Saint Helens

Researchers are studying the safety and effects of an investigational medicine called PF-08653944 in adults who are overweight or have obesity along with type 2 diabetes. This condition involves carrying too much body weight and having high blood sugar levels. The study is a phase 3, multi-center, randomized placebo-controlled trial that aims to evaluate the medicine's ability to help with weight loss and monitor its safety. Participants will receive either the study medicine or a placebo by weekly injections under the skin in the belly area. About two-thirds of participants will get the study medicine, while one-third will receive the placebo. Participants will be trained to administer the injections themselves at home. The study will last about 21 months and includes up to 14 visits to the study site and 5 phone calls. During the study, participants will be closely monitored through visits and phone contacts. Researchers will measure changes in body weight from the start to week 64 to evaluate effectiveness. The study will also include assessments of safety and treatment effects over the entire duration. Participants need to perform finger-stick glucose monitoring as required and follow the study procedures throughout the trial.

Researchers are evaluating the use of Targeted Sentinel Node Biopsy (TSNB) in patients with breast cancer who have limited nodal disease. This study focuses on patients with biopsy-confirmed axillary nodal metastases and aims to audit surgical outcomes of TSNB against sentinel node biopsy outcomes, arm lymphoedema rates, and disease progression. The research highlights the importance of assessing nodal tumour burden and compares TSNB with other treatments like axillary lymph node dissection (ALND) and axillary radiotherapy (ART). Previous trials like AMAROS, OTOASOR, and POSNOC provide background on nodal treatment strategies and outcomes. Participants will undergo TSNB during primary surgery, where at least three lymph nodes, including a marked biopsy-proven positive node, are removed. Node marking can be done at biopsy or a separate visit using various techniques such as clips, dyes, or magnetic markers. The procedure follows a standardized approach adapted from the ATNEC trial, with either dual- or single-tracer sentinel node biopsy methods. If the marked node is not found or multiple black nodes appear, removal may stop after four nodes. The study focuses on patients with one or two macrometastases identified in the removed nodes. During the study, patients will be monitored for outcomes including the number of nodal macrometastases over 12 to 60 months, the identification rate of the marked node, and the false negative rate of the TSNB procedure. Arm lymphoedema will also be assessed up to 60 months. This audit collects data to benchmark surgical outcomes and evaluate arm morbidity and disease progression compared to existing trials, aiming to establish TSNB as a reliable staging method in this patient group.

Researchers are evaluating the efficacy and safety of once-weekly injectable MET097 in adults who have obesity or are overweight with related weight complications, but who do not have type 2 diabetes. This phase 3, multi-center randomized controlled trial aims to understand how well MET097 works and how safe it is over a long period. The study will last 84 weeks, with the primary effectiveness measured after 64 weeks of treatment. Participants will receive either MET097 or a placebo, both given once a week by subcutaneous injection. The study compares these two groups to assess the impact of MET097 on weight and related health issues. The treatment period is followed by continued monitoring to evaluate longer-term effects up to 84 weeks. During the study, participants' body weight changes will be carefully tracked from the start through week 64, which is the main outcome measure. Additional health assessments will occur through the 84-week duration to monitor safety and overall responses. Participants will be supported and monitored regularly to assess the medication's impact and any side effects throughout the trial.

Researchers are evaluating the long-term effects of lidocaine infusions given during and after surgery on the development of moderate or severe chronic post-surgical pain (CPSP) one year after breast cancer surgery in adult female patients. This Phase 3, international, randomized, double-blind, placebo-controlled trial involves more than 4,000 participants undergoing mastectomy or breast conserving surgery. The study aims to detect a 25% reduction in CPSP incidence and also assesses safety, pain relief effectiveness, neuropathic pain characteristics, psychological well-being, and quality of life. Participants receive either a lidocaine infusion or a placebo infusion starting with an intravenous bolus after anesthesia induction, followed by continuous intravenous infusion during surgery. After surgery, a subcutaneous lidocaine or placebo infusion is continued for up to 24 hours. Dosages are based on lean body weight and capped at 68 kg. Patients undergoing day-case surgery receive only the intraoperative bolus and infusion without the postoperative infusion. Throughout the study, patient pain levels, opioid use, safety events, neuropathic pain symptoms, psychological status, and quality of life are closely monitored. The primary outcome is the patient-reported incidence of moderate or severe CPSP one year after surgery. Data collection includes follow-up visits and assessments to track both short-term and long-term effects of the treatments.

The trial investigates the role of ixazomib in patients with relapsed multiple myeloma who have previously undergone autologous stem cell transplant (ASCT). This phase III, open-label, randomized, controlled study aims to evaluate whether adding a proteasome inhibitor to the salvage ASCT conditioning improves the depth of response, and to assess the impact of consolidation and maintenance treatments on the durability of response. The study also looks at overall survival, progression time, quality of life, and treatment safety among participants with measurable disease and good performance status. All participants first receive re-induction therapy consisting of 4 to 6 cycles of ixazomib, thalidomide, and dexamethasone (ITD) over 28-day cycles to achieve maximum disease control. Those who reach stable disease or better are randomized to receive either conventional ASCT using melphalan or augmented ASCT combining melphalan with ixazomib. Following this, participants who maintain minimal response or better undergo a second randomization to either receive consolidation therapy with 2 cycles of ITD followed by ixazomib maintenance until disease progression, or no further treatment. During the study, participants will undergo regular assessments including blood tests, disease response evaluations, and monitoring for adverse effects. The primary outcomes measured are overall response rate 100 days after ASCT and progression-free survival up to 10 years. Secondary evaluations include overall survival, time to disease progression, minimal residual disease status at various stages, engraftment kinetics, and quality of life. Follow-up continues with clinic visits every three months until disease progression is observed, enabling long-term monitoring of treatment effects and safety.