Arvada

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.

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

This study evaluates JADE101 in adults aged 18 to 60 with Immunoglobulin A Nephropathy IgAN, aiming to understand its safety and effectiveness. It is a Phase 2, open-label trial conducted by Jade Biosciences, focusing on this kidney condition confirmed by biopsy and treated under standard care. The trials purpose is to contribute to the overall clinical knowledge of JADE101 in this patient group. Participants receive JADE101 through subcutaneous injections. The study includes a single group where all participants receive this treatment. The trial monitors participants from the first dose through up to 100 weeks, assessing both safety and effects on kidney-related measurements, including urine protein and creatinine levels. Throughout the study, participants will attend scheduled visits and comply with treatment plans, laboratory tests, and other procedures. Researchers will track any treatment-related adverse events and changes in urine protein creatinine ratio over the 100-week period. Participants must follow contraceptive and lifestyle guidelines and agree to provide informed consent to participate.

Researchers are conducting a Phase 2 randomized, double-blind, placebo-controlled study to evaluate the effects and safety of praliciguat in adults diagnosed with biopsy-confirmed focal segmental glomerulosclerosis FSGS. This kidney condition is being studied to understand how praliciguat impacts protein levels in urine and other health measures compared to placebo. The study is sponsored by Akebia Therapeutics and involves multiple centers. Participants will be randomly assigned to receive either praliciguat or a matching placebo daily during a 24-week double-blind period. The praliciguat dose will be gradually increased to a target level. After this period, all participants will continue with an open-label phase where everyone receives praliciguat daily for another 24 weeks. Throughout the study, participants will have their urine protein-to-creatinine ratio UPCR measured from baseline through Week 24 to assess treatment effects. Additional evaluations include monitoring partial remission rates at Week 24 and measuring plasma praliciguat levels at Weeks 24, 32, and 36. The total participation lasts up to 48 weeks, with safety and efficacy assessments occurring regularly during and after the treatment periods.

Researchers are conducting a phase 3 randomized, double-masked study to compare the effects of EYP-1901 against Aflibercept in patients with diabetic macular edema DME, a condition related to diabetic retinopathy. The study aims to evaluate the treatments impact on vision improvement, with a focus on the average change in best-corrected visual acuity BCVA over one year. Participants are assigned to receive either EYP-1901 or Aflibercept, both delivered by intravitreal injection directly into the eye. The study uses a parallel group design with random allocation and masking to compare these two drug treatments. The primary measurement is taken at weeks 52 and 56, with secondary outcomes including the rate of injection burden by week 56. During the study, participants will undergo regular vision assessments using the ETDRS letter score. Researchers will monitor treatment effects and safety throughout the trial period, which extends until October 2028. The total participation time includes screening, treatment, and follow-up visits designed to evaluate vision changes and treatment needs over approximately one year.

Researchers are conducting a combined Phase 2b and Phase 3 clinical trial to study CSL300 Clazakizumab in adults with end stage kidney disease ESKD who are undergoing maintenance dialysis. The study aims to find the right dose of CSL300 and then evaluate its effect on cardiovascular outcomes and safety in people with systemic inflammation and either atherosclerotic cardiovascular disease ASCVD or diabetes. This is a randomized, double-blind, placebo-controlled study involving multiple centers. Participants will receive intravenous IV administration of either CSL300 or a placebo. The Phase 2b part focuses on determining the appropriate dose of CSL300 compared to placebo over about 12 weeks, while the Phase 3 part examines CSL300s effect on cardiovascular events over approximately five years. The study includes different dosing groups in Phase 2b and a larger comparison of CSL300 versus placebo in Phase 3. During the study, participants will be monitored regularly with blood tests that measure inflammation markers such as high-sensitivity C-reactive protein hs-CRP, cardiovascular events, and safety outcomes. Researchers will track changes in various blood components and adverse events up to 32 weeks in Phase 2b and follow cardiovascular outcomes for up to five years in Phase 3. The total participation lasts through these periods with scheduled assessments to evaluate treatment effects and safety.

