Trencin

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

Researchers are evaluating faricimab in patients with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) affecting at least one eye. The study, called FaReal, aims to assess the effectiveness, safety, clinical insights, and treatment patterns of faricimab in real-world routine clinical practice over a two-year follow-up period. It also seeks to describe and evaluate health economic aspects related to prior anti-VEGF treatments and current faricimab therapy. Faricimab will be given following local clinical practice and labeling guidelines. Patients must have started faricimab treatment at or within three months before signing consent and have received at least one dose in the study eye. The study does not specify fixed dosing schedules but observes real-world use over time. Participants will have data collected on visual acuity and central subfield thickness at baseline and throughout the study. The main outcome measure is the change in visual acuity from the start date to 12 months. Data on treatment safety, clinical practice insights, and health economic factors will also be gathered. The total follow-up period for patients is two years, allowing for long-term monitoring of treatment effects and safety.

This research aims to evaluate the safety and effectiveness of BMS-986504, a selective PRMT5 inhibitor, when combined with Nab-paclitaxel and Gemcitabine, compared to a placebo combined with Nab-paclitaxel and Gemcitabine. The study focuses on participants with untreated metastatic Pancreatic Ductal Adenocarcinoma (PDAC) who have a specific genetic alteration called homozygous MTAP deletion. This is a randomized Phase 2/3 trial designed to explore treatment options for this patient population. Participants will be assigned to receive either BMS-986504 at specified doses on certain days along with Nab-paclitaxel and Gemcitabine, or a placebo with the same chemotherapy drugs. The treatments are given according to protocol schedules. Some participants may have received up to one cycle of Nab-paclitaxel and Gemcitabine before starting the study treatment, provided they did not experience disease progression or intolerable side effects. The initial cycle must be completed before randomization. During the study, researchers will monitor participants for progression-free survival and overall survival for up to three years after the last participant is randomized. Assessments include measuring tumor response using established criteria (RECIST v1.1). Participants will undergo evaluations to track safety, treatment effects, and disease status throughout the trial period.

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 evaluating the effectiveness and safety of opevesostat combined with hormone replacement therapy compared to alternative treatments with abiraterone acetate or enzalutamide in people with metastatic castration-resistant prostate cancer (mCRPC) who have already been treated with one next-generation hormonal agent. This Phase 3 study aims to determine whether opevesostat improves radiographic progression-free survival, assessed by independent central review, in participants with or without androgen receptor ligand binding domain mutations. Participants will receive either oral opevesostat along with hormone replacement therapy drugs such as dexamethasone and fludrocortisone acetate, or they will receive alternative oral treatments including abiraterone acetate with prednisone acetate or enzalutamide. Hydrocortisone can be used as a rescue drug if needed. The study is open-label and randomized, comparing these treatment strategies in participants who have progressed after prior hormonal therapy. During the study, participants will undergo assessments including imaging scans to monitor disease progression. Researchers will measure radiographic progression-free survival up to approximately 52 months. Safety and overall survival are also monitored as secondary outcomes. Participants must attend scheduled visits for evaluations, provide tumor tissue samples, and have ongoing monitoring of organ function, hormone levels, and other relevant health parameters throughout the study period.

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

Researchers are evaluating the combination of the investigational drug PF-06821497 (mevrometostat) with enzalutamide compared to enzalutamide alone in men with metastatic castration-resistant prostate cancer (mCRPC) who have not previously received androgen receptor signaling inhibitors (ARSi) or abiraterone. This global, multicenter Phase 3 study focuses on participants whose cancer has progressed despite androgen deprivation therapy (ADT) or first-generation anti-androgens but who have not started other systemic anti-cancer treatments for mCRPC. The study excludes those with prior treatment using enzalutamide, darolutamide, apalutamide, or abiraterone in any setting, though chemotherapy is allowed in the hormone-sensitive setting. The study includes a Screening Phase, followed by randomization where participants are assigned equally to one of two groups: one receiving PF-06821497 plus enzalutamide, and the other receiving placebo plus enzalutamide. All treatments are taken orally on a continuous basis. After the treatment phase, participants enter a Safety Follow-up and a Long-Term Follow-up period to monitor ongoing effects. Participants will undergo assessments during the study to evaluate radiographic progression-free survival over about three years. Researchers will collect imaging data such as bone scans and CT or MRI scans to monitor disease progression. Additional evaluations include performance status, life expectancy assessments, and safety monitoring for adverse events. The study duration spans from screening through treatment and follow-up phases to gather comprehensive data on the combination therapy's impact on mCRPC.

Researchers are evaluating adults aged 18 and older who have a specific eye condition called centre-involved diabetic macular edema (CI-DME), a type of diabetic macular edema. The study aims to find out whether an oral medicine called BI 1815368 can improve vision in people with CI-DME and to determine the best dose. This is a Phase 2 study focused on assessing the medicine's safety, efficacy, and tolerability over 48 weeks of treatment. The study has two parts. In the first part, participants are randomly assigned to one of two equal groups: one group takes BI 1815368 tablets and the other takes placebo tablets, which look like the medicine but contain no active drug. In the second part, participants are randomized into four groups of equal size, three of which receive different daily doses of BI 1815368, while one group continues to take placebo. All participants take tablets twice daily for about 11 months. Participants stay in the study for about a year and visit the study site 16 times. During visits, doctors check vision and collect detailed eye pictures along with health information. Researchers compare changes in vision and eye condition over time between the groups. The main outcome measured is whether participants gain 10 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters of visual acuity at week 48 compared to baseline, indicating improved sight.

Researchers are evaluating the safety and effectiveness of lutetium (177Lu) vipivotide tetraxetan (AAA617) in adult men with oligometastatic prostate cancer (OMPC) that is progressing after initial treatment to the primary tumor. This Phase III study aims to determine if AAA617 can control recurrent tumors and delay the need for androgen deprivation therapy (ADT), while preserving quality of life. The study focuses on early-stage prostate cancer patients with limited metastatic lesions that are positive for prostate-specific membrane antigen (PSMA). All participants will undergo a baseline PET/CT scan using either gallium (68Ga) gozetotide or piflufolastat (18F) to confirm PSMA-positive lesions, along with conventional imaging such as CT/MRI and bone scans. Following randomization, all metastatic lesions will receive stereotactic body radiation therapy (SBRT) over approximately 3 weeks. Participants randomized to the investigational arm will then receive up to 4 cycles of AAA617 treatment, given once every 6 weeks. Those in the observation group will end treatment after SBRT. Visits are scheduled weekly during treatment cycles and every 16 weeks afterward until disease progression, with the overall study lasting about 6.5 years. During the study, participants will have regular assessments including imaging scans, laboratory tests, and clinical evaluations to monitor disease progression and side effects. A blinded independent review committee will measure metastasis-free survival, tracking time from randomization until evidence of distant metastasis or death, for up to 30 months. Safety and quality of life will also be closely monitored throughout the study and follow-up periods.

Researchers are evaluating the safety and effectiveness of selinexor as a maintenance treatment for patients with p53 wild-type endometrial carcinoma who have responded to platinum-based chemotherapy. This phase 3 trial will enroll 276 adults who have achieved either a partial or complete response after at least 12 weeks of treatment. The goal is to understand if selinexor can help prevent cancer from progressing in these patients. Participants will be randomly assigned to receive either selinexor tablets or matching placebo tablets by mouth. Selinexor is given as 60 mg doses, consisting of three 20 mg tablets. Treatment will begin 3 to 8 weeks after completing platinum chemotherapy. This is a double-blind study, meaning neither the participants nor the researchers will know who receives selinexor or placebo during the trial. During the study, participants will be regularly assessed for disease progression using standardized criteria called RECIST v1.1. Investigators will monitor progression-free survival from the time of randomization until either disease worsens or death occurs, up to 34 months. Participants will also have evaluations to check their health status and organ function throughout the trial to ensure safety and treatment adherence.