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Found 47 Actively Recruiting clinical trials
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Researchers are studying a medicine called MK-8527 to understand how it behaves in the bodies of healthy adults aged 18 to 55. The study aims to learn how MK-8527 interacts when taken with food or combined with other medicines like probenecid and itraconazole. The goal is also to assess the safety of MK-8527 and whether participants can tolerate it without needing to stop due to health issues. Participants will receive single doses of MK-8527 under different conditions with food and without food, alone and combined with probenecid, and alone and combined with itraconazole. This crossover study allows each participant to experience all these dosing scenarios to compare how the medicine behaves in each case. During the study, participants will be monitored through blood and urine tests at specified times up to 336 hours after dosing to measure MK-8527 levels and its clearance. Researchers will also track any side effects or reasons for stopping treatment over approximately 43 days. The study is conducted by Merck Sharp & Dohme LLC and is expected to complete in October 2026.
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This research aims to evaluate the safety and effectiveness of the FloStent, a medical device used for treating men experiencing symptoms of Benign Prostatic Hyperplasia BPH. The study compares the FloStent implant procedure to a sham procedure without deploying the device. It involves men aged 45 and older with symptomatic BPH to better understand how this device may impact urinary symptoms. Participants will undergo a flexible cystoscopy procedure. Those randomized to the treatment group will receive the FloStent implant during this procedure, while those in the control group will have the cystoscopy without the implant deployment, serving as a sham treatment. The study is randomized, double-blind, and includes parallel groups to compare outcomes over time. Throughout the study, participants will be assessed on changes in their International Prostate Symptom Score IPSS over 12 months. Researchers will monitor symptom improvements at 3, 6, and 12 months to evaluate response rates. Participants will complete study visits and follow the protocol to help researchers gather data on the devices safety and impact on urinary symptoms.
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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.
Actively Recruiting
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.
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Researchers are evaluating the efficacy and safety of azenosertib ZN-c3, an oral drug that inhibits WEE1, in people with platinum-resistant, high-grade serous ovarian, fallopian tube, or primary peritoneal cancer. This Phase 2 study includes patients whose tumors test positive for Cyclin E1 protein. The study is designed to understand how azenosertib affects cancer cell growth by allowing damaged cells to continue the cell cycle, leading to cancer cell death. The study has two parts Part 1 included all patients regardless of biomarker status and has completed enrollment. Part 2 focuses on patients with Cyclin E1 positive tumors. Participants receive azenosertib orally at doses of either 300mg or 400mg daily, following a schedule of five days on treatment followed by two days off. Several study arms explore different dosing groups within this intermittent treatment plan. Participants will be monitored for up to approximately 12 months after the last patients enrollment. The study includes regular assessments of tumor response using RECIST criteria, measurement of biomarkers like CA-125, and tracking of side effects. Researchers will measure objective response rate as the primary outcome, along with duration of response, progression-free survival, clinical benefit rate, and treatment-emergent adverse events. This comprehensive monitoring aims to understand the treatments effects and safety profile over time.
Actively Recruiting
Researchers are evaluating brenipatide alongside buprenorphine, with or without naloxone, to assess its safety and effectiveness in people with opioid use disorder. This Phase 2 study includes two separate participant groups Part A involves a double-blind treatment phase with a later open-label extension, and Part B features an open-label treatment phase. Participants join only one part of the study. In Part A, participants receive either brenipatide or a placebo by subcutaneous injection plus buprenorphine taken under the tongue or inside the cheek. Part B participants receive open-label brenipatide injections with buprenorphine. The maximum study participation duration is about 144 weeks for Part A and 116 weeks for Part B, depending on enrollment timing and pace. Treatments are given as subcutaneous injections and transmucosal buprenorphine. Participants will attend regular study visits to monitor opioid use through urine drug screens and self-reports, track adherence to buprenorphine, and assess cravings and quality of life. Other measurements include changes in body weight, blood pressure, and healthcare visits. Safety is monitored throughout, and the main outcome focuses on weeks of abstinence from opioid use between weeks 13 and 24. Total participation time varies with study part and enrollment timing.
