Coral Gables

Researchers are evaluating molnupiravir, an oral medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 in people at high risk of disease progression. The study focuses on adults with confirmed COVID-19 infection who are at increased risk due to age, medical conditions, or other factors. This is a Phase 3 randomized, placebo-controlled, double-blind clinical trial led by Merck Sharp & Dohme LLC. Participants will be randomly assigned to receive either molnupiravir or a matching placebo. Those in the molnupiravir group will take 800 mg orally every 12 hours for 5 days, totaling 10 doses. The same dosing schedule applies to the placebo group. Some participants may also receive remdesivir as part of standard care if clinically appropriate. During the study, participants will be monitored for up to 29 days to assess outcomes such as hospitalization, death, or medically attended visits related to COVID-19. Safety will be evaluated by tracking adverse events and discontinuation due to side effects. Researchers will also measure symptom relief, viral RNA levels, and other health indicators. The study is expected to continue until January 2031.

Researchers are evaluating the long-term safety and effectiveness of APG777 in adults with moderate-to-severe atopic dermatitis who have completed treatment in a previous APG777 study. This phase 2 extension study involves participants who, according to their doctors, would benefit from continued treatment with APG777. The study is designed as a multicenter, double-blind trial to assess ongoing treatment outcomes and safety over several years. Participants in this study will continue receiving APG777 through three main periods a screening visit coinciding with the last visit of the prior studys maintenance period, an extended treatment period, and a post-treatment follow-up period. Participants who met certain skin improvement criteria and did not use topical rescue medication during the prior study will maintain their previous dose and injection frequency. Those who did not meet these criteria or used rescue medication will receive APG777 according to a specific dosing plan in an open-label escape arm. During the study, participants will be closely monitored for treatment-emergent adverse events up to 3 years. The research team will also measure skin improvements using tools such as the Eczema Area and Severity Index EASI and the Investigator Global Assessment for Atopic Dermatitis vIGA-AD, as well as tracking itch severity, use of rescue therapy, and serum drug concentrations. The overall participation time includes up to 3 years of follow-up to evaluate long-term safety and efficacy outcomes.

Researchers are conducting a master protocol study to evaluate multiple pain treatments for people experiencing chronic pain conditions such as osteoarthritis of the knee, diabetic neuropathic pain, and chronic low back pain. This study aims to compare different pain interventions by using a flexible design where specific intervention appendices ISAs can begin independently as new treatments become available. The study is sponsored by Eli Lilly and Company and is designed as a phase 2 randomized, placebo-controlled trial. Participants may receive one of several study drugs administered either intravenously or orally, including LY3016859 given through IV and LY3556050, LY3526318, and LY3857210 given orally. Each treatment group is compared to a matching placebo group. The study uses a parallel design where participants are assigned randomly to one of the intervention groups or placebo. The protocol includes disease-state addenda to define target populations and assessment scales for each pain condition. During the trial, participants undergo screening to confirm eligibility based on pain levels, history, and health status. They are monitored for outcomes such as the number of participants allocated to each intervention up to week 8. Researchers assess pain and other health measures while participants maintain consistent use of any ongoing non-drug pain therapies and discontinue other chronic pain medications except for rescue use. The study includes safety monitoring and will continue through April 2027, with results posted for each intervention.

This research investigates a new self-administered digital application designed to improve sexual health, quality of life, and psychological distress among survivors of hematopoietic stem cell transplants HCT. HCT survivors often face long-term sexual dysfunction due to complex biological, psychological, and social factors, which significantly affect their well-being and relationships. The study aims to address these challenges through a multidisciplinary approach delivered via a digital platform. Participants will be randomly assigned to either use the SHIFT digital application or receive enhanced usual care. The SHIFT app includes interactive features like gamification, survivor videos, intimacy exercises, and optional content to engage users over eight weeks. Those in the usual care group will meet with their clinicians and may be referred to specialists if needed but will not have access to the SHIFT app. During the study, participants will complete assessments measuring sexual satisfaction, function, quality of life, anxiety, and depression at various points up to 24 weeks. Researchers will monitor global satisfaction with sex at week 8 as the primary outcome. The study involves medical evaluations and tracks psychological and physical health through questionnaires and scales, aiming to evaluate the impact of the digital intervention on sexual health outcomes and overall well-being in HCT survivors.

Researchers are evaluating the safety, side effects, and best dose of the drug SNDX-5613 combined with standard chemotherapy in patients newly diagnosed with acute myeloid leukemia AML that has specific genetic changes in the NPM1, MLLKMT2A, or NUP98 genes. This phase Ib trial focuses on patients aged 18 to 75 who are eligible for intensive induction therapy and aims to find the recommended dose for further studies while assessing the treatments effects on cancer cell behavior and response. Participants receive a combination treatment starting with induction therapy where SNDX-5613 is given orally twice daily from days 2 to 28, along with daunorubicin intravenously on days 1 to 3, and cytarabine by continuous infusion on days 1 to 7. Those who respond move on to consolidation treatment with cycles of SNDX-5613 and cytarabine every 42 days for up to three cycles. Patients with persistent disease may receive re-induction therapy. Various scans, blood tests, and bone marrow biopsies are done throughout these treatment phases to monitor progress and safety. During the study, participants undergo regular evaluations including heart scans echocardiogram or MUGA, bone marrow aspiration and biopsy before, during, and after treatment phases, and blood collections at specific times. Researchers measure recommended doses, treatment responses, drug levels in the body, and explore biomarkers related to treatment effectiveness and resistance. Follow-up continues for up to two years after treatment to observe long-term outcomes such as disease relapse or survival.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are studying the treatment of accelerated or blast phase Philadelphia chromosome-negative myeloproliferative neoplasms MPNs, a type of blood cancer, by comparing two drug regimens. This phase II trial evaluates whether combining ASTX727, which includes the drugs cedazuridine and decitabine, with iadademstat is more effective than ASTX727 alone. ASTX727 works by helping bone marrow produce normal blood cells and attacking abnormal ones, while iadademstat may stop tumor growth by blocking enzymes needed for cell growth. Patients are randomly assigned to one of two treatment groups. One group takes ASTX727 orally once daily for five days in a 28-day cycle. The other group takes ASTX727 on the same schedule plus iadademstat orally on days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle. Treatment cycles continue unless the disease progresses or side effects are unacceptable. During the study, patients provide buccal swabs, blood samples, and bone marrow samples for analysis. Participants are monitored throughout treatment with various tests including blood and bone marrow examinations. After stopping treatment for reasons other than disease progression, patients have follow-up visits every three months if they stop due to progression, follow-up occurs every six months. Researchers measure the rate of complete acute leukemia response within four treatment cycles and track event-free survival, overall survival, and stem cell transplantation rates over up to two years.

Researchers are evaluating the effects of azetukalner in adults diagnosed with bipolar I or II disorder who are currently experiencing a depressive episode, also known as bipolar depression. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to assess the safety and efficacy of azetukalner in this population. Participants must have had their first major depressive episode before age 50 and meet specific diagnostic criteria confirmed by clinical interview. Participants will be randomly assigned to receive either azetukalner 20 mg or a placebo orally once daily with food, preferably with the evening meal, for six weeks. The study has two groups one receiving the experimental drug and one receiving a placebo, both taken over the same period. The study is designed to keep participants and researchers unaware of the group assignments to ensure unbiased results. Throughout the trial, participants will be evaluated using various measures, including changes in depression severity assessed by the Montgomery-sberg Depression Rating Scale MADRS at baseline and at week 6, along with other scales at different time points. Safety and response will be monitored regularly during the six-week treatment period. The entire participation period is focused on this treatment phase, with assessments conducted to measure changes in symptoms and overall condition.

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

Researchers are evaluating AZD0120, a dual-targeted CAR-T therapy aimed at BCMA and CD19, compared with standard treatment regimens for participants with relapsed refractory multiple myeloma RRMM. This Phase III, randomized, open-label global study aims to assess how AZD0120 performs relative to established therapies including DKd, DPd, PVd, or Kd. The study focuses on participants who have received previous treatments and now require additional therapy due to disease progression. Participants will receive either AZD0120 or one of four standard regimens chosen by their investigator, including combinations of daratumumab, carfilzomib, pomalidomide, bortezomib, and dexamethasone. The treatment period and dosing depend on the assigned regimen, and the study compares these approaches over time. The trial is designed to measure progression-free survival and response rates to evaluate the benefits of AZD0120 compared to standard care. During the study, participants will undergo regular assessments to monitor disease status and treatment effects. These include laboratory tests to measure disease markers, imaging, and safety evaluations. The primary outcomes include progression-free survival over three years and minimal residual disease negativity at nine months. Secondary outcomes assess response rates and overall survival over several years. The study duration extends up to 2030 with ongoing monitoring and follow-up to collect comprehensive data on participant health and treatment impact.