Santa Clarita

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.

Researchers are evaluating insulin icodec, a once-weekly insulin injection, compared to insulin glargine, a once-daily injection, in adults with type 1 diabetes. The study aims to see how well weekly insulin icodec controls blood sugar levels compared to daily insulin glargine when both are combined with insulin aspart. This phase 3 study will last about 26 weeks, or roughly 8.5 months. Participants will receive either insulin icodec or insulin glargine, both given as subcutaneous injections. All participants will also use insulin aspart as a subcutaneous injection. The study compares these two insulin regimens to assess their effects on blood sugar control over the 26-week period. During the study, researchers will monitor changes in glycosylated hemoglobin (HbA1c) from the start of the study to week 26. Participants will follow the study protocol including self-measured plasma glucose profiles. Safety and efficacy will be evaluated throughout the treatment period to understand the impact of the insulin regimens on blood sugar control and participant health.

Researchers are evaluating the drug disitamab vedotin, alone or combined with pembrolizumab, to treat urothelial cancer that expresses HER2. This cancer is locally advanced, cannot be removed by surgery, or has spread to other parts of the body. The study aims to see how well the drug works and how safe it is for participants by monitoring side effects and treatment responses. Participants will receive disitamab vedotin through an intravenous (IV) infusion every two weeks. Pembrolizumab, when given, is administered by IV on the first day of each six-week cycle. The study includes several groups, called cohorts, each with different treatment histories and eligibility criteria. Treatment and evaluation may continue for about two years. During the study, participants will have regular tests including scans to measure tumor response, lab tests, heart function checks, and monitoring for adverse events. Researchers will also track drug levels in the blood and any changes in heart function. The study will assess confirmed tumor responses and safety outcomes over approximately two years, with close monitoring to understand how participants respond to the treatments and any side effects experienced.

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 side effects of LY4005130 in adults with non-segmental vitiligo (NSV). This Phase 2 study compares LY4005130 with a placebo to understand how well the drug is tolerated. Participants have NSV affecting certain areas of their body and face, with the condition being either active or stable for at least 3 months. Participants will receive LY4005130 or a placebo through an intravenous (IV) infusion into a vein in the arm. The treatment phase lasts 24 weeks, during which the effects and safety of the drug will be monitored. The entire study, including screening, will take about 48 weeks. Throughout the study, participants will undergo blood tests to assess how their body processes the drug and how the drug affects their body. Researchers will measure the percentage of participants achieving significant improvement in facial vitiligo after 24 weeks. Safety and side effects will be followed carefully during treatment and the study period.

Researchers are evaluating how well LY4005130 works in adults with severe alopecia areata, a condition causing significant hair loss. This Phase 2 study compares LY4005130 with a placebo to assess its effectiveness, safety, and side effects. Blood tests will be conducted to understand how the body processes the drug and how the drug affects the body. The study drug, LY4005130, and placebo are both given intravenously into a vein in the arm. The treatment period includes administration of these study drugs under controlled conditions. The study lasts about 48 weeks in total, which includes a screening period before treatment. Participants will be involved in various assessments such as blood tests and evaluations of hair loss severity using the Severity of Alopecia Tool (SALT). The main outcome measured is the percentage of participants who achieve a SALT score of 20 or less by week 24. Safety and tolerability will be monitored throughout the study, with follow-up visits scheduled during the 48-week period.

Researchers are evaluating the efficacy and safety of induction therapy with Afimkibart (also called RO7790121) in people aged 16 to 80 years who have moderately to severely active Crohn's disease. This Phase III, multicenter, double-blind, placebo-controlled study focuses on how well Afimkibart works compared to placebo in improving symptoms and healing the intestine. Participants will receive Afimkibart either as an intravenous (IV) infusion or a subcutaneous (SC) injection. The study includes a placebo group receiving a matching IV infusion. Treatment is given during the induction phase to assess the initial response. During the study, participants will be monitored for clinical remission using the Crohn's Disease Activity Index and for endoscopic response at 12 weeks. Researchers will assess safety, effectiveness, and any side effects throughout the study. Participants will undergo evaluations including symptom tracking and medical tests to measure treatment outcomes.

Researchers are evaluating the safety, tolerability, and effectiveness of IMVT-1402 in adults with Graves' disease who continue to have hyperthyroidism despite treatment with antithyroid drugs (ATD). This Phase 2b randomized, double-blind, placebo-controlled study aims to compare IMVT-1402 with placebo by measuring thyroid hormone levels and ATD dose after 26 weeks. Participants will receive IMVT-1402 as a 600 mg injection under the skin once a week for either 52 weeks, or for 26 weeks followed by placebo injections for another 26 weeks. The placebo group will receive weekly placebo injections for 52 weeks. This design allows assessment of the drug's effects over time compared to placebo. During the study, participants will be monitored through laboratory tests measuring thyroid hormones (T3, FT4, TSH) to determine if they achieve normal thyroid function without ATD by Week 26. Safety and tolerability will also be evaluated throughout the treatment period. Participants must be adults between 18 and 75 years old and able to comply with study procedures.

Researchers are evaluating the safety and effectiveness of Armour Thyroid compared to synthetic T4 treatment in adults with primary hypothyroidism who are currently stable on synthetic T4. The study focuses on assessing how well patients respond to dose conversion from synthetic T4 therapy to Armour Thyroid. This trial is conducted as a Phase 2/3 multicenter, double-blind, randomized, active-controlled study. Participants receive either Armour Thyroid in oral capsule or tablet form or synthetic T4 capsules. They must have been on a stable dose of synthetic T4 for at least 12 months before screening, with a dose of at least 25 mcg daily. The study compares both treatments over time to evaluate efficacy and safety in maintaining thyroid function. During the study, researchers monitor thyroid-stimulating hormone (TSH) levels to measure treatment response at week 55. They also track any adverse events related to the treatments for up to approximately 90 weeks. Participants undergo regular assessments to ensure safety and effectiveness throughout the study period.

Researchers are evaluating the safety and how the body processes AZD7760 when given as an intravenous infusion. The study includes healthy adults (Phase I) and adults with end-stage kidney disease who are receiving hemodialysis through a central venous catheter (Phase IIa). It aims to understand the occurrence of adverse events and how the drug behaves in these two groups. In Phase I, participants are randomly assigned to receive one of three doses of AZD7760 or a placebo as a single intravenous infusion. This part includes a 28-day screening period, a 3-day dosing period with the infusion given on Day 1, followed by a 12-month follow-up. In Phase IIa, participants receive either AZD7760 or placebo as two intravenous infusions spaced three months apart (Day 1 and Day 91), along with a 28-day screening period and a 12-month follow-up after the last infusion. Participants will be monitored for adverse events, serious adverse events, and special interest events from Day 1 up to 361 days in Phase I and 181 days in Phase IIa. Assessments will include safety laboratory tests, physical exams, and vital signs. Researchers will closely observe participants during follow-up to evaluate safety and gather pharmacokinetic data over the course of one year after dosing.