Meadowbrook

Researchers are evaluating the efficacy and safety of enicepatide, a dual GLP-1GIP receptor agonist, at multiple doses compared with placebo for weight management in adults with obesity or overweight and type 2 diabetes mellitus T2DM. This Phase III study aims to better understand how enicepatide affects body weight and other health measures in this population. Participants will be randomly assigned to receive either placebo or one of three dosing regimens of enicepatide, administered once weekly using an integrated drug-device combination product. The study lasts for 72 weeks, during which participants will self-administer the study drug or receive injections from a trained individual if needed. Throughout the study, participants will undergo various assessments including body weight, hemoglobin A1c, waist circumference, fasting glucose and insulin, cholesterol levels, blood pressure, and quality of life questionnaires. Safety will be monitored through adverse event reporting and specific rating scales. This comprehensive evaluation will help determine the effects of enicepatide on weight and diabetes management over the study period.

Researchers are studying the effectiveness and safety of eloralintide in adults who are obese or overweight but do not have type 2 diabetes. This Phase 3 trial aims to understand how eloralintide affects body weight and related health measures over a long period. The study includes a main phase and an extension phase for those with prediabetes to evaluate ongoing effects. Participants are randomly assigned to receive one of four doses of eloralintide or a placebo, all given by subcutaneous injection once weekly. The main phase lasts about 75 weeks, and participants with prediabetes may continue in an extension phase for an additional two years. This structure allows researchers to assess both short-term and longer-term outcomes. During the study, participants will have regular visits to measure body weight, body fat, waist size, blood pressure, blood markers like triglycerides and insulin, and quality of life questionnaires. Safety and treatment effects are monitored throughout. The main outcome is the percent change in body weight from the start to week 64, with follow-up continuing up to week 191 for some. Overall participation can last up to several years depending on the participants health status.

Researchers are evaluating whether a medicine called BI 3034701 can help adults living with obesity or overweight lose weight. The study includes adults aged 18 to 74 years who have a body mass index BMI of 30 or more, or a BMI of 27 or more with at least one weight-related health problem. People with type 2 diabetes are not allowed to participate. The study is a phase II treatment trial sponsored by Boehringer Ingelheim. Participants are randomly assigned to one of seven groups, with six groups receiving different doses of BI 3034701 and one group receiving a placebo that looks like the medicine but contains no active drug. Each participant receives two injections under the skin every week for 42 weeks. Alongside the injections, all participants receive counseling to help improve their diet and encourage regular exercise. The study lasts about 10 months for each participant. During the study, participants visit the study site 15 times where their body weight is regularly measured and laboratory tests are performed. They also complete questionnaires about their well-being and keep diaries of their food intake and physical activity. Researchers monitor health status and any side effects throughout the trial. The main measure of success is the percentage change in body weight after 42 weeks of treatment, with additional measures including weight loss milestones, waist size, and blood pressure changes.

Researchers are evaluating the effect of muvalaplin in lowering cardiovascular risks among adults with elevated lipoproteina who either have atherosclerotic cardiovascular disease or are at risk of a first heart attack or stroke. This phase 3, randomized, double-blind study aims to investigate whether muvalaplin can reduce major adverse cardiovascular events compared to placebo in this high-risk population. Participants are randomly assigned to receive either muvalaplin or a placebo, both given orally. The study is designed with parallel groups and will last about 5.25 years, during which the occurrence of cardiovascular events and changes in lipoproteina levels will be closely monitored. Throughout the study, participants will undergo regular assessments including measurement of lipoproteina levels, monitoring of cardiovascular events such as heart attacks or strokes, and evaluation of healthcare resource use. The primary outcome is the time to first major adverse cardiac event, tracked from baseline until the study ends. Safety and pharmacokinetics of muvalaplin will also be evaluated during the trial period.

