Lenexa

Researchers are evaluating whether two drugs, retatrutide and tirzepatide, can prevent serious liver problems in adults with metabolic dysfunction-associated steatotic liver disease MASLD who are at high risk based on non-invasive tests. This Phase 3 randomized clinical trial plans to enroll about 4,500 adults and will last approximately 224 weeks, including up to 25 to 30 clinic visits to monitor health and liver disease progression. The study is sponsored by Eli Lilly and Company. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. After completing the main study, eligible participants may join a 2-year extension where everyone receives either retatrutide or tirzepatide, regardless of their original group. This Master Protocol evaluates multiple pharmacologic agents under controlled conditions. Throughout the study, participants will undergo various assessments including liver function tests, imaging to measure liver stiffness and fat content, and body weight measurements. Researchers will track the time to major adverse liver outcomes and cardiovascular events. Safety and disease progression will be closely monitored, and the study includes evaluations at baseline, week 104, and up to study completion.

Researchers are studying the safety and immune response of the rVSV6G-MARV-GP vaccine in adults who are in good general health. This Phase 1 clinical trial uses a randomized, observer-blind, placebo-controlled design to evaluate different dose levels of the vaccine. The study focuses on understanding how the vaccine affects the body and its ability to trigger an immune response against Marburg Virus Disease. Participants will receive one of four different dose levels of the rVSV6G-MARV-GP vaccine or a placebo. The dosing starts at the lowest level and gradually increases after safety checks at each stage. About 112 adults will be involved, and the vaccine or placebo will be given following a careful dose-escalation plan to ensure safety at each step. During the study, participants will be monitored closely for safety, including common side effects and serious adverse events up to seven months after vaccination. Their immune response will be measured through blood tests over six months to assess antibody levels and neutralization. The trial includes regular follow-up visits and testing, with a total participation duration extending up to several months to evaluate both short and longer-term effects of the vaccine.

Researchers are evaluating changes in bone mineral density in premenopausal women with heavy menstrual bleeding caused by uterine fibroids or moderate-to-severe pain from endometriosis. This Phase 3B, open-label study looks at the effects of continuous treatment with a relugolix combination tablet for up to 48 months 4 years, followed by a 1-year period to monitor bone health after stopping treatment. Participants will take a daily oral relugolix combination tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg for 4 years. Bone mineral density will be measured every 6 months using dual-energy X-ray absorptiometry DXA. Some women who have completed a previous related study may join to complete 3 years of treatment. After treatment ends, bone density will be checked again at 6 months and 12 months during the follow-up year. Women in the study will have regular visits for bone density scans and health assessments, including physical and gynecological exams, lab tests, and vital signs. Researchers will track changes in bone density at the spine, hip, and femoral neck throughout treatment and follow-up. They will also monitor for any fractures or adverse events during the 4 years of treatment and the 1-year post-treatment period. Total participation can last up to 5 years including the follow-up.

This research aims to gather long-term safety information from men with prostate cancer who have previously been treated with enzalutamide in an earlier study sponsored by Astellas or Medivation. The study focuses on participants who are still benefiting from enzalutamide treatment after the primary analysis or evaluation period of their prior trial has ended. Participants will continue taking the same treatment they received in their previous study, including enzalutamide once daily. Depending on which prior study they were part of, some may also take additional medications like abiraterone acetate with prednisone, or leuprolide acetate every 12 weeks alongside enzalutamide. Any dose changes require medical approval. The study also continued as a post-marketing clinical study in South Korea after local drug approval. During the study, participants will visit their institution every 24 weeks to review any side effects, medications, and confirm eligibility to continue. They will return every 12 weeks to return and receive study medication if applicable. Researchers will collect and monitor all adverse events, including serious ones, from consent until study completion, up to 96 months. This allows for thorough long-term safety monitoring while participants follow their usual care.

Researchers are studying the effects of experimental drugs called pozelimab and cemdisiran on people with Geographic Atrophy GA, a late stage of Age-related Macular Degeneration AMD that affects central vision. The trial aims to compare the rate at which GA progresses in patients receiving cemdisiran alone, pozelimab combined with cemdisiran, or a placebo. The study also explores possible side effects, how much of the drugs remain in the blood over time, and whether the body develops antibodies that might impact treatment. Participants are randomly assigned to one of three groups one receiving both pozelimab and cemdisiran, one receiving cemdisiran alone, and one receiving a placebo. All treatments are given by subcutaneous injection. The study is conducted in a double-masked manner to ensure unbiased results. Vaccinations against meningococcal and pneumococcal infections are required before participation. During the study, participants will attend regular clinic visits where eye imaging and vision tests will be performed to monitor the size of GA lesions and changes in visual acuity. Blood samples will be taken to measure drug levels and antibody development. The primary outcome is the growth rate of GA lesion area over 52 weeks. Safety will be monitored throughout and up to nearly six years. The overall study duration allows detailed assessment of treatment effects and tolerability.

