Lenexa

Researchers are evaluating the safety and tolerability of MRT-8102, an experimental oral drug, in healthy adults and in adults at cardiovascular risk with elevated C-reactive protein (CRP). This is the first time MRT-8102 will be given to humans. The study aims to gather safety, tolerability, and pharmacokinetic data to help determine suitable dosing for future research. The study has three parts: In Part 1, healthy participants will receive a single oral dose of MRT-8102 or placebo on Day 1. In Part 2, healthy participants will receive multiple oral doses of MRT-8102 or placebo for 7 consecutive days. In Part 3, participants at cardiovascular risk with elevated CRP will receive daily oral doses of MRT-8102 or placebo for 28 consecutive days. Participants will be monitored for safety and tolerability over different periods: 15 days for the single dose, 21 days for multiple doses in healthy adults, and 56 days for the 28-day dosing in participants at cardiovascular risk. Assessments will include clinical evaluations, laboratory tests, and monitoring for any side effects. The study will also collect pharmacokinetic data to understand how the drug is processed in the body.

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 conducting a Phase 1, randomized, observer-blind, placebo-controlled clinical trial to evaluate the safety and immune response of the rVSV6G-MARV-GP vaccine in adults who are in good general health. The study focuses on Marburg Virus Disease and aims to assess how well the vaccine is tolerated and how the body reacts to different doses. Approximately 112 participants between the ages of 18 and 50 will take part in this study. The trial involves a dose-escalation design where four groups receive increasing doses of the vaccine or placebo one step at a time. After each dose is given, safety assessments are conducted before moving to the next higher dose to monitor tolerability. Participants will receive either the rVSV6G-MARV-GP vaccine or a placebo during the study, with the gradual dosing method ensuring careful safety evaluation. Participants will be monitored for safety and immune response following vaccination. This includes tracking common side effects for up to 28 days and serious adverse events for 7 months. The study also involves HIV testing, risk counseling, pregnancy testing for those who can become pregnant, and requires participants to use contraception and condoms for specific periods. Follow-up visits will assess vaccine safety, immune response, and overall health over the study duration to ensure participant well-being.

Researchers are investigating how bone mineral density changes during long-term treatment with the relugolix combination tablet in premenopausal women aged 18 to 50 who have heavy menstrual bleeding caused by uterine fibroids or moderate to severe pain related to endometriosis. This Phase 3B, single-arm, open-label study aims to assess the safety and effects of up to 48 months (4 years) of continuous treatment, followed by a 1-year post-treatment follow-up period. Participants will receive a daily fixed-dose tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg. Bone mineral density will be monitored every 6 months using dual-energy X-ray absorptiometry during treatment. Some women who completed a prior related study may join for 3 years of treatment under this protocol. After treatment ends or if stopped early, participants will be followed for 1 year with bone density checks at 6 and 12 months. Women in the study will have regular physical, gynecological, and laboratory assessments to monitor health and treatment effects. Researchers will measure the percentage change from baseline in bone mineral density at the lumbar spine after 48 months of treatment. Safety and health status will be closely observed throughout the treatment and follow-up periods to understand the long-term impact of the relugolix combination tablet on bone health.

This research focuses on men with prostate cancer who have previously participated in an enzalutamide clinical study sponsored by Astellas or Medivation. It aims to gather long-term safety information from participants who continue to benefit from enzalutamide treatment. This is a Phase 2 open-label extension study designed to monitor ongoing treatment effects after the initial study has completed its primary analysis or evaluation period. Participants will continue their previous treatment regimens, which may include enzalutamide taken orally once daily. Some may also receive abiraterone acetate with prednisone or leuprolide acetate depending on their prior study enrollment. Dose adjustments are allowed with medical monitor approval. The first visit of this study should occur within seven days of the last visit of the prior study unless treatment is temporarily paused. Participants are asked to return to their study site every 24 weeks for safety reviews, including adverse event monitoring and medication checks. At visits every 12 weeks, participants return unused study drugs and receive new supplies if needed. Safety data, including all adverse events and serious adverse events, are collected from consent until study completion, which may last up to 96 months. The study follows local standard care guidelines and includes a post-marketing phase in South Korea.

Researchers are studying the effects of two experimental drugs, pozelimab and cemdisiran, in adults aged 50 to 85 who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD), a condition that affects central vision. The study aims to compare how quickly GA progresses in patients treated with cemdisiran alone, a combination of pozelimab and cemdisiran, or a placebo. Additional goals include monitoring possible side effects, measuring drug levels in the blood, and checking for antibodies that might reduce drug effectiveness or cause side effects. Participants receive subcutaneous injections of either pozelimab combined with cemdisiran, cemdisiran alone, or a placebo. The study is randomized, double-masked, and placebo-controlled, conducted at multiple centers. Treatment schedules and dosing are managed as described in the protocol, with vaccinations for meningococcal and pneumococcal infections required prior to participation. Throughout the study, participants undergo regular clinic visits where eye imaging using Fundus Autofluorescence (FAF) tracks the progression of GA lesion area over 52 weeks. Researchers also monitor safety, side effects, and immune responses, ensuring adherence to study procedures. The main outcome measured is the growth rate of the GA lesion area over one year, helping to evaluate the potential benefits and risks of the study drugs.

