Richmond

Researchers are evaluating the safety and tolerability of Efimosfermin Alfa in adults with known or suspected metabolic dysfunction-associated steatohepatitis MASH with fibrosis at stages F2 or F3. This phase 3 clinical trial aims to understand how participants respond to this treatment compared to a placebo, focusing on managing this liver condition characterized by metabolic syndrome components and liver fibrosis. Participants will be randomly assigned to one of three groups two groups receiving different dose levels of Efimosfermin Alfa and one group receiving a placebo. The study involves administering the drug or placebo injections over a period of up to 52 weeks. Researchers will monitor participants throughout this time to assess the drugs effects and tolerability. During the study, participants will undergo regular assessments including laboratory tests for liver enzymes and fibrosis markers, imaging tests such as magnetic resonance elastography and MRI-derived fat fraction measurements, and evaluations of metabolic factors like blood sugar and cholesterol. Safety will be closely monitored by tracking adverse events and laboratory abnormalities. The total participation time is about one year, during which participants will have scheduled visits for treatment and evaluation.

Researchers are evaluating efimosfermin alfa in adults with biopsy-confirmed metabolic dysfunction-associated steatohepatitis MASH and stage F2 or F3 liver fibrosis. The study aims to assess the safety and effectiveness of efimosfermin alfa compared to a placebo in resolving steatohepatitis and improving liver-related clinical outcomes. This Phase 3 trial is randomized, double-blind, and placebo-controlled, focusing on participants with specific liver conditions and metabolic syndrome components. Participants are assigned to one of three groups two groups receive different dose levels of efimosfermin alfa, while the third group receives a placebo. Treatments are given under controlled conditions, and the study follows a parallel design. The trial monitors participants at set intervals over a course of 52 weeks, with some outcomes tracked up to 48 months to evaluate long-term effects on liver fibrosis and steatohepatitis. During the study, participants undergo liver biopsies to confirm diagnosis and assess changes. Researchers evaluate improvements in fibrosis stage, steatohepatitis resolution, and various liver function measurements using imaging and blood tests. Safety is monitored by tracking adverse events and laboratory abnormalities. Quality of life and other health indicators are also assessed throughout the study, which lasts several years to capture both short- and long-term outcomes.

Researchers are studying weight reduction in adults living with obesity or overweight who also have type 2 diabetes. The study evaluates two drugs, macupatide and eloralintide, given alone or together, to understand their effects on body weight. This Phase 2 trial is designed to assess these treatments in a controlled setting with participants randomly assigned to different groups. Participants will receive one of four treatments macupatide with an eloralintide placebo, eloralintide with a macupatide placebo, both macupatide and eloralintide together, or double placebo. All drugs are administered by subcutaneous injection. The main treatment period lasts about 32 weeks, during which the effects on body weight and diabetes-related measures are monitored. Throughout the study, participants will have evaluations including body weight, hemoglobin A1c levels, body mass index, and fasting glucose at the start and at week 32. The study involves a total participation duration of about 48 weeks, allowing for treatment, follow-up, and monitoring. The sponsor is Eli Lilly and Company, and the trial uses double-blind, randomized design to compare treatments fairly.

Researchers are evaluating the effects of RSLV-132 in adult females with Primary Sjgren Syndrome pSS, a condition characterized by symptoms like fatigue, dryness, and pain. This Phase 2 clinical trial aims to determine if RSLV-132 improves these key symptoms, assess its safety, and study immune responses and blood levels of the drug over time. The study compares RSLV-132 to a placebo to understand its impact on symptom relief and safety in participants with moderate to severe symptom burden. Participants receive intravenous infusions of either 10 mgkg RSLV-132 or a placebo solution on Days 1, 8, 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, and 155, covering a total of 22 weeks of treatment. This double-blind, randomized study includes regular clinic visits weekly for the first two weeks, then every two weeks until the end of treatment, with a final follow-up visit at Day 211. Each infusion and visit involves monitoring and assessments to track progress and responses. During the study, participants will record their symptoms daily using an electronic device and attend scheduled clinic visits for check-ups, tests, and questionnaires. Researchers will assess fatigue and tiredness, measure drug levels and immune responses in blood samples, and monitor for any adverse events throughout and after treatment. The main outcome focuses on the evaluation of key symptoms of Sjgrens disease, with safety and immune response also closely observed until Day 211.

Researchers are evaluating the immune response and safety of an investigational combined measles, mumps, rubella, and varicella vaccine MMRVNS compared to the already licensed MMRV vaccine ProQuad. The study focuses on healthy children aged 15 months to 6 years who have previously received a first dose of any measles, mumps, rubella, and varicella-containing vaccine. This Phase 3a, randomized, observer-blind trial aims to assess prevention by comparing these two vaccines when given as a second dose intramuscularly. Participants receive a single intramuscular dose of either the investigational MMRVNS vaccine or the licensed MMRV vaccine on Day 1. The study uses a parallel design with two groups one receiving MMRVNS and the other receiving MMRV. The vaccines are administered as a second dose to children previously vaccinated according to their countrys immunization schedule. The study monitors participants closely for immune response and safety after vaccination. Throughout the study, children undergo assessments including blood tests to measure Immunoglobulin G IgG responses against measles, mumps, rubella, and varicella at Day 43. Safety evaluations include monitoring for injection site reactions, systemic events, and adverse events up to 181 days after vaccination. The study tracks solicited and unsolicited adverse events and serious adverse events to understand the safety profile. Participation lasts until study completion, with multiple follow-up periods to ensure thorough monitoring.

Researchers are evaluating the safety of an investigational varicella vaccine VNS Vaccine compared to an approved varicella vaccine called Varivax. This study focuses on healthy children aged 12 to 15 months who have not had chickenpox or received any varicella vaccine before. The goal is to understand how well the new vaccine is tolerated in this young population. Participants will receive one dose of either the investigational varicella vaccine or the marketed Varivax vaccine, both given by injection under the skin. Along with the varicella vaccine, each child will also receive one dose each of measles, mumps, and rubella MMR vaccine, hepatitis A vaccine, and a pneumococcal conjugate vaccine PCV, which may be PCV 13, Vaxneuvance, or PCV 20, depending on availability and national recommendations. All vaccines are given on the first day of the study. During the study, parents will record any side effects their child experiences, particularly those related to the injection site or systemic symptoms like fever, for up to 43 days. Researchers will monitor any adverse events, including serious and medically attended events, for up to 181 days after vaccination. This helps assess the safety and tolerability of the investigational vaccine over a period of about six months.

Bipolar disorder is a serious, long-lasting mood condition affecting both adults and children. This research focuses on studying the effects and safety of cariprazine, a medication approved for adults, in treating depressive episodes linked to bipolar I disorder in children and adolescents aged 10 to 17. The study aims to better understand how this drug impacts the pediatric population, where treatment options are currently limited. Participants will be randomly assigned to one of two groups one receiving cariprazine at flexible doses adjusted by age and weight, and the other receiving a placebo. The treatment lasts six weeks, with dose adjustments at week 3 depending on response. Following treatment, there is a four-week safety follow-up period. Weekly visits at clinics or hospitals will support monitoring and treatment. During the study, participants will undergo medical assessments, blood tests, questionnaires, and side effect checks to evaluate the drugs impact. Researchers will track changes in mood symptoms using scales like the Childrens Depression Rating Scale and monitor safety through vital signs, lab tests, and movement assessments. The total study participation spans around 10 weeks, including treatment and follow-up.

Researchers are evaluating the safety and immune response of a new multivalent pneumococcal vaccine called PG4 compared to the currently used 20-valent pneumococcal conjugate vaccine 20vPnC in healthy infants. The study aims to understand how well the new vaccine helps fight germs causing pneumonia, meningitis, and ear infections. This phase 3 trial involves infants aged 2 to 6 months and seeks to determine if the new vaccine is as safe as the existing one while assessing its immune response when given alongside other childhood vaccines. Participants are divided into three groups based on age and location. Group 1 includes about 3000 infants aged 2 months who receive either PG4 or 20vPnC by injection into the left thigh muscle at ages 2, 4, 6, and 12 to 15 months. Groups 2 and 3, with about 230 infants outside the United States aged 2 to 6 months, receive vaccinations on a slightly different schedule, with Group 3 exploring both intramuscular and subcutaneous administration of PG4. Participants have a randomized chance of receiving one of the study vaccines. During the study, infants will attend six clinic visits and one phone call where parents report any side effects. Blood samples will be collected three times to assess the immune response by measuring proteins that fight the germs. Researchers will track local and systemic reactions, adverse events, and serious adverse events throughout the study period, which lasts about 1 to 1.5 years depending on the group. The study monitors safety closely to compare the new vaccines effects with the current standard vaccine.

Researchers are evaluating the combined use of vicadrostat and empagliflozin in adults with chronic heart failure who have a reduced left ventricular ejection fraction LVEF below 40%. Participants must have had chronic heart failure diagnosed at least three months before starting the study. The trial aims to find out if this combination helps people with symptomatic heart failure classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups, with an equal chance of receiving either vicadrostat plus empagliflozin tablets or placebo plus empagliflozin tablets. The study medicines are taken once daily for approximately six months up to about 3.5 years. During this time, participants may continue their usual heart failure treatments, excluding certain medications. The trial includes a double-blind design, meaning neither participants nor study staff know who receives the active drug or placebo. Throughout the study, participants visit the study site regularly, with the number of visits depending on how long they stay enrolled. Some visits may occur by phone. They answer questions about their well-being, and doctors monitor health status, record any heart failure worsening, hospitalizations, or deaths. The main outcome is the time until cardiovascular death, heart failure hospitalization, or urgent heart failure visit, which is compared between groups. Safety and side effects are also closely followed during the trial.

Researchers are evaluating depemokimab as a treatment for adults aged 40 to 80 with moderate to severe chronic obstructive pulmonary disease COPD who have type 2 inflammation and uncontrolled symptoms despite standard care. The study aims to assess the safety and effectiveness of depemokimab compared to a placebo when added to the usual treatment. This phase 3 trial is sponsored by GlaxoSmithKline and focuses on reducing COPD exacerbations and improving respiratory symptoms over a long period. Participants will receive either depemokimab by subcutaneous injection alongside their standard inhaler therapy or a placebo injection plus standard care. The study is randomized, double-blind, and includes two groups one receiving depemokimab and the other a placebo, both continuing optimized inhaler treatments. This study will last up to 104 weeks, with regular assessments throughout. During the study, participants will undergo evaluations including lung function tests, symptom questionnaires such as the COPD assessment test and St. Georges Respiratory Questionnaire, and monitoring for COPD flare-ups or hospital visits. Researchers will track the number and severity of exacerbations and changes in quality of life measures. Safety and tolerability will also be closely monitored throughout the trial duration, which extends up to two years.