Tempe

This trial studies the pharmacokinetics of casdatifan in healthy adults aged 18 to 55 years. It compares the absorption and concentration levels of a single 100 mg dose given as one tablet versus four 25 mg tablets under fasting conditions. The study also evaluates how food intake affects the drugs pharmacokinetics when the 100 mg dose is taken as four tablets with food. Participants receive casdatifan in three different ways four 25 mg tablets while fasting, one 100 mg tablet while fasting, and four 25 mg tablets after a meal. This crossover design allows each participant to receive all treatments in a randomized order, enabling direct comparison of absorption and drug levels. During the study, participants are monitored for up to 168 hours after each dose to measure drug concentration and how the body processes casdatifan. Researchers assess the peak concentration, time to peak, elimination rate, and total exposure to the drug. Safety is monitored by recording any adverse events for up to 43 days. The entire study is conducted with healthy volunteers, and participation lasts until all dosing and follow-up assessments are complete.

Researchers are evaluating two medicines, enlicitide and rosuvastatin, in healthy adults aