Cordele

This research aims to evaluate the safety, tolerability, and impact on albuminuria of the drug MZE829 in adults who have proteinuric chronic kidney disease and carry the APOL1 high-risk genotype. This Phase 2 open-label study focuses on participants with specific genetic markers associated with kidney disease to better understand treatment effects. Participants will receive MZE829 in the form of oral capsules. The study involves monitoring the participants over a 12-week period to assess the drug's safety and how well patients tolerate it. Researchers will also measure changes in albuminuria, which reflects kidney function. During the study, participants will be closely monitored for any adverse events from the first day through week 12. Safety assessments and laboratory tests will be performed to track the drug’s effects. The main goal is to determine how safe and tolerable MZE829 is, along with its impact on kidney disease markers over the treatment duration.

Researchers are conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease (COPD). Participants must have experienced at least two moderate or one severe COPD exacerbations in the year before joining and be receiving inhaled maintenance therapy. The study focuses on adults who continue to experience symptoms despite current treatments and aims to assess the impact of tezepelumab on COPD exacerbations. Participants will be randomly assigned to receive monthly subcutaneous injections of either one of two doses of tezepelumab or a placebo. Treatment will last for a minimum of 52 weeks and may extend up to 76 weeks. After the treatment period, there will be a 12-week safety follow-up phase to monitor participants after stopping the study drug. The study compares tezepelumab to placebo to determine its efficacy and safety over this extended period. During the study, participants will undergo regular assessments to monitor their COPD status and any exacerbations. The main outcome measured is the annual rate of moderate or severe COPD exacerbations from the start of treatment through up to 76 weeks. Safety and tolerability will also be closely monitored throughout the treatment and follow-up periods. This long-term involvement ensures comprehensive data on how tezepelumab affects COPD progression and exacerbation frequency.

Researchers are conducting a two-part, phase 2b/3 study to evaluate CSL300 (Clazakizumab) in adults with end stage kidney disease (ESKD) undergoing dialysis who have systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes. The study aims to determine the best dose of CSL300 and assess its effects on cardiovascular outcomes and safety in this population. This multicenter, randomized, double-blind, placebo-controlled trial targets patients with elevated inflammation markers and significant health risks due to their conditions. In the first part (phase 2b), the study focuses on finding the appropriate dose of CSL300 compared to placebo. CSL300 is given through intravenous (IV) administration. The second part (phase 3) evaluates the impact of CSL300 on cardiovascular events such as heart attack or cardiovascular death over approximately 5 years, continuing to compare CSL300 to placebo for safety and efficacy. The placebo matches CSL300's excipient content but lacks the active drug. Participants will undergo baseline and regular assessments for inflammation markers like high-sensitivity C-reactive protein (hs-CRP) up to 12 weeks in phase 2b, and long-term monitoring for cardiovascular outcomes in phase 3. The study involves ongoing safety evaluations and efficacy measurements during the entire follow-up period. This comprehensive approach helps researchers understand how CSL300 affects inflammation and cardiovascular health in patients with ESKD on dialysis.

Researchers are evaluating depemokimab as a treatment for adults aged 40 to 80 years with moderate to severe chronic obstructive pulmonary disease (COPD) who have type 2 inflammation and frequent exacerbations. This Phase 3 study aims to assess the safety and effectiveness of depemokimab when added to optimized inhaler therapy compared to placebo in participants whose COPD is uncontrolled despite current treatment. Participants must have an elevated blood eosinophil count and a history of COPD symptoms and exacerbations. Participants will receive depemokimab, a sterile liquid drug, or a placebo consisting of a sterile 0.9% sodium chloride solution. The treatments are administered as an add-on to their usual inhaler therapies, which include inhaled corticosteroids, long-acting muscarinic antagonists, and long-acting beta2-adrenergic agonists. The study is randomized, double-blind, placebo-controlled, and takes place across multiple centers. Treatment duration and detailed dosing schedules are not specified but participants are monitored up to 104 weeks. Throughout the study, participants will be monitored for the annual rate of moderate to severe COPD exacerbations. Researchers will also assess safety and other clinical outcomes related to lung function and COPD symptoms. Participants will have regular visits for evaluation of their disease status, treatment adherence, and any side effects. The total duration of participation includes baseline screening and follow-up visits over the study period to ensure comprehensive data collection for efficacy and safety analysis.

Researchers are evaluating the effectiveness, safety, and tolerability of subcutaneous lunsekimig compared to a placebo in adults aged 40 to 80 years with inadequately controlled chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype. This Phase 2b/Phase 3, parallel, 3-arm study focuses on participants who have a history of COPD with an eosinophilic profile and have not achieved control with current treatments. Eligible participants will receive either lunsekimig or a matching placebo through subcutaneous injections over a randomized treatment period of approximately 48 weeks. The study involves three periods: an initial screening period lasting up to 4 weeks, followed by the 48-week treatment period, and finally an 8-week follow-up period. The total study duration may last up to 60 weeks. During the study, participants will be regularly assessed for the annualized rate of moderate-to-severe COPD exacerbations from baseline up to 48 weeks. Researchers will monitor safety, tolerability, and treatment effects through various evaluations throughout the treatment and follow-up periods. Participant involvement includes completing assessments and receiving scheduled injections as part of the study protocol.

