Broadmeadow

Researchers are evaluating whether retatrutide and tirzepatide can prevent major adverse liver outcomes in adults with metabolic dysfunction-associated steatotic liver disease MASLD who are at high risk based on non-invasive tests. This Phase 3 randomized controlled trial aims to assess these treatments compared to placebo in about 4,500 adults over approximately 224 weeks. The study is sponsored by Eli Lilly and Company and focuses on liver disease progression and related health measures. Participants will be randomly assigned to receive retatrutide, tirzepatide, or placebo, all administered by subcutaneous injection. The trial includes two placebo groups corresponding to each experimental drug. After completing the main study, eligible participants may join a 2-year extension where all will receive either retatrutide or tirzepatide regardless of their initial assignment. During the study, participants may attend around 25 to 30 clinic visits for health monitoring, study procedures, and assessments of liver function and disease status. Researchers will measure the time to major adverse liver outcomes, changes in liver fibrosis scores, liver stiffness, liver fat content, liver enzyme levels, body weight, and cardiovascular events. Monitoring will continue from baseline through study completion, with detailed evaluations at multiple timepoints including week 104.

Researchers are evaluating efimosfermin alfa in adults with biopsy-confirmed metabolic dysfunction-associated steatohepatitis MASH and stage F2 or F3 liver fibrosis. The study aims to assess the safety and effectiveness of efimosfermin alfa compared to a placebo in resolving steatohepatitis and improving liver-related clinical outcomes. This Phase 3 trial is randomized, double-blind, and placebo-controlled, focusing on participants with specific liver conditions and metabolic syndrome components. Participants are assigned to one of three groups two groups receive different dose levels of efimosfermin alfa, while the third group receives a placebo. Treatments are given under controlled conditions, and the study follows a parallel design. The trial monitors participants at set intervals over a course of 52 weeks, with some outcomes tracked up to 48 months to evaluate long-term effects on liver fibrosis and steatohepatitis. During the study, participants undergo liver biopsies to confirm diagnosis and assess changes. Researchers evaluate improvements in fibrosis stage, steatohepatitis resolution, and various liver function measurements using imaging and blood tests. Safety is monitored by tracking adverse events and laboratory abnormalities. Quality of life and other health indicators are also assessed throughout the study, which lasts several years to capture both short- and long-term outcomes.

Researchers are evaluating efruxifermin EFX in a phase 3, randomized, double-blind, placebo-controlled study involving adults with compensated cirrhosis caused by NASH Nonalcoholic Steatohepatitis or MASH Metabolic Dysfunction-Associated Steatohepatitis. This study aims to assess the safety and effectiveness of EFX in preventing significant clinical events such as disease progression and liver decompensation over a period of up to 5 years. Participants are randomly assigned to receive either efruxifermin 50 mg or a placebo, both given by subcutaneous injection. The study includes two cohorts one with biopsy-proven compensated cirrhosis and specific metabolic scores, and another with biopsy-proven or non-invasive diagnosis of compensated cirrhosis. The study treatment and monitoring extend up to 5 years, with evaluations at 96 weeks and long-term follow-up to track liver fibrosis, markers of liver injury, insulin sensitivity, glycemic control, body weight, and safety outcomes. During the trial, participants undergo regular assessments including laboratory tests, ECGs, ultrasounds, and vital sign monitoring. Researchers will measure changes in liver fibrosis, steatohepatitis resolution, and metabolic markers throughout the study. Safety and tolerability are closely tracked by documenting adverse events and exposure duration. The study duration allows for long-term observation of treatment effects and disease progression, with participant involvement lasting up to 5 years.

Researchers are evaluating efruxifermin EFX in adults with non-cirrhotic nonalcoholic steatohepatitis NASH or metabolic dysfunction-associated steatohepatitis MASH who have liver fibrosis stage 2 or 3. This Phase 3, multi-center, randomized, double-blind, placebo-controlled study aims to assess the safety and efficacy of EFX compared with placebo. The trial includes about 1,650 participants divided into two cohorts based on liver biopsy characteristics and fibrosis stage. Participants will be randomly assigned to one of three groups EFX 28 mg, EFX 50 mg, or placebo, each given as a weekly subcutaneous injection. Cohort 1 will be evaluated over 52 weeks for histologic efficacy endpoints, while Cohort 2 will have assessments over 96 weeks. After these periods, participants may continue long-term treatment and clinical follow-up for up to approximately 240 weeks total. A follow-up visit will occur about 30 days after the last dose. During the study, participants will undergo liver biopsies, blood tests, and non-invasive assessments such as FibroScan and Enhanced Liver Fibrosis ELF score to monitor liver health and fibrosis. Researchers will track liver-related clinical outcomes, including liver events and survival, as well as safety and tolerability of the treatment. Participants who stop the study drug may still continue with scheduled assessments to support long-term safety and efficacy evaluations.

