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Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

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 effectiveness and safety of brenipatide when given along with standard care compared to a placebo with standard care in adults with bipolar disorder. This Phase 2 study aims to see if brenipatide can delay the worsening of bipolar symptoms. The trial includes participants aged 18 to 75 years and involves a careful assessment of how well the treatment works and its safety profile. The trial has three main periods: a screening period lasting about one month, a treatment period of at least six months, and a follow-up period of around two months. Participants receive either brenipatide or placebo, both given by subcutaneous injection, alongside their usual bipolar disorder medications. The study may end earlier if symptoms worsen or if participants withdraw for any reason. Participants will be asked to self-inject the study medication, maintain diaries, complete questionnaires, and attend regular visits throughout the study. Researchers will monitor the time to relapse, defined as the number of days from randomization until symptoms worsen according to specific criteria, over at least six months. Safety and adherence to treatment will also be closely observed during the study.

Researchers are evaluating the effectiveness and safety of eloralintide compared to a placebo for reducing body weight in adults who have overweight or obesity along with type 2 diabetes. This Phase 3, randomized, double-blind study focuses on participants who have been on stable treatment for their type 2 diabetes and aims to provide detailed information on body weight changes over time. Participants will receive either eloralintide or a placebo administered by subcutaneous injection once weekly. The study lasts about 75 weeks, including treatment and follow-up periods. The goal is to monitor the changes in body weight from the beginning of the study through week 64. During the study, participants will undergo various assessments to track body weight and overall health. Researchers will collect data on weight changes and monitor safety throughout the study period. The main outcome measured is the percentage change in body weight from baseline to week 64, ensuring close observation of participants' responses to the treatment.

Researchers are evaluating the safety and effectiveness of obexelimab in adults with systemic lupus erythematosus (SLE). Participants must have had an SLE diagnosis for at least 24 weeks and meet the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria. Eligible patients must have active SLE with specific disease activity scores and be receiving certain standard lupus treatments such as oral corticosteroids, antimalarials, or immunosuppressants. The study includes a 24-week treatment period where participants are randomly assigned to receive either obexelimab or a placebo through weekly subcutaneous injections. Before treatment, there is a screening period lasting up to 28 days, and after the treatment phase, participants enter a 12-week follow-up period. Visits to the study site occur at weeks 2, 4, and then every 4 weeks throughout the study. During the study, participants will undergo regular assessments to monitor treatment effectiveness, safety, drug levels, immune response, and overall health. The maximum time a participant can be involved in the study, including screening and follow-up, is about 40 weeks. Researchers will collect data to evaluate how well obexelimab works and its safety profile in managing SLE symptoms.

Researchers are evaluating the safety and effectiveness of a new oral medicine called vepugratinib compared with a placebo in adults with advanced or metastatic urothelial carcinoma, a type of bladder cancer that has a specific FGFR3 genetic alteration. This Phase 3 study aims to see if vepugratinib combined with two other drugs, enfortumab vedotin (EV) and pembrolizumab, can improve treatment outcomes for people who have not received prior systemic therapy for their cancer. Participants will receive either vepugratinib or placebo taken orally alongside enfortumab vedotin and pembrolizumab, both administered by intravenous infusion. The study is randomized, double-blind, and placebo-controlled to ensure reliable comparison between the vepugratinib and placebo groups. Treatment and monitoring will continue for up to approximately 6 years, allowing long-term assessment of safety and treatment effects. During the study, participants will be regularly evaluated for treatment-related side effects, response rates, and how long the cancer remains controlled without progression. Researchers will use established criteria to measure tumor response and will conduct thorough safety monitoring over the entire study period. Participation may last up to six years, during which participants will undergo laboratory tests, imaging, and clinical assessments to track their health and treatment response.

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 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.