Ashton Under Lyne

Researchers are evaluating the efficacy and safety of elecoglipron, an oral tablet taken once daily, for weight management in adults with obesity or overweight. This Phase III global, randomized, double-blind, placebo-controlled trial includes two independent pivotal studies one in adults without type 2 diabetes T2DM and the other in adults with T2DM, all having at least one weight-related health condition. The goal is to understand how elecoglipron compares to placebo when combined with diet and exercise. Participants will be randomly assigned to receive either one of two doses of elecoglipron or a matching placebo daily. Study 1 involves about 3000 adults living with obesity or overweight without T2DM, while Study 2 involves about 1500 adults with obesity or overweight and T2DM. Both studies last 72 weeks, during which changes in body weight and other health measures will be monitored. During the trial, participants will undergo regular health assessments including measurements of body weight, waist circumference, blood sugar control, blood pressure, and other related health indicators. Researchers will track percent change in body weight from baseline at 72 weeks as the primary outcome. Participants will be monitored closely throughout the study to assess safety and effectiveness of the treatment in managing weight and associated health conditions.

Researchers are studying the effectiveness and safety of eloralintide in adults who are obese or overweight but do not have type 2 diabetes. This Phase 3 trial aims to understand how eloralintide affects body weight and related health measures over a long period. The study includes a main phase and an extension phase for those with prediabetes to evaluate ongoing effects. Participants are randomly assigned to receive one of four doses of eloralintide or a placebo, all given by subcutaneous injection once weekly. The main phase lasts about 75 weeks, and participants with prediabetes may continue in an extension phase for an additional two years. This structure allows researchers to assess both short-term and longer-term outcomes. During the study, participants will have regular visits to measure body weight, body fat, waist size, blood pressure, blood markers like triglycerides and insulin, and quality of life questionnaires. Safety and treatment effects are monitored throughout. The main outcome is the percent change in body weight from the start to week 64, with follow-up continuing up to week 191 for some. Overall participation can last up to several years depending on the participants health status.

Researchers are evaluating tirzepatide in adults with obesity who do not have diabetes but have at least one weight-related health condition. The study aims to assess body weight loss and the development of type 2 diabetes over a long period in a real-world setting. This is a Phase 4 clinical trial sponsored by Eli Lilly and Company. Participants will be randomly assigned to receive either weekly subcutaneous injections of tirzepatide in addition to standard care or standard care alone. The study uses a parallel design to compare these two groups and lasts about 260 weeks 5 years. The focus is on long-term effects and real-world treatment outcomes. During the study, participants will have regular assessments including measurements of body weight, blood sugar control HbA1c, waist circumference, blood pressure, cholesterol, kidney function, quality of life, and healthcare resource use. The primary outcome is the percent change in body weight from baseline to 24 months. Secondary outcomes cover diabetes onset, metabolic changes, obesity-related complications, and quality of life over 60 months. Participants will be monitored throughout the study duration for safety and health changes.

Researchers are evaluating whether skipping additional axillary treatment for patients with early-stage breast cancer who had cancer in their lymph nodes before chemotherapy but show no remaining cancer in those nodes after treatment is as effective as the standard approach. This study focuses on disease-free survival and reducing the risk of lymphoedema five years after treatment. It is a randomized, open, multicenter trial including patients with specific breast cancer stages and confirmed nodal metastases. Participants will all receive standard therapies including HER2-targeted treatment, endocrine therapy, and radiotherapy to the breast or chest wall if needed. They will be randomly assigned to one of two groups one group will not get further axillary treatment such as lymph node removal or radiotherapy, while the other group will receive these axillary treatments according to local guidelines. Follow-up visits will occur annually for at least five years. During the study, participants will undergo assessments to monitor disease-free survival and self-reported lymphoedema using specific questionnaires. Additional evaluations include arm function, quality of life, recurrence rates, survival, and cost-effectiveness analyses. The total study duration is planned for 120 months, including setup, recruitment, follow-up, analysis, and reporting.

Diabetes mellitus requires regular monitoring of blood sugar control to reduce the risk of complications. This research aims to compare the standard venous blood draw done in clinics with a home-based self-collection method for measuring HbA1c, cholesterol lipids, and thyroid function. The goal is to assess the accuracy, patient acceptance, and economic impact of collecting blood samples at home using capillary blood sampling. Participants will first visit the clinic where a venous blood sample will be taken by a nurse. They will then be randomly assigned to collect a capillary blood sample either by finger prick or an upper arm device while at the clinic. After training, participants will perform the same type of blood collection at home within two days of their clinic visit and mail the sample to a central laboratory. Questionnaires will be completed after each blood collection to evaluate ease of use and patient preferences. During the study, researchers will track sample collection success, temperature during shipping, and any issues with self-collection. Participants will be monitored for 12 months, with outcomes focusing on HbA1c, lipids, thyroid function, patient acceptance, and health economics. Participants will also receive compensation for travel and inconvenience. Confidentiality and data protection will be maintained according to regulations throughout the study.

Researchers are evaluating whether cognitive analytic therapy-guided self-help CAT-GSH is as effective and acceptable as cognitive behavioural therapy-guided self-help CBT-GSH for people with anxiety or depression returning to NHS Talking Therapies services for further treatment. The study aims to compare outcomes between those returning and those using CBT-GSH for the first time, considering factors like age. This is a prospective, quasi-experimental study involving participants who have previously received CBT-GSH. Participants choose between CAT-GSH and CBT-GSH treatments, each consisting of six one-to-one guided self-help sessions lasting 35 minutes. Sessions occur weekly or bi-weekly and can be face-to-face, online, or by telephone. Psychological wellbeing practitioners PWPs deliver the therapies and record the third session for competency review by the research team. The study collects routine outcome measures during and after treatment. Participants are identified during initial assessments and complete consent procedures by phone or email. Before, during, and after therapy, routine measures such as the Generalised Anxiety Disorder-7 GAD-7, Patient Health Questionnaire-9 PHQ-9, and Work and Social Adjustment Scale WSAS are collected to assess treatment outcomes over 6 to 12 weeks. The research team will analyze these data starting December 2025 to compare the effectiveness and acceptability of CAT-GSH versus CBT-GSH for returning patients.

Researchers are evaluating the impact of two different default dialysate sodium concentrations on major cardiovascular events and death in adults receiving maintenance haemodialysis for end-stage kidney disease. This pragmatic, cluster-randomised, open-label Phase 4 study compares sodium levels of 137 mmoll and 140 mmoll in real-world dialysis settings across multiple sites globally. Dialysis sites will be randomly assigned to use either a default dialysate sodium concentration of 137 mmoll or 140 mmoll for at least 90% of dialysis sessions. Other aspects of patient care will follow standard local practices. Sites must consent to participate, and individual patients will provide waiver or opt-out consent. The study expects to enroll sites over 5 to 7 years, with each participant followed for approximately 2 to 5 years until the study endpoints are reached. Participants will receive dialysis at their assigned sites with the designated sodium concentration. Researchers will monitor the time to first occurrence of major cardiovascular events or death as the primary outcome. Secondary outcomes include other cardiovascular events and individual components of the composite outcomes. Data collection and patient monitoring will continue throughout the study period, estimated to last around five years per participant.

Researchers are evaluating a new blood test called Avantect to detect pancreatic cancer early in people aged 50 to 84 who were recently diagnosed with type 2 diabetes. Pancreatic cancer is often deadly because it is usually found late. This study aims to see if the Avantect test can find signs of cancer sooner, allowing for earlier treatment and better chances of survival. The study is interventional and includes a large group of participants recruited from general practices over three years. Participants will be randomly assigned to one of two groups the intervention arm or the control arm. Those in the intervention arm will have their blood samples tested with the Avantect test quickly, and if cancer markers are found, they will be informed and offered imaging scans like MRI or CT to check for pancreatic cancer. The control group will have their blood samples stored for possible future testing but will receive standard diabetes care. Blood samples and health outcomes will be tracked for three years. Each participant will attend three study visits over 12 months, providing blood samples and completing anxiety questionnaires. Researchers will monitor cancer diagnosis and mortality through registries for three years after consent. They will evaluate the tests sensitivity, specificity, and ability to detect cancer early enough for surgery. The study also measures predictive values and cancer resectability. This design helps understand the tests potential to improve pancreatic cancer detection in people with new diabetes diagnoses.

Researchers are evaluating the effectiveness and cost-effectiveness of a link work intervention designed to help people with severe mental health difficulties attend routine dental appointments. The study focuses on two main outcomes attendance at dental visits and oral health-related quality of life. The trial aims to improve dental access and oral health among people with severe mental illness, addressing inequities in care. Participants will be randomly assigned to one of two groups treatment as usual or treatment as usual plus the link work intervention. Treatment as usual may include support from mental health professionals and usual oral health care. The link work intervention consists of six sessions over nine months, where a link worker provides practical and emotional support to help participants access routine dental care. Participants will complete assessments at the start and after nine months, including questionnaires and data collection on dental visits. Researchers will evaluate dental appointment attendance, oral health quality of life, and other factors such as dental anxiety, self-esteem, and healthcare use. The study includes a cost-effectiveness analysis and a qualitative evaluation to understand how the intervention works and could be implemented.