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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 evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating whether less frequent dosing of pembrolizumab after six months of standard treatment is safe and effective for patients with advanced non-small cell lung cancer NSCLC. Pembrolizumab, an immunotherapy targeting the PD-1 receptor, has improved outcomes in NSCLC, but current dosing every six weeks for up to two years may result in overtreatment. This UK phase III trial aims to find if reducing dose frequency can maintain effectiveness while improving quality of life and lowering costs. Participants who have received six months of pembrolizumab, with or without chemotherapy, and plan to continue treatment will be randomized to receive pembrolizumab intravenously every six weeks control or every twelve weeks initially. If the 12-week dosing is found to be not less effective, additional groups receiving doses every nine, fifteen, and eighteen weeks will be included. Patients who experience disease progression while on reduced frequency dosing can return to the standard six-week schedule. Throughout the study, participants will be monitored for overall survival at 18 months from randomization, along with other outcomes such as progression-free survival, response rate, duration of response, and adverse events over two years. The study involves regular hospital visits for treatment and assessments, and the results may lead to safer, more convenient treatment options for NSCLC patients. The total participation time varies depending on individual treatment and follow-up schedules.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating LY3457263 compared with a placebo in adults with type 2 diabetes who have not reached their hemoglobin A1c HbA1c goal despite being on stable doses of semaglutide or tirzepatide. This Phase 2, double-blind study focuses on measuring changes in HbA1c levels. Participation in the trial lasts about nine months, aiming to provide insights into treatment effects in this specific patient group. Participants will be randomly assigned to receive one of three doses of LY3457263 or a placebo, all given by subcutaneous injection once weekly. The study uses a parallel-group design where each participant receives only one assigned treatment. The trial compares these treatments over a 24-week period to assess their impact on blood sugar control and body weight. During the study, participants will undergo regular assessments including blood tests to measure HbA1c and fasting serum glucose, as well as body weight measurements. These evaluations occur at baseline and at 24 weeks. The study team will monitor participants health and treatment effects throughout the trial, which is expected to last about nine months in total.

Researchers are evaluating orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.

Researchers are evaluating the efficacy, safety, and tolerability of a study drug called elecoglipron compared with oral semaglutide in adults with Type 2 Diabetes Mellitus T2DM who have an increased risk of cardiovascular events. The study focuses on adults whose diabetes is not adequately controlled by lifestyle changes or stable treatment with other glucose-lowering medications. This is a phase III randomized trial sponsored by AstraZeneca, aiming to compare these two oral medications in managing T2DM and cardiovascular risk. Participants will be assigned to receive either elecoglipron or semaglutide, both administered orally once daily at specified doses. The study runs in parallel groups, with one group receiving elecoglipron and the other receiving semaglutide. Treatment and observation will continue for 52 weeks, during which the effects on blood sugar control and other health indicators will be evaluated. Throughout the 52-week study period, participants will undergo regular assessments including measurements of Hemoglobin A1c HbA1c, body weight, and blood pressure. Researchers will monitor changes from baseline to week 52 to understand the drugs impact on diabetes control and cardiovascular risk factors. The study also tracks safety and tolerability to ensure participant wellbeing during the trial.

Researchers are evaluating the use of circulating tumour DNA ctDNA analysis to detect early molecular relapse in patients with estrogen receptor positive ER and HER2 negative breast cancer who are undergoing adjuvant endocrine therapy. This trial aims to determine if treatment with palbociclib plus fulvestrant can delay or prevent relapse in patients who show positive ctDNA results. The study is a Phase 2, multi-centre, randomized, open-label trial focusing on high-risk patients with early-stage breast cancer. The trial has two main phases a surveillance phase and a treatment phase. During the surveillance phase, patients receive ctDNA testing every three months for up to three years to monitor for molecular relapse. If ctDNA is detected without visible disease on imaging, patients enter the treatment phase, where they are randomly assigned to receive either standard endocrine therapy or a combination of palbociclib and fulvestrant for up to 24 months. Palbociclib is taken orally daily for 21 days of each 28-day cycle, while fulvestrant is given as intramuscular injections on specific days of each cycle. Imaging is performed every six months to check for overt disease. Participants undergo regular blood tests for ctDNA monitoring during the surveillance phase and receive clinical assessments, imaging scans, and quality of life questionnaires during the treatment phase. Researchers measure the incidence of positive ctDNA results, relapse-free survival, and monitor adverse events. The total follow-up for relapse-free survival extends up to 60 months from randomization, while safety and quality of life are assessed up to 24 months. If macroscopic disease appears, participants stop trial treatment and receive standard care outside the study.

This research aims to find out if NNC0487-0111 is safe and effective for adults with excess body weight. The study compares this medicine to a placebo in people who have a history of unsuccessful attempts to lose weight through diet. It is a phase 3 clinical trial that evaluates treatment for obesity, focusing on weight loss and related health measures. Participants receive weekly injections under the skin with either NNC0487-0111 at one of four dose levels or a placebo. These injections are given using pre-filled pen-injectors to the thigh, abdomen, or upper arm. All participants follow a reduced-calorie diet and increase physical activity during the study. The trial lasts up to 136 weeks, with treatment and follow-up periods designed to assess long-term effects. Throughout the study, participants attend regular visits where researchers measure changes in body weight, waist circumference, blood pressure, blood sugar levels, cholesterol, and quality of life scores. Safety is monitored by tracking any adverse events during and after treatment. The main outcome is the relative change in body weight from the start of the study to week 84, with continued observation up to week 136. Participants remain under medical supervision throughout the trial.

Researchers are evaluating the effect of muvalaplin in lowering cardiovascular risks among adults with elevated lipoproteina who either have atherosclerotic cardiovascular disease or are at risk of a first heart attack or stroke. This phase 3, randomized, double-blind study aims to investigate whether muvalaplin can reduce major adverse cardiovascular events compared to placebo in this high-risk population. Participants are randomly assigned to receive either muvalaplin or a placebo, both given orally. The study is designed with parallel groups and will last about 5.25 years, during which the occurrence of cardiovascular events and changes in lipoproteina levels will be closely monitored. Throughout the study, participants will undergo regular assessments including measurement of lipoproteina levels, monitoring of cardiovascular events such as heart attacks or strokes, and evaluation of healthcare resource use. The primary outcome is the time to first major adverse cardiac event, tracked from baseline until the study ends. Safety and pharmacokinetics of muvalaplin will also be evaluated during the trial period.