Waterbury

Researchers are evaluating the effect of AZD0780, an oral PCSK9 inhibitor, compared with a placebo in reducing the risk of major adverse cardiovascular events plus MACE-PLUS in adults with established atherosclerotic cardiovascular disease ASCVD or at high risk for a first ASCVD event. This phase 3, randomized, placebo-controlled, and double-blind study aims to assess the time to first MACE-PLUS event over up to approximately 54 months from randomization until the primary analysis censoring date. Participants will be randomly assigned to receive either oral AZD0780 once daily or an oral placebo once daily. The study includes a parallel-group design with two arms the experimental AZD0780 group and the placebo comparator group. After the primary analysis censoring date, a study closure visit will be scheduled as the final visit for each participant. During the study, participants will be monitored for the occurrence of cardiovascular events including myocardial infarction, stroke, urgent coronary revascularization, cardiovascular death, major adverse limb events, and all-cause mortality. Researchers will assess these events through regular follow-up visits up to approximately 54 months. The study includes detailed safety monitoring and outcome evaluations to understand the effects of AZD0780 compared to placebo in this population at risk for cardiovascular events.

Researchers are studying whether the medicine NNC0487-0111 is safe and effective for adults with excess body weight and knee osteoarthritis. The trial focuses on how this treatment may help reduce weight and knee pain compared to a placebo, which contains no active medicine. This is a Phase 3 randomized study sponsored by Novo Nordisk AS.

Researchers are evaluating the safety and effects of disitamab vedotin for treating adults with advanced breast cancer that is difficult to treat and has spread in the body. The study focuses on patients whose tumors express HER2 and who have previously received treatment for their advanced breast cancer. This open-label, non-randomized study is sponsored by Pfizer and includes multiple groups based on HER2 and hormone receptor status. All participants will receive disitamab vedotin as an intravenous infusion every two weeks at the study clinic. The treatment continues until either the participant or doctor decides to stop, which may be due to cancer progression, side effects, or personal choice. After stopping treatment, participants will have follow-up visits about every six weeks, followed by phone calls every twelve weeks to monitor their health. During the study, participants will attend visits every two weeks for treatment and assessments. Researchers will evaluate tumor response, duration of response, disease control, progression-free survival, overall survival, and drug levels in the blood. Safety will be monitored for up to two years, and participants can expect regular checkups and tests throughout the study period, which may last up to three years.

Researchers are studying the effects of eloralintide in adults who are obese or overweight but do not have type 2 diabetes. The study aims to evaluate how well and how safely eloralintide works in this group. This phase 3 trial is sponsored by Eli Lilly and Company and includes adults with specific weight-related health conditions or a history of unsuccessful weight loss efforts. Participants in this randomized, double-blind study will receive weekly subcutaneous injections of eloralintide at one of four doses or a placebo. The main phase lasts about 75 weeks, during which participants are monitored closely. Those with prediabetes at the start may continue in an extension phase for an additional two years to further assess long-term effects. Throughout the study, participants will undergo various assessments including body weight, body fat mass, waist circumference, blood pressure, blood markers like triglycerides and HbA1c, and quality of life questionnaires. Researchers will track changes from baseline at week 64 and monitor the onset of type 2 diabetes up to week 191. Safety and medication use will also be observed, ensuring comprehensive evaluation over the course of participation.

Researchers are evaluating the effectiveness and safety of eloralintide compared to a placebo in adults with persistent obesity or overweight. Participants may have type 2 diabetes or not and must be on a stable incretin therapy. This phase 3, randomized, double-blind study aims to understand how eloralintide works in this population and is sponsored by Eli Lilly and Company. The study lasts about 80 weeks in total. Participants receive eloralintide or placebo through weekly subcutaneous injections. There are four different doses of eloralintide being tested, and one group receives a placebo injection. The treatment period includes monitoring from the start until week 64, focusing on changes in body weight and various health measures. The study compares eloralintide with placebo to assess its impact on obesity and related health factors. Throughout the study, participants will have regular evaluations including body weight, waist circumference, blood pressure, glucose levels, and other metabolic and physical function assessments. Patient-reported outcomes such as quality of life and control of eating are also measured. Safety and medication use are monitored, along with blood tests for insulin, inflammation markers, and kidney function. The study includes pharmacokinetic assessments to understand drug levels. Overall participation is about 80 weeks, allowing for comprehensive monitoring and follow-up.