Researchers are conducting a Phase I clinical trial to assess the safety, tolerability, and pharmacokinetics of a single dose of IBI3032 in healthy adult volunteers. This randomized, double-blind, placebo-controlled study involves a single ascending dose design to evaluate how the drug behaves in the body and its potential side effects. Approximately 32 healthy participants will be enrolled to provide initial safety data for this investigational treatment. Participants will be divided into four groups of eight individuals each. Within each group, six participants will receive a single oral dose of IBI3032 after fasting, while two will receive a matching placebo without active ingredients, also administered orally in a fasted state. The study includes a screening period lasting up to four weeks before dosing, followed by a safety monitoring period of 15 days after administration to observe any adverse effects. Throughout the study, participants will undergo laboratory tests and medical evaluations to confirm health status and monitor safety. Researchers will track the number and severity of any adverse events or serious adverse events occurring from baseline through 15 days post-dose, with particular attention to those related to the study drug. This study is solely for research purposes and does not provide treatment for any medical condition.

Researchers are evaluating the safety and side effects of LY4088044 in healthy adult participants aged 18 to 65 years. This Phase 1 study aims to understand how well LY4088044 is tolerated when given to healthy people and to measure how the drug moves through and is processed by the body. The study includes monitoring for any serious adverse events related to the drug up to about day 190. Participants will receive LY4088044 or a placebo administered either under the skin (subcutaneously) or through a vein in the arm (intravenously). The study includes single and multiple ascending doses to assess safety and drug behavior. The treatment period covers Parts A, B, and C, lasting up to approximately 92 weeks, not including the screening phase. Throughout the study, participants will undergo blood tests to measure LY4088044 levels in the bloodstream and assess how the body eliminates the drug. Researchers will also perform medical evaluations including physical exams, vital signs, laboratory tests, cardiac monitoring, and track any serious side effects. Safety and tolerability are the main outcomes monitored during the study period.

Researchers are evaluating the safety, immune response, and clinical efficacy of a candidate urinary tract infection (UTI) vaccine in adults aged 18 to 64 years. This study includes two parts: Part 1 focuses on escalating doses of the vaccine in healthy participants to assess safety, while Part 2 evaluates the vaccine's effectiveness in females with a recent history of E. coli-confirmed UTI. The study is designed as a Phase 1/2, observer-blind, randomized, placebo-controlled trial conducted across multiple centers. Participants receive different formulations of the candidate UTI vaccine or placebo given by intramuscular injection on a schedule of two doses, separated by two months. Part 1 involves a safety lead-in with increasing antigen doses, and Part 2 begins after reviewing safety data from Part 1, focusing on effectiveness in women who have had at least one confirmed UTI episode in the previous year. Both parts follow the same dosing schedule and include placebo groups for comparison. Participants will be monitored for adverse events, including local and systemic reactions within 7 days after each dose and any unsolicited events within 30 days. Serious adverse events and immune-related conditions leading to withdrawal will be tracked throughout the study, which lasts up to 426 days from the first dose. Blood tests will assess laboratory changes, and urinary tract infection rates will be recorded in Part 2. Safety and immune response data will be collected to evaluate the vaccine's profile over the study period.

Researchers are evaluating the safety and tolerability of GIGA-2339, given as single and multiple intravenous doses, in adults with chronic Hepatitis B Virus (HBV) infection. This Phase 1, randomized, double-blind, placebo-controlled study focuses on participants who are HBeAg negative and have stable or no nucleos(t)ide analogue treatment. The study aims to monitor adverse events and pharmacokinetics of GIGA-2339. Participants will receive either GIGA-2339 or placebo by intravenous infusion. The study includes single ascending dose (SAD) and multiple ascending dose (MAD) periods, with safety monitored up to Day 105 for SAD and up to Day 245 for MAD. The dosing schedule and details are arranged to assess how the body processes the drug and how well it is tolerated. During the study, participants will undergo evaluations including laboratory tests, ECGs, liver imaging, and monitoring for treatment-emergent adverse events. Researchers will track drug levels and safety signals throughout the study. Participants are expected to remain on stable antiviral therapy if applicable and use contraception as required. The overall participation timeframe covers the dosing and follow-up periods to ensure thorough safety assessment.