Moore

Researchers are evaluating the long-term effects of aleniglipron, a drug taken orally, in adults with overweight or obesity who also have type 2 diabetes mellitus T2DM. This is a randomized, double-blind, placebo-controlled Phase 3 study designed to assess the drugs effectiveness, safety, and tolerability over an extended period. The study focuses on the management of weight and diabetes in this population. Participants will be randomly assigned to receive either aleniglipron or a placebo, all administered orally. The treatment period lasts for 76 weeks, during which participants will take multiple doses of the assigned medication. The study includes three different aleniglipron arms and one placebo arm, all aiming to evaluate weight change and diabetes control over time. Throughout the study, participants will undergo assessments to measure changes in body weight, waist circumference, HbA1c levels, blood pressure, and cholesterol levels. The primary outcome is the percent change in body weight from the start of the study to week 76. Secondary outcomes include the proportion of participants achieving various levels of weight loss and diabetes targets. The study also monitors safety and tolerability during the treatment period, which lasts approximately 76 weeks.

Researchers are studying the long-term effects of aleniglipron, taken once daily, in adults with obesity or overweight who also have weight-related health problems. This Phase 3 global, randomized, placebo-controlled, and double-blind trial aims to evaluate how well aleniglipron works, how safe it is, and how well patients tolerate it over at least 76 weeks. The study also compares aleniglipron with placebo in terms of body weight changes, blood pressure, lipid levels, and patient-reported outcomes. Participants will be randomly assigned to receive one of three doses of aleniglipron or a placebo, all taken orally once daily. Along with the medication, all participants will follow a reduced-calorie diet and increase physical activity. The treatment phase lasts at least 76 weeks, during which effects on weight and other health measures will be assessed. During the study, participants will undergo assessments of body weight, waist size, blood pressure, cholesterol, blood sugar, and quality of life measures from the start through week 76. Researchers will monitor safety and tolerability throughout the treatment period. This long-term study will help understand the impact of aleniglipron on weight management and related health factors over more than a year of treatment.

Researchers are comparing the effectiveness, acceptability, and side effects of two treatments for adults with treatment-resistant depression TRD intravenous racemic ketamine and intranasal Esketamine Spravato. This study aims to see how well each treatment helps with depression symptoms, patient willingness to use the treatments, and how patients cope with side effects. It also explores which patient factors might predict better responses to each treatment. Participants will be randomly assigned to receive either racemic ketamine, given as a 40-minute intravenous infusion with a maximum dose of 60 mg per day and a lifetime limit of 8 doses, or Esketamine nasal spray, dosed between 56 and 84 mg according to FDA guidelines, with lower doses allowed if needed for tolerance. This multi-site study plans to enroll about 400 patients over five years. During the study, participants will undergo assessments including self-reported and clinician-reported measures of depression effectiveness, response, remission, suicidal thoughts, disability level, quality of life, healthcare resource use, acceptability, global severity and improvement, and safety monitoring. These evaluations occur from baseline through the 4-week treatment period and include a primary outcome measured at 30 days. Participants must attend visits for treatment and evaluation over the study duration ending in 2030.

This research aims to provide long-term follow-up data on patients with moderate to severe treatment-resistant depression who are either starting or continuing treatment with IV ketamine or Spravato intranasal esketamine. The study will observe patient acceptability, satisfaction, treatment patterns, long-term effectiveness, and safety of these two approaches. It is an observational study conducted across six sites, including academic medical centers and community psychiatric practices. Participants will be observed over a 5-year period after initiating or continuing treatment with either IV ketamine or Spravato as prescribed by their clinician. Two groups include patients currently receiving IV ketamine and those receiving Spravato. The study collects data on treatment patterns such as the number of treatments, reasons for discontinuation, and average dose during the first 6 months. During the study, participants will provide information through assessments that evaluate treatment satisfaction TSQM-9 and depression severity from both self-report and clinician perspectives. Researchers will also monitor adverse events and treatment patterns from baseline to 6 months. Participants are expected to comply with study procedures and remain available throughout the 5-year follow-up to provide long-term data on treatment outcomes and safety.

Researchers are evaluating whether adding zilebesiran to standard antihypertensive treatment can reduce major cardiovascular events in adults with hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This phase 3, randomized, double-blind study aims to determine if zilebesiran lowers the risk of cardiovascular death, heart attacks, strokes, or heart failure events compared to placebo. The study will continue until a targeted number of these events have occurred, which may take up to about 5 years. Participants will be randomly assigned to receive either 300 mg of zilebesiran or a placebo, both given as subcutaneous injections every 6 months, alongside their usual blood pressure medications. The study uses a parallel design and includes careful monitoring of blood pressure and cardiovascular events over time. Both groups will continue their standard antihypertensive therapies, including at least two medications where one must be a diuretic. During the study, participants will be regularly assessed for cardiovascular events such as heart attacks, strokes, heart failure hospitalizations, and cardiovascular death. Blood pressure measurements will be taken at baseline and at 6 months, among other times. The primary outcome is the time until the first occurrence of a major cardiovascular event, with secondary outcomes including changes in blood pressure and other cardiovascular events. Participants will be followed for up to approximately 5 years to monitor these outcomes and overall survival.