This study is researching an experimental drug called REGN7508 (called "study drug") and how it compares against another treatment called apixaban. The study is focused on people who have atrial fibrillation, which means that the heart beats too fast and unevenly.
The aim of the study is to see how safe and effective REGN7508 is in preventing stroke and/or systemic embolism in participants with atrial fibrillation and how it compares against participants that will receive apixaban in this study.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drug
* Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
LAAOS-4 aims to determine if catheter-based endovascular left atrial appendage occlusion prevents ischemic stroke or systemic embolism in participants with atrial fibrillation, who remain at high risk of stroke, despite receiving ongoing treatment with oral anticoagulation.
Atrial Fibrillation· Hamilton Health Sciences Corporation· Atlanta, Georgia · Evanston, Illinois
This study aims to identify genetic causes of adverse events after cardiac surgery, such as atrial fibrillation, myocardial infarction, renal dysfunction and heart failure.
Patients undergoing heart surgery at Brigham and Women's Hospital and Texas Heart Institute are eligible to participate.
This study is researching 2 different experimental drugs called REGN7508 and REGN9933 (called "study drugs"). The study is focused on people who have atrial fibrillation, which means that the heart beats too fast and unevenly. When this happens, blood cannot move smoothly through the heart; it can slow down or pool in one spot, which can lead to the formation of blood clots.
REGN7508 and REGN9933 are designed to help stop blood clots forming in patients with atrial fibrillation. The aim of the study is to see how effective and safe REGN7508 and REGN9933, individually, are in preventing ischemic stroke or systemic embolism in people with atrial fibrillation who cannot or may choose to not take blood thinners.
The study is looking at several other research questions, including:
* What side effects may happen from taking REGN7508 or REGN9933
* How well does REGN7508 or REGN9933 lower the risk of having an ischemic stroke and/or systemic embolism compared to the placebo
* How well does REGN7508 or REGN9933 lower the risk of having a major health problem affecting heart and blood circulation compared to placebo
* How well does REGN7508 or REGN9933 lower the risk of death compared to placebo
* How much REGN7508 or REGN9933 is in the blood at different times
* Whether the body makes antibodies against REGN7508 or REGN9933 (which could make the study drugs less effective or could lead to side effects)
Psoriatic arthritis (PsA) is a long-term inflammatory disease that affects the joints and skin.
The purpose of this study is to check how safe zasocitinib is, how well it is tolerated and how well it works in adults with PsA over a longer period of time.
Adults who completed the 1-year (52-week) treatment period in one of the parent studies (TAK-279-PsA-3001 \[NCT06671483\] or TAK-279-PsA-3002 \[NCT06671496\]) may be able to join this continuation study (also called long-term extension or LTE study). All participants in this continuation study, will receive zasocitinib (lower or higher dose), once a day (QD).
Each participant can be in this study for approximately 2 years (108 weeks). This includes a treatment period of up to 2 years (104 weeks) and a 1-month (4-week) follow-up period to monitor a participant's health.
Psoriatic Arthritis· Takeda· Tucson, Arizona · Fountain Valley, California +2 more
Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time. This study will evaluate the efficacy and safety of targeted therapies through a series of substudies, for the treatment of active psoriatic arthritis and to assess the changes in disease symptoms.
The therapies being assessed in this sub-study are risankizumab and lutikizumab. Participants will be randomized in a 1:1:1 ratio to one of the three treatment arms: lutikizumab monotherapy, risankizumab monotherapy or a combination therapy of lutikizumab and risankizumab. Around 120 participants will be enrolled in the study at approximately 40 sites worldwide.
There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Psoriatic Arthritis· AbbVie· Huntington Beach, California · Avon Park, Florida +3 more
The purpose of this study is to evaluate the efficacy of icotrokinra (JNJ-77242113) compared to placebo in biologic-experienced and biologic-naive participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
Arthritis, Psoriatic· Janssen Research & Development, LLC· Philadelphia, Pennsylvania
Researchers are looking for new ways to treat Psoriatic Arthritis (PsA). This study will help find out if a study medicine called tulisokibart (MK-7240) can treat symptoms of active PsA. This study assesses the efficacy, safety, and tolerability of tulisokibart in adult participants with active PsA.
