Pennington

Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

Researchers are evaluating the safety of OviTex PRS, a reinforced tissue matrix used in implant-based breast reconstruction surgeries, in women aged 18 to 75 years. This observational study looks at patients who previously received either permanent or resorbable OviTex PRS devices during immediate or two-stage unilateral or bilateral breast reconstructions, placed either above or below the chest muscle. The goal is to understand the safety profile of these devices and help guide future studies on their effectiveness. Participants in the study had undergone breast reconstruction surgery using OviTex PRS combined with implants, either permanent or resorbable types. The procedures included initial surgeries and any necessary exchange surgeries. The study collects data retrospectively and prospectively across multiple centers to assess outcomes related to the use of these devices. During the study, researchers track any significant adverse events within 24 months after implantation of the OviTex PRS device. Participants may be asked to return for follow-up visits, including photographic documentation. The study focuses on monitoring safety outcomes over two years, ensuring patients' recovery and device performance are carefully observed.

Researchers are evaluating the safety and effectiveness of the ETHIZIA patch compared to SURGICEL Original in controlling minimal, mild, or moderate soft tissue bleeding during open surgery. This study focuses on achieving hemostasis, which means stopping bleeding, within three minutes after applying the product, and ensuring there is no rebleeding up to ten minutes after application. The trial includes various types of open surgeries such as abdominal, retroperitoneal, pelvic, thoracic (non-cardiac), and extremity surgeries. Participants will receive either the ETHIZIA patch or SURGICEL Original applied directly to the bleeding site during surgery. The bleeding site must be from soft tissue like organ beds, loose tissue, fat, lymphatic tissue, or muscle, and traditional methods to stop bleeding like sutures or cautery must be ineffective or impractical. Pressure will be applied to the hemostatic agent to help stop the bleeding. This study is conducted in multiple centers and patients are randomly assigned to one of the two treatment groups. During the study, researchers will closely observe the bleeding site for up to ten minutes after product application to measure the percentage of cases achieving hemostasis at three minutes and no rebleeding afterward. Participants will be monitored for any safety concerns during the follow-up period. The study includes detailed assessments during surgery and careful documentation of bleeding control, with a total participation period covering surgery and follow-up evaluations.

Researchers are evaluating the change in hemoglobin A1c (HbA1c) levels in people with type 2 diabetes who have not reached their HbA1c goal despite stable treatment with semaglutide or tirzepatide. This phase 2, double-blind study compares the effects of LY3457263, a drug given by subcutaneous injection, with a placebo in this patient group. Participants will be adults aged 18 to 75 with type 2 diabetes and specific HbA1c and BMI criteria. Participants will receive either LY3457263 or a placebo, both administered once weekly by subcutaneous injection. All participants must be on a stable dose of either injectable semaglutide or tirzepatide for at least three months before the study. The treatment period is 24 weeks, during which researchers will monitor changes in HbA1c levels from the start of the study. Throughout the study, participants will undergo assessments to measure HbA1c at the beginning and at week 24. The total participation duration is about 9 months. Researchers will also track participants' safety and treatment adherence during this time to evaluate the effects of LY3457263 compared to placebo in managing type 2 diabetes.

Researchers are evaluating the safety and effectiveness of solbinsiran in reducing triglycerides and other fat-related measures in adults with severe hypertriglyceridemia. This phase 2 study compares solbinsiran to a placebo to better understand its potential benefits and risks in this condition. Participants will receive two subcutaneous injections of either solbinsiran or a placebo. The study is randomized and double-blind, meaning neither the participants nor the researchers know who receives the actual drug or placebo during the treatment period. Participants will be monitored for changes in their triglyceride levels from baseline through weeks 16 to 24. The study tracks safety and efficacy by measuring lipid changes and observing any side effects. The total duration of participation includes screening and treatment phases with regular assessments throughout the study.

