Secaucus

Researchers are evaluating the safety, tolerability, and how the body processes Semaglutide Nasal Spray compared to a placebo and a known injection in adults who are overweight or obese. This Phase I clinical trial aims to better understand the effects of the nasal spray formulation of Semaglutide in this population. The study is sponsored by Shanghai World Leader Pharmaceutical Co., Ltd. and focuses on adults aged 18 to 65 years with specific body mass index ranges. Participants will receive either the Semaglutide Nasal Spray, placebo, or a Semaglutide injection (Wegovy®) in different randomized groups. The study involves a single-dose administration and includes several cohorts receiving various combinations of the nasal spray and placebo or the injection. Treatments are given once, and the study monitors the participants for up to 36 days after administration to assess drug levels and effects. During the study, participants will undergo various evaluations including blood tests, vital signs monitoring, physical examinations, electrocardiograms (ECGs), and urine analyses from Day 1 to Day 36. Researchers will measure how much of the drug reaches the blood, how long it stays, and any side effects that occur. Antibody levels against the drug will also be checked up to Day 29. Participants will be closely monitored for any safety concerns throughout the study period.

Researchers are evaluating the safety, immune response, and preliminary clinical efficacy of a candidate vaccine for urinary tract infections (UTIs) in adults aged 18 to 64 years. This trial focuses on adults generally for safety and immune response, and specifically on females with a history of at least one confirmed E. coli UTI within the past year for clinical efficacy. The study includes two parts: an initial dose-escalation safety phase and a proof-of-principle efficacy phase, designed to establish the highest tolerated dose and evaluate the vaccine's impact on UTI occurrence. Participants receive one of several vaccine dose formulations or placebo administered by injection on Day 1 and Day 61. Part 1 involves healthy male and female adults and tests increasing antigen doses for safety. After safety review, Part 2 enrolls females with previous E. coli UTIs to assess vaccine efficacy compared to placebo over a 12-month period. The vaccine is given intramuscularly following a 0 and 2 months schedule. Throughout the study, participants are monitored for side effects at the injection site and systemic reactions during the first week after each dose, as well as for any adverse events up to 426 days from the first dose. Blood tests, pregnancy monitoring, and clinical exams are conducted. The main outcome measures include the frequency of adverse events and the rate of urine culture confirmed UTIs in females during the follow-up period. Participants are followed closely for safety and immune response, with the trial lasting over a year from initial vaccination.

Researchers are evaluating the outcomes of two treatments for lumbar spinal stenosis with neurogenic claudication (LSS with NC) in Medicare beneficiaries. This observational study compares the rates of surgical and minimally invasive interventions, as well as any harms, occurring within 24 months after receiving either the MILD procedure or Interspinous Process Decompression (IPD). The study uses Medicare claims data starting from patients treated on or after January 1, 2017, and continues enrollment until the sponsor stops it. The study groups include Medicare patients who underwent the MILD procedure, which involves a partial decompression performed under fluoroscopic image guidance through the removal of tissue and bone at the symptomatic spinal level. The control group consists of Medicare patients treated with Interspinous Process Decompression during the same enrollment period. Both groups are monitored for reoperation and harms for 24 months following their initial treatment. Participants are included based on Medicare claims with the study's NCT number, which automatically enrolls them without requiring prior consent. Researchers will analyze Medicare claims data to track surgical or minimally invasive interventions and any complications related to the initial procedure over two years. The study does not involve direct patient visits or interventions and is exempt from Institutional Review Board oversight. The total follow-up duration for outcome measurement is 24 months after the index procedure.

Researchers are evaluating olpasiran, a drug given by injection, to see if it can reduce the risk of first major heart-related events like coronary heart disease death, heart attacks, or urgent coronary procedures in people with high levels of lipoprotein(a) and risk factors for cardiovascular disease. This is a phase 3, double-blind, randomized, placebo-controlled study aiming to improve prevention strategies for cardiovascular disease. Participants will be randomly assigned to receive either subcutaneous injections of olpasiran or a placebo. The study compares these two groups over a period of up to approximately 6.2 years to assess their impact on major cardiovascular events. The treatment is given by injection under the skin, with one group receiving the active drug and the other receiving a placebo injection. During the study, participants will be monitored regularly for heart-related events including death from coronary heart disease, heart attacks, strokes, and urgent coronary procedures. Blood levels of lipoprotein(a) and olpasiran will be measured at baseline and at week 48. The study will also track any treatment-emergent side effects and overall health outcomes over the course of up to 6.2 years, giving a comprehensive view of the drug’s potential effects and safety.

Researchers are evaluating an outreach campaign to increase participation in Pack Health, a wellness program by Quest Diagnostics that offers personalized health coaching for weight management and diabetes prevention. The study focuses on employees and their spouses or domestic partners who have metabolic syndrome, a condition defined by having three or more specific risk factors. The goal is to see if automatically enrolling eligible individuals, with the option to opt out, improves engagement and health outcomes compared to the usual invitation-based approach. Participants are randomly assigned to one of two groups: the intervention group receives outreach that automatically enrolls them in the program and invites them to begin their first session, while the control group receives the standard invitation to join. The study compares these two outreach methods over time to determine which leads to higher engagement and better health results. During the study, researchers will track how many participants start and continue the program, the number of program modules completed, changes in health measures like HbA1c and weight over two years, and employee retention after one year. The main measurement is the likelihood that participants begin the program within 12 months. The study will run until August 2026, with ongoing assessments through healthcare claims and risk evaluations to monitor outcomes and program effectiveness.