In this study, researchers will look at different doses of tulisokibart. Researchers want to learn if at least one of the study doses of tulisokibart works better than a placebo to lessen PsA symptoms. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of the study medicine.
Psoriatic Arthritis· Merck Sharp & Dohme LLC· Sun City, Arizona · Tucson, Arizona +3 more· Ages 18–80
The main aim of this study is to see 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 will be done in 2 parts: Part A will include both children and teenagers, while part B will only include children.
At first, only teenagers who meet the study rules can participate in this study. Children may only start to participate once enough information has been collected from other studies with zasocitinib.
Participants in Part A will initially be assigned to receive either zasocitinib or placebo for the first 16 weeks of treatment, then all participants will receive zasocitinib through the end of the study. All participants in Part B will be assigned to receive treatment with zasocitinib throughout the study.
Participants will be in the study for up to 4 years and 2 months (217 weeks), including up to 35 days for the screening period, 208 weeks of treatment (Part A and Part B) and a 4-week safety follow-up period. During the study, participants will visit their study site multiple times.
Plaque Psoriasis· Takeda· Chula Vista, California · Fountain Valley, California +3 more· Ages 4–17
Continuation of the CARRA Registry as described in the protocol will support data collection on patients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies. In particular, this observational registry will be used to answer pressing questions about therapeutics used to treat pediatric rheumatic diseases, including safety questions.
Rheumatic Joint Disease· Duke University· Birmingham, Alabama · Phoenix, Arizona +2 more
The main purpose of this study is to assess the effectiveness of adding tirzepatide to ixekizumab therapy in standard clinical practice in participants with moderate-to-severe plaque PsO and obesity or overweight with at least 1 weight-related comorbidity.
The study will last up to 12 months.
Psoriasis· Eli Lilly and Company· Phoenix, Arizona · Fountain Valley, California +3 more
Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects the joints and skin in people who have psoriasis (PsO).
The main aim of the study is to know how well zasocitinib (TAK-279) works in participants with active PsA based on their previous experience with specific treatments.
The participants will be treated with either zasocitinib, or placebo. Participants will be in the study for up to 60 weeks.
Psoriatic Arthritis· Takeda· Mesa, Arizona · Phoenix, Arizona +3 more
Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects the joints and skin in people who have psoriasis (PsO).
The main aim of the study is to know how well zasocitinib (TAK-279) works in participants with active PsA who have not previously been treated with biologic disease-modifying antirheumatic drugs.
The participants will be treated with either zasocitinib, active comparator, or placebo. Participants will be in the study for up to 60 weeks.
Psoriatic Arthritis· Takeda· Chandler, Arizona · Phoenix, Arizona +2 more
The main purpose of the SYNERGY-OUTCOMES study is to find out whether retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in people with high-risk metabolic dysfunction-associated steatotic liver disease (MASLD). The study will enroll adults who have MASLD based on non-invasive tests (NITs), which indicate they are more likely to develop MALO. Participants will be randomly assigned within a Master Protocol to receive either retatrutide (N1T-MC-RT01), tirzepatide (N1T-MC-TZ01) or placebo. The trial plans to enroll about 4,500 adults and will run for approximately 224 weeks. Participants may have up to approximately 25 to 30 clinic visits throughout the study to monitor their health, complete study procedures, and assess liver function and disease progression.
Once the study is complete, eligible participants may participate in an optional 2-year extension study, in which all participants will receive either retatrutide or tirzepatide, even if they received placebo in the main study.