Type 2 diabetes is a condition where the body does not respond well to insulin, leading to high blood sugar levels that can cause serious health problems. This research evaluates HP-211, a botanical extract derived from common herbs and vegetables, which has shown promise in laboratory and animal studies to enhance insulin's ability to help cells absorb glucose. The study aims to see if HP-211 can reduce blood sugar and insulin levels in people with type 2 diabetes, especially those who are insulin-resistant, over a 90-day treatment period. Participants will take 0, 1, 2, or 3 tablets of HP-211 twice daily, preferably at least 60 minutes before meals, for 90 days. The study compares different doses of HP-211 to a placebo, all taken orally in the morning and evening. Researchers will measure hemoglobin A1c (HbA1c), which reflects average blood glucose levels over time, to assess the treatment's effect. Additional measures of glucose control and safety will also be monitored throughout the study. During the trial, participants will undergo blood tests to measure HbA1c and other markers of glucose control. Safety assessments will include monitoring blood pressure, heart rhythm via ECG, and other health evaluations. The primary outcome is the change in HbA1c after 12 weeks of treatment. Participants must have type 2 diabetes diagnosed within the last 5 years and be on stable metformin therapy or diet and exercise. The total participation time includes screening and 90 days of treatment with regular study visits for assessments.

Researchers are evaluating the effectiveness and safety of icovamenib in adults with Type 2 Diabetes (T2D) who are not meeting blood sugar targets despite using Ozempic-based therapy. This phase 2 trial focuses on participants aged 18 to 70 years who have been on Ozempic for at least three months but still have elevated HbA1c levels above the target recommended by the American Diabetes Association (ADA). Participants will be randomly assigned to receive either icovamenib 100 mg once daily or a matching placebo, both alongside their ongoing Ozempic-based therapy. The main treatment period lasts 12 weeks, with a total study duration of 52 weeks. The trial aims to see if adding icovamenib leads to better blood sugar control compared to continuing Ozempic therapy alone. During the study, participants will undergo regular evaluations including blood tests to measure HbA1c and fasting plasma glucose levels. Researchers will monitor safety, adherence to medication, and overall effectiveness of the treatment over 26 weeks, focusing on glycemic control. Participants must consent to the study and comply with all procedures throughout the trial.

Researchers are evaluating icovamenib, a drug being studied for people with Type 2 Diabetes whose blood sugar levels are not well controlled despite taking standard antihyperglycemic medications. This Phase 2, randomized, double-blind, placebo-controlled trial aims to see if adding icovamenib to current treatments can better reduce HbA1c levels, a measure of blood sugar control, over 52 weeks. Participants must have been on stable doses of medications like metformin, SGLT2 inhibitors, alogliptin, or sitagliptin for at least 3 months and still have higher than recommended HbA1c levels according to the American Diabetes Association. Participants will be randomly assigned to receive either 100 mg of icovamenib once daily or a matching placebo for 12 weeks to compare effects on glycemic control. The study also includes ongoing use of their existing antihyperglycemic medications and lifestyle management. The trial will assess the drug’s impact over a total of 26 weeks to determine its superiority to placebo in managing blood sugar. Throughout the study, participants will undergo regular assessments including blood tests to monitor HbA1c, fasting plasma glucose, triglycerides, and kidney and liver function. Safety and effectiveness will be closely followed, with monitoring for adverse events or changes in diabetes control. The total participation time includes screening, treatment, and follow-up periods to fully evaluate icovamenib’s effects and safety in this population.

Researchers are evaluating the effects of baxdrostat combined with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with systolic blood pressure of at least 130 mmHg at screening, and at least one additional risk factor for heart failure. This Phase III randomized, placebo-controlled, event-driven study aims to determine if the combination reduces the risk of heart failure events or cardiovascular death, with follow-up lasting up to 38 months. Participants who meet screening criteria but are not currently treated with SGLT2 inhibitors or have been treated for less than 4 weeks will enter a run-in period receiving dapagliflozin 10 mg once daily for 4 to 6 weeks before randomization. The study involves random assignment to either baxdrostat plus dapagliflozin or placebo plus dapagliflozin. Site visits occur at approximately 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months. Participants discontinuing the blinded study drug may continue open-label dapagliflozin, with ongoing visits and data collection as per protocol. Participants will undergo an optional pre-screening period without site visits or consent to help identify eligibility, followed by up to 14 days of formal screening after informed consent. Researchers will monitor heart failure events and cardiovascular deaths as primary outcomes. Safety and adherence will be tracked throughout the study, including during any premature discontinuation of blinded treatment. The study will conclude when a predetermined number of secondary endpoint events have occurred, with continued follow-up as needed.

Researchers are evaluating the efficacy, safety, and tolerability of adding subcutaneous lunsekimig compared with placebo as treatment for adults aged 18 to 80 with high-risk asthma who currently do not qualify for biologic therapies. This Phase 2, randomized, double-blind, placebo-controlled study focuses on participants with mild-to-moderate asthma diagnosed for over a year, who have had at least one asthma exacerbation in the previous year. The goal is to better understand lunsekimig's effects in this specific asthma population. Participants will be randomly assigned to receive either subcutaneous injections of lunsekimig or placebo over approximately 52 weeks. Alongside this, they may continue using other asthma medications such as various inhaled treatments including fluticasone/salmeterol, budesonide/formoterol, budesonide/albuterol, or short-acting beta agonists. The study includes up to 18 visits throughout the treatment period, with some participants possibly continuing into a long-term safety (LTS) study lasting up to 60 weeks total. During the study, participants will undergo regular assessments to monitor asthma control, lung function, and the rate of asthma exacerbations. The primary measurement is the annualized rate of asthma exacerbation events from baseline up to 52 weeks. Safety and tolerability will also be closely observed. The total study duration for most participants will be around 64 weeks if they do not enter the LTS study. Researchers will gather data through clinical visits, lung function tests, and ongoing safety monitoring to evaluate the treatment's impact and participant health throughout the trial.