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Found 61 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the efficacy and safety of elecoglipron, an oral tablet taken once daily, for weight management in adults with obesity or overweight. This Phase III global, randomized, double-blind, placebo-controlled trial includes two independent pivotal studies one in adults without type 2 diabetes T2DM and the other in adults with T2DM, all having at least one weight-related health condition. The goal is to understand how elecoglipron compares to placebo when combined with diet and exercise. Participants will be randomly assigned to receive either one of two doses of elecoglipron or a matching placebo daily. Study 1 involves about 3000 adults living with obesity or overweight without T2DM, while Study 2 involves about 1500 adults with obesity or overweight and T2DM. Both studies last 72 weeks, during which changes in body weight and other health measures will be monitored. During the trial, participants will undergo regular health assessments including measurements of body weight, waist circumference, blood sugar control, blood pressure, and other related health indicators. Researchers will track percent change in body weight from baseline at 72 weeks as the primary outcome. Participants will be monitored closely throughout the study to assess safety and effectiveness of the treatment in managing weight and associated health conditions.
Actively Recruiting
Researchers are studying treatments for patients with hormone receptor-positive HR-positive and HER2-negative early-stage breast cancer who are at higher risk of relapse after surgery. This phase II, open-label study focuses on using a biomarker called circulating tumor DNA ctDNA to monitor minimal residual disease. The goal is to identify patients at molecular relapse and evaluate whether treatment at this stage can improve outcomes. The study involves multiple centers and is designed to test different treatment options based on ctDNA results. The study has three phases pre-screening, molecular follow-up ctDNA surveillance, and treatment. After giving consent, about 976 eligible patients will enter the ctDNA surveillance phase where tumor tissue and blood samples are collected to create a personalized mutation panel. Blood samples will be analyzed every three months during the first year and every six months thereafter to detect ctDNA. When ctDNA positivity is confirmed, up to 40 patients will be assigned sequentially to one of four treatment arms continuing standard endocrine therapy ET, giredestrant alone, giredestrant with abemaciclib, or giredestrant with inavolisib. Treatments are taken orally in cycles lasting 28 days and may continue up to five years or until disease recurrence or unacceptable side effects. Male and premenopausal participants receive additional hormone therapy LHRH agonist as needed. Participants will undergo regular blood sample collections during surveillance and treatment to monitor ctDNA levels and correlate changes with treatment response. Safety and side effects will be tracked throughout the treatment phase, which can last up to five years. After stopping treatment, patients enter a follow-up period where survival and new cancer therapies are recorded every three months. The primary outcome is measuring a decrease or clearance of ctDNA three months after starting treatment. Secondary outcomes include various ctDNA changes over time and treatment-related adverse events. Additional treatment arms may be added based on ongoing results.
Actively Recruiting
Researchers are conducting a prospective, multicenter observational study to create a registry for patients with unresectable locally advanced or metastatic breast cancer. This study includes patients diagnosed from January 2016 onwards, either at first diagnosis or after recurrence. Treatment choices are made independently by physicians, and the study does not specify any treatment regimen. The study groups are defined by breast cancer subtypes based on receptor expression, including Luminal A-like, Luminal B-like HER2 negative and positive, HER2-enriched, and Triple Negative subtypes. Since this is an observational study, patients receive standard care as determined by their doctors, and no intervention is assigned by the study. Participants medical records and disease management data will be collected and reviewed over an 8-year period. Researchers will evaluate the distribution of breast cancer subtypes, patient and tumor characteristics, hereditary risk factors, gender differences in disease progression, timing of primary tumor surgery, and biomarker presence in tumor and blood samples. Patients may withdraw consent at any time, and the study aims to follow patients until death or study completion.
Actively Recruiting
Researchers are investigating whether a coronary CT angiography CCTA-guided calcium modification approach can improve the treatment of patients with significant calcified coronary artery disease undergoing percutaneous coronary intervention PCI. This prospective, multicenter, randomized controlled trial compares the CCTA-guided strategy to the current standard of care using intravascular ultrasound IVUS-guided PCI. The study aims to see if the CT-based approach can improve procedural efficiency and stent results while maintaining similar clinical outcomes to IVUS guidance. Participants will be randomly assigned to one of two groups one using CCTA to inform calcium modification and plaque preparation before PCI, and the other using IVUS imaging to guide the procedure. Both groups undergo imaging to evaluate lesion characteristics before the procedure, with IVUS also used after stent placement to confirm correct implantation. The trial includes two main goals showing superiority in minimal stent area by IVUS and demonstrating non-inferiority in 12-month target vessel failure rates. During the study, participants receive imaging and PCI treatments according to their assigned group. Researchers will collect data on procedure time, radiation exposure, contrast volume, and detailed stent measurements. Clinical safety outcomes such as myocardial infarction and stent thrombosis will be monitored up to 12 months, along with patient-reported angina symptoms. Total participant involvement spans the procedure and follow-up assessments to evaluate both imaging and clinical outcomes.
Actively Recruiting
Researchers are studying the use of bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin, known as triple therapy, in adults with primary hypercholesterolemia or mixed dyslipidemia. The study aims to evaluate the effectiveness and safety of this combination in real-world clinical practice, focusing on lowering LDL cholesterol LDL-C levels. This is an observational study, meaning no drugs are administered by the study team instead, existing treatments are monitored. Participants are adults who have started triple therapy within the past four weeks and are followed for up to one year. The study looks at LDL-C changes after 8 weeks and 1 year of treatment, adherence to the therapy, side effects, and cardiovascular events such as heart attacks and strokes. No new treatments are given instead, researchers collect information on the participants ongoing treatments involving bempedoic acid, ezetimibe, and either rosuvastatin or atorvastatin. During the study, participants LDL-C levels, laboratory values, and treatment adherence are regularly reviewed. Researchers will also record any adverse events and track major cardiovascular events over the year. The primary measurement is the change in LDL-C from before treatment to 8 weeks after starting triple therapy. Participants health is followed through routine clinical assessments, and the study lasts for up to one year after beginning triple therapy.