Researchers are evaluating the effect and safety of orforglipron taken once daily in adults with Fontaine Stage II peripheral arterial disease PAD who experience symptoms such as intermittent claudication. This phase 3 trial aims to understand how the drug affects walking ability and symptom relief over a period of about 58 weeks. The study is sponsored by Eli Lilly and Company and involves participants with confirmed PAD and reduced ankle brachial index ABI. Participants are randomly assigned to receive either orforglipron or a placebo in a double-blind design. Participants will take the study drug or placebo orally once daily. The study includes two groups one receiving orforglipron, and the other receiving a placebo. The treatment period lasts for approximately 52 weeks, during which participants will be monitored closely. This design allows comparison of the drugs effects against placebo on walking distance, symptoms, and quality of life measures. During the study, participants will undergo assessments including measuring their maximum walking distance, pain-free walking distance, and performance in a six-minute walk test at baseline and after 52 weeks. Questionnaires evaluating vascular quality of life and blood tests measuring inflammatory markers and blood pressure will also be collected. Safety and symptom relief will be monitored throughout the nearly one-year participation, helping to determine the drugs impact on PAD symptoms and overall vascular health.

This research aims to evaluate the effects of lowering blood phosphate levels in adults with end-stage kidney disease ESKD who are receiving dialysis. Elevated phosphate levels are common in ESKD and linked to higher risk of death and heart problems, but it is unclear if reducing phosphate improves important patient outcomes. The study will compare intensive lowering of phosphate to a more liberal phosphate target to see if this reduces heart-related deaths and events, improves physical health, and is cost-effective. Participants will be randomly assigned to one of two groups one aiming for a liberal serum phosphate target of 2.0 to 2.5 mmolL, and the other aiming for an intensive target of 1.50 mmolL or lower. Doctors will decide the type and dose of phosphate-lowering medications to help participants reach their assigned phosphate levels, following usual local practices. The study will last up to five years and is conducted internationally with 3600 adults on dialysis. During the study, researchers will monitor participants for major heart-related events and deaths, physical health, fatigue, quality of life, patient satisfaction, and itching. Regular assessments will include measuring time to cardiovascular death or major cardiovascular events and evaluating overall survival and quality of life using the EQ5D-5L tool. The study will also assess cost-effectiveness and continue to observe participants for five years to collect comprehensive data on these outcomes.

Researchers are evaluating the impact of two different default dialysate sodium concentrations on major cardiovascular events and death in adults receiving maintenance haemodialysis for end-stage kidney disease. This pragmatic, cluster-randomised, open-label Phase 4 study compares sodium levels of 137 mmoll and 140 mmoll in real-world dialysis settings across multiple sites globally. Dialysis sites will be randomly assigned to use either a default dialysate sodium concentration of 137 mmoll or 140 mmoll for at least 90% of dialysis sessions. Other aspects of patient care will follow standard local practices. Sites must consent to participate, and individual patients will provide waiver or opt-out consent. The study expects to enroll sites over 5 to 7 years, with each participant followed for approximately 2 to 5 years until the study endpoints are reached. Participants will receive dialysis at their assigned sites with the designated sodium concentration. Researchers will monitor the time to first occurrence of major cardiovascular events or death as the primary outcome. Secondary outcomes include other cardiovascular events and individual components of the composite outcomes. Data collection and patient monitoring will continue throughout the study period, estimated to last around five years per participant.

The trial investigates treatments for bloodstream infection caused by Staphylococcus aureus SAB, which can be life-threatening with a 15-30% death rate within three months. This international, multi-center randomized adaptive platform trial aims to find the best treatment options to reduce mortality within 90 days of infection. The trial adapts over time by assigning more patients to treatments that show better outcomes and removing less effective options. Participants receive various antibiotic treatments depending on their group. These include intravenous vancomycin or daptomycin, flucloxacillin or cloxacillin, cefazolin, or benzylpenicillin, with dosages adjusted for kidney function or illness severity. Some receive adjunctive drugs like clindamycin, and others may switch from intravenous to oral antibiotics if eligible after 7 or 14 days. Additionally, some participants undergo PETCT scans as part of the study. During the study, participants are monitored closely with blood cultures, temperature checks, and clinical assessments to track infection clearance and complications. Researchers measure all-cause mortality at 90 days as the primary outcome, along with other outcomes such as survival at earlier time points, hospital stay length, microbiological treatment failure, serious reactions, and antibiotic use. Safety and health economic data are also collected to evaluate treatments comprehensively throughout the trial.