Zhubei City

Researchers are evaluating the efficacy, safety, and tolerability of elecoglipron compared with placebo in adults who have type 2 diabetes mellitus T2DM with impaired kidney function. Participants are also on dapagliflozin 10 mg as part of their guideline-directed medical therapy for chronic kidney disease CKD, along with other glucose-lowering medications. This Phase III study aims to understand how elecoglipron performs in this specific group of patients. Participants will be randomly assigned to one of three groups elecoglipron at dose level 1, elecoglipron at dose level 2, or placebo. All treatments are given orally once daily alongside background dapagliflozin 10 mg. The study uses a parallel design and includes a 40-week treatment period during which participants take their assigned medication. During the study, participants will have their blood sugar control measured through Hemoglobin A1c HbA1c levels from baseline to Week 40, which is the primary outcome. Additional assessments include body weight changes, blood pressure, fasting plasma glucose, and time to needing additional diabetes medication. Safety and tolerability will be monitored throughout the study, which lasts up to 40 weeks for each participant.

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.

Researchers are evaluating the safety, tolerability, and effectiveness of baxdrostat compared to a placebo in adults aged 18 years and older with Primary Aldosteronism PA. This Phase III, global study involves approximately 250 participants and aims to reduce seated blood pressure and normalize the Renin Angiotensin Aldosterone System RAAS. Participants may have prior treatment with Mineralocorticoid Receptor Antagonists MRAs or potassium-sparing diuretics. Participants will be randomly assigned to receive either baxdrostat or a matching placebo, both given orally once daily. The dose may be increased after two weeks depending on the participants clinical response and how well they tolerate the medication. The study is conducted across about 90 centers in 12 countries and involves parallel groups. Throughout the study, participants will have their seated systolic blood pressure and RAAS activity measured at week 8 to assess changes from baseline. Additional assessments include monitoring potassium levels, urine aldosterone, and albumin levels up to week 52. Safety and treatment effects will be regularly evaluated during visits. Total participation spans from screening through treatment and follow-up visits as scheduled.

Researchers are evaluating Pumitamig compared to Durvalumab in adults with unresectable stage III Non-small Cell Lung Cancer NSCLC who have completed concurrent chemoradiation therapy. This phase 3 study aims to assess which treatment better controls cancer progression and improves survival outcomes in this patient population. Participants are randomly assigned to receive either Pumitamig or Durvalumab at specified doses on designated days. Both treatments are administered following at least two cycles of platinum-based concurrent chemoradiotherapy with a radiation dose of at least 54 Gy. The study focuses on patients who have no progressive disease after this initial treatment and have good performance status. Throughout the trial, participants will be monitored for progression-free survival and other outcomes such as overall survival, objective response, disease control rate, and duration of response over several years. Assessments include imaging reviewed by independent central reviewers and investigators according to standardized criteria. The study involves regular evaluations to track cancer status and safety, with follow-up extending up to approximately nine years to understand long-term effects.

Researchers are evaluating the efficacy and safety of tulisokibart in participants with moderately to severely active Crohns disease. This program includes two studies Study 1 involves both induction and maintenance treatment phases, while Study 2 focuses only on induction treatment. The main goal is to determine if one or more doses of tulisokibart are more effective than placebo in achieving clinical remission and endoscopic response at various time points up to Week 52. Participants are randomly assigned to receive different dosing regimens of tulisokibart or placebo. These regimens include high or low doses administered intravenously followed by subcutaneous injections, or subcutaneous injections alone. Some participants may continue in an extension phase receiving subcutaneous doses after completing their original treatment arm if they meet specific requirements. The studies use a double-blind design to compare tulisokibarts effects against placebo. During the trial, participants undergo regular assessments to measure clinical remission, endoscopic response, and other health outcomes using tools like the Crohns Disease Activity Index and stool frequency with abdominal pain scores. Safety evaluations include monitoring adverse events and treatment discontinuations. The studies last up to 52 weeks for Study 1 and 12 weeks for Study 2, with multiple visits to assess treatment effects and participant health under medical supervision.

Researchers are investigating the treatment outcomes of subcutaneous anifrolumab 120 mg given once weekly as add-on therapy to antimalarials, with or without glucocorticoids GCs, in patients with systemic lupus erythematosus SLE who have not previously received immunosuppressants or biologic therapies and are not in low disease activity status at enrollment. This Phase 3, multinational, open-label study aims to better understand remission rates, including DORIS remission, and the ability to taper and withdraw chronic GCs in this patient group. Participants will receive anifrolumab administered subcutaneously once weekly for 52 weeks using an autoinjector pen. The study includes a screening period of up to 35 days before treatment starts. For patients on higher doses of GCs at baseline, a structured tapering protocol will be followed from week 5 to week 40, aiming to reduce GC doses to 5 mgday and potentially withdraw GCs completely after sustained remission. After week 40, no further GC dose reductions will occur. An additional 12-week safety follow-up is planned for participants who discontinue anifrolumab after week 52. During the study, participants will undergo regular assessments including clinical evaluations, quality of life and fatigue questionnaires, and laboratory tests to monitor disease activity and remission status. Researchers will measure outcomes such as attainment and duration of DORIS remission, low disease activity, flare incidence, and changes in GC use. Safety will be monitored throughout treatment and in the follow-up period. The total study duration for participants is approximately 69 weeks, including screening, treatment, and safety follow-up.

Researchers are investigating the role of circulating tumor emboli CTM and natural killer NK cell activity in patients with recurrent or metastatic head and neck squamous cell carcinoma. This observational study aims to assess how CTM and the immune cells within them relate to patient outcomes and treatment effectiveness, focusing on a Taiwanese population with distinct risk factors like betel nut use. The study seeks to improve understanding of tumor microenvironment changes and their impact on prognosis under various treatments. Participants will receive their usual care from their primary doctors while researchers collect blood samples to analyze circulating tumor cells, CTM clusters, and NK cell composition using a microfluidic liquid biopsy platform called the DS-SACA chip. The study does not involve administering treatments but observes patients receiving different therapies. The goal is to correlate these biological markers with clinical data to help predict progression and survival. During the study, participants will provide blood samples for detailed analyses of tumor and immune cells. Researchers will monitor progression-free survival and overall survival for up to 60 months to evaluate correlations with the biomarkers. Medical records and clinical outcomes will be reviewed to support these assessments. The study includes adults aged 20 years and older with measurable recurrent or metastatic tumors who can provide informed consent and cooperate with blood sampling procedures.