Island Lake

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 VE303, a live biotherapeutic product made of eight nonpathogenic bacterial strains, to prevent recurrent Clostridioides difficile infection (CDI). This randomized, double-blind, placebo-controlled Phase 3 trial aims to assess the safety and CDI recurrence rate at 8 weeks in participants receiving a 14-day course of VE303 or a matching placebo. The study includes two stages: one focusing on participants with recurrent CDI and the other on those with primary CDI at high risk of recurrence. Participants will receive either VE303 or placebo capsules that look identical and contain no active drug. The treatment lasts for 14 days, starting on the last planned day of standard antibiotic therapy for the qualifying CDI episode or within 2 days after completing antibiotics. Participants must have completed and responded to standard antibiotic treatment before receiving study medication. The study evaluates the effect of VE303 versus placebo on preventing CDI recurrence after antibiotic therapy. During the study, participants will be monitored through clinical evaluations to track CDI recurrence by Week 8, including stool samples tested for CDI. Safety and clinical response will be assessed throughout the study period. Participants are followed to ensure stability after the qualifying CDI episode and to monitor any complications or adverse events. The total participation duration includes treatment and follow-up through Week 8 to measure CDI recurrence rates and safety.