Silverdale

Researchers are studying the effects of ribupatide KAI-9531, given as a weekly subcutaneous injection, in adults living with obesity or overweight who also have type 2 diabetes. The main goal is to see if ribupatide is better than a placebo in reducing body weight and lowering hemoglobin A1c HbA1c, a key marker of blood sugar control. This is a Phase 3, randomized, double-blind, placebo-controlled trial evaluating safety and efficacy. Participants will be randomly assigned to receive one of four doses of ribupatide or a matching placebo once weekly. The study compares the effects of these different doses over time, focusing on changes in weight and HbA1c levels at week 76. The intervention involves subcutaneous injections administered once a week, with multiple doses tested to evaluate their impact relative to placebo. During the study, participants will be monitored regularly to measure changes in body weight, HbA1c, waist circumference, blood pressure, cholesterol levels, glucose, insulin, and quality of life related to weight. Safety assessments include tracking adverse events and immune responses to the drug. Blood samples will be collected to measure ribupatide concentrations. The study lasts up to 76 weeks, with ongoing monitoring for treatment effects and safety throughout this period.

Researchers are evaluating the effect of MAR001 compared to a placebo in adults with elevated triglycerides TG and remnant cholesterol RC. This Phase 2b randomized, double-blind, placebo-controlled study aims to understand how MAR001 influences TG levels in participants with these conditions. The study includes two parts with different participant groups based on their baseline TG levels. Participants are assigned randomly to receive either MAR001 or placebo through subcutaneous injections every 4 weeks. Part A includes about 216 participants with baseline TG between 150 to 880 mgdL, treated with three different doses of MAR001 or placebo at a 31 ratio. Part B enrolls around 100 participants with baseline TG between 450 and 2000 mgdL, using the dose selected from Part A data, assigned at a 11 ratio. The study timeline consists of up to 8 weeks of screening, a 24-week treatment period, and a 12-week safety follow-up with clinic visits at weeks 28 and 36. During the study, participants will undergo assessments including blood tests and clinical evaluations to monitor TG and RC levels and safety outcomes. The primary outcome is measured at 12 weeks, with additional secondary outcomes assessed at various time points. Participants adherence to stable diet and medication regimens is monitored. The total participation duration extends through the screening, treatment, and follow-up periods, with safety monitored until study completion.

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.