DeLand

Researchers are evaluating the safety and efficacy of the study drug LY4065967 for treating diabetic peripheral neuropathic pain DPNP. This trial is part of a larger chronic pain master protocol designed to accelerate the development of new treatments for chronic pain conditions. The study focuses on adults with DPNP related to type 1 or type 2 diabetes. Participants will be randomly assigned to receive either LY4065967 or a placebo, both taken orally. The study is double-blinded, meaning neither participants nor researchers know who receives the active drug or placebo. The treatment period lasts eight weeks, during which participants take the assigned study drug daily. Throughout the trial, participants will report their pain intensity and other symptoms at the start and after eight weeks using various scales, including the Numeric Rating Scale and Brief Pain Inventory. Researchers will also monitor sleep quality, emotional functioning, and the use of rescue medication. Safety and tolerability will be assessed, and the study concludes in July 2027.

Researchers are evaluating the effectiveness of pegloticase administered by two different methodssubcutaneous under the skin injection versus intravenous into a vein infusioneach combined with methotrexate MTX in participants who have uncontrolled gout. The main goal is to compare how well these two treatment methods maintain normal serum uric acid levels over a six-month period. This Phase 3 trial is designed as a double-blind, randomized controlled study to provide reliable information on treatment responses.

Researchers are conducting a master protocol study to evaluate multiple pain treatments for people experiencing chronic pain conditions such as osteoarthritis of the knee, diabetic neuropathic pain, and chronic low back pain. This study aims to compare different pain interventions by using a flexible design where specific intervention appendices ISAs can begin independently as new treatments become available. The study is sponsored by Eli Lilly and Company and is designed as a phase 2 randomized, placebo-controlled trial. Participants may receive one of several study drugs administered either intravenously or orally, including LY3016859 given through IV and LY3556050, LY3526318, and LY3857210 given orally. Each treatment group is compared to a matching placebo group. The study uses a parallel design where participants are assigned randomly to one of the intervention groups or placebo. The protocol includes disease-state addenda to define target populations and assessment scales for each pain condition. During the trial, participants undergo screening to confirm eligibility based on pain levels, history, and health status. They are monitored for outcomes such as the number of participants allocated to each intervention up to week 8. Researchers assess pain and other health measures while participants maintain consistent use of any ongoing non-drug pain therapies and discontinue other chronic pain medications except for rescue use. The study includes safety monitoring and will continue through April 2027, with results posted for each intervention.

This research aims to evaluate the effectiveness, safety, and tolerability of DermaBind TL, a full-thickness dehydrated placental allograft, in patients with chronic non-healing ulcers, including diabetic foot ulcers DFUs and venous leg ulcers VLUs. The trial focuses on patients whose wounds have not responded to standard treatments. The study is a prospective, multi-center, open-label, single-arm clinical trial led by HealthTech Wound Care, designed to collect outcome data over a 12-week treatment period. Participants will receive DermaBind TL applied to their wounds while following standard care, including offloading with devices like CAM boots or total contact casting, wound debridement, infection management, and layered dressings for protection. The treatment phase lasts 12 weeks with assessments for wound area protection, infection rates, and adverse events. The study includes a screening phase to determine eligibility before treatment begins. During the study, clinicians will assess wounds regularly to monitor wound size, infection, and healing progress. Data will be collected on the number of grafts used and any treatment-related adverse effects. Outcome measures include wound area preservation and protective effects of the dressing over 13 weeks. Participants must comply with offloading and dressing protocols and will be followed for safety and treatment tolerability throughout the study duration.

Researchers are evaluating changes in bone mineral density in premenopausal women with heavy menstrual bleeding caused by uterine fibroids or moderate-to-severe pain from endometriosis. This Phase 3B, open-label study looks at the effects of continuous treatment with a relugolix combination tablet for up to 48 months 4 years, followed by a 1-year period to monitor bone health after stopping treatment. Participants will take a daily oral relugolix combination tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg for 4 years. Bone mineral density will be measured every 6 months using dual-energy X-ray absorptiometry DXA. Some women who have completed a previous related study may join to complete 3 years of treatment. After treatment ends, bone density will be checked again at 6 months and 12 months during the follow-up year. Women in the study will have regular visits for bone density scans and health assessments, including physical and gynecological exams, lab tests, and vital signs. Researchers will track changes in bone density at the spine, hip, and femoral neck throughout treatment and follow-up. They will also monitor for any fractures or adverse events during the 4 years of treatment and the 1-year post-treatment period. Total participation can last up to 5 years including the follow-up.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating the efficacy, safety, and tolerability of elecoglipron compared with placebo in adults with Type 2 Diabetes Mellitus T2DM who are already being treated with insulin and other glucose-lowering medications. This Phase III study focuses on adults with T2DM who have had the condition for at least 90 days and meet certain health criteria. Participants will be randomly assigned to one of three groups elecoglipron at dose level 1, elecoglipron at dose level 2, or placebo. All treatments are taken orally once daily. The study treatment period lasts up to 40 weeks, during which participants continue their background insulin and glucose-lowering medications. During the study, participants will have regular assessments to monitor changes in blood sugar control, including Hemoglobin A1c HbA1c, body weight, blood pressure, and insulin dose. Researchers will also track safety, side effects, and tolerability. The main outcome is the change in HbA1c from baseline to Week 40. Overall, participation involves visits for monitoring and evaluations over approximately 40 weeks.

Researchers are collecting data to assess the safety and effectiveness of the Truliant knee prosthesis used in total knee replacement surgeries. This observational study aims to gather clinical and patient outcomes, including survivorship data, from individuals who have received or will receive this knee device. The study focuses on patients with various knee conditions, such as osteoarthritis, rheumatoid arthritis, and post-traumatic arthritis, who have undergone or will undergo surgery involving the Truliant system. Participants include those enrolled before surgery, those enrolled after surgery who continue to participate prospectively, and those enrolled only retrospectively with no prospective follow-up. The study collects data from medical records and patient follow-ups over an extended period. The Truliant Total Knee System, compatible with Optetrak components, is the device being evaluated. Surgeries are performed by investigators or surgeon sub-investigators following approved device indications. During the study, participants will complete assessments using tools such as the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement KOOS JR, Oxford Knee Score, and Visual Analog Scale VAS for pain at multiple time points from before surgery up to ten years post-surgery. Data collection includes demographic, operative, and postoperative information obtained from medical records and patient responses. This long-term follow-up helps researchers monitor outcomes and device performance over time, with the study expected to continue until 2035.

Researchers are evaluating the efficacy and safety of brenipatide compared to a placebo for reducing the risk of relapse to cigarette smoking in adults who have recently quit. The study is a phase 2, multicenter, randomized, double-blind trial focused on helping adults maintain abstinence from smoking. Participants are adults aged 18 to 75 years who have recently quit smoking and are motivated to stay quit. Participants are randomly assigned to receive either brenipatide or a placebo, both administered by subcutaneous injection. The study involves a 2-week screening period, followed by a 24-week treatment period where participants self-inject the assigned intervention. After treatment, there is an 8-week safety follow-up period to monitor participants health and any effects related to the study drug. Throughout the approximately 34-week study, participants are expected to attend up to 17 study visits. Researchers will measure the percentage of participants who achieve continuous abstinence from cigarette smoking, confirmed by carbon monoxide levels, from week 1 to week 24. Additional assessments include patient-reported outcomes, body weight changes, drug plasma concentration levels, and monitoring for anti-drug antibodies. Safety and adherence are closely monitored during and after the treatment phase.

Researchers are evaluating the long-term safety of buntanetap in people with Parkinsons Disease PD. This 36-month open-label study involves two groups one includes PD participants previously in buntanetap trials, and the other includes participants receiving deep brain stimulation DBS treatment. The study aims to monitor safety and adverse events related to buntanetap over an extended period. Qualified participants will take buntanetap capsules at a dose of 30 mg once daily after a screening period lasting up to 42 days. Cohort 1 includes those invited from prior buntanetap studies, while Cohort 2 consists of PD participants treated with DBS in specific brain areas for at least 12 months. Medication adjustments are required before visits to observe participants in an OFF medication state. Throughout the study, participants will have regular assessments conducted by trained clinicians using tools like MMSE, MoCA, C-SSRS, and MDS-UPDRS to evaluate cognitive and motor functions. Safety will be closely monitored, focusing on adverse events during the full 36 months. Support persons will accompany participants to visits, and medication stability and general health will be regularly evaluated to ensure study compliance and participant well-being.