Waterbury

Researchers are conducting a phase 3 study to evaluate the safety and effectiveness of orforglipron for treating hypertension in adults who are overweight or have obesity. The study framework supports two independent trials and aims to better understand how orforglipron works in this specific population with high blood pressure and excess weight. Participants receive orforglipron or a placebo orally once daily. The study includes screening and baseline visits to confirm eligibility based on blood pressure and body mass index. Treatment is randomized and double-blind, meaning neither participants nor researchers know who receives the active medication or placebo during the trial. Throughout the study, researchers monitor blood pressure and other health factors to assess the number of participants assigned to each treatment group. Safety and efficacy are evaluated regularly, with ongoing observation of participants’ response to the medication and any potential side effects.

Researchers are evaluating the safety and effectiveness of orforglipron for treating people who have both hypertension and are either overweight or obese. This study is part of a larger master protocol called GZPL and focuses specifically on these health conditions. The trial is designed as a Phase 3 study to provide important information about this potential treatment. Participants will receive either orforglipron or a placebo, both given orally once daily. The study compares these two groups to understand the impacts of orforglipron on blood pressure and weight-related health issues. The treatment period lasts up to 36 weeks, during which participants are monitored closely. During the study, participants will have their office systolic blood pressure measured to track changes from the start of the trial to week 36. Researchers will also monitor safety and other health measures throughout the trial. The study involves regular visits and assessments to ensure participant well-being and to gather thorough data on the treatment's effects.

This research aims to assess the effectiveness and safety of orforglipron for treating hypertension in adults with obesity or overweight. It is conducted as part of the GZPL master protocol and focuses on participants who have both high blood pressure and elevated body weight. The study is designed as a Phase 3 clinical trial to provide detailed evaluation of this new treatment approach. Participants will receive either orforglipron or a placebo, both given orally once daily. The study compares these two groups to understand the benefits and any side effects of orforglipron when used for managing hypertension in this specific population. The treatment period and detailed dosing schedule are based on the master protocol, which guides participant management and study procedures. During the study, participants will have their systolic blood pressure measured regularly to track changes from the start through week 36. Researchers will monitor safety and treatment effects closely, following all procedures outlined in the master protocol. The overall duration of participant involvement and additional assessments are determined by the master protocol guidelines for this comprehensive evaluation.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating the safety and effectiveness of NNC0487-0111 for people with excess body weight and knee osteoarthritis. This Phase 3 study compares NNC0487-0111 to a placebo, a treatment with no active medicine, to see if it helps reduce weight and knee pain. Participants have knee osteoarthritis diagnosed by specific clinical and radiographic criteria and experience ongoing knee pain. Participants receive weekly injections under the skin using a pre-filled pen injector. The injections, either NNC0487-0111 or placebo, are given in the thigh, abdomen, or upper arm. The study treatments include two dose levels of NNC0487-0111. Treatment assignment is randomized and blinded, meaning participants receive either the medicine or placebo by chance, not by choice. During the study, participants will be monitored for changes in body weight and knee pain using a standardized pain questionnaire over about 80 weeks. They will follow specific instructions about pain medication before assessments. Researchers will track treatment effects, safety, and any side effects throughout the study period.

Researchers are evaluating the safety and effects of a medicine called disitamab vedotin for adults with advanced breast cancer that is hard to treat and has spread in the body. This study focuses on participants whose tumors express HER2 and who have received previous treatments for their advanced breast cancer. The goal is to understand how well this medicine works and its safety in these patients through a Phase 1b/2 open-label study. All participants will receive disitamab vedotin intravenously (IV) once every two weeks at the study clinic. They will continue the treatment until they or their doctor decide to stop, which could be due to cancer progression, side effects, or personal choice. During treatment, study visits occur every two weeks. After stopping treatment, participants will have follow-up visits about every six weeks, and later follow-up phone calls approximately every twelve weeks. Participants will undergo evaluations including assessments of their cancer response by the study doctors, following recognized criteria. The study team will monitor the participants for up to about two years or until their disease progresses or they pass away. This includes safety monitoring and collecting information about the medicine’s effects to determine its safety and effectiveness.