Researchers are evaluating two surgical procedures, bilateral salpingectomy and bilateral salpingo-oophorectomy, to see how well they reduce the risk of ovarian cancer in women who have BRCA1 gene mutations. The study aims to determine if removing just the fallopian tubes (bilateral salpingectomy) is almost as effective as removing both the fallopian tubes and ovaries (bilateral salpingo-oophorectomy) in lowering ovarian cancer risk. This trial also assesses symptoms related to estrogen loss, quality of life, sexual function, cancer-related distress, decision-making about surgery, and treatment side effects in these patients. Participants choose between two groups: one group undergoes bilateral salpingectomy and may have their ovaries removed later, while the other group undergoes bilateral salpingo-oophorectomy. Both groups receive pelvic or transvaginal ultrasounds or pelvic MRI scans during screening, and blood samples are collected throughout the trial. Ancillary studies include quality-of-life assessments and questionnaires. The study also collects tissue and blood samples for future research. After surgery, participants have follow-up visits at 10 to 60 days, then at 6, 12, and 24 months, and annually for up to 20 years. Researchers monitor the time until any high-grade serous carcinomas develop, specifically ovarian, primary peritoneal, or fallopian tube cancers. They also track menopausal symptoms, sexual function, quality of life, cancer distress, medical decisions about surgery, and any adverse events during this long-term follow-up.

This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.

Researchers are investigating how often adults from minority groups, specifically Black/African American and Hispanic/Latino individuals with refractory metastatic colorectal cancer, experience high blood pressure after treatment with fruquintinib. The study also aims to assess the safety and tolerability of fruquintinib in these populations. This phase 4 trial focuses on patients who have already undergone standard therapies but continue to have advanced disease. Participants will receive oral fruquintinib capsules in treatment cycles lasting four weeks each. They will continue the treatment until their condition worsens, they cannot tolerate the medication, or they choose to stop for other reasons. After completing the treatment phase, participants will be monitored every three months until the study ends. Throughout the study, participants will undergo regular health assessments to monitor blood pressure and evaluate any treatment-related side effects. Researchers will track the occurrence of severe hypertension from the first dose through approximately 35 months of follow-up. Additional safety evaluations and disease assessments will help determine how well participants tolerate fruquintinib and its effects on their cancer.

Researchers are evaluating the effect of muvalaplin on reducing cardiovascular risk in adults with elevated lipoprotein(a) levels who either have atherosclerotic cardiovascular disease or are at risk for a heart attack or stroke. This Phase 3, randomized, double-blind, placebo-controlled study focuses on adults with high Lp(a) levels and prior or potential cardiovascular events. The study aims to assess the time to the first major adverse cardiovascular event over about 5.25 years. Participants will be randomly assigned to receive either muvalaplin or a placebo, both administered orally. The study includes individuals with Lp(a) levels of at least 175 nanomoles per liter who have had a prior cardiovascular event within 10 years or are at risk for a first event due to conditions such as coronary artery disease, carotid stenosis, peripheral artery disease, high coronary artery calcium score, reduced kidney function with diabetes, or other high-risk factors. The treatment period lasts through the study duration, with close monitoring. During the study, participants will be regularly evaluated to track the occurrence of major adverse cardiovascular events, including heart attacks and strokes. Safety assessments will monitor blood pressure, kidney function, and heart failure status among other health indicators. The primary outcome measures the time to the first major cardiovascular event from baseline up to the end of the study, which spans approximately 5.25 years.

Researchers are collecting blood and tissue samples from people with and without cancer to study and evaluate tests that could help detect cancer early. The goal is to create a blinded reference set of samples to validate blood-based tests for early detection of multiple types of cancer, including leukemia, lymphoma, breast, lung, and others. The study also aims to assess how well these tests perform at the time of initial cancer diagnosis, considering different tumor types and cancer stages. Participants complete a baseline questionnaire and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also provide tissue samples at these times. The study includes patients aged 40 to 75 years, with cancer diagnoses at various stages or individuals without cancer. Special procedures are in place for patients with high suspicion of certain cancers before confirmation. During the study, researchers collect detailed information through questionnaires, blood draws, and tissue sampling to analyze test accuracy. Participants are monitored for up to one year after registration to follow outcomes. The primary measure is providing this blinded set of blood samples to help validate future cancer detection tests, supporting research that could improve early diagnosis and treatment.