Researchers are evaluating the use of PTP-001 MOTYS, an allogeneic human placental tissue particulate, for treating knee osteoarthritis OA. This Phase 3, multicenter, randomized, double-blind, placebo-controlled trial aims to assess the safety, tolerability, and effectiveness of a single injection of PTP-001 compared to placebo over a 52-week period in adults aged 40 to 80 with symptomatic and radiographically confirmed knee OA. Participants will be randomly assigned to receive one injection into the target knee of either 200 mg PTP-001 or 4 mL of placebo saline solution. The study includes a screening period lasting up to 28 days before treatment, a one-day treatment phase when the injection occurs, and a follow-up phase of 12 months to monitor outcomes and safety. Approximately 260 participants will be enrolled, with 130 in each treatment group. During the study, participants will undergo assessments at multiple time points, including evaluations of knee pain and function using standardized scales such as WOMAC and patient global assessments. The main outcomes focus on the proportion of participants showing strict improvement in knee pain and function at 6 months, with additional measurements at 9 and 12 months. Safety and tolerability will also be monitored throughout the follow-up period.

This research aims to evaluate a new delivery method of spinal cord stimulation using the Evoke System for patients with chronic pain in the trunk andor limbs. The study focuses on a novel approach called ECAP-controlled closed-loop spinal cord stimulation, which includes new software and hardware features to better manage pain. The trial is designed as a prospective, multicenter, single-arm feasibility study sponsored by Saluda Medical Pty Ltd. Participants will receive treatment with the Evoke Spinal Cord Stimulation SCS System, which continuously measures and records evoked compound action potentials ECAPs and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude. This closed-loop system aims to provide a more personalized and controlled pain management experience. The study includes only one experimental treatment group using this device. During the study, participants will be closely monitored for changes in ECAPs as measured by the Evoke SCS System through the completion of the study, which can last up to two years. Assessments will focus on the devices performance in controlling pain signals, with ongoing evaluations to track the stability and effectiveness of the stimulation. Participants will provide informed consent and comply with study requirements throughout their involvement.

Researchers are reviewing anonymous medical records from multiple centers to understand the outcomes of different treatments for chronic pain. This study includes several groups to assess how various approaches work in distinct patient subgroups. The focus is on patients who have had or may have spinal cord stimulation systems or other treatments like radiofrequency RF or intradiscal therapies IDS. The study looks at patients who have previously received spinal cord stimulation or other therapies and those who have switched to different treatments afterward. Treatments under review include Boston Scientific devices and non-Boston Scientific systems such as spinal cord stimulation, RF, and IDS. The data is retrospective, meaning it examines past patient experiences without introducing new treatments. Participants involvement consists of the analysis of their de-identified medical charts, with no active treatment or visits required. Researchers will measure responder rates approximately two years from the start of data collection to evaluate treatment outcomes. The study spans from April 2012 to December 2030, focusing on long-term clinical results in chronic pain management.

Researchers are conducting a global, prospective, multi-center observational study to gather real-world data on the long-term effectiveness, economic value, and technical performance of Boston Scientifics commercially approved neurostimulation systems for pain management. The study focuses on patients using these neurostimulation devices according to their approved instructions for use in routine clinical practice. Participants will first undergo a neurostimulation trial period using any commercially approved Boston Scientific neurostimulator for pain. Those who experience a positive outcome from this trial may then receive a permanent implant of the neurostimulation system. Treatment customization will be guided by the investigators judgment and routine care practices at each site. During the study, participants will be observed to collect information on clinical outcomes, technical device performance, and economic factors related to neurostimulation therapy. The research team will monitor participants over the long term to assess how well the therapy manages pain and its associated benefits. The study is expected to continue until May 2035, with ongoing follow-up and data collection throughout this period.

Researchers are evaluating the safety and tolerability of C-1101 given as a single transforaminal epidural injection in adults with chronic painful lumbosacral radiculopathy, also known as sciatica. This phase 1, randomized, double-blind study compares C-1101 to a placebo sterile saline to better understand how patients tolerate this treatment and to monitor for adverse effects. Participants will receive one dose of either C-1101 at varying low, mid, or high doses, or a sterile saline placebo via transforaminal epidural injection. The study includes different cohorts for different dose levels and is designed to observe how the drug behaves in the body and its safety profile compared to the placebo. During the study, participants will be monitored for treatment-emergent adverse events and adverse events of special interest from day 1 through week 24. This includes regular safety assessments to track any side effects or reactions to the injection. The total participation duration spans at least 24 weeks, allowing researchers to collect detailed safety data over time.

Researchers are evaluating the safety and performance of the PRIMUS System, a device designed to provide neurostimulation to branches of the trigeminal and occipital nerves, for treating resistant migraine. The study focuses on patients with chronic or high-frequency episodic migraine who have not responded to multiple preventive drug therapies. It aims to assess clinical benefits and safety over a 12-week period. Participants will be randomly assigned in a double-blind manner to one of several groups including active therapy modalities or sham therapy. The PRIMUS System delivers subcutaneous neurostimulation, and the study compares different therapy approaches to evaluate their effects on migraine symptoms. The study is set to run from June 2024 to January 2029. During the study, participants will be monitored over 12 weeks to evaluate both safety and effectiveness. Researchers will assess clinical outcomes related to migraine treatment, with follow-ups as per study protocols. This period will involve treatment administration and regular evaluations to collect data on responses and any side effects experienced.