Pendik

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 evaluating the efficacy and safety of verekitug (UPB-101) in adults with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), a long-term inflammatory lung condition. This global, multicenter Phase 2b study aims to understand how well verekitug works compared to a placebo, alongside participants' usual COPD medications. Participants must have a confirmed COPD diagnosis and meet specific lung function and symptom criteria to join the study. Participants will be randomly assigned to receive one of two doses of verekitug or a matching placebo, in addition to their regular COPD background treatments. The study includes a screening period of about 4 weeks, followed by treatment lasting between 60 and 108 weeks. After treatment, there is a 16-week follow-up period to monitor participants after their last dose. Throughout the study, participants will undergo various assessments including lung function tests and symptom evaluations. Researchers will track the annual rate of moderate or severe COPD flare-ups from the start of treatment through week 108. Safety and tolerability will be closely monitored during the treatment and follow-up periods to ensure participants' well-being over the course of the trial.

Researchers are evaluating LY3537021, a drug given by injection, to see how well it controls nausea and vomiting caused by chemotherapy in adults with cancer. This Phase 2 study compares LY3537021 to a placebo while participants also receive standard anti-nausea treatments. The study aims to understand the safety and effectiveness of LY3537021 during the period 24 to 120 hours after chemotherapy starts. Participants will receive chemotherapy drugs such as cisplatin or anthracycline with cyclophosphamide through an intravenous line. They will be randomly assigned to get either LY3537021 or a placebo, both given by subcutaneous injection, along with standard antiemetic therapies including medications taken by mouth, IV, or skin patches. The treatment period lasts through the chemotherapy cycle. During the study, participants will be monitored for their response to the anti-nausea treatment, particularly looking at how many achieve complete control of nausea and vomiting in the delayed phase after chemotherapy. Researchers will also track safety and any side effects. The entire participation may take about two months, covering all study parts until completion.

Cervical radiculopathy is a condition caused by irritation or compression of cervical nerve roots, often due to disc herniation, resulting in neuropathic pain and functional problems in one arm. This study aims to evaluate how a treatment called interlaminar epidural steroid injection (ILESI) affects the sense of joint position (proprioception) in the upper extremity of patients with chronic cervical radiculopathy. It also looks at how changes in proprioception relate to pain, disability, grip strength, and quality of life. Participants will receive a single unilateral ILESI at the C7-T1 level under fluoroscopic guidance. The injection includes a mixture of triamcinolone acetonide, lidocaine, and saline. The procedure is performed in sterile conditions by an experienced specialist, followed by about two hours of observation before discharge. Assessments will take place at three time points: before the injection, three weeks after, and three months after. During the study, participants will undergo tests measuring upper extremity joint position sense using the PRO-Reach test. Researchers will also evaluate neuropathic pain, pain intensity, disability, hand-grip strength, and health-related quality of life. Data collection is blinded to reduce bias. The main outcome is the change in proprioception error at baseline, three weeks, and three months after treatment. The study seeks to understand how ILESI may influence sensorimotor function and support rehabilitation planning.

Lumbar spinal stenosis is a condition characterized by narrowing of the spinal canal due to degenerative changes in the spinal joints, discs, and ligaments. This narrowing can cause symptoms like neurogenic claudication, leg pain, low back pain, and issues with urinary or fecal control. The condition may impair daily activities when standing or walking. Researchers are investigating whether the presence of spinal dural pulsation, which reflects rhythmic movements of the dura mater and spinal cord, is related to clinical symptoms and imaging findings in people with lumbar spinal stenosis. In this study, patients will be examined for the presence of dural pulsation using ultrasound while lying face down. Magnetic Resonance Imaging (MRI) will be used to confirm lumbar spinal stenosis and assess anatomical changes. The study does not involve administering treatments but focuses on evaluating dural pulsation and its relationship to clinical and radiological features. This approach aims to better understand how dural pulsation affects or indicates the severity of lumbar spinal stenosis. Participants will be assessed using several measures including the Numeric Rating Scale for pain, the Oswestry Disability Index for physical disability, the Short Form-12 for overall health, and walking distance capacity. These assessments will be done at the time of data collection alongside ultrasound and MRI evaluations. The study monitors participants carefully to explore associations between dural pulsation and patient symptoms, disability, and imaging findings to improve understanding of lumbar spinal stenosis.

Researchers are evaluating the effect of Seladelpar on clinical outcomes in patients with Primary Biliary Cholangitis (PBC) who have compensated cirrhosis. This Phase 3 study focuses on adults with PBC and cirrhosis classified as Child-Pugh (CP) score A or B to better understand how Seladelpar may impact the disease course compared to placebo treatment. Participants will be assigned to receive either Seladelpar or a placebo daily for up to 36 months. Those with CP-A cirrhosis will take 10 mg of Seladelpar once daily, while those with CP-B cirrhosis will take 5 mg once daily. The placebo group will take one capsule daily for the same duration. This randomized, double-blind, placebo-controlled design ensures that the effects of Seladelpar can be assessed rigorously against a control. Throughout the study, participants will be monitored regularly with scheduled assessments to evaluate their health and response to treatment. Researchers will measure Event Free Survival over 36 months as the primary outcome. Safety and liver function will be closely observed through laboratory tests and clinical evaluations. Participants must comply with study requirements and complete all scheduled visits during the treatment period.

Researchers are investigating whether olomorasib combined with pembrolizumab is more effective than pembrolizumab plus placebo for participants with resected KRAS G12C-mutant non-small cell lung cancer (NSCLC) in part A. In part B, they are assessing if olomorasib combined with durvalumab is more effective than durvalumab plus placebo for participants with unresectable KRAS G12C-mutant NSCLC. This Phase 3 study may last up to 3 years for each participant.