Researchers are evaluating the safety and effectiveness of eloralintide, a drug given by injection, in adults who are obese or overweight but do not have type 2 diabetes. This Phase 3 study includes both a main phase and an extension phase to understand the drug's impact on body weight and overall health in this population. The study aims to compare eloralintide with a placebo to see how well it works in reducing weight. Participants will receive either eloralintide or a placebo, both administered under the skin once a week. The main study phase will last about 75 weeks, during which participants will be regularly monitored. Those participants who have prediabetes will have the option to continue into an extension phase lasting an additional 2 years to further assess long-term effects. During the study, participants will have their body weight measured at the start and throughout the trial, with the primary outcome being the percent change in body weight at week 64 compared to baseline. Researchers will also monitor safety and any side effects. Participants will be asked about their weight history and health conditions, and they must maintain stable body weight before joining. The total involvement time for most participants will be about 75 weeks, with longer follow-up for some.

Researchers are investigating the safety and effectiveness of eloralintide compared to a placebo in adults with persistent obesity or overweight. This includes people with or without type 2 diabetes who are already on stable weekly incretin therapy. The study is a phase 3, randomized, double-blind trial focusing on this specific group to better understand treatment outcomes. Participants will receive either eloralintide or a placebo, both given by subcutaneous injection once a week. The study compares these two treatments over the course of the trial. Participants must continue their stable incretin therapy throughout the study period. The study lasts about 80 weeks in total. Researchers will monitor changes in body weight from the start of treatment to week 64 as the main outcome. Participants will have regular assessments to track their health, safety, and treatment effects during this time.

Researchers are evaluating whether the drug RTN-001 can reduce high blood pressure in adults with uncontrolled hypertension. This Phase 2b study involves patients aged 18 to 70 who have high blood pressure despite taking at least two antihypertensive medications. The trial aims to compare the effects and safety of RTN-001 against a placebo to understand its impact on blood pressure and possible side effects. The study includes three main periods: Screening, Run-in, and Treatment. After screening and a 14-day Run-in period to check patient compliance and baseline blood pressure, about 280 patients will be randomly assigned to receive daily doses of RTN-001 at 15, 30, or 45 mg or a matching placebo for 12 weeks. Blood pressure and laboratory tests will be taken regularly throughout the treatment period, with additional ambulatory blood pressure monitoring around weeks 4 and 12. A safety review is planned after about 25% of participants reach week 2, and a follow-up phone call occurs two weeks after treatment ends to check for adverse events. Participants will visit the clinic about every two weeks for checkups, blood sampling, and blood pressure measurements. They will keep a diary of symptoms and medications. Researchers will assess changes in systolic blood pressure as the main outcome and monitor safety through laboratory tests and adverse event reports. The total study duration for each participant includes screening, treatment, and a follow-up period lasting approximately 14 weeks in total.

Researchers are evaluating the safety and effectiveness of orforglipron, taken once daily, in people who are overweight or have obesity and also suffer from knee osteoarthritis with pain. This phase 3, multicenter, randomized, double-blind, placebo-controlled trial aims to understand how well orforglipron works over about 74 weeks. The study is part of a larger master protocol supporting two independent studies focused on this condition and population. Participants will receive either orforglipron or a placebo, both administered orally. The study compares these two groups in a parallel-arm design to assess treatment effects. The trial includes a long treatment and observation period lasting about 74 weeks to monitor changes and safety outcomes. Throughout the study, participants will be assessed for changes in their knee pain using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, measured at the start and at week 72. Researchers will also monitor the participants' safety and overall health during the trial. The participation duration is approximately 74 weeks, including screening, treatment, and follow-up visits.