Lithonia

Researchers are evaluating the effects of macupatide and eloralintide, alone or combined, on weight loss in adults who are overweight or have obesity along with type 2 diabetes. This Phase 2 study aims to understand how these treatments might help reduce body weight in this population. The study is designed as a parallel-group, double-blind, placebo-controlled trial to ensure unbiased results. Participants will receive either macupatide, eloralintide, both drugs together, or matching placebos. All treatments are administered by subcutaneous injection. The study treatment period lasts approximately 48 weeks, during which the effects of the drugs on weight and diabetes control will be assessed. During the study, participants will be monitored for changes in body weight from the start of the study to week 32 as the primary outcome. Researchers will also evaluate safety and other health measures throughout the nearly year-long participation. The study includes regular assessments to track the effects of treatment and to ensure participant health and safety.

Researchers are evaluating the safety and effectiveness of astegolimab compared to a placebo in adults aged 40 to 80 years who have chronic obstructive pulmonary disease (COPD). The study focuses on participants who are former or current smokers with a history of frequent COPD flare-ups. This phase III trial aims to determine how well astegolimab reduces moderate and severe COPD exacerbations over one year. Participants will be randomly assigned to receive either subcutaneous astegolimab every two or four weeks or a placebo every two weeks. All participants will continue their optimized COPD maintenance treatments, which may include combinations of inhaled corticosteroids, long-acting beta-agonists, and long-acting muscarinic antagonists. Study treatments will be administered over a 52-week period. Throughout the study, researchers will monitor the annual rate of moderate and severe COPD exacerbations. Participants will undergo lung function tests, chest imaging, and assessments of breathlessness and lung health. The study will also carefully track the safety of the treatments, including any infections or heart-related problems. The total participation time is 52 weeks, during which the effectiveness and safety of astegolimab will be evaluated.

This research aims to evaluate the long-term safety and explore the effectiveness of astegolimab in people with chronic obstructive pulmonary disease (COPD) who have already completed a 52-week treatment in previous studies GB43311 or GB44332. The study focuses on participants aged 40 to 90 years and is a Phase III open-label extension trial designed to continue monitoring patients after their initial treatment period. Participants will receive astegolimab as a subcutaneous injection every two weeks during this extension study. This treatment continues from the prior placebo-controlled phase, allowing researchers to observe any ongoing effects and safety concerns over a longer period. The study does not include a placebo group during this extension phase, and all participants receive the active treatment. Throughout the study, researchers will closely monitor participants for any adverse events up to 12 weeks after the last dose of astegolimab. Participants will be assessed regularly to ensure their safety and to gather data on the treatment's long-term impact. The total duration of participant involvement depends on when they completed the parent studies but involves continued monitoring during and after the treatment period.

Researchers are evaluating the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease (COPD). These participants must have a history of COPD for at least one year and have experienced multiple COPD exacerbations despite using inhaled maintenance therapy. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on those who have had at least two moderate or one severe exacerbation in the prior year while on inhaled triple or dual therapy. Participants will 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 up to 76 weeks. After the treatment period, there will be a 12-week off-treatment safety follow-up to monitor any lasting effects or safety concerns. During the study, researchers will assess the participants' lung function and monitor the annual rate of moderate or severe COPD exacerbations. Participants will undergo screening to confirm eligibility based on lung function tests, eosinophil counts, and symptom scores. Safety will be closely monitored throughout the treatment and follow-up periods to evaluate adverse effects and overall participant health.

Researchers are evaluating the use of rademikibart as an additional treatment for adults and adolescents with asthma experiencing an acute exacerbation linked to type 2 inflammation. This Phase 2, randomized, double-blind, placebo-controlled trial aims to compare the effects of rademikibart plus standard therapy versus standard therapy alone in urgent healthcare settings. The study focuses on participants who have a history of asthma and require urgent treatment for an acute asthma exacerbation. Participants will receive either 600 mg of rademikibart administered subcutaneously via a prefilled syringe or a matching placebo injection alongside their standard asthma treatment. The trial is designed as a parallel-group study to assess the added impact of rademikibart during acute episodes. The treatment is given once during the urgent care visit for the exacerbation. Throughout the study, researchers will monitor participants for treatment failure within 28 days after randomization. Assessments include lung function tests such as FEV1, blood tests for eosinophil counts, and clinical evaluations of asthma control and exacerbation status. The trial also carefully tracks safety and efficacy outcomes during this 28-day period to understand how well rademikibart works as an add-on treatment.

