New Iberia

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 multinational, multicenter, randomized, double-blind, placebo-controlled Phase 3 study is designed to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease. The study includes three sub-studies focusing on induction treatment, with specific co-primary endpoints assessing clinical remission and endoscopic response at 12 weeks. Participants will receive either duvakitug or a placebo via subcutaneous injection during the treatment periods. The study duration can last up to 35 weeks and consists of a screening period of up to 5 weeks, followed by a 12-week induction phase in either Sub-Study 1 (open-label feeder induction) or Sub-Study 2 (pivotal induction). Non-responders may enter a 12-week extended induction phase in Sub-Study 3. After treatment, participants not enrolling in the maintenance study will have a 6-week follow-up period. Throughout the study, participants will have scheduled visits for assessments, including monitoring of clinical remission and endoscopic response using standardized scoring systems at 12 weeks. The total number of visits varies depending on sub-study participation, with up to 15 visits for those in Sub-Study 3. Safety and treatment effects will be closely monitored during these visits and follow-up periods.

Researchers are evaluating the safety and effectiveness of duvakitug in people with moderately to severely active Ulcerative Colitis (UC). This multinational, multicenter, randomized, double-blind, placebo-controlled Phase 3 study aims to see if duvakitug can help achieve clinical remission in this condition. The study targets participants aged 16 to 80 years with a confirmed diagnosis of active UC for at least 3 months who have not responded well or are intolerant to other treatments. Participants will receive either duvakitug or a placebo as a solution injected under the skin (subcutaneous injection). The study includes up to 35 weeks with multiple periods: a screening period, a 12-week induction phase (either open-label or randomized), a 12-week extended induction for those who do not respond initially, and a 45-day follow-up for those not continuing into the maintenance study. During these phases, participants may have up to 8 to 15 on-site visits depending on their sub-study group. Throughout the study, participants will be monitored closely with scheduled visits for assessments including clinical evaluations related to UC activity and response to treatment. The main outcome measured is the proportion of participants who achieve clinical remission by week 12. Safety and tolerability will also be tracked during and after the treatment period, with follow-up visits to ensure participant well-being.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are investigating if combining mirikizumab with tirzepatide can reduce symptoms of moderately to severely active ulcerative colitis (UC) and help adults with obesity or overweight lose at least 10% of their body weight. This Phase 3b study compares this combination treatment to mirikizumab with a placebo to see which is more effective over a 52-week treatment period, followed by additional monitoring up to 61 weeks. Participants receive mirikizumab either intravenously (IV) or subcutaneously (SC), along with either tirzepatide or a placebo administered subcutaneously. The study randomly assigns adults with UC and obesity or overweight into these treatment groups to evaluate the effects over the full treatment duration. During the study, participants will undergo various assessments including evaluations of UC symptoms and body weight changes. Researchers will measure the percentage of participants who achieve clinical remission of UC and at least 10% weight loss at week 52. Safety and health monitoring will continue throughout the study to ensure participant well-being during the treatment and follow-up periods, which together can last up to 61 weeks.

Researchers are evaluating the effectiveness and safety of mirikizumab alone or combined with tirzepatide compared to mirikizumab with placebo in adults who have moderately to severely active Crohn's disease along with obesity or overweight conditions. This Phase 3b study focuses on patients with confirmed Crohn's disease or perianal fistulizing Crohn's disease who also meet specific weight-related criteria and have shown inadequate response or intolerance to previous Crohn's disease treatments. The study may last up to 61 weeks. Participants receive treatments involving mirikizumab administered intravenously or subcutaneously, tirzepatide given subcutaneously, or placebo administered subcutaneously. The trial includes groups receiving mirikizumab with placebo or mirikizumab combined with tirzepatide to compare outcomes. Dosage schedules and exact administration details are provided throughout the treatment period. During the study, participants will undergo various assessments including clinical evaluations using the Crohn's Disease Activity Index, endoscopic examinations, and monitoring of weight changes. Researchers will track the percentage of participants achieving clinical remission, endoscopic remission, and at least 10% weight reduction by week 52. Safety and response to treatments will be closely monitored throughout the duration of up to 61 weeks.