Naples

Researchers are evaluating MK-2214, a study treatment designed to slow brain changes in people with early Alzheimers disease AD. AD is a form of dementia that causes memory loss, communication difficulties, and challenges in decision-making, affecting daily tasks. This phase 2 trial aims to determine if MK-2214 slows the spread of tau protein in the brain compared to a placebo, as well as to assess the safety and tolerability of MK-2214. Participants will be randomly assigned to receive either MK-2214 or a placebo through intravenous IV infusion every 4 weeks during the study. The study uses a parallel design with quadruple masking to compare the effects of the study drug versus placebo over a period of up to approximately 23 months. Both groups receive infusions on the same schedule to maintain the studys integrity. During the study, participants will undergo brain scans including positron emission tomography PET to measure tau protein levels and other assessments such as cognitive and daily living function tests. Researchers will monitor adverse events and treatment discontinuations throughout the study, which lasts up to about 26 months. These assessments help determine the impact of MK-2214 on disease progression and safety in individuals with early AD.

Researchers are evaluating whether retatrutide and tirzepatide can prevent major adverse liver outcomes in adults with metabolic dysfunction-associated steatotic liver disease MASLD who are at high risk based on non-invasive tests. This Phase 3 randomized controlled trial aims to assess these treatments compared to placebo in about 4,500 adults over approximately 224 weeks. The study is sponsored by Eli Lilly and Company and focuses on liver disease progression and related health measures. Participants will be randomly assigned to receive retatrutide, tirzepatide, or placebo, all administered by subcutaneous injection. The trial includes two placebo groups corresponding to each experimental drug. After completing the main study, eligible participants may join a 2-year extension where all will receive either retatrutide or tirzepatide regardless of their initial assignment. During the study, participants may attend around 25 to 30 clinic visits for health monitoring, study procedures, and assessments of liver function and disease status. Researchers will measure the time to major adverse liver outcomes, changes in liver fibrosis scores, liver stiffness, liver fat content, liver enzyme levels, body weight, and cardiovascular events. Monitoring will continue from baseline through study completion, with detailed evaluations at multiple timepoints including week 104.

This trial studies adults aged 50 to under 80 with mild or moderate calcific aortic valve stenosis and elevated lipoproteina levels. Researchers are assessing the safety, tolerability, and ability of pelacarsen TQJ230 given once monthly by injection to slow the progression of this heart valve condition. The study compares pelacarsen to a placebo in a randomized, double-blind design. Participants receive either pelacarsen 80 mg or a matching placebo as a subcutaneous injection monthly. They continue treatment and monitoring for up to 36 months to observe changes in heart valve narrowing and calcium buildup. The study also tracks lipoproteina levels and clinical heart-related events during this period. Throughout the study, participants will have regular assessments including imaging to measure aortic valve function and calcium score, blood tests for lipoproteina, and monitoring for safety. The main outcomes analyzed after 36 months include changes in valve jet velocity and calcium score, alongside clinical events. Participants remain under medical care while being observed for any effects of the study drug or placebo.

Researchers are evaluating IM-101 in adults with generalized myasthenia gravis gMG and ocular myasthenia gravis oMG, focusing on those with acetylcholine receptor AChR antibody-positive and AChR antibody-negative forms. The goal is to assess the safety, tolerability, how the drug moves through and affects the body, and the potential effectiveness of IM-101. This Phase 1b2 trial is sponsored by ImmunAbs Inc. and includes multiple study parts to explore these aspects thoroughly. Participants will receive IM-101 or a placebo through intravenous infusions. In Part A, participants get a loading dose on Day 1 and Day 15, followed by a maintenance dose on Day 29, with doses escalating across cohorts. In Part B, dosing includes loading doses on Day 1 and Day 15 and maintenance doses on Days 29, 57, and 85. Some may receive additional doses depending on decisions by an independent data monitoring committee. The study uses randomized, double-blind assignments to compare different dose levels and placebo effects. During the study, participants will be monitored for side effects and safety up to about 99 days in Part A and 169 days in Part B. Researchers will assess the impact of treatment on daily living activities and specific myasthenia gravis severity scores at baseline and Week 16. Safety assessments include tracking adverse events, serious adverse events, and events leading to discontinuation. Participants will undergo regular evaluations to measure the pharmacokinetics and pharmacodynamics of IM-101, with follow-up visits scheduled according to the dosing timeline.

Researchers are evaluating zelquistinel, a drug aimed at reducing symptoms of major depressive disorder in adults aged 18 to 64 years. This Phase 2 clinical trial compares the effects and safety of zelquistinel to a placebo in participants diagnosed with major depressive disorder. The study will focus on changes in depression severity and monitor any medical issues that arise during treatment. Participants will take one tablet of either zelquistinel or placebo once a week for six weeks. The trial includes a screening period of up to 28 days, followed by a 42-day treatment phase, and then a four-week follow-up period. During treatment, participants will visit the clinic weekly to receive their dose and have their depression symptoms assessed using the Hamilton Depression Rating Scale-17. Throughout the study, participants will have their depression severity regularly evaluated, along with monitoring for adverse events or side effects. The study lasts up to 98 days, including screening, treatment, and follow-up. Researchers will measure changes in depression scores from the beginning to the end of treatment and monitor overall safety during this time.