Metabolic Dysfunction-Associated Steatotic Liver Disease· Eli Lilly and Company· Tuscaloosa, Alabama · Chandler, Arizona +2 more
Non-alcoholic fatty liver disease (NAFLD) is a new condition that has become the most common chronic liver disease in the world and a main cause of liver cirrhosis, liver failure and liver cancer. Obesity and diabetes, conditions that are very common among Veterans are the main risk factors for NAFLD. Therefore, the burden of NAFLD and its complications among Veterans is substantial. However, most VA patients with NAFLD are undiagnosed and untreated, and their care is not consistent with practice guidelines. The NAFLD Clinical Care Pathway (NCCP) intervention seeks to close this major gap in the care of Veterans by automatically identifying patients at risk of NAFLD, calculating their risk scores of having severe NAFLD, and educating the primary care providers on the diagnosis and treatment of NAFLD. This clinical trial will test the benefit of this NCCP intervention against usual care in increasing the rates of NAFLD diagnosis as well as referral to and enrollment in appropriate treatment. The study will also identify barriers and promotors of future NCCP implementation.
NAFLD· VA Office of Research and Development· Houston, Texas
This study is researching an experimental drug called ALN-PNP (called "study drug"). This is a first in human study. The study drug is not approved by any public health agency such as the United States Food and Drug Administration (FDA) for any kind of treatment.
This study consists of 3 parts. Part A is focused on healthy participants. Parts B and C of the study are focused on participants who are known to have MASLD and a specific variant of the PNPLA3 gene.
The aim of the study is to see how safe, tolerable and effective the study drug is.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drug (Parts A, B and C)
* How much study drug (Parts A, B and C) and study drug metabolites (byproduct of the body breaking down the study drug) (Parts B and C) are in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) (Part A, B and C)
* Explore impact of Japanese ethnicity on safety and PK (Pharmacokinetics, or study of what the body does to the drug) of single doses of ALN-PNP over time (Part A)
* How the study drug works to change liver fat content in MASLD (Part B and C)
* Better understanding of the study drug and MASLD (Part B and C)
This study is researching an investigational drug, ALN-HSD called "study drug". This study is focused on participants who are known to have Metabolic dysfunction-Associated SteatoHepatitis (MASH). MASH is a form of Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD). MASH occurs when fat builds up in liver cells, damaging them, and making the liver inflamed and stiff from fibrosis (scar tissue). MASH can progress to cirrhosis (long term scarring) and liver failure (when the liver cannot perform its job). The aim of the study is to see the effect of the study drug on lessening liver scarring related to MASH.
The study is looking at several other research questions, including:
* How ALN-HSD works to improve liver function and lessen MASH-related inflammation in the liver
* What side effects may happen from receiving the study drug
* How much study drug and study drug metabolites (byproduct of the body breaking down the study drug) are in the blood at different times
* Better understanding of the study drug and MASH
The Non-Invasive Biomarkers for Metabolic Liver Disease (NIMBLE) study is a comprehensive, multi-year collaborative effort to standardize, validate and advance the regulatory qualification of blood- and imaging-based biomarkers to diagnose and stage Metabolic dysfunction-associated steatohepatitis (MASH), previously known as nonalcoholic steatohepatitis (NASH). MASH is characterized by liver inflammation accompanied by simultaneous fat accumulation in the liver.
Metabolic Associated Fatty Liver Disease· Foundation for the National Institutes of Health· Miami, Florida · Columbus, Ohio +2 more· Ages 18–75
This study is open to adults who are at least 18 years old and have:
* A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or
* A confirmed liver disease called metabolic-associated steatohepatitis (MASH)
* BMI of 27 kg/m2 or more or
* 25 kg/m2 or more if the participant is Asian.
People with a history of other chronic liver diseases or high alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with NASH or MASH improve their liver function.
Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. All participants regularly receive counselling to make changes to their diet and to exercise regularly.
Participants are in the study for up to 4 and a half years. During this time, they visit the study site or have a remote visit by video call every 2, 4 or 6 weeks for about a 1 year and 5 months. After this time participants visit the trial site or have a remote visit every 3 months until the end of the study.
The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At some visits the liver parameters are measured using different imaging methods. The participants also fill in questionnaires about their symptoms. The results are compared between the groups to see whether the treatment works.