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Researchers are evaluating the safety, tolerability, and effectiveness of CYB003, a Deuterated Psilocin Analog, compared to a placebo when added to current antidepressant treatment in adults with moderate to severe Major Depressive Disorder (MDD). This Phase III trial focuses on participants aged 18 to 85 years who have had inadequate response to a stable antidepressant dose, aiming to better understand how CYB003 might improve depressive symptoms. Participants receive oral doses of CYB003 or matching placebo along with manualized psychological support provided by trained facilitators. The treatment period includes multiple dosing sessions with monitoring and assessments throughout. Placebo is used as a comparator to evaluate the combined safety and efficacy of CYB003 in this population. During the study, participants undergo evaluations using the Montgomery-Åsberg Depression Rating Scale (MADRS) at several time points, including screening, baseline, and multiple days up to the end of treatment at Day 42. Researchers monitor symptoms, side effects, and overall safety. Participants provide informed consent and are assessed regularly to track changes in depression severity and any adverse events over the course of the study.

Researchers are studying a medicine called enlicitide to reduce low-density lipoprotein cholesterol (LDL-C) in adults with high cholesterol (hyperlipidemia). This trial aims to find out if taking enlicitide together with rosuvastatin, a standard cholesterol-lowering drug, works better than a placebo in lowering LDL-C levels. The study is a Phase 3 trial that is randomized, double-blind, and placebo-controlled to ensure accurate and unbiased results. Participants will receive oral tablets of enlicitide or placebo along with oral capsules of rosuvastatin or placebo. The study compares the effect of enlicitide plus rosuvastatin against placebo to evaluate their impact on LDL-C. The treatment period lasts 8 weeks, during which participants take their assigned medications as directed. During the study, researchers will measure the average percent change in LDL-C from the start of the trial to week 8. Participants will be monitored for safety and any side effects throughout the study. The total participation time includes screening, treatment, and follow-up assessments to evaluate the medicines' effects and safety in adults aged 18 to 64 with hyperlipidemia.

Researchers are evaluating the safety and effectiveness of Alpha DaRT-224, a novel treatment for patients with recurrent cutaneous squamous cell carcinoma who have not responded to standard therapies and are not candidates for surgery or standard radiation. This multicenter, pivotal, single-arm, open-label clinical study aims to determine the objective response rate and duration of response following treatment, as well as assess progression-free survival, overall survival, local tumor control, and quality of life. The treatment involves placing DaRT seeds, which contain a radium-224 source that releases alpha-emitting atoms, directly into the tumor. These seeds remain in the tumor for 14 to 21 days before being removed. The procedure is planned using radiotherapy parameters and monitored with volumetric imaging to ensure proper placement and coverage of the tumor. Participants will undergo evaluations including CT scans and blood tests before and during the study. Researchers will measure tumor response from day 14 through 52 weeks after treatment and monitor safety by tracking adverse events related to the device. The study also includes assessments of quality of life and long-term outcomes over several months. Participants are followed closely to document tumor changes, side effects, and overall health during the study period.

Researchers are evaluating a culturally-tailored, home-based physical activity program designed to improve physical fitness in Hispanic or Latino/Latina adolescent and young adult childhood cancer survivors. These survivors may face long-term effects such as weight gain, fatigue, and reduced fitness after cancer treatment, with Hispanic or Latino/Latina individuals potentially at higher risk. The study aims to increase moderate to vigorous physical activity (MVPA) through a mobile health and social media intervention. The study has two stages. Stage 1 involves developing the intervention using feedback from 20 Latinx survivors who speak either English or Spanish. Stage 2 is a randomized controlled trial comparing the intervention group with a control group that only uses a Fitbit tracker. The intervention group receives Fitbit trackers, weekly reminders, goal-setting sessions, social media peer support 2-3 times a week, badges, monthly Zoom meetings, and may choose a physical activity partner who also receives support. After 12 weeks, a 4-week maintenance phase continues these supports with less structure. The control group wears a Fitbit daily for 12 weeks without additional support. Participants wear Fitbit trackers daily, attend weekly sessions, post on social media, and complete interviews and questionnaires. Researchers measure changes in physical activity levels, sedentary time, quality of life, and cardiometabolic health indicators. Data is collected using Fitbit devices, interviews, and surveys, with follow-up over 12 weeks plus maintenance. Safety and acceptability of the intervention are also assessed throughout the study.

Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

Researchers are evaluating the effectiveness of a single layer placental-based allograft combined with standard care for treating nonhealing diabetic foot ulcers. This multicenter, prospective, controlled clinical trial focuses on patients with type 1 or type 2 diabetes who have persistent foot ulcers that did not fully heal during a previous CAMPX trial using standard care alone. The study is designed as a rescue trial where patients who did not heal in the standard care group receive the placental-based allograft treatment. Participants will receive the XWRAP treatment along with standard care for up to 12 weeks. This involves applying the study product to the target ulcer while continuing the prescribed offloading method to reduce pressure on the wound. The trial includes weekly visits to monitor healing progress and adherence to treatment. Patients must have previously participated in the CAMPX trial's standard care arm without achieving full ulcer closure by 12 weeks. During the study, participants will attend weekly visits to assess wound healing and safety. Researchers will monitor wound closure over 1 to 12 weeks as the primary outcome. Patients must consent to the treatment plan, follow offloading instructions, and be able to participate in the informed consent process. Safety is monitored carefully, including the exclusion of ulcers with infections, exposed bone or tendon, or other complicating factors. The total participation period includes up to 12 weeks of treatment with regular evaluations to measure wound healing.

Researchers are evaluating the safety, tolerability, and effectiveness of EIK1001 combined with standard treatments in adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received vein-based treatment for their advanced disease. This phase 2, open-label, multicenter trial includes participants with confirmed stage 4 squamous or non-squamous NSCLC without mutations suitable for first-line targeted therapy. The study aims to find appropriate dosing and monitor adverse events alongside treatment response. Participants receive EIK1001, a Toll-like receptor 7/8 agonist, together with pembrolizumab, a PD-1 inhibitor, and chemotherapy drugs such as paclitaxel, pemetrexed, or carboplatin. These treatments are combined as part of the standard care for stage 4 NSCLC. The trial assesses safety and efficacy over the treatment period, including a dose-finding phase to determine the best dose of EIK1001. During the study, participants undergo regular assessments including tumor measurements based on RECIST 1.1 criteria, organ function tests, and monitoring of performance status. Researchers track the percentage of participants experiencing safety events throughout up to two years of treatment. Follow-up includes ongoing evaluation of side effects and effectiveness to understand the treatment impact and participant well-being over the course of the trial.

This research aims to evaluate the safety, tolerability, and impact on albuminuria of the drug MZE829 in adults who have proteinuric chronic kidney disease and carry the APOL1 high-risk genotype. This Phase 2 open-label study focuses on participants with specific genetic markers associated with kidney disease to better understand treatment effects. Participants will receive MZE829 in the form of oral capsules. The study involves monitoring the participants over a 12-week period to assess the drug's safety and how well patients tolerate it. Researchers will also measure changes in albuminuria, which reflects kidney function. During the study, participants will be closely monitored for any adverse events from the first day through week 12. Safety assessments and laboratory tests will be performed to track the drug’s effects. The main goal is to determine how safe and tolerable MZE829 is, along with its impact on kidney disease markers over the treatment duration.

This clinical study is testing a new medication, VH4524184, to see if it can effectively treat HIV-1 in adults who have never received treatment for their infection. The study is comparing two different doses of VH4524184, each taken with the medications emtricitabine and tenofovir alafenamide (FTC/TAF), to a standard HIV treatment called dolutegravir and lamivudine (DTG/3TC). The purpose of the study is to provide data on the long-term antiviral activity of the VH4524184 and provide information regarding dosing formulation for further evaluations.

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.