Macomb County

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.

This research aims to evaluate the safety, tolerability, and impact on albuminuria of the drug MZE829 in adults who have proteinuric chronic kidney disease and carry the APOL1 high-risk genotype. This Phase 2 open-label study focuses on participants with specific genetic markers associated with kidney disease to better understand treatment effects. Participants will receive MZE829 in the form of oral capsules. The study involves monitoring the participants over a 12-week period to assess the drug's safety and how well patients tolerate it. Researchers will also measure changes in albuminuria, which reflects kidney function. During the study, participants will be closely monitored for any adverse events from the first day through week 12. Safety assessments and laboratory tests will be performed to track the drug’s effects. The main goal is to determine how safe and tolerable MZE829 is, along with its impact on kidney disease markers over the treatment duration.

Researchers are evaluating efruxifermin (EFX) in adults aged 18 to 80 who have compensated cirrhosis caused by nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH). This Phase 3, randomized, double-blind, placebo-controlled study aims to assess the safety and effectiveness of EFX in improving liver health and delaying disease progression in this population. The study focuses on subjects with advanced liver fibrosis (stage 4) but without liver decompensation. Participants are randomly assigned to receive either efruxifermin or a placebo, both administered by subcutaneous injection. The study includes two cohorts: Cohort 1 requires biopsy confirmation of liver fibrosis and specific metabolic features, while Cohort 2 allows biopsy or non-invasive diagnosis. Treatment and observation continue over an extended period to evaluate changes in liver fibrosis and clinical events. During the study, researchers will monitor the time until significant clinical events such as disease progression or liver decompensation occur, with a follow-up of up to five years. For Cohort 1, the proportion of participants showing improvement in fibrosis without worsening steatohepatitis will be assessed at 96 weeks. Participants will undergo regular evaluations including clinical assessments and laboratory tests to track liver function and safety throughout the study period.

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.

Hidradenitis suppurativa (HS) is a chronic and often painful skin disease that causes lumps, abscesses, and scars in areas like under the breasts, armpits, inner thighs, groin, and buttocks. Researchers are evaluating the investigational drug lutikizumab compared to placebo in adults and adolescents with moderate to severe HS. This study aims to assess the disease activity and safety of lutikizumab in a Phase 3 clinical trial involving about 1280 participants worldwide.

Researchers are evaluating whether adding immunotherapy drugs brentuximab vedotin and nivolumab to standard chemotherapy, with or without radiation, can improve survival for patients aged 5 to 60 years with newly diagnosed stage I or II classical Hodgkin lymphoma. This phase III trial compares outcomes in groups based on their early response to initial chemotherapy, aiming to understand if immunotherapy can lead to better progression-free survival and overall survival compared to standard treatment alone. The study also looks at side effects, quality of life, and long-term health impacts across different patient groups. Participants first receive two cycles of standard ABVD chemotherapy every 28 days, followed by imaging to classify their response as rapid or slow early responders and their risk status as favorable or unfavorable. Based on these factors, patients are assigned to one of eight treatment arms that include either continued standard chemotherapy regimens or immunotherapy with brentuximab vedotin and nivolumab, sometimes combined with involved-site radiation therapy. Treatments are given intravenously or orally depending on the drugs, and cycles typically last 28 days. Imaging and blood samples are collected regularly throughout the study. Throughout the trial, participants undergo frequent scans such as FDG-PET, CT, MRI, and PET-CT to monitor their disease status. Blood samples and questionnaires assess treatment effects and quality of life. After completing treatment, patients have scheduled follow-up visits every 3 months for the first year, then every 6 months for two years, and annually up to 12 years to track long-term outcomes, side effects, and survival. The main measurements focus on progression-free survival, overall survival, treatment-related adverse events, and patient-reported experiences.