Actively Recruiting
Researchers are evaluating if adding LY3537982 olomorasib to standard anti-cancer drugs improves treatment for participants with untreated advanced non-small cell lung cancer NSCLC that has a specific KRAS G12C gene change. This Phase 3 treatment study includes participants with locally advanced or metastatic NSCLC and aims to compare this combination against standard care. The study is sponsored by Eli Lilly and Company and could last up to 3 years depending on individual response and disease progression. Participants receive LY3537982 orally combined with pembrolizumab given intravenously in 21-day cycles. Some groups also receive chemotherapy drugs pemetrexed and platinum cisplatin or carboplatin intravenously. There are different dose levels and combinations being tested, including placebo groups for comparison. Treatment continues until specific discontinuation criteria are met. Parts of the study are randomized and double-blinded, with some parts non-randomized for safety lead-in. During the study, participants have regular assessments including imaging scans to measure tumor response, blood tests, and questionnaires about symptoms and quality of life. Researchers monitor side effects and survival outcomes. The main measures include progression-free survival and treatment-emergent adverse events over about one year, with overall survival followed for up to three years. Participants are closely followed throughout treatment and after to evaluate the effects and safety of the study medications.
Actively Recruiting
This research aims to observe the real-life effectiveness, safety, and patient-reported outcomes of standard antimyeloma treatments in adults with previously treated relapsed andor refractory multiple myeloma over a 24-month period. The study focuses on participants receiving routine care for this condition as part of their regular medical treatment. Participants with relapsed or refractory multiple myeloma undergoing standard antimyeloma treatments in routine clinical practice will be observed. There is no investigational treatment administered by the study instead, medical records will be the primary data source to track treatments and outcomes during the study. During the study, participants medical records will be reviewed to assess response rates, survival, disease progression, quality of life, and adverse events over up to 52 months. Patient health and well-being will be monitored using standardized questionnaires, and safety will be evaluated through reported side effects. The overall involvement includes observation and data collection without changing the participants treatment plans.
Actively Recruiting
Multiple myeloma MM is a cancer affecting plasma cells in the blood, often found in bones and bone marrow. It can cause bone pain, fractures, infections, weaker bones, and kidney failure. Researchers are studying the investigational drug Etentamig to understand its side effects, impact on disease activity, and how it behaves in the body for adults with MM. This study is conducted in two phases, phase 2 and phase 3, involving about 660 adult participants worldwide who have newly diagnosed MM and are not eligible for transplant. In phase 2, participants receive one of three doses of Etentamig combined with daratumumab in phase 3, participants receive the recommended phase 3 dose RP3D of Etentamig with daratumumab or a combination of daratumumab, lenalidomide, and dexamethasone DRd. Etentamig is given as intravenous infusions, daratumumab as subcutaneous injections, lenalidomide as capsules, and dexamethasone as oral tablets or intravenous injections. The study lasts approximately 16 years, with treatments continuing until the recommended dose is reached or as part of the study duration. Participants will attend regular hospital or clinic visits where their response to treatment will be monitored through medical exams, blood tests, side effect checks, and questionnaires. Researchers will measure outcomes like adverse events, disease activity changes, minimal residual disease rates, progression-free survival, and overall survival over up to 16 years. The study aims to assess both safety and disease control with ongoing monitoring and evaluations throughout the long study period.
Actively Recruiting
This trial investigates the effectiveness and safety of two treatment combinations for people with relapsed or refractory multiple myeloma who have received one to three prior treatments and were previously treated with lenalidomide. It compares mezigdomide, bortezomib, and dexamethasone MeziVd against pomalidomide, bortezomib, and dexamethasone PVd to see which is better for this condition. The study is a Phase 3, randomized, open-label trial sponsored by Celgene. Participants receive either the MeziVd combination or the PVd combination, with specified doses given on certain days according to the study plan. These treatments are given as drugs, and participants are randomly assigned to one of these two groups to compare their effects. The study will continue for up to approximately five years to evaluate long-term outcomes. During the study, participants will be monitored regularly through various assessments including measuring disease progression, survival, response to treatment, and quality of life using specific questionnaires EORTC QLQ-C30 and QLQ-MY20. Blood samples may be checked for drug levels, and adverse events will be tracked. The main focus is progression-free survival, measured from randomization until disease worsening or death. Participants health and responses will be followed for up to five years, with ongoing visits and evaluations throughout this period.
Actively Recruiting
This trial evaluates the safety and effectiveness of GSK4532990 in adults aged 18 to 70 who have alcohol-related liver disease, including those with advanced chronic liver disease. The study aims to understand how this drug affects liver health, including changes in liver stiffness and liver disease severity over time, compared to a placebo. It is a phase 2, double-blind, placebo-controlled trial sponsored by GlaxoSmithKline. Participants will be assigned to receive one of four doses of GSK4532990 or a placebo. The study uses a sequential design where dosing and treatment effects are monitored closely. Treatment and safety assessments are conducted up to 8 weeks, with liver measurements taken at baseline and at 52 weeks to evaluate long-term effects. During the trial, participants will undergo regular safety evaluations including monitoring for adverse events, heart and vital sign checks, and laboratory tests. Liver stiffness and disease severity scores will be measured at the start and after one year. Additional blood tests will assess drug levels and liver function. The total study participation includes initial screening, treatment, and follow-up visits lasting up to 52 weeks.
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