Researchers are evaluating the drug RTN-001 in adults with uncontrolled hypertension to see if it can lower high blood pressure and to assess its safety. This Phase 2b, randomized, double-blind study includes patients aged 18 to 70 years who have uncontrolled hypertension despite taking two or more antihypertensive medications. The study also stratifies patients by medication use, sex, and race to better understand the treatment effects across groups. The trial has three periods Screening, Run-in, and Treatment. After initial screening, patients enter a 14-day Run-in Period to assess compliance and baseline blood pressure using 24-hour ambulatory monitoring. Eligible patients are then randomly assigned to one of four groups to receive daily oral RTN-001 at doses of 15, 30, or 45 mg, or a matching placebo for 12 weeks. Study visits occur approximately every two weeks, including blood pressure measurements and blood sampling for safety and drug level assessments. Two weeks after treatment ends, a follow-up call checks for adverse events and medication changes. Participants will visit the clinic about every two weeks for checkups and tests, including peripheral and central blood pressure measurements and blood draws. They will keep diaries of symptoms and medications throughout the study. Researchers will measure changes in systolic blood pressure at 4 weeks as the main outcome, along with several secondary blood pressure measures during and after treatment. Safety reviews may occur during the trial, and overall participation lasts from screening through the follow-up call approximately 14 weeks after treatment starts.

Researchers are evaluating the medication orforglipron in people who are obese or overweight and have osteoarthritis OA of the knee with pain. The study aims to understand how well and safely orforglipron works for this group. This phase 3 trial is sponsored by Eli Lilly and Company and participation will last about 74 weeks. Participants will be randomly assigned to receive either orforglipron or a placebo, both taken orally. The study includes two independent groups within the protocol, each with an orforglipron and placebo arm. Treatments are given once daily, and the trial is double-blind, meaning neither participants nor researchers know who receives the active drug or placebo during the study. During the study, participants will have regular assessments including pain and physical function evaluations using the WOMAC score, body weight measurements, walking tests, and blood tests for inflammation markers. The main outcome is the change in knee pain from the start to week 72. Safety and drug levels in the blood will also be monitored. Participants may use allowed pain medications, and all assessments will help researchers understand the effects of orforglipron over the study period.

Researchers are evaluating whether adding immunotherapy drugs, brentuximab vedotin and nivolumab, to the standard chemotherapy treatment with or without radiation improves survival in patients with early-stage stage I and II classical Hodgkin lymphoma. This phase III trial compares the standard treatment alone to the combination with immunotherapy. The study also aims to assess differences in side effects, quality of life, and long-term health outcomes among patients receiving these treatments. All patients start by receiving two cycles of ABVD chemotherapy every 28 days, followed by imaging to assess their early response. Based on their risk status and response, they are placed into groups receiving different treatments some continue with standard chemotherapy, while others receive the immunotherapy drugs with or without radiation. Treatments are given intravenously on specific days and cycles, and patients undergo various scans and blood tests throughout the trial. Participants are closely monitored with periodic imaging tests such as PET, CT, MRI scans, and blood sample collections. Follow-up visits occur every three months for the first year, then less frequently up to 12 years to track progression-free survival, overall survival, treatment side effects, fatigue, cognitive function, and quality of life. Researchers also study tumor metabolism, patient-reported outcomes, and the impact of social factors on treatment results.

Researchers are evaluating the safety and effects of the study medicine PF-07248144 combined with fulvestrant for treating hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. This study focuses on participants whose breast cancer has worsened after prior treatment with CDK46 inhibitor-based therapy. The trial compares PF-07248144 plus fulvestrant to the current standard treatment involving everolimus and endocrine therapy. Participants will be randomly assigned to one of two groups. One group will take PF-07248144 tablets daily at home in 28-day cycles along with fulvestrant injections administered at the clinic. The other group will receive everolimus tablets daily plus either exemestane tablets or fulvestrant injections, based on the study doctors choice. Treatments will continue according to the schedule for each participant. During the study, participants will undergo regular evaluations including scans to measure tumor response, lab tests, electrocardiograms, and monitoring of side effects. Researchers will track progression-free survival up to about two years, as well as overall survival and response duration up to about five years. Safety and drug levels will also be monitored throughout and after treatment. The total duration of participation may span several years depending on individual outcomes.

Researchers are evaluating whether adding the immunotherapy drug durvalumab to the usual chemotherapy treatment can improve outcomes for adults with MammaPrint High 2 Risk MP2 stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial compares standard chemotherapy alone to chemotherapy combined with durvalumab. Previous evidence suggests patients with this specific cancer profile may respond better to chemotherapy and immunotherapy, so this study aims to see if durvalumab helps prevent cancer from returning. Participants are first screened with MammaPrint testing on tumor tissue to confirm MP2 status. Those eligible are then randomly assigned to one of two treatment groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for 6 cycles, followed by doxorubicin and cyclophosphamide every 14 days for 4 cycles. The other group receives the same chemotherapy schedule plus durvalumab intravenously during specific cycles. Mammography is done during screening, and optional tumor tissue and blood samples are collected throughout the study. During the trial, participants undergo regular assessments including mammograms, tissue biopsies, and blood tests to monitor response and safety. Researchers measure event-free survival, pathologic complete response, residual cancer burden, distant relapse-free survival, and overall survival for up to 10 years after treatment. Quality of life is also evaluated through questionnaires during and after treatment. Participants are followed long-term to track outcomes and side effects.