Researchers are conducting a Phase 2, randomized, double-blind, placebo-controlled trial to study adults aged 40 to 80 years with an acute exacerbation of chronic obstructive pulmonary disease (COPD) who also have type 2 inflammation. The study aims to compare the effects of adding rademikibart to standard therapy versus standard therapy alone in an urgent healthcare setting. Participants have a history of COPD with at least one previous exacerbation and meet specific blood eosinophil or FeNO levels indicating type 2 inflammation. Participants will receive either 600 mg of rademikibart or a matching placebo, both administered as a 4 mL subcutaneous injection. This treatment is given in addition to their usual standard care, which includes systemic corticosteroids. The study follows a parallel-group design where participants are randomly assigned to one of the two treatment groups, and neither the participants nor the researchers know which treatment is given. During the study, participants will undergo assessments to monitor their response to treatment and safety. The primary outcome being measured is the rate of treatment failure within 28 days. Researchers will also evaluate various health parameters and monitor for any side effects. The total participation duration and follow-up procedures are designed to ensure thorough evaluation of the treatment's impact on acute COPD exacerbations with type 2 inflammation.

This research focuses on participants with Hidradenitis Suppurativa (HS) who have previously taken part in specific Incyte-sponsored clinical trials of povorcitinib. The study is a Phase 3b rollover trial designed to continue monitoring these individuals to gather further information on the treatment. It aims to evaluate the safety of povorcitinib over an extended period, including the proportion of participants experiencing treatment-emergent adverse events for up to about three years. Participants will continue taking the study drug povorcitinib orally as specified by the study protocol. This rollover study includes individuals who completed the treatment period in the parent studies without safety or tolerability issues and who showed clinical benefit from povorcitinib. During this study, participants will follow the protocol-defined dosing and procedures while avoiding pregnancy or fathering children as required. Throughout the study, participants will attend scheduled visits and assessments to monitor their health and treatment effects. Researchers will track adverse events and adherence to the treatment plan. The study involves ongoing evaluation for up to approximately three years to ensure safety and collect important long-term data on povorcitinib use in this group of patients with HS.

Researchers are evaluating the effect of abelacimab compared to a placebo in patients with atrial fibrillation (AF) who are considered unsuitable for oral anticoagulation therapy. This study focuses on people at high risk for ischemic stroke or systemic embolism and aims to assess the safety and effectiveness of abelacimab in preventing these events. The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial involving patients with AF who have specific risk factors and treatment challenges. Participants will receive either abelacimab, provided as a liquid in vials at 150 mg/mL, or a matching placebo liquid. The study design includes parallel groups with blinded treatment assignment. The trial does not describe additional treatment phases or extensions but focuses on the comparison of abelacimab and placebo over the study duration. During the study, participants will be monitored for up to 30 months to measure the time until the first occurrence of ischemic stroke or systemic embolism, as well as the time until the first occurrence of serious bleeding as defined by the Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding. Safety and efficacy will be closely evaluated, with ongoing assessments to track these outcomes throughout the follow-up period.

Researchers are evaluating whether the drug zilebesiran can reduce the risk of major cardiovascular events such as cardiovascular death, nonfatal heart attacks, strokes, or heart failure in adults who have hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This Phase 3 global study is designed to continue until enough cardiovascular events have occurred to assess the treatment's effect. Participants will be randomly assigned to receive either zilebesiran or a placebo, both given as injections under the skin (subcutaneous administration). All participants will continue with their standard care, which includes treatment with at least two antihypertensive medications, one of which must be a diuretic such as a thiazide or loop diuretic. The study is double-blind, so neither participants nor researchers know who is receiving the active drug or placebo. During the study, participants will be closely monitored for cardiovascular events including heart attacks, strokes, heart failure hospitalizations, and cardiovascular deaths over approximately five years. Researchers will collect data on these events to determine the time until the first occurrence of any of these outcomes. Safety assessments and standard clinical evaluations will also be performed throughout the study period to ensure participant well-being.