Mission

Researchers are evaluating the effectiveness and safety of eloralintide compared to a placebo in adults with persistent obesity or overweight. Participants may have type 2 diabetes or not and must be on a stable incretin therapy. This phase 3, randomized, double-blind study aims to understand how eloralintide works in this population and is sponsored by Eli Lilly and Company. The study lasts about 80 weeks in total. Participants receive eloralintide or placebo through weekly subcutaneous injections. There are four different doses of eloralintide being tested, and one group receives a placebo injection. The treatment period includes monitoring from the start until week 64, focusing on changes in body weight and various health measures. The study compares eloralintide with placebo to assess its impact on obesity and related health factors. Throughout the study, participants will have regular evaluations including body weight, waist circumference, blood pressure, glucose levels, and other metabolic and physical function assessments. Patient-reported outcomes such as quality of life and control of eating are also measured. Safety and medication use are monitored, along with blood tests for insulin, inflammation markers, and kidney function. The study includes pharmacokinetic assessments to understand drug levels. Overall participation is about 80 weeks, allowing for comprehensive monitoring and follow-up.

Researchers are evaluating the effectiveness and safety of fusidic acid 1% eye drops compared to a placebo for treating bacterial conjunctivitis in both adults and children. This Phase 3 clinical trial aims to show that fusidic acid 1% is superior to placebo in curing bacterial conjunctivitis and to further confirm its safety when applied topically to the eyes. Participants will be randomly assigned to one of two groups: one group will apply one drop of fusidic acid 1% in each eye twice daily for seven days, and the other group will use a placebo eye drop with the same schedule. The doses are ideally spaced about 12 hours apart, but the twice-daily application schedule is prioritized over exact timing. During the study, participants will be assessed for clinical cure and microbial eradication at Day 4 and Day 8 visits. Researchers will monitor safety and treatment effects through these evaluations and by tracking any adverse events. The total participation duration covers at least the seven days of treatment plus follow-up assessments, helping establish both effectiveness and safety profiles for the treatment.

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 the safety and effectiveness of SelfWrap, a bioabsorbable perivascular wrap, in patients with chronic kidney disease (CKD) who are referred for creation of a new arteriovenous fistula (AVF). This multi-center, prospective, randomized, double-arm, single-blind clinical trial involves about 600 participants across up to 30 sites. The purpose is to compare SelfWrap-assisted AVF creation with the standard surgical procedure without any additional intervention over a 36-month follow-up period. Participants are randomly assigned to one of two groups: one receiving the SelfWrap device during AVF creation surgery, and the other undergoing the usual AVF surgery without intervention as a control group. The SelfWrap device offers mechanical support intended to improve the maturation and patency of the fistula. The trial follows participants for 36 months after surgery to monitor outcomes. During the study, participants will undergo assessments to measure unassisted maturation of the AVF at up to 6 months and monitor freedom from access-related adverse events through 30 days. Researchers will evaluate safety and effectiveness through these primary outcome measures. Participants are expected to comply with study requirements and attend follow-up visits throughout the 36-month period to allow comprehensive evaluation of the device's impact and any complications.