Chula Vista

Researchers are evaluating the safety and effectiveness of tenapanor in adults with Chronic Idiopathic Constipation CIC. This study is a 26-week, multi-center, randomized, double-blind, placebo-controlled trial followed by a 4-week treatment-free safety follow-up period. It aims to compare three different doses of tenapanor with a placebo taken twice daily to assess their impact on constipation symptoms. The study includes a 2-week screening period to confirm eligibility, followed by a 26-week randomized treatment period where patients receive either 5 mg, 25 mg, or 50 mg of tenapanor twice daily, or a matching placebo. Patients record their constipation symptoms daily in an electronic diary. After the treatment period, there is a 4-week safety follow-up without treatment to monitor any adverse effects. Participants will have regular visits every 2 to 6 weeks for safety checks including medical assessments, vital signs, ECG, and lab tests. Their symptom diaries will be reviewed throughout the study. The main outcome measured is the durable complete spontaneous bowel movements response at 12 weeks. Secondary outcomes include changes in bowel movement frequency, stool consistency, and straining. The total study duration is approximately 32 weeks including all phases.

Researchers are investigating new treatments for radiographic axial spondyloarthritis r-axSpA, a form of arthritis causing pain, stiffness, and swelling in the spine and pelvis joints. This condition shows visible damage on X-rays. The study aims to evaluate if different doses of the medicine tulisokibart can improve r-axSpA symptoms compared to a placebo, which helps measure the medicines effects accurately. Participants will be assigned to one of several groups receiving high, medium, or low doses of tulisokibart, or a placebo. The study includes a 16-week placebo-controlled phase. After that, participants receiving the low dose or placebo will be re-assigned to medium or high doses. Following this, there is a long-term extension lasting 124 weeks, which has a 40-week main extension and an 84-week optional extension, allowing continued treatment and observation. Throughout the study, participants will have regular assessments to monitor symptoms and disease activity using various indexes and imaging scores. Researchers will track the percentage of participants who achieve improvement at week 16 and monitor safety by recording adverse events up to approximately 154 weeks. The study uses injections of tulisokibart or placebo under the skin and includes ongoing evaluations of physical function, pain, inflammation, and quality of life.

Researchers are evaluating the safety and tolerability of a study drug called MK-1403 in adults with Type 2 diabetes mellitus T2D. The study also aims to understand how MK-1403 behaves in the body over time pharmacokinetics and its effect on levels of high-sensitivity C-reactive protein hsCRP in the blood. This is a phase 1 clinical trial focused on treatment in adults aged 18 to 75 with T2D. Participants will be assigned randomly to one of four groups receiving either MK-1403 combined with an additive coformulation or a placebo combined with the same additive coformulation. These treatments are taken orally once daily, with two different dosage levels studied sequentially. The study compares the effects and safety of MK-1403 plus the additive at two different doses against placebo plus the additive at matching doses. During the study, participants will be monitored for adverse events and any discontinuation due to side effects for up to 28 days. Researchers will measure changes in hsCRP levels from baseline and examine the concentration of MK-1403 in the blood 24 hours after dosing on Day 14. The trial involves regular assessments to track safety, tolerability, and drug behavior, with the overall participation lasting approximately four weeks.

Researchers are evaluating the effectiveness of pegloticase administered by two different methodssubcutaneous under the skin injection versus intravenous into a vein infusioneach combined with methotrexate MTX in participants who have uncontrolled gout. The main goal is to compare how well these two treatment methods maintain normal serum uric acid levels over a six-month period. This Phase 3 trial is designed as a double-blind, randomized controlled study to provide reliable information on treatment responses.

Researchers are studying how well the medicine zasocitinib works, how safe it is, and how children and teenagers aged 4 to under 18 with moderate-to-severe plaque psoriasis respond to it. The study is divided into two parts Part A includes both children and teenagers, while Part B includes only children. Initially, only teenagers who meet the study requirements can participate, with children joining after sufficient information is collected from other studies. Participants in Part A will be randomly assigned to receive either zasocitinib or a matching placebo daily for the first 16 weeks, followed by open-label zasocitinib treatment until the study ends. In Part B, all children will receive zasocitinib throughout the study. The treatment doses for children will be based on their weight, and adolescents will receive a fixed dose. The study lasts up to 4 years and 2 months, including screening, treatment, and safety follow-up periods. During the study, participants will visit the study site multiple times for assessments. Researchers will measure improvements in skin condition using tools like the Static Physicians Global Assessment and Psoriasis Area and Severity Index at Week 16 and throughout the open-label period. Safety and drug levels in the body will also be monitored. After treatment, there is a 4-week safety follow-up. Overall, participants will be involved for up to 217 weeks, including screening, treatment, and follow-up.