Researchers are conducting a randomized, double-blind, placebo-controlled Phase I study to evaluate the safety, tolerability, and pharmacokinetics of a single dose of IBI3032 in healthy adults. This study is a single ascending dose trial involving approximately 32 healthy participants and is intended for research purposes only, not treatment of any condition. Participants will be divided into four groups cohorts of eight people each. In each cohort, six participants will receive a single oral dose of IBI3032, and two will receive a placebo, all given while fasting. The different cohorts will receive escalating doses of IBI3032 or placebo. The study includes a screening period of four weeks, followed by dosing and then a safety follow-up lasting 15 days. During the study, participants will undergo safety and laboratory assessments to ensure they are healthy and monitor any adverse effects from the drug or placebo. Researchers will track serious and non-serious adverse events up to 15 days after dosing. Blood samples will be collected up to 168 hours post-dose to study how the drug is processed in the body. Overall participation will last through the screening, dosing, and 15-day safety follow-up periods.

Researchers are evaluating LY4088044, a drug given either under the skin subcutaneously or into a vein intravenously, to see how well it is tolerated and to identify any side effects in healthy adults. This Phase 1 study is sponsored by Eli Lilly and Company and focuses on assessing the safety, how the drug moves through and is processed by the body, and its effects. The study is designed to include single and multiple increasing doses to better understand LY4088044s behavior in the body. The study includes three parts Part A and Part B involve single ascending doses of LY4088044 given intravenously or subcutaneously, while Part C includes multiple ascending doses given intravenously. Participants may receive either the study drug LY4088044 or a placebo, with treatment assignments made randomly and the study conducted in a double-blind manner. The drug is administered using injections either under the skin or into the vein. Participants will be monitored for up to approximately 92 weeks, excluding screening. Throughout the study, blood tests will be performed to measure how much LY4088044 enters the bloodstream and how quickly it is eliminated. Researchers will also monitor for serious side effects possibly related to the drug, and assess protein levels in skin samples. Safety checks include medical exams, vital signs, laboratory tests, and cardiac monitoring. The main outcome is the number of serious adverse events related to the study drug occurring up to about 190 days after dosing.

Researchers are evaluating the safety, immune response, and preliminary clinical efficacy of a candidate vaccine for urinary tract infections UTIs in adults aged 18 to 64 years. This trial focuses on adults generally for safety and immune response, and specifically on females with a history of at least one confirmed E. coli UTI within the past year for clinical efficacy. The study includes two parts an initial dose-escalation safety phase and a proof-of-principle efficacy phase, designed to establish the highest tolerated dose and evaluate the vaccines impact on UTI occurrence. Participants receive one of several vaccine dose formulations or placebo administered by injection on Day 1 and Day 61. Part 1 involves healthy male and female adults and tests increasing antigen doses for safety. After safety review, Part 2 enrolls females with previous E. coli UTIs to assess vaccine efficacy compared to placebo over a 12-month period. The vaccine is given intramuscularly following a 0 and 2 months schedule. Throughout the study, participants are monitored for side effects at the injection site and systemic reactions during the first week after each dose, as well as for any adverse events up to 426 days from the first dose. Blood tests, pregnancy monitoring, and clinical exams are conducted. The main outcome measures include the frequency of adverse events and the rate of urine culture confirmed UTIs in females during the follow-up period. Participants are followed closely for safety and immune response, with the trial lasting over a year from initial vaccination.

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 aims to better understand how the drug behaves in the body and its safety profile in participants with this long-term viral infection. Participants receive either a single intravenous infusion of GIGA-2339 or placebo in ascending doses on Day 1. In the multiple ascending dose part, they receive repeated infusions every 4 weeks at a dose determined from the single dose part. The study has two parts Part 1 assesses single ascending doses and Part 2 evaluates multiple ascending doses of the study drug or placebo. Throughout the study, participants undergo regular safety assessments, including monitoring for any treatment-emergent or serious adverse events up to Day 105 for single doses and Day 245 for multiple doses. Blood samples are collected at various times to measure drug levels and pharmacokinetics. The study lasts several months, with detailed evaluations of how the drug is processed in the body and its potential side effects.

Researchers are evaluating BMS-986470, a new drug, in healthy volunteers and people with sickle cell disease to study its safety, how the body processes it, how it affects blood pH and food interactions, and its early effects. This Phase 12a, randomized, double-blinded, placebo-controlled study aims to find the right dose and understand tolerability over a long period. Participants receive BMS-986470 or placebo, sometimes with famotidine, at specific doses and days across different study groups called cohorts. The trial includes multiple parts focusing on dose finding and effect evaluations. Some participants are healthy adults without childbearing potential, while others have sickle cell disease with specific genotypes and recent vaso-occlusive crises. During the study, participants are closely monitored for safety, including adverse events for up to 26 months. Researchers measure blood drug levels and hemoglobin changes, including sickle and fetal hemoglobin fractions, and markers of red blood cell breakdown. The study tracks treatment effects over weeks to months with lab tests, physical exams, and vital signs to assess the drugs impact and safety.