Bridgewater

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating the effects of survodutide in adults aged 18 years and older who have a confirmed liver condition called non-alcoholic steatohepatitis (NASH) or metabolic-associated steatohepatitis (MASH). Eligible participants must have a body mass index (BMI) of 27 kg/m2 or higher, or at least 25 kg/m2 if they are Asian. The study excludes those with other chronic liver diseases or a history of significant alcohol use. The main goal is to see if survodutide can improve liver function and delay progression of liver damage over time. Participants are randomly assigned to receive either survodutide or a placebo, with twice the chance of receiving survodutide. Both treatments are given as weekly injections under the skin using a pre-filled syringe. Alongside treatment, all participants receive regular counseling to encourage healthy diet and exercise habits. The study lasts up to four and a half years, with frequent visits or remote video calls during the first year and five months, then quarterly visits thereafter. During the study, doctors monitor participants' health, including body weight and liver function using imaging tests at certain visits. Participants complete symptom questionnaires to help assess their condition. Researchers track outcomes such as survival, need for liver transplant, worsening liver disease, and liver-related complications. Safety and any side effects are closely watched throughout the study period to understand the treatment's impact.

Researchers are evaluating the effects of survodutide on adults living with obesity who have a liver disease called non-alcoholic steatohepatitis (NASH) or metabolic associated steatohepatitis (MASH), along with moderate or advanced liver fibrosis. The study focuses on whether survodutide can improve liver function and reduce liver damage in these participants. This Phase III trial aims to assess both the effectiveness and safety of survodutide over a long-term period. Participants are randomly assigned to one of two groups: one receiving weekly injections of survodutide and the other receiving placebo injections that look like the medicine but contain no active drug. The doses of survodutide are gradually increased until the target dose is reached. All participants receive counseling to support healthy diet changes and regular exercise throughout the study. The study lasts up to 7 years, with frequent visits to the study site or remote video calls. In the first year, visits occur every 2 weeks, then every 4 to 6 weeks, and later every 3 months alternating between in-person and remote. Throughout the study, researchers monitor participants' health, liver condition through imaging and biopsies, body weight, digestive system effects, and questionnaires about symptoms and quality of life. The main outcomes include liver fibrosis improvement, resolution of MASH without worsening fibrosis, and long-term safety and efficacy measures.

Researchers are investigating transmural healing (TMH) as a treatment target for patients with moderately to severely active Crohn's disease (CD). TMH, assessed by intestinal ultrasound (IUS), may be linked to better long-term outcomes but is not yet a formal treatment goal. This phase 4 study aims to find out if targeting corticosteroid-free IUS outcomes along with clinical symptoms and biomarkers improves corticosteroid-free endoscopic remission compared to targeting clinical symptoms and biomarkers alone, measured by the Simple Endoscopic Score for Crohn's Disease (SES-CD). Participants will be randomly assigned to one of two groups for 48 weeks of treatment with vedolizumab. All start with an induction regimen of 300 mg IV at weeks 0, 2, 6, and 10, followed by 300 mg IV every 8 weeks beginning at week 14. Group 1's treatment targets corticosteroid-free IUS-based outcomes plus clinical and biomarker remission, with IUS response assessments at weeks 22 and 30 and transmural healing as the final target at week 38. Group 2 aims for corticosteroid-free clinical and biomarker remission without the IUS component. Treatment adjustments may occur at weeks 22, 30, and 38 based on target assessments. During the study, participants will undergo regular evaluations to monitor disease activity and treatment response, including IUS assessments, clinical symptom reviews, and biomarker testing. Researchers will measure the percentage of participants achieving corticosteroid-free endoscopic remission at week 48. Safety and adherence will be monitored throughout the 48-week treatment period. The study includes adults aged 18 to 80 with moderately to severely active Crohn's disease who meet specific disease activity and treatment history criteria.