Huntington Park

This research aims to establish a Phase-2 master protocol framework to evaluate the safety and effectiveness of various investigational treatments for chronic weight management in adults with obesity or overweight. The study sets common entry criteria for participants across multiple specific intervention groups, called intervention-specific appendices (ISAs), which may begin independently as new treatments become available for clinical testing. The overall results will be reported after all ISAs are completed. The study involves multiple investigational drugs administered either by injection (subcutaneously) or orally. These include LY3305677, LY3841136, Tirzepatide, LY3549492, LY3532226, and placebo treatments matching the administration methods of the active drugs. Each ISA will detail the specific intervention procedures. Treatments are given according to the ISA schedules as participants are assigned to different groups. Participants will be involved from screening through treatment and monitoring phases, where their body weight stability and other health parameters are assessed. Researchers will track the number of participants allocated to each ISA during the first six weeks. Safety and efficacy will be evaluated throughout the study, which includes regular assessments and adherence monitoring. The study includes adults aged 18 to 75 with specific body mass index (BMI) criteria and weight stability prior to enrollment.

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 personalized management strategy for people with symptoms suggesting coronary artery disease (CAD). The study compares this strategy, which uses AI-based software to analyze coronary plaque from CT scans, against the usual care based on current guidelines. The goal is to see if this new approach improves diagnosis certainty, risk factor control, and referral efficiency for invasive coronary angiography with appropriate percutaneous coronary intervention (PCI). This is a prospective, randomized, open-label trial focusing on symptomatic patients suspected of having CAD. Participants assigned to the personalized management group will undergo a coronary CT angiography (CCTA) at the start. The images from these scans are processed using Cleerly Labs and Cleerly ISCHEMIA software to assess coronary plaque. This information is used to guide medical and interventional treatment decisions. The usual care group will receive standard diagnostic and treatment approaches based on American Heart Association/American College of Cardiology guidelines. During the study, which lasts about one year, researchers will monitor participants to evaluate the effectiveness and efficiency of these management strategies. They will measure outcomes such as improved diagnosis certainty, better control of CAD risk factors, and more appropriate use of invasive procedures like PCI. Safety and adherence will also be followed throughout the study period to understand the overall impact of the personalized approach compared to usual care.

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.

This research aims to evaluate the effectiveness and safety of two different dose schedules of pegozafermin compared to a placebo in adults with metabolic dysfunction-associated steatohepatitis (MASH) who have liver fibrosis at stage F2 or F3. This phase 3 study focuses on improving liver fibrosis and steatohepatitis in this patient group, which involves chronic liver disease associated with metabolic dysfunction. Participants will receive either pegozafermin or a placebo through subcutaneous injections. The study compares two doses of pegozafermin to assess their impact on liver fibrosis and steatohepatitis. The treatment period lasts up to 52 weeks, with outcomes measured at this time point. During the study, participants will be monitored for improvements in liver fibrosis and resolution of steatohepatitis without worsening fibrosis by week 52. Researchers will also track the time until any disease progression occurs, up to 5 years. Throughout the trial, safety and efficacy will be carefully assessed through clinical evaluations and laboratory tests to ensure participant well-being.

Researchers are evaluating the safety and effectiveness of obexelimab in adults with systemic lupus erythematosus (SLE). Participants must have had an SLE diagnosis for at least 24 weeks and meet the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria. Eligible patients must have active SLE with specific disease activity scores and be receiving certain standard lupus treatments such as oral corticosteroids, antimalarials, or immunosuppressants. The study includes a 24-week treatment period where participants are randomly assigned to receive either obexelimab or a placebo through weekly subcutaneous injections. Before treatment, there is a screening period lasting up to 28 days, and after the treatment phase, participants enter a 12-week follow-up period. Visits to the study site occur at weeks 2, 4, and then every 4 weeks throughout the study. During the study, participants will undergo regular assessments to monitor treatment effectiveness, safety, drug levels, immune response, and overall health. The maximum time a participant can be involved in the study, including screening and follow-up, is about 40 weeks. Researchers will collect data to evaluate how well obexelimab works and its safety profile in managing SLE symptoms.

Researchers are evaluating the immune response and safety of an investigational chickenpox vaccine and a marketed measles, mumps, and rubella (MMR) vaccine when given to healthy children aged 12 to 15 months. This Phase 3a study compares the investigational varicella vaccine given as a muscle injection to Merck's chickenpox vaccine administered just under the skin. The study also looks at the immune response and safety of giving these GSK vaccines together with other routine childhood vaccines via muscle injection. Participants receive either the investigational varicella vaccine by intramuscular injection or the marketed varicella vaccine given subcutaneously. The MMR vaccine is administered either subcutaneously or intramuscularly. Other vaccines such as Hepatitis A vaccine, 13-valent, 15-valent (Vaxneuvance), or 20-valent pneumococcal conjugate vaccines may be co-administered intramuscularly depending on country recommendations and availability. During the study, researchers will measure immune responses by assessing antibodies to varicella zoster virus and MMR antigens at Day 43 after vaccination. They will also monitor safety and tolerability throughout the study period. Parents or legal representatives complete diaries and return for follow-up visits to support ongoing safety and immunogenicity assessments. Overall, the study aims to understand how well the vaccines work and how safe they are when given to young children in this age group.

Autosomal Dominant Polycystic Kidney Disease (ADPKD) is a genetic condition causing fluid-filled cysts in the kidneys, leading to kidney disease. This Phase 2 study is investigating the safety and effectiveness of ABBV-CLS-628, an investigational drug, in adults with ADPKD. The study aims to evaluate how well ABBV-CLS-628 works and monitor any side effects in this population. Participants will be assigned to one of four groups, with each group receiving a different treatment. There is a 1 in 4 chance of receiving a placebo. Treatments, either ABBV-CLS-628 or placebo, will be given by intravenous infusion every 4 weeks for 92 weeks. After this treatment period, participants will be followed for up to an additional 15 weeks. During the study, participants will attend regular visits at hospitals or clinics where their health will be monitored through medical exams, blood tests, and questionnaires. Researchers will measure changes in total kidney volume over 96 weeks and track any adverse events up to approximately 118 weeks. The study involves around 240 adults aged 18 to 55 years with specific stages of ADPKD.

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 whether giving XEMBIFY® every two weeks along with Standard Medical Treatment (SMT) over one year can reduce the rate of serious bacterial infections in adults with low antibody levels (hypogammaglobulinemia) who have B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma. This phase 3 clinical trial compares XEMBIFY® plus SMT to a placebo plus SMT to see which better prevents infections in this group. Participants receive either XEMBIFY® or placebo through a subcutaneous infusion pump every two weeks, combined with their regular medical treatments. The study is randomized, double-blinded, and placebo-controlled, ensuring that neither participants nor researchers know who receives which treatment during the trial. Throughout the study, researchers will monitor participants for infection rates, specifically tracking major bacterial infections over about 51 weeks. Participants will have regular assessments including safety monitoring, pharmacokinetics, and infection tracking. The total study duration for each participant includes one year of treatment and observation, with careful follow-up to evaluate the treatment’s impact and safety.