Researchers are evaluating the effects of ALN-APP on disease progression in adults with sporadic Cerebral Amyloid Angiopathy sCAA and Dutch-type Cerebral Amyloid Angiopathy D-CAA. This Phase 2 study aims to assess the safety, tolerability, and pharmacodynamics of ALN-APP in these patient groups. The study is sponsored by Alnylam Pharmaceuticals and includes a randomized, double-blind, placebo-controlled design. Participants will receive multiple doses of ALN-APP or placebo administered intrathecally during a 24-month double-blind treatment period. Those who continue into an optional 18-month open-label extension will receive ALN-APP. The study involves two main periods the initial double-blind treatment phase followed by an optional open-label extension. During the study, participants will undergo brain MRIs to measure new cerebral microbleeds and other brain changes. Researchers will also assess cerebrovascular vasoreactivity using functional MRI and measure amyloid precursor protein levels in cerebrospinal fluid. Safety and adverse events will be monitored throughout the up to 50 months of participation, which includes screening, treatment, and safety follow-up.

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 evaluating the safety profile of OviTex PRS, a reinforced tissue matrix device, in patients who have previously undergone implant-based breast reconstruction. This observational study includes both retrospective and prospective data and focuses on women aged 18 to 75 years who received either pre-pectoral or sub-pectoral breast implants using OviTex PRS. The study aims to understand overall safety and device-specific safety to help guide future studies on effectiveness. The study involves patients who had immediate or two-stage unilateral or bilateral implant-based breast reconstruction using OviTex PRS devices, either permanent or resorbable. The reconstruction could have been performed in the sub-pectoral or pre-pectoral position. This multi-center study includes patients who have completed their initial and, if applicable, exchange surgeries. Some participants may also take part in a prospective portion that includes returning for in-person visits and photograph completion. Participants will be followed for safety outcomes up to 24 months after OviTex PRS implantation. Researchers will collect data on the occurrence of relevant adverse events, time to expander or implant exchange, intraoperative fill volumes and visits, and aesthetic assessments using the Telemark Breast Score and Rainbow Scale. Hospitalization length of stay at the time of procedure will also be recorded. The study monitors participant adherence and safety throughout this period, providing important insights into the devices use in breast reconstruction.

Researchers are evaluating efruxifermin EFX in a phase 3, randomized, double-blind, placebo-controlled study involving adults with compensated cirrhosis caused by NASH Nonalcoholic Steatohepatitis or MASH Metabolic Dysfunction-Associated Steatohepatitis. This study aims to assess the safety and effectiveness of EFX in preventing significant clinical events such as disease progression and liver decompensation over a period of up to 5 years. Participants are randomly assigned to receive either efruxifermin 50 mg or a placebo, both given by subcutaneous injection. The study includes two cohorts one with biopsy-proven compensated cirrhosis and specific metabolic scores, and another with biopsy-proven or non-invasive diagnosis of compensated cirrhosis. The study treatment and monitoring extend up to 5 years, with evaluations at 96 weeks and long-term follow-up to track liver fibrosis, markers of liver injury, insulin sensitivity, glycemic control, body weight, and safety outcomes. During the trial, participants undergo regular assessments including laboratory tests, ECGs, ultrasounds, and vital sign monitoring. Researchers will measure changes in liver fibrosis, steatohepatitis resolution, and metabolic markers throughout the study. Safety and tolerability are closely tracked by documenting adverse events and exposure duration. The study duration allows for long-term observation of treatment effects and disease progression, with participant involvement lasting up to 5 years.

Researchers are evaluating efruxifermin EFX in adults with non-cirrhotic nonalcoholic steatohepatitis NASH or metabolic dysfunction-associated steatohepatitis MASH who have liver fibrosis stage 2 or 3. This Phase 3, multi-center, randomized, double-blind, placebo-controlled study aims to assess the safety and efficacy of EFX compared with placebo. The trial includes about 1,650 participants divided into two cohorts based on liver biopsy characteristics and fibrosis stage. Participants will be randomly assigned to one of three groups EFX 28 mg, EFX 50 mg, or placebo, each given as a weekly subcutaneous injection. Cohort 1 will be evaluated over 52 weeks for histologic efficacy endpoints, while Cohort 2 will have assessments over 96 weeks. After these periods, participants may continue long-term treatment and clinical follow-up for up to approximately 240 weeks total. A follow-up visit will occur about 30 days after the last dose. During the study, participants will undergo liver biopsies, blood tests, and non-invasive assessments such as FibroScan and Enhanced Liver Fibrosis ELF score to monitor liver health and fibrosis. Researchers will track liver-related clinical outcomes, including liver events and survival, as well as safety and tolerability of the treatment. Participants who stop the study drug may still continue with scheduled assessments to support long-term safety and efficacy evaluations.