Researchers are studying the effects of MAR001 on adults with high triglycerides and remnant cholesterol. This phase 2, randomized, double-blind, placebo-controlled trial aims to compare MAR001 with a placebo to see how it changes triglyceride levels after eating a mixed meal. The study focuses on the postprandial after eating state in adults aged 18 to 75 years with elevated triglycerides and remnant cholesterol. Participants receive either MAR001 or a matching placebo through subcutaneous injections. The treatment period lasts 12 weeks, during which researchers measure changes in triglycerides and remnant cholesterol levels after a mixed meal. The study uses a quadruple-blind design, meaning participants, care providers, investigators, and outcomes assessors do not know who receives MAR001 or placebo. During the study, participants will have fasting triglyceride tests at screening and regular assessments throughout the 12 weeks. Researchers will track the area under the curve and peak plasma concentrations of triglycerides and remnant cholesterol after meals to evaluate treatment effects. Participants must maintain stable diets and medication regimens during the trial. Safety and adherence will be monitored with ongoing assessments to understand the impact of MAR001 compared to placebo.

Researchers are evaluating the safety, tolerability, and how the body processes TIX100, an oral drug that inhibits thioredoxin-interacting protein, in healthy adults aged 18 to 70. This Phase 1, randomized, placebo-controlled study aims to understand how different doses of TIX100 affect healthy participants. The study is sponsored by TIXiMED, Inc. and is conducted at a single center. Participants will receive a single oral dose of TIX100 at varying amounts 20 mg, 60 mg, 100 mg, 160 mg, or 200 mg or a placebo. The study uses a randomized and quadruple-blind design to compare these groups. The intervention is a one-time administration, and participants are closely monitored afterward for safety and drug behavior in the body. During the study, participants undergo assessments including medical exams, vital sign checks, laboratory tests, ECGs, and physical examinations to monitor for any treatment-related side effects and clinically important changes. These evaluations are done up to 7 days post-dose. The study includes careful observation of adverse events and laboratory results to ensure participant safety over the follow-up period, which concludes by May 2025.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are studying an investigational drug called ALN-HSD in adults with Metabolic Dysfunction-Associated SteatoHepatitis MASH, a liver condition caused by fat buildup that damages liver cells and causes inflammation and scarring. This condition can worsen to cirrhosis and liver failure. The study aims to evaluate how ALN-HSD affects liver scarring related to MASH and to understand its impact on liver function and inflammation, as well as potential side effects and how the drug is processed in the body. Participants will be randomly assigned to receive either ALN-HSD or a placebo in a double-blind setup. The study involves a 52-week treatment period during which the effects of ALN-HSD on liver fibrosis and other liver-related biomarkers will be assessed. The trial includes genetic risk factor screening for enrollment and collects data on drug levels and metabolites. Treatment is administered according to the study protocol, with monitoring continuing through week 84 for adverse events. Throughout the study, participants will undergo liver biopsies and various laboratory tests to measure liver fibrosis, enzyme levels, and other biomarkers related to MASH. Researchers will track changes from baseline to week 52 in liver fibrosis and inflammation, along with monitoring adverse events until week 84. Participants are involved in regular assessments to evaluate the study drugs impact on their liver health over the course of the trial.

Researchers are evaluating a new care strategy for people at increased risk of atherosclerotic cardiovascular disease ASCVD but without symptoms. The study compares a Cleerly Coronary Artery Disease CAD Staging System-based care approach against the usual risk factor-based care to see if it better reduces cardiovascular events. This pragmatic, randomized trial addresses the need for improved methods to identify and personalize treatment for asymptomatic individuals at risk due to age, diabetes, prediabetes, or metabolic syndrome. Participants are randomly assigned to one of two groups. The risk factor-based care group receives usual care managed by their providers, while a cardiology team monitors and supports guideline-based treatment without revealing certain imaging results during the study. The Cleerly stage-based care group gets personalized management from a remote cardiologist-led team using the Cleerly CAD Staging System, which includes imaging to assess coronary atherosclerosis and guides pharmacotherapy and education. Treatment intensity may increase if plaque worsens after 24 months. During the study, participants will have assessments to monitor heart health and treatment adherence over an average of 3.5 years. Researchers will measure cardiovascular events and other related health outcomes to compare the two care strategies. The study involves ongoing medication monitoring, lab tests, and feedback to optimize prevention, with the goal of improving personalized care for cardiovascular risk management.