. The study involves a double-blind design, meaning neither participants nor researchers know which treatment is given. The treatment period lasts 64 weeks, during which body weight and other health measures are closely monitored. Participants will undergo regular assessments including measurements of body weight, fat mass, waist circumference, blood sugar control HbA1c, blood pressure, and other health indicators. Questionnaires about quality of life and eating behavior are also used. Safety and medication use changes are tracked throughout. Participation includes screening, treatment, and follow-up visits over the total duration of about 75 weeks.

Researchers are evaluating the safety, tolerability, and how the body processes a drug called ORX142 in healthy adults aged 18 to 80 years. This Phase 1 clinical trial includes several parts to study single and multiple doses, the effects of food on the drug, and tests in both younger and older adults, as well as in people who have been acutely sleep-deprived. The study aims to understand the drugs effects on excessive daytime sleepiness. Participants will receive ORX142 or placebo tablets in different parts of the study. Parts A, B, and C focus on single and multiple ascending doses in healthy adults, with Part B examining the food effect on the drug. Part D studies single doses in healthy older adults, while Part E tests the drug in acutely sleep-deprived healthy adults. The study uses a randomized, double-blind, placebo-controlled design. During the trial, participants will be closely monitored for side effects and treatment-emergent adverse events from enrollment until 13 days after discharge. Blood samples will be taken before and after dosing to measure drug levels and how the body processes it over time. Sleepiness will be assessed using tests like the Maintenance of Wakefulness Test and the Karolinska Sleepiness Scale in Part E. Overall participation duration varies depending on the part of the study involved.

Researchers are evaluating the efficacy, safety, and tolerability of VLS-01 buccal film VLS-01-BU in adults with treatment resistant Major Depressive Disorder TRD. This Phase 2, multicenter, randomized, placebo-controlled trial aims to understand the onset and duration of antidepressant effects of VLS-01-BU compared to placebo in patients who have not responded to previous treatments. Participants will be randomly assigned to receive two doses of either VLS-01-BU or placebo administered via a buccal transmucosal film, with two weeks between doses. After a 12-week follow-up monitoring period, all participants will be re-randomized to receive one additional dose of VLS-01-BU at one of two dose strengths. Safety and efficacy will be assessed two weeks after this third dose during a non-placebo-controlled treatment phase. Throughout the study, participants depressive symptoms will be regularly monitored using the Montgomery-sberg Depression Rating Scale MADRS from baseline to Day 29 and through Day 43. The study includes multiple assessments to measure the antidepressant effects and safety of the treatment. The total duration of participant involvement covers the initial dosing, follow-up, re-randomization, and final evaluation, ensuring thorough observation of treatment impact and tolerability.

Researchers are evaluating the long-term safety of INZ-701, an investigational protein treatment for patients with ENPP1 Deficiency or ABCC6 Deficiency. These rare genetic conditions are linked to gene mutations causing arterial calcification and other complications. The study focuses on patients who have previously received INZ-701 in earlier trials and are continuing treatment to assess ongoing safety. INZ-701 is given as a once-weekly subcutaneous injection. Children aged 1 to under 13 years receive a dose based on their weight 2.4 mgkg, while participants 13 years and older receive either a 1.8 mgkg dose or a flat 150 mg dose. The study includes a 30-day screening period followed by an open-label treatment phase. Participants will continue treatment until the drug becomes commercially available or the sponsor stops development, with a safety follow-up visit about 30 days after their last treatment. Participants will be monitored closely throughout the study with safety assessments including tracking treatment-emergent adverse events and the presence of anti-drug antibodies over six years. Additional measures include blood tests for drug concentration and plasma markers related to the condition. The study ensures long-term observation of participants receiving INZ-701 to gather important safety data while supporting their ongoing care.

Researchers are evaluating the AK Guard21 software, an investigational medical device designed to detect moderate to severe hyperkalemia high potassium levels in adults with chronic kidney disease CKD stages III-IV. This observational pilot study aims to assess the diagnostic accuracy of the software in an outpatient setting and its usability and reliability during daily remote monitoring. The study focuses on adults at risk of hyperkalemia, including those on specific kidney-related therapies, by analyzing Lead I ECG data from standard or wearable devices. The study includes two arms Arm 2A involves participants scheduled for routine outpatient potassium blood tests who will have ECGs recorded using three devices 12-lead ECG, Apple Watch, HeartBeam. The softwares diagnostic performance for detecting high potassium is compared to lab results. Arm 2B includes a subset of these participants who agree to use the Apple Watch and study app for daily ECG recordings at home for up to four weeks. Participants also complete weekly surveys and may return for confirmatory lab tests if high potassium is indicated. Participants will have ECGs collected and compared to blood potassium levels to evaluate sensitivity, specificity, and other diagnostic measures. During the remote monitoring phase, researchers will track daily compliance, data completeness, and system reliability, including app performance and user experience through surveys. The study measures include diagnostic accuracy at baseline and usability scores after four weeks. The total participation duration varies with the arm, including up to four weeks of remote monitoring.

Researchers are evaluating the long-term safety, tolerability, pharmacokinetics PK, pharmacodynamics PD, and clinical effects of CTI-1601, a recombinant fusion protein designed to deliver human frataxin, in people with Friedreichs ataxia FRDA. The study includes children aged 2 years and older, adolescents, and adults with FRDA, including those who have or have not participated in previous CTI-1601 studies. This open-label Phase 2 study aims to assess tissue frataxin levels, clinical evaluations, gene expression, and select lipids related to FRDA. Participants receive daily subcutaneous injections of CTI-1601. Adults 18 years and older receive a fixed 50 mg dose, while children and adolescents aged 2 to 17 years receive a weight-based dose of 0.8 mgkg, up to a maximum of 50 mg. The study includes long-term treatment administration and monitoring to evaluate safety and clinical effects. During the study, participants will undergo various assessments including motor function tests, neurological evaluations using the modified Friedreichs Ataxia Rating Scale mFARS, fatigue scales, daily living activities, and safety measures like electrocardiograms and echocardiograms. Researchers will also measure frataxin concentrations from cheek swabs and skin biopsies. The study will monitor treatment-emergent adverse events and other clinical outcomes over a period of up to 24 months.

Researchers are evaluating a new approach to treating opioid use disorder OUD by studying a vaccine targeted against oxycodone, one of the commonly abused prescription opioids. This Phase 1a1b clinical trial aims to assess the safety, immune response, and effectiveness of the OxyGly4-sKLH vaccine in adults aged 18 to 59 years who meet criteria for moderate to severe OUD and are physically dependent on opioids. The study is supported by the New York State Psychiatric Institute and includes participants not currently seeking treatment for their opioid use. The study compares two doses of the OxyGly4-sKLH vaccine low and high dose to a placebo, administered by injection into the deltoid muscle at Weeks 0, 3, 6, and 18. Participants will be randomly assigned to one of these groups in a triple-masked design. The trial includes several phases a screening phase lasting from 6 to 2 weeks before vaccination, an outpatient study visit phase from Week 0 to Week 21, three laboratory sessions at Weeks -1, 7, and 19, and an extended follow-up period from Weeks 23 to 42. During the approximately 42-week participation, individuals will undergo safety monitoring for adverse events, assessments of immune response to the vaccine, and evaluations of the vaccines effect on drug liking after opioid administration. Assessments include blood tests for antibodies, urine drug screens, and subjective effect measures during testing sessions lasting up to 4.5 hours post-dose. Participants must comply with scheduled visits, dosing, and lab tests, with continuous monitoring for safety and immune response throughout the study.