Edgewater

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 the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the effectiveness and safety of veverimer in adults with moderate-to-severe chronic kidney disease (CKD) and metabolic acidosis over a 26-week period. This Phase 3, randomized, double-blind study aims to compare veverimer to a placebo in improving health outcomes related to this condition. The study focuses on changes in serum bicarbonate levels and physical performance as key measures of treatment impact. Participants are randomly assigned to one of two groups: one receiving 9 grams of veverimer twice daily, and the other receiving a placebo twice daily. The study involves a treatment period lasting 26 weeks, during which participants take their assigned medication regularly. The study design ensures that neither the participants nor the researchers know which treatment is being given to maintain objectivity. During the study, participants undergo several assessments including blood tests to measure serum bicarbonate concentration and physical performance tests like the Sit-to-Stand 5 times test. These evaluations occur from the screening visit through Day 168. Researchers monitor adherence to the treatment and any side effects to ensure participant safety and to measure the effectiveness of veverimer compared to placebo throughout the study duration.

Researchers are evaluating the effectiveness and safety of rimegepant compared to a placebo for preventing migraines in children and adolescents aged 6 to under 18 years who experience episodic migraine. This Phase 3 study focuses on participants who have had migraines for at least six months with a limited number of headache and migraine days per month. The study aims to understand how well rimegepant works to reduce the number of migraine days over a 12-week period. Participants will receive either rimegepant in doses of 75mg or 50mg (two 25mg orally disintegrating tablets) or a matching placebo. The treatment is administered over a double-blind 12-week phase where neither the participants nor the researchers know which treatment is given. This setup helps ensure unbiased results when comparing the preventive effects of rimegepant against placebo. Throughout the study, participants will be monitored for changes in their migraine frequency, specifically the average number of migraine days per month from the start to the end of the 12 weeks. Evaluations include headache and migraine tracking, as well as assessments of daily activity disruption. Safety and side effects will also be closely observed to understand the medication's impact on young patients.

Researchers are evaluating maridebart cafraglutide, a drug given as an addition to standard care, to see if it reduces heart-related problems and deaths better than a placebo in people with atherosclerotic cardiovascular disease who are overweight or obese. This phase 3 study focuses on cardiovascular events such as heart attacks, strokes, and deaths related to heart conditions, aiming to improve outcomes in this high-risk population. Participants will receive either maridebart cafraglutide or a placebo, both administered by injection under the skin. The study compares these two groups over a period of up to approximately 35 months, monitoring heart-related health events to assess the drug's impact. The placebo group will receive injections that look identical but contain no active drug, ensuring a double-blind study design. During the study, participants will be regularly evaluated for major cardiovascular events, including heart attack, stroke, heart failure, and death. Researchers will track the time until these events occur to measure the drug's effectiveness. Safety and health will be closely monitored throughout the study period, and participants will be followed for up to nearly three years to gather comprehensive data on cardiovascular outcomes and overall survival.

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 effects of clofutriben, an 11-hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor, in patients with type 2 diabetes who have elevated cortisol levels. This Phase 2, multicenter, randomized, double-blind, placebo-controlled trial aims to understand how different doses of clofutriben may improve blood sugar control and to identify suitable doses for future studies. The trial includes two parts: an initial screening phase and a treatment phase. The screening phase lasts about 5 to 9 weeks and involves assessing eligibility, performing a dexamethasone suppression test, and further evaluations. Eligible participants are then randomly assigned to receive either placebo or one of four doses of clofutriben during the 24-week treatment phase. After completing treatment, participants receive a follow-up phone call four weeks later to check on their status. Participants will undergo various assessments during the study, including measuring morning serum cortisol and plasma dexamethasone levels after a dexamethasone dose, as well as changes in glycated hemoglobin A1c over 24 weeks. Researchers will monitor medication adherence, laboratory results, and safety throughout the study. The total participation duration includes the screening period and the 24-week treatment, followed by the post-treatment follow-up.