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Researchers are evaluating the long-term safety of buntanetap in people with Parkinsons Disease PD. This 36-month open-label study involves two groups one includes PD participants previously in buntanetap trials, and the other includes participants receiving deep brain stimulation DBS treatment. The study aims to monitor safety and adverse events related to buntanetap over an extended period. Qualified participants will take buntanetap capsules at a dose of 30 mg once daily after a screening period lasting up to 42 days. Cohort 1 includes those invited from prior buntanetap studies, while Cohort 2 consists of PD participants treated with DBS in specific brain areas for at least 12 months. Medication adjustments are required before visits to observe participants in an OFF medication state. Throughout the study, participants will have regular assessments conducted by trained clinicians using tools like MMSE, MoCA, C-SSRS, and MDS-UPDRS to evaluate cognitive and motor functions. Safety will be closely monitored, focusing on adverse events during the full 36 months. Support persons will accompany participants to visits, and medication stability and general health will be regularly evaluated to ensure study compliance and participant well-being.
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Researchers are evaluating disitamab vedotin alone or combined with pembrolizumab to treat urothelial cancer that expresses HER2. This study focuses on participants with locally advanced or metastatic urothelial cancer that cannot be removed by surgery. It aims to assess how well the drug works and to monitor the side effects experienced by participants. Participants receive disitamab vedotin intravenously every 2 weeks, either alone or with pembrolizumab given by intravenous infusion on Day 1 of each 6-week cycle. The study includes multiple cohorts receiving different combinations or monotherapy treatments. The treatment period and monitoring last approximately 2 years, with ongoing assessments of drug effects and safety. During the study, participants undergo regular evaluations including imaging scans to measure tumor response, laboratory tests, electrocardiograms to monitor heart function, and assessments of side effects. Researchers measure treatment response using established cancer evaluation criteria and track survival and disease control over about 3 years. Participants are closely monitored for adverse effects and blood levels of the drugs to understand how the treatments behave in the body.
Actively Recruiting
Researchers are evaluating the efficacy and safety of eloralintide compared with placebo for reducing body weight in adults with overweight or obesity who also have type 2 diabetes. This phase 3 study is designed to assess the treatments effects over a course of about 75 weeks, aiming to provide insights into managing weight in this population. Participants are randomly assigned to receive one of several doses of eloralintide or a placebo, all administered by weekly subcutaneous injections. The study involves a double-blind design, meaning neither participants nor researchers know which treatment is given. The treatment period lasts 64 weeks, during which body weight and other health measures are closely monitored. Participants will undergo regular assessments including measurements of body weight, fat mass, waist circumference, blood sugar control HbA1c, blood pressure, and other health indicators. Questionnaires about quality of life and eating behavior are also used. Safety and medication use changes are tracked throughout. Participation includes screening, treatment, and follow-up visits over the total duration of about 75 weeks.
Actively Recruiting
Healthy Volunteer
Researchers are evaluating three different forms of LY4065967a tablet and two types of capsulesin healthy adult participants to understand how much and how quickly each form enters the bloodstream after being swallowed. This Phase 1, randomized, open-label, crossover study aims to compare the relative bioavailability of these formulations while monitoring for any side effects. The study is sponsored by Eli Lilly and Company and focuses on basic science to improve knowledge of LY4065967 pharmacokinetics. Participants will receive LY4065967 orally in three separate treatment periods, each involving one of the three formulations a tablet, a capsule, or a formulated capsule. The treatment periods are organized in a crossover design, meaning each participant will receive all three forms in sequence. Each treatment period includes a stay of 3 nights in a Clinical Research Unit. Across the study, participants will have three such stays totaling about 7 weeks of involvement. During the study, participants will undergo medical evaluations including blood sampling to measure drug concentrations over time, electrocardiograms, and laboratory tests to assess health status and monitor safety. Researchers will measure pharmacokinetic outcomes such as maximum drug concentration and the area under the concentration-time curve. Throughout the study, side effects and drug absorption rates will be monitored. The total participation time lasts approximately 7 weeks, including three inpatient stays for detailed observation and testing.
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