Researchers are studying the effects of povetacicept in adults with primary membranous nephropathy pMN, a kidney condition. This study aims to evaluate how well povetacicept works, its safety, and how well patients tolerate it compared to another treatment called tacrolimus. The trial includes adults aged 18 to 75 years and is conducted by Vertex Pharmaceuticals Incorporated. Participants will be randomly assigned to receive either one of two doses of povetacicept, which is given as a solution for subcutaneous injection, or tacrolimus capsules taken orally. The dosing for povetacicept is based on previous phase 2b results. This study follows a sequential design and is conducted in phases 2 and 3. During the study, researchers will monitor participants for clinical remission of their kidney disease at 104 weeks. They will also track safety by recording adverse events up to week 112. Participants will have scheduled visits to assess their condition and treatment response. The total study duration extends up to nearly four years, concluding in late 2028.

This research aims to evaluate the effectiveness and safety of LUPKYNIS combined with belimumab, obinutuzumab, or anifrolumab in adults with lupus nephritis LN. The study focuses on how well these combinations induce a rapid kidney response in patients diagnosed with LN, a condition affecting kidney health. It is a phase 4 clinical trial sponsored by Aurinia Pharmaceuticals Inc. that assesses treatment approaches for this condition. Participants will receive LUPKYNIS along with one of the biologic agents belimumab, obinutuzumab, or anifrolumab. In addition, all patients will be treated with a mycophenolic acid analog MPAA, such as mycophenolate mofetil or mycophenolic acid, and corticosteroids like prednisone or an equivalent. The biologic treatment schedules vary depending on the specific drug, with some patients already receiving treatment before the study starts or beginning it at the start of the trial. During the study, participants will be monitored for kidney response over 24 weeks, including complete and partial renal responses. Researchers will assess safety by tracking treatment-emergent adverse events up to 28 weeks. Other assessments include measuring changes in kidney-related antibodies and complement levels at baseline, 12 weeks, and 24 weeks. The total participation duration extends to about 28 weeks, during which various evaluations, laboratory tests, and safety monitoring will occur to understand treatment effects and patient outcomes.

Researchers are evaluating the effects of tonlamarsen, an investigational drug, in adults who were recently hospitalized due to acute severe hypertension, including hypertensive emergency and urgency. This Phase 2b study aims to measure how well tonlamarsen lowers blood pressure and its safety compared to a placebo. The drug works by blocking the livers production of angiotensinogen, a protein involved in blood pressure regulation. Participants will receive either tonlamarsen or a placebo via subcutaneous injections once every four weeks for approximately three months, totaling three doses. The study is designed as a randomized, double-blind, placebo-controlled trial with parallel groups. The research includes two parts Part A focuses on clinical and biomarker variability, while Part B assesses the pharmacodynamic effects on plasma angiotensinogen levels and blood pressure at Weeks 4 and 12. Throughout the study, participants will visit the clinic about seven times for evaluations, tests, and follow-up. Researchers will monitor blood pressure using office and daily home measurements, as well as blood levels of angiotensinogen. Safety and tolerability of tonlamarsen will be assessed up to Week 36. Participation involves regular checkups and blood tests to understand the drugs impact and side effects over time.

Researchers are gathering detailed data in a prospective, multicenter electronic registry to study pregnant women who receive general anesthesia during cesarean delivery. This research aims to understand why general anesthesia is chosen, how airway management is handled, and what factors influence anesthetic and obstetric outcomes. The study involves multiple hospitals participating in this registry to provide a broad view of practices and outcomes. The registry collects information from about 25 to 40 participating institutions, including institutional characteristics like maternal care levels, live birth numbers, and staffing models. Data collected focuses on patient demographics, delivery details, gestational age, maternal health conditions, and anesthesia management. Anesthesiologists enter data soon after patient care to capture detailed clinical decisions and outcomes. Data collection is planned for approximately five years and will be stored indefinitely in a secure, deidentified database. Participants will be pregnant women aged 15 to 55 years who received general anesthesia for cesarean delivery. The study measures include rates of general anesthesia use for cesarean deliveries, associations between institutional factors and anesthesia rates, and predictors of difficult airway intubation. Data entry is done by treating anesthesiologists, and the study will monitor outcomes such as intubation difficulty using various clinical scores and physical measurements. The registry aims to enroll around 5000 subjects, with ongoing data monitoring and analysis over the study period.