Guntersville

Researchers are evaluating the safety and effectiveness of enicepatide, a dual GLP-1/GIP receptor agonist, for managing weight in adults with obesity or overweight who also have Type 2 diabetes mellitus (T2DM). This Phase III study compares multiple doses of enicepatide to a placebo to understand its impact on weight loss in this population. Participants receive either enicepatide or a placebo once weekly through an integrated drug-device combination. The study uses a randomized, double-blind, placebo-controlled design to assess the effects of the treatment. The placebo is volume-matched and administered using the same method as the active drug. During the study, participants will have their body weight changes measured up to week 72 to assess efficacy. Researchers will monitor weight changes as the primary outcome. Participants must be able to self-administer the injections or receive them from a trained individual, and their safety and adherence will be observed throughout the study period.

Researchers are evaluating how effective, safe, and tolerable a vaccine for Clostridioides difficile (C. difficile) infection is in adults aged 65 years and older. The study focuses on reducing the number of C. difficile infections, which can cause diarrhea, in this older adult population. This is a Phase 3, placebo-controlled, double-blinded, randomized trial involving participants who are at risk because of recent or planned contact with healthcare systems or recent antibiotic use. Participants will receive either the C. difficile vaccine or a saline placebo. Both are given by injection into the upper arm muscle. The study includes 3 planned clinic visits and 3 phone visits initially, followed by yearly clinic visits until the study ends. Participants will remain in the study until enough infection events have occurred—this period may last up to about three and a half years, but could be shorter or longer depending on how quickly events happen or if the study stops early due to clear results. Throughout the study, participants will report any side effects such as local reactions and systemic events for 7 days after each vaccination, and adverse events for up to one month. Serious adverse events are monitored for up to 18 months after the last dose. If participants experience 3 or more loose stools within 24 hours during the study, they must save the next stool and contact the study team for infection testing. This ongoing monitoring helps assess the vaccine's impact on preventing medically attended C. difficile infections over time.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Researchers are evaluating the safety and effectiveness of adding a human placental allograft called BioREtainAmnion Chorion (BR-AC) to standard care for treating non-healing, non-infected venous leg ulcers (VLUs) with confirmed venous reflux and adequate arterial blood flow. The study includes patients with VLUs between 2 cm and 20 cm in area that have lasted between 4 weeks and 52 weeks. It aims to find out if weekly applications of BR-AC plus standard care lead to more wounds fully healing within 12 weeks compared to standard care alone. Participants first undergo a two-week run-in period with standardized care including compression therapy to exclude those whose wounds are likely to heal quickly without BR-AC. Eligible subjects are then randomly assigned to receive either standard care alone or standard care plus weekly BR-AC applications. Standard care involves sharp wound cleaning, moist wound dressings, and compression with the UrgoK2dual compression system. If wounds do not fully heal after 12 weeks on standard care alone, participants can crossover to receive BR-AC treatment for an additional 12 weeks. Throughout the study, weekly visits monitor wound healing progress using an electronic device to measure wound size accurately. Participants who achieve complete wound closure enter a four-week follow-up with visits every two weeks to assess the durability of healing. The main goal is to determine whether BR-AC combined with standard care improves the chance of full wound closure within 12 weeks compared to standard care by itself.