Chula Vista

Researchers are evaluating the safety and effectiveness of tenapanor in adults with Chronic Idiopathic Constipation (CIC) in this 26-week phase 3 study. The study is randomized, double-blind, and placebo-controlled, involving multiple centers. It aims to compare three doses of tenapanor (5 mg, 25 mg, and 50 mg taken twice daily) against a placebo, with a focus on improving spontaneous bowel movements. Participants will first undergo a 2-week screening where their eligibility is assessed through medical history, physical exams, lab tests, ECG, and self-reported constipation symptoms using an electronic diary (eDiary). Eligible patients will then be randomly assigned to receive one of the three doses of tenapanor or placebo twice daily for 26 weeks. During this treatment period, patients will continue daily and weekly symptom reporting via the eDiary and attend regular safety visits at weeks 2, 4, 8, 12, 16, 20, and 26. After completing the 26-week treatment, patients enter a 4-week treatment-free safety follow-up period to monitor any adverse events. A final visit occurs at the end of this follow-up to assess safety. The main outcome measured is the durable complete spontaneous bowel movements response over 12 weeks. Overall, the study involves careful monitoring of symptoms, safety, and treatment effects over approximately 32 weeks.

Researchers are studying a new oral weight loss medicine called MK-4082 in healthy adults who are overweight or obese. This Phase 1 study aims to find a safe dose and understand how the medicine behaves in the body over time. The focus is on whether people tolerate MK-4082 and its safety compared to a placebo. Participants will receive MK-4082 or a placebo in tablet form. The study uses multiple ascending doses to evaluate different levels of the medicine. The goal is to identify a dose that is safe and well tolerated for use in future research. During the study, researchers will monitor participants for any adverse events and whether anyone stops treatment due to side effects. The safety monitoring lasts up to about 98 days for adverse events and 84 days for treatment discontinuation. Participants' health and tolerability of the medication will be closely observed throughout the study period.

Researchers are evaluating tulisokibart as a potential treatment for radiographic axial spondyloarthritis (r-axSpA), a type of arthritis causing pain, stiffness, and inflammation in the spine and pelvis joints, visible on X-rays. This Phase 2b study aims to determine if different doses of tulisokibart improve symptoms better than a placebo, which looks like the study medicine but contains no active drug. The study has two main parts: a 16-week placebo-controlled period where participants receive either tulisokibart or placebo through subcutaneous injections, followed by a 124-week long-term extension divided into a 40-week main extension and an 84-week optional extension. This allows researchers to assess both the short-term and longer-term effects and safety of tulisokibart. Participants will be monitored for their response using the Assessment of Spondyloarthritis International Society (ASAS) 40 response at week 16 as the primary outcome. Throughout the study, researchers will evaluate disease activity and safety while tracking symptoms and any side effects. The total involvement spans up to 140 weeks, including both initial treatment and extension phases.

This research aims to learn about the safety and tolerability of a study medicine called MK-1403 in people with type 2 diabetes mellitus (T2D). It also investigates how the body processes MK-1403 over time and its effect on the levels of high-sensitivity C-reactive protein (hsCRP) in the blood. The study is a Phase 1 clinical trial focused on these key aspects in adults with T2D. Participants will receive either MK-1403 combined with an additive coformulation or a placebo combined with the same additive coformulation. Both are given orally. The study includes multiple doses to evaluate the medicine's safety, tolerability, and how it behaves in the body compared to placebo. During the study, researchers will monitor participants for adverse events and any discontinuation related to these events, which will be tracked for up to about 28 days for adverse events and 14 days for discontinuations. Blood tests will measure hsCRP levels and other pharmacokinetic parameters. The trial involves adult participants aged 18 to 75 years with type 2 diabetes, and safety and response to the study drug will be closely followed.

Researchers are evaluating the effects, safety, and response to the medicine zasocitinib in children and teenagers aged 4 to under 18 years who have moderate-to-severe plaque psoriasis. The study is designed in two parts, with Part A including both children and teenagers and Part B including only children. Initially, only teenagers meeting the study criteria can join, with children joining later after more data is collected from other studies. In Part A, participants are randomly assigned to receive either zasocitinib or a placebo for the first 16 weeks, after which all receive zasocitinib for the rest of the study. Participants in Part B receive zasocitinib throughout. The treatment period lasts up to 208 weeks, followed by a 4-week safety follow-up. Both drug and matching placebo are used, and the study is conducted at multiple centers. Participants will attend multiple visits to the study site over a total duration of up to 4 years and 2 months, including a screening period of up to 35 days. Researchers will assess improvements in psoriasis severity using measures like the Static Physician's Global Assessment and Psoriasis Area and Severity Index at week 16. In Part B, they will also study how the body absorbs and processes zasocitinib by measuring drug levels at specific times. Safety and tolerability will be monitored throughout the study.

