DeLand

Researchers are evaluating the safety, how the body processes, and effects on body weight of the investigational drug CRB-913 in participants with obesity. This Phase 1b study includes two parts: Part 1 focuses on healthy adults to measure drug levels in the blood after a single dose, while Part 2 involves obese participants to assess safety and weight effects using different doses compared to placebo. Part 2 is blinded so that participants, doctors, and the sponsor do not know who receives the drug or placebo. In Part 1, healthy adults receive a single dose of CRB-913 tablets to study how much of the drug enters the bloodstream and how long it stays. In Part 2, obese participants take one of three doses of CRB-913 or placebo once daily for 12 weeks. After treatment ends, participants are monitored for 28 days. The study includes a randomized, double-blind, placebo-controlled design for Part 2. Participants will attend study visits for drug administration, safety assessments, and blood tests to measure drug levels and effects on body weight. Researchers will monitor for side effects and adverse events from the first dose through 28 days after final dosing. The total participation time includes the 12-week treatment period plus the 28-day follow-up phase to evaluate safety and drug behavior in the body.

Researchers are evaluating the safety and effectiveness of the drug LY4065967 for treating diabetic peripheral neuropathic pain (DPNP). This study is part of a larger chronic pain master protocol aimed at speeding up the development of new treatments for chronic pain. Participants have diabetic peripheral neuropathy mainly affecting their lower limbs and have had this condition for at least six months. The study compares oral LY4065967 to a placebo, with participants randomly assigned to either group. The trial is a Phase 2, randomized, placebo-controlled clinical trial. Treatments are given by mouth, and participants continue their usual diabetes care with stable treatment for at least 90 days before screening. During the study, researchers monitor changes in average pain intensity using a numeric rating scale from baseline to week 8. Participants undergo assessments including blood sugar control (HbA1c), body mass index measurement, and safety monitoring for heart and vitamin B12 status. The trial is designed for adults aged 18 years and older and includes close observation to ensure participant safety throughout the study period.

Researchers are evaluating the safety and effectiveness of Alpha DaRT-224, a novel treatment for patients with recurrent cutaneous squamous cell carcinoma who have not responded to standard therapies and are not candidates for surgery or standard radiation. This multicenter, pivotal, single-arm, open-label clinical study aims to determine the objective response rate and duration of response following treatment, as well as assess progression-free survival, overall survival, local tumor control, and quality of life. The treatment involves placing DaRT seeds, which contain a radium-224 source that releases alpha-emitting atoms, directly into the tumor. These seeds remain in the tumor for 14 to 21 days before being removed. The procedure is planned using radiotherapy parameters and monitored with volumetric imaging to ensure proper placement and coverage of the tumor. Participants will undergo evaluations including CT scans and blood tests before and during the study. Researchers will measure tumor response from day 14 through 52 weeks after treatment and monitor safety by tracking adverse events related to the device. The study also includes assessments of quality of life and long-term outcomes over several months. Participants are followed closely to document tumor changes, side effects, and overall health during the study period.

Researchers are evaluating multiple independent pain treatments under a master protocol designed for chronic pain conditions including osteoarthritis of the knee, chronic low back pain, and diabetic peripheral neuropathic pain. This phase 2 study aims to compare different interventions through disease-state addenda and intervention-specific appendices to better understand their effects on chronic pain. Participants may receive various investigational drugs administered either orally or intravenously, including LY3016859 (IV), LY3556050 (oral), LY3526318 (oral), LY3857210 (oral), or placebo versions given orally or intravenously. Each intervention-specific appendix may begin independently as treatments become available for clinical testing, following the master protocol structure. During the study, participants will be monitored for pain levels using specific scales and assessments related to their condition. Researchers will track the number of participants assigned to each intervention from baseline through week 8. Participants must maintain consistent non-drug pain therapies and discontinue chronic pain medications except for rescue medication during the study. Safety assessments, including physical exams and laboratory tests, will be conducted to ensure participant well-being throughout the trial.

Researchers are evaluating the safety, tolerability, and effectiveness of DermaBind TL, a placental membrane allograft, in adult patients with chronic non-healing wounds such as diabetic foot ulcers and venous leg ulcers. This Phase 4, open-label, single-arm clinical trial aims to collect patient outcome data over a 12-week treatment period, comparing results to each participant's historical treatment data. The study focuses on wound area preservation, infection rates, wound recurrence, graft usage, and treatment-emergent adverse events. During the 12-week treatment phase, participants will receive DermaBind TL applied to their affected chronic wounds. The trial involves two phases: screening and treatment. Clinicians will assess wounds regularly, and the intervention will be monitored for its ability to protect wounds, reduce infections, and promote healing. The study includes careful evaluation of wound characteristics and patient response to the graft treatment. Participants will be closely monitored throughout the trial, including wound assessments by clinicians and data collection on infection rates, wound size, and safety events. The primary outcome is to measure how well the wound covering protects the wound over the 13-week treatment period. The study also tracks adverse events and other clinical outcomes through the end of the study. Overall participation includes screening and a 12-week treatment period, with detailed follow-up to evaluate the intervention's effects.

Researchers are investigating how bone mineral density changes during long-term treatment with the relugolix combination tablet in premenopausal women aged 18 to 50 who have heavy menstrual bleeding caused by uterine fibroids or moderate to severe pain related to endometriosis. This Phase 3B, single-arm, open-label study aims to assess the safety and effects of up to 48 months (4 years) of continuous treatment, followed by a 1-year post-treatment follow-up period. Participants will receive a daily fixed-dose tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg. Bone mineral density will be monitored every 6 months using dual-energy X-ray absorptiometry during treatment. Some women who completed a prior related study may join for 3 years of treatment under this protocol. After treatment ends or if stopped early, participants will be followed for 1 year with bone density checks at 6 and 12 months. Women in the study will have regular physical, gynecological, and laboratory assessments to monitor health and treatment effects. Researchers will measure the percentage change from baseline in bone mineral density at the lumbar spine after 48 months of treatment. Safety and health status will be closely observed throughout the treatment and follow-up periods to understand the long-term impact of the relugolix combination tablet on bone health.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are collecting data to evaluate the safety, effectiveness, and outcomes of the Truliant4 Knee System, an orthopedic device used in total knee replacement surgery. This post-market study includes patients who have received or will receive the Truliant knee prosthesis for conditions like osteoarthritis, avascular necrosis, rheumatoid arthritis, post-traumatic arthritis, polyarthritis, primary implantation failure, or conversion from uni-compartmental knee replacement. The study gathers important clinical and patient-reported outcomes over time to better understand the device's performance in real-world use. Participants receive the Truliant Total Knee System, which is compatible with the Optetrak branded components for total knee arthroplasty. The study includes three cohorts: those enrolled before surgery and followed prospectively, those enrolled after surgery with retrospective and prospective data collection, and those enrolled retrospectively only without prospective follow-up. The knee replacement surgeries are performed by the study investigators or designated surgeons, using the device according to its approved indications. Throughout the study, participants will have their knee function, pain levels, and quality of life measured using tools like the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement JR., the Oxford Knee Score, and the Visual Analog Scale for pain. These assessments occur preoperatively and then repeatedly up to 10 years after surgery. Data collection includes clinical records, adverse events, and follow-up evaluations to monitor the device's long-term safety and effectiveness.

Researchers are evaluating the effectiveness and safety of brenipatide compared to a placebo in reducing the chance of relapse to cigarette smoking in adults who have recently quit. This is a Phase 2, multicenter, randomized, double-blind study focused on adults aged 18 to 75 who want to maintain abstinence from smoking. The study aims to measure continuous abstinence confirmed by carbon monoxide levels from week 1 through week 24. Participants will receive either brenipatide or placebo administered subcutaneously during a 24-week treatment period. The study includes a 2-week screening phase before treatment begins and an 8-week safety follow-up after treatment ends. Treatment involves self-injection of the study drug or placebo, and participants are expected to attend up to 17 study visits throughout the approximately 34-week study duration. During the study, participants will be monitored regularly to confirm smoking abstinence and assess safety. Researchers will measure the percentage of participants who maintain continuous abstinence from smoking, verified by carbon monoxide levels. The study includes evaluation of adherence to treatment, safety assessments, and follow-up visits to monitor participants for any adverse effects or relapse.

Researchers are investigating the long-term safety of buntanetap in people with Parkinson's Disease (PD) over a 36-month period. This open-label study includes two groups: one with participants previously involved in buntanetap trials and another with those receiving deep brain stimulation (DBS) treatment. The study focuses on evaluating safety outcomes, including adverse and serious adverse events during treatment. Qualified participants will receive a daily oral dose of 30 mg buntanetap after a screening period lasting up to 42 days. Cohort 1 includes invited participants from prior buntanetap studies, who will stop their standard PD medications 12 hours before baseline and annual visits to ensure an OFF medication state. Cohort 2 includes participants treated with DBS for at least 12 months; they will stop PD medications 12 hours prior to all clinic visits and adjust their DBS settings to baseline the night before these visits. Throughout the study, participants will be assessed by trained clinicians using cognitive and motor evaluations such as MMSE, MoCA, C-SSRS, and MDS-UPDRS. Each participant is assessed by the same clinician during the study. Researchers will monitor treatment safety, adverse events, and emergent side effects for 36 months. Participants must have a support person for study visits, and certain medication and health stability requirements apply. The total participation can last up to three years, including regular clinical visits and assessments.