Sippy Downs

Researchers are studying the effectiveness and safety of eloralintide in adults who are obese or overweight but do not have type 2 diabetes. This Phase 3 trial aims to understand how eloralintide affects body weight and related health measures over a long period. The study includes a main phase and an extension phase for those with prediabetes to evaluate ongoing effects. Participants are randomly assigned to receive one of four doses of eloralintide or a placebo, all given by subcutaneous injection once weekly. The main phase lasts about 75 weeks, and participants with prediabetes may continue in an extension phase for an additional two years. This structure allows researchers to assess both short-term and longer-term outcomes. During the study, participants will have regular visits to measure body weight, body fat, waist size, blood pressure, blood markers like triglycerides and insulin, and quality of life questionnaires. Safety and treatment effects are monitored throughout. The main outcome is the percent change in body weight from the start to week 64, with follow-up continuing up to week 191 for some. Overall participation can last up to several years depending on the participants health status.

Researchers are evaluating orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.

Psoriatic arthritis PsA is a long-lasting inflammatory condition affecting joints and skin in people with psoriasis. This trial evaluates how well the drug zasocitinib TAK-279 works in adults with active PsA, focusing on participants past experiences with certain treatments. The study is a phase 3 clinical trial designed to assess treatment effectiveness and safety. Participants will be randomly assigned to one of three groups one receiving zasocitinib Dose A tablets once daily for up to 52 weeks, another receiving zasocitinib Dose B tablets once daily for up to 52 weeks, and a third group receiving a placebo once daily for 16 weeks followed by either Dose A or Dose B of zasocitinib once daily through week 52. This design allows comparison of doses and placebo effects during the early treatment period. During the study, participants will undergo regular assessments including joint counts and skin evaluations to monitor disease activity and response to treatment. Researchers will measure the percentage of participants achieving specific response criteria such as the American College of Rheumatology 20 ACR20 response at week 16. Safety and other health outcomes like fatigue, physical function, and quality of life will also be tracked. Total participation can last up to 60 weeks, including treatment and follow-up periods.

Researchers are evaluating the effectiveness and safety of inavolisib combined with Phesgo compared to a placebo combined with Phesgo as maintenance treatment for participants with previously untreated HER2-positive advanced breast cancer that has a PIK3CA mutation. This Phase 3 study focuses on participants with locally advanced or metastatic breast cancer who have completed induction therapy. Participants first receive induction therapy with Phesgo plus taxane-based chemotherapy. Following this, they enter the maintenance phase where they are randomly assigned to receive either inavolisib tablets taken orally once daily for 21 days of each 21-day cycle along with Phesgo administered subcutaneously every 3 weeks, or a matching placebo tablet with Phesgo on the same schedule. Optional endocrine therapy may be given based on the investigators choice according to standard care. Throughout the study, participants undergo regular monitoring including tumor assessments, quality of life questionnaires, and safety evaluations lasting up to approximately 111 months. Key outcomes measured include progression-free survival assessed by investigators, overall survival, response rates, duration of response, and adverse event rates. Plasma concentrations of inavolisib are also measured at specific timepoints. Participants will be followed closely during and after treatment to assess these outcomes over an extended period.

Researchers are evaluating the effect of muvalaplin in lowering cardiovascular risks among adults with elevated lipoproteina who either have atherosclerotic cardiovascular disease or are at risk of a first heart attack or stroke. This phase 3, randomized, double-blind study aims to investigate whether muvalaplin can reduce major adverse cardiovascular events compared to placebo in this high-risk population. Participants are randomly assigned to receive either muvalaplin or a placebo, both given orally. The study is designed with parallel groups and will last about 5.25 years, during which the occurrence of cardiovascular events and changes in lipoproteina levels will be closely monitored. Throughout the study, participants will undergo regular assessments including measurement of lipoproteina levels, monitoring of cardiovascular events such as heart attacks or strokes, and evaluation of healthcare resource use. The primary outcome is the time to first major adverse cardiac event, tracked from baseline until the study ends. Safety and pharmacokinetics of muvalaplin will also be evaluated during the trial period.

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 olpasiran, compared to a placebo, to see how it affects the risk of coronary heart disease death, heart attacks, or urgent coronary revascularization in people at risk for their first major cardiovascular event who have high levels of lipoproteina. This Phase 3 study focuses on participants aged 50 to 105 years with multiple cardiovascular risk factors or evidence of atherosclerosis. Participants will be randomly assigned to receive either olpasiran or a placebo through subcutaneous injections. The study is double-blind, so neither participants nor researchers know who receives the active drug or placebo. Treatments and evaluations will continue for up to approximately 6.2 years. Throughout the study, participants will be monitored for heart-related events such as heart attacks, cardiovascular death, strokes, and coronary revascularizations. Researchers will also measure changes in lipoproteina levels at baseline and at Week 48, along with tracking adverse events. The total participation duration can extend up to about 6.2 years, with ongoing assessments to evaluate the treatments effect over time.

Researchers are evaluating the effects of olpasiran, compared to a placebo, on the volume of non-calcified plaque in participants with stable atherosclerotic cardiovascular disease and elevated lipoproteina. This Phase 3 trial aims to study how olpasiran impacts coronary artery plaque burden using Coronary Computed Tomography Angiography CCTA. The study is sponsored by Amgen and includes adults aged 35 to 80 years with a history of coronary artery disease and elevated lipoproteina levels. Participants are randomly assigned to receive either olpasiran or placebo administered as a subcutaneous injection every 12 weeks. The trial lasts for 72 weeks during which changes in non-calcified plaque volume will be measured from baseline to week 72. Secondary outcomes include changes in low attenuation plaque volume, total plaque volume, calcified plaque volume, and monitoring of treatment-emergent adverse events up to week 74. Throughout the study, participants will undergo regular assessments including CCTA scans to measure plaque volumes. Safety and tolerability will be closely monitored by tracking adverse events. The primary outcome focuses on the change in non-calcified plaque volume over the 72-week treatment period. Participants can expect scheduled visits for injections and imaging assessments, with the entire trial lasting approximately 18 months.

Researchers are studying the safety and effectiveness of HB-1 compared to a placebo in adults aged 18 to 65 years who have Post-Traumatic Stress Disorder PTSD. This is a phase 2, multi-center, double-blind, placebo-controlled trial involving approximately 200 to 500 adults diagnosed with PTSD who do not have severe neuropsychiatric or medical conditions. The study takes place at multiple sites in Australia and the United States. Participants will receive either HB-1 or a placebo tablet once daily for 12 weeks. HB-1 doses start at 64192 mg of telmisartanverapamil extended release and may be increased to 86258 mg based on treatment response and tolerance assessed at weeks 4 and 8. Those showing a 50% or greater reduction in PTSD symptoms remain on the same dose, while others without severe side effects may have their dose increased. A safety follow-up visit occurs one week after the last dose to monitor any adverse effects. During the study, participants will undergo assessments at baseline, week 4, week 8, and week 12, including symptom rating scales such as CAPS-5 and other PTSD-related questionnaires. Safety evaluations include monitoring for adverse events, vital signs, ECGs, and laboratory tests. The studys main goal is to measure changes in clinician-rated PTSD symptoms, along with secondary measures of stress, symptoms, and disability. Participation lasts for approximately 13 weeks including treatment and safety follow-up.

Researchers are evaluating the safety and immune response of different vaccine formulations targeting the Respiratory Syncytial Virus RSV monovalent antigen and the Influenza AH5N1 hemagglutinin subtype 5 H5 antigen in healthy adults aged 18 to 49 years. This phase 1 study aims to understand how well these vaccines work and how safe they are for this age group, with participation durations varying by treatment group and study stage. Participants receive vaccines through intramuscular injections. For certain groups, injections are given on day 1 and day 22 with the H5 Flu vaccines, while others receive a single injection on day 1 with the RSV vaccines. The study is divided into two stages, with Stage 1 lasting approximately 6 to 7 months depending on the arm, and Stage 2 lasting about 7 months for all arms. Vaccines are given according to a randomization schedule across multiple experimental arms. Throughout the study, participants will be monitored closely for side effects such as injection site reactions, systemic symptoms, and any adverse events up to 6 months after vaccination. Researchers will collect blood samples to measure antibody responses before and after vaccination at various time points. The study includes detailed safety assessments, including biological tests and documentation of any serious adverse events or events leading to discontinuation. Participants immune responses to both RSV and Flu H5 antigens will be measured using specific antibody tests over the course of the study.