Methuen

Researchers are studying the safety and effects of VHB937 in people with early Alzheimers disease, including those with Mild Cognitive Impairment due to Alzheimers or mild Alzheimers itself. This randomized, double-blind, placebo-controlled Phase II trial aims to evaluate whether VHB937 can benefit memory, thinking abilities, daily functioning, and brain changes. The study also looks at how the body processes VHB937 and responds to it. Participants receive intravenous infusions of either a low dose or high dose of VHB937, or a placebo, over a 72-week double-blind period. After this, an extension phase follows for further observation. The treatments are given through infusions, and participants are randomly assigned to one of the three groups in parallel. Throughout the study, participants and their study partners attend regular visits for assessments including clinical dementia rating scales, cognitive tests, daily living activities evaluation, and brain imaging biomarkers. Safety is monitored by tracking adverse events and serious adverse events. Blood samples are collected to measure VHB937 levels and immune responses. The total study duration includes the 72-week treatment period plus additional time in the extension phase.

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.

Researchers are evaluating azetukalner as a treatment for adults diagnosed with moderate-to-severe Major Depressive Disorder MDD. This Phase 3, randomized, double-blind, placebo-controlled study aims to assess the clinical efficacy, safety, and tolerability of azetukalner when taken alone. The study involves participants aged 18 to 74 who have experienced their first major depressive episode before age 50. Participants receive either azetukalner 20 mg or a placebo orally once a day with food, preferably with the evening meal, for a total of 6 weeks. The study includes two groups one taking azetukalner and the other taking placebo, both under blinded conditions to ensure unbiased results. During the study, participants will be regularly monitored through clinical evaluations, including changes in depression severity scores such as the Hamilton Depression Rating Scale HAMD-17 and other scales measuring pleasure and clinical global impression. Safety and tolerability will be observed from screening through 8 weeks after the final dose. The total study duration includes screening, 6 weeks of treatment, and post-treatment safety follow-up.

Researchers are evaluating the long-term effects of aleniglipron, a drug taken orally, in adults with overweight or obesity who also have type 2 diabetes mellitus T2DM. This is a randomized, double-blind, placebo-controlled Phase 3 study designed to assess the drugs effectiveness, safety, and tolerability over an extended period. The study focuses on the management of weight and diabetes in this population. Participants will be randomly assigned to receive either aleniglipron or a placebo, all administered orally. The treatment period lasts for 76 weeks, during which participants will take multiple doses of the assigned medication. The study includes three different aleniglipron arms and one placebo arm, all aiming to evaluate weight change and diabetes control over time. Throughout the study, participants will undergo assessments to measure changes in body weight, waist circumference, HbA1c levels, blood pressure, and cholesterol levels. The primary outcome is the percent change in body weight from the start of the study to week 76. Secondary outcomes include the proportion of participants achieving various levels of weight loss and diabetes targets. The study also monitors safety and tolerability during the treatment period, which lasts approximately 76 weeks.

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

Researchers are studying the effects of a drug called TNX-102 SL on adults with moderate to severe major depressive disorder MDD. This clinical trial aims to find out if TNX-102 SL improves depression symptoms compared to a placebo and to assess its safety. The study focuses on changes in depression symptoms measured by a rating scale over six weeks. Participants will take either 5.6 mg of TNX-102 SL two 2.8 mg tablets or placebo tablets every night at bedtime for six weeks. The study is randomized and double-blind, meaning neither participants nor researchers know who receives the drug or placebo. Checkups and tests will take place at the clinic every two weeks during the treatment period. During the trial, participants will have depression symptom assessments and other evaluations to monitor safety and treatment effects. The main measurement is the change in depression rating scores from the start to week six. Participants will be closely followed throughout the six-week treatment, with regular visits every two weeks for monitoring and questionnaires.

This research aims to evaluate the effectiveness and safety of North Star desiccated porcine thyroid extract tablets in adults with primary hypothyroidism, including Hashimotos Thyroiditis. The trial is a Phase 3, open-label, single-arm study conducted across multiple centers, focusing on treatment outcomes for this condition. Participants will receive North Star desiccated porcine thyroid extract tablets as the study treatment. The study monitors thyroid-stimulating hormone TSH levels to assess whether they remain within the normal range at 24 weeks and at prior post-baseline visits without abnormal readings. Safety evaluations include tracking adverse events, serious adverse events, laboratory tests, ECGs, and physical exams through 30 weeks. During the study, participants will be closely monitored with regular assessments of thyroid function and safety measures. Researchers will collect clinical data, lab results, and examine physical health to understand treatment impact. The total follow-up period extends to at least 30 weeks, allowing detailed observation of treatment effects and potential side effects in adults aged 18 to 75 years with stable hypothyroidism management.

This trial focuses on both women and men diagnosed with Stage I HER2-positive invasive breast cancer. It aims to compare two different combinations of HER2-targeted therapies given after surgery, studying how well each treatment controls the cancer and their side effects. The study is a randomized phase II trial supported by Genentech and led by the Dana-Farber Cancer Institute, evaluating long-term benefits and disease-free survival over several years. Participants are randomly assigned to one of two groups. One group receives six cycles of intravenous trastuzumab-emtansine T-DM1 every three weeks, followed by eleven cycles of subcutaneous trastuzumab every three weeks. The other group receives weekly intravenous paclitaxel for twelve weeks along with subcutaneous trastuzumab every three weeks, continuing trastuzumab alone for additional cycles. The entire treatment period lasts about one year. During the study, participants undergo screening and regular laboratory evaluations along with follow-up visits. Researchers monitor side effects, quality of life, symptoms related to therapy, and cardiac function. The main outcomes measured include the incidence of toxicities during the first 18 weeks and disease-free survival over up to 72 months. Participants are followed for five years after treatment to assess long-term outcomes and safety.

Researchers are evaluating treatments for older adults aged 70 and above with advanced stage IIIB-IV non-small cell lung cancer that expresses PD-L1 in 1-49% of tumor cells. This phase III trial compares the effects of adding chemotherapy to immunotherapy with pembrolizumab against pembrolizumab alone. The study aims to assess improvements in overall survival, progression-free survival, response rates, toxicity, quality of life, and explore geriatric assessment factors and gut microbiome correlations. Participants are randomly assigned to one of two groups. Arm A receives pembrolizumab intravenously every 21 days for four cycles, followed by maintenance pembrolizumab every 21 or 42 days for up to two years. Arm B receives the same pembrolizumab schedule plus one of several chemotherapy regimens, including combinations of pemetrexed, carboplatin, nab-paclitaxel, or paclitaxel administered intravenously on different schedules for four cycles, followed by pembrolizumab maintenance. Imaging with MRI, CT, and PET scans is performed at baseline and throughout the trial. During the study, participants undergo regular assessments including imaging scans to monitor disease status, blood tests, and quality of life questionnaires. After treatment completion, follow-up visits occur every three months for up to two years and then every six months up to five years. Researchers measure overall survival as the primary outcome and also track progression-free survival, response rates, adverse events, and patient-reported quality of life. Safety and tolerability are closely monitored along with exploratory analyses of chemotherapy dose intensity and microbiome factors.

Researchers are evaluating ivonescimab as a first-line treatment for patients with metastatic non-small cell lung cancer NSCLC whose tumors show high PD-L1 expression. This phase 3 study compares ivonescimab to pembrolizumab, focusing on overall survival and progression-free survival to understand which treatment may better support patients with this condition. Participants will be randomly assigned to receive either ivonescimab or pembrolizumab through intravenous injection. The study is double-blinded and multiregional, involving continuous treatment and monitoring for up to approximately 36 months. Both groups receive their assigned treatment regularly during this period, with careful observation of treatment responses and side effects. During the trial, participants will undergo evaluations including scans to measure tumor size, laboratory tests, and assessments of adverse events. Researchers will track overall survival, progression-free survival, response rates, disease control, and duration of response. Safety monitoring will continue for up to 24 months after the last dose. The total study period extends until June 2029, allowing long-term data collection on treatment effects and safety.