Researchers are evaluating the effect of the drug MAR001 compared to a placebo on triglyceride levels after meals in adults who have high triglycerides and remnant cholesterol. This Phase 2 study focuses on understanding how MAR001 influences post-meal lipid levels in this population. The goal is to determine changes in triglyceride levels in the blood following a mixed meal. Participants will receive either MAR001 or a placebo through subcutaneous injections. The study compares these two treatments over a 12-week period to assess their impact on triglyceride levels after eating. This design allows researchers to study the drug's effects while maintaining a blinded and controlled environment. During the study, participants will have their triglyceride levels measured before and after a mixed meal to monitor changes over 12 weeks. The primary outcomes include the change in triglyceride area under the curve and the peak plasma triglyceride concentration. Participants must follow a stable diet and medication regimen during the trial and attend scheduled assessments to ensure accurate monitoring of the drug's effects.

Researchers are conducting a Phase 1 clinical trial to evaluate the safety, tolerability, and pharmacokinetics of TIX100, an oral drug that inhibits thioredoxin-interacting protein, in healthy adult volunteers aged 18 to 70 years. This randomized, placebo-controlled study takes place at a single center and focuses on healthy individuals without significant medical conditions or recent clinical events. The goal is to understand how the drug behaves in the body and to monitor any side effects or safety concerns. Participants will receive a single oral dose of either TIX100 or a placebo. The study involves careful monitoring of treatment-related adverse events, laboratory tests, vital signs, electrocardiograms (ECGs), and physical examinations, all assessed on Day 7 after dosing. The trial compares the effects of TIX100 to those of placebo in order to assess tolerability and pharmacokinetics. During the study, participants will undergo medical history reviews, physical exams, vital sign checks, laboratory tests, cardiac and respiratory monitoring, and will be observed for any significant clinical findings. Safety assessments include tracking of adverse events and abnormalities in lab results, ECGs, and physical exams. The entire participation period includes screening, dosing, and follow-up assessments up to Day 7 to ensure comprehensive safety evaluation.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating an investigational drug called ALN-HSD for adults with Metabolic dysfunction-Associated SteatoHepatitis (MASH), a type of liver disease where fat buildup causes liver cell damage, inflammation, and scarring. This condition can lead to serious complications like cirrhosis and liver failure. The study aims to assess how ALN-HSD affects liver scarring associated with MASH and to explore its impact on liver function, inflammation, side effects, and how the drug and its breakdown products appear in the blood. Participants will receive either ALN-HSD or a placebo according to the study protocol in this Phase 2, randomized, double-blind, placebo-controlled trial. The treatment is given based on the protocol's schedule, but specific dosing details are not provided. The study focuses on adults with specific genetic risk factors for MASH and with certain disease stages, ensuring a targeted precision medicine approach. During the study, participants will be monitored for changes in quantitative liver fibrosis from the start of the study to week 52. Researchers will evaluate liver scarring, liver function, inflammation, drug levels in the blood, and any side effects. The study includes genetic testing and specific liver assessments like FibroScan and FAST scores. Participants will be followed closely to understand the drug's effects and safety over the one-year period.

Researchers are evaluating a new approach to prevent cardiovascular events in patients at increased risk due to age and conditions like type 2 diabetes, prediabetes, or metabolic syndrome but without known symptomatic cardiovascular disease. The study compares a Cleerly Coronary Artery Disease (CAD) Staging System-based care strategy with standard risk factor-based care to see if the former can better reduce cardiovascular events. The Cleerly system uses imaging to visualize and quantify coronary artery disease and guides personalized treatment and education based on this assessment. The trial uses the Cleerly CAD Staging System device, which employs a proprietary algorithm to detect and stage coronary artery disease and generate a risk score to guide treatment decisions. Participants receive either this stage-based care or the usual care based on traditional risk factors. The study is prospective, randomized, and pragmatic, designed to follow patients over an average of 3.5 years to compare cardiovascular event outcomes between these two care approaches. Participants will be monitored through cardiovascular event tracking throughout the study period. Data collected includes imaging results, risk scores, and treatment adherence to evaluate the impact of the care strategies. The primary outcome is the comparison of cardiovascular event risk between the Cleerly stage-based care and risk factor-based care groups. The study also includes ongoing safety monitoring and personalized management by a cardiologist-led team via digital communication devices.