Researchers are evaluating the effectiveness and safety of pegozafermin in adults aged 18 to 75 years who have compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis (MASH), previously known as nonalcoholic steatohepatitis (NASH). Participants in this phase 3 study must have biopsy-confirmed advanced liver fibrosis (stage F4) due to MASH and meet specific metabolic health criteria. The study aims to understand how well pegozafermin can help improve liver fibrosis and delay disease progression over time. Participants will receive either pegozafermin or a placebo through subcutaneous injections. The study will monitor participants over a long period, up to five years, to observe changes in liver fibrosis and any clinical events related to disease progression. The treatment is given to those with compensated cirrhosis, meaning their liver is damaged but still functioning, and the study carefully evaluates the safety and potential benefits of pegozafermin in this group. Throughout the study, participants will undergo regular assessments to track liver health, including fibrosis regression and timing of disease progression. Researchers will use clinical events and laboratory tests to measure outcomes from the start of the study through 24 months and up to five years. Safety and health will be monitored closely, ensuring any side effects or complications are identified promptly. This comprehensive follow-up helps provide detailed information on the long-term effects of the treatment and participants' liver condition.

Researchers are evaluating the safety and effectiveness of tulisokibart, a humanized monoclonal antibody, in people with moderately to severely active Crohn's disease. The research includes two studies: Study 1, which has induction and maintenance treatment phases, and Study 2, which only includes induction treatment. The main goals are to see if tulisokibart can help participants achieve clinical remission and endoscopic response compared to placebo, measured at 12 and 52 weeks depending on the study and region (US/FDA or EU/EMA).

Researchers are evaluating the safety, side effects, and best dose of the drug cabozantinib combined with standard chemotherapy in treating patients newly diagnosed with osteosarcoma. This study aims to compare the effect of adding cabozantinib to the usual chemotherapy drugs methotrexate, doxorubicin, and cisplatin. Cabozantinib is a kinase inhibitor that may slow tumor growth by blocking signals involved in blood vessel formation and growth pathways. The trial includes both phase II and phase III components and involves patients with localized or metastatic high-grade osteosarcoma, including those with pelvic tumors or unresectable disease. During the feasibility phase, patients received cabozantinib orally and standard chemotherapy intravenously in a series of induction, consolidation, and maintenance cycles over several months. In the efficacy phase, patients are randomized into groups receiving either standard chemotherapy alone or combined with cabozantinib, with treatment cycles lasting 35 days each followed by local control procedures like surgery. The study monitors the impact of adding cabozantinib on event-free survival and overall survival. All participants undergo imaging (X-ray, CT, MRI, PET or bone scan) and blood sample collection at diagnosis and throughout the trial. Participants are closely monitored through scans and blood tests at various time points to assess treatment effects and safety. Researchers measure dose-limiting toxicities during the initial 6 weeks and track event-free survival and overall survival for up to five years after completing treatment. The study also collects tumor tissue and blood samples to study tumor DNA and assess response to therapy. Patient-reported outcomes on therapy-specific side effects and symptom burden are evaluated to understand tolerability. The total participation duration varies based on treatment cycles and long-term follow-up assessments.

Researchers are evaluating the safety, tolerability, and effects of a drug called HU6 for adults diagnosed with metabolic dysfunction-associated steatohepatitis (MASH). This Phase 2a study compares HU6 with a placebo to assess how the drug affects liver fat content and other symptoms of MASH, as well as to understand its pharmacokinetics, which is how the drug moves through the body. The trial has two parts: a blinded intervention period where participants receive either HU6 or a placebo without knowing which one, followed by an optional open-label extension where participants may continue receiving HU6. The study includes a screening phase, treatment period, end of treatment or early termination visit, safety follow-up, and two long-term follow-up visits. Participants will be monitored through various assessments including MRI scans to measure liver fat, blood tests to evaluate drug levels and safety, and tracking of any side effects over 26 weeks. Researchers will measure the number and percentage of adverse events, changes in liver fat, and detailed pharmacokinetic parameters to understand HU6's behavior and safety profile during and after treatment.