Danville

This research focuses on adults with obesity or overweight and aims to evaluate the safety and effectiveness of various investigational treatments for chronic weight management. It is a Phase 2 master protocol study that uses a framework to test multiple interventions, each detailed in separate appendices. The study establishes criteria for enrolling new participants and reports results when all intervention appendices have completed. Participants may receive different investigational drugs administered either by subcutaneous injection or orally, including LY3305677, LY3841136, tirzepatide, LY3549492, and others. Each intervention-specific appendix outlines the particular treatment details and analyses. Some participants receive placebos matching the administration method of the active treatments. Treatments and analyses are conducted in parallel groups, and interventions may start independently as they become available. Throughout the study, participants undergo screening to confirm eligibility and are randomly assigned to one of the intervention groups or placebo. Researchers monitor participant allocation up to week 6. The trial emphasizes double-blind procedures, and participant involvement includes receiving study treatments and attending scheduled visits. Safety and efficacy data are collected, and the study is planned to continue until early 2028, with primary outcome measures focusing on participant allocation to interventions.

Researchers are evaluating the short-term and long-term effects and safety of belimumab in adults with early systemic lupus erythematosus SLE who have positive autoantibodies and ongoing disease activity despite stable first-line treatment. This is a prospective, open-label, single-arm Phase 4 clinical study sponsored by GlaxoSmithKline. The study focuses on adults diagnosed within two years with active SLE, aiming to better understand how belimumab works in this group. Participants will receive belimumab GSK1550188 administered subcutaneously throughout the study. The treatment and observation period lasts for three years, with key evaluations at one year and longer-term follow-ups up to three years. There is no placebo or comparison group, as all participants receive the study drug. During the study, participants will have regular visits to assess disease activity, including the Lupus Low Disease Activity State LLDAS at week 52 and other measures such as the SLE Responder Index 4 SRI4, flare frequency, and improvements in skin symptoms. Researchers will monitor safety by tracking adverse events and serious adverse events. Blood tests, questionnaires, and physical assessments will be done to evaluate fatigue, damage, and disease remission. Participants will be followed for up to 156 weeks to assess long-term outcomes and safety.

Researchers are evaluating the effects of macupatide and eloralintide, alone or combined, on body weight reduction in adults with obesity or overweight who do not have type 2 diabetes. This Phase 2b clinical trial aims to study the weight-lowering effectiveness and safety of these drugs compared with placebo under a randomized, double-blind, placebo-controlled design. Participants are assigned to one of several groups receiving macupatide, eloralintide, both drugs together, or placebo, all administered by subcutaneous injection. The study lasts about 64 weeks, including treatment and follow-up periods, with dosing at different levels and combinations to assess the interventions effects on weight management. During the study, participants undergo regular visits for assessments including body weight measurements up to at least week 36 and beyond. Researchers monitor changes in body weight, body mass index BMI, and the proportion of participants who achieve significant weight loss percentages. Safety and adherence are also tracked throughout the trial to evaluate the treatments over the full participation period.

Researchers are evaluating the safety and effectiveness of the AcoArt Litos Paclitaxel Coated Balloon PCB catheter compared to a standard non-coated PTA balloon catheter in treating blockages in the infrapopliteal arteries of patients with chronic limb-threatening ischemia CLTI, specifically Rutherford category 4 or 5. The study aims to determine if the AcoArt Litos PCB offers better treatment outcomes while maintaining similar safety to the control device. This randomized controlled trial involves patients with critical blood flow issues in the lower leg arteries affecting limb health. Participants will be randomly assigned to receive either the PCB catheter experimental group or the standard PTA balloon catheter control group to treat narrowing or blockages in arteries below the knee but above the ankle joint. The devices are used during angioplasty procedures targeting vessels with specific size and lesion length criteria. The study includes a comprehensive evaluation of treatment success, safety events within 30 days, and longer-term vessel openness and limb outcomes over several years. During the trial, participants will undergo follow-up visits at multiple time points up to five years to assess limb health, vessel patency, wound healing, and adverse events. Researchers will measure outcomes such as major amputation-free survival, re-narrowing rates, and changes in blood flow indexes. Safety monitoring includes tracking major adverse limb events and peri-operative deaths shortly after treatment. Participants are expected to comply with scheduled visits and evaluations to provide detailed data on the treatments impact and durability.

This research evaluates the effects of ribupatide KAI-9531 given as a weekly subcutaneous injection compared to a placebo. It focuses on adults living with obesity or overweight who also have weight-related health issues but do not have diabetes. The study aims to understand how ribupatide influences body weight changes over time. Participants are randomly assigned to one of several groups receiving different doses of ribupatide once weekly or a matching placebo injection once weekly. The study is double-blind, so neither participants nor researchers know who receives the drug or placebo. Dosages range from Dose 1 to Dose 4, and the treatment period lasts up to 76 weeks. During the study, participants will have their body weight and various health indicators measured, including waist circumference, blood pressure, cholesterol levels, blood glucose, and quality of life related to weight. Safety is monitored by tracking adverse events and immune responses to the drug. The trial spans over approximately 76 weeks, with assessments at baseline and week 76 to evaluate changes and effects.

Researchers are evaluating whether adding zilebesiran to standard antihypertensive treatment can reduce major cardiovascular events in adults with hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This phase 3, randomized, double-blind study aims to determine if zilebesiran lowers the risk of cardiovascular death, heart attacks, strokes, or heart failure events compared to placebo. The study will continue until a targeted number of these events have occurred, which may take up to about 5 years. Participants will be randomly assigned to receive either 300 mg of zilebesiran or a placebo, both given as subcutaneous injections every 6 months, alongside their usual blood pressure medications. The study uses a parallel design and includes careful monitoring of blood pressure and cardiovascular events over time. Both groups will continue their standard antihypertensive therapies, including at least two medications where one must be a diuretic. During the study, participants will be regularly assessed for cardiovascular events such as heart attacks, strokes, heart failure hospitalizations, and cardiovascular death. Blood pressure measurements will be taken at baseline and at 6 months, among other times. The primary outcome is the time until the first occurrence of a major cardiovascular event, with secondary outcomes including changes in blood pressure and other cardiovascular events. Participants will be followed for up to approximately 5 years to monitor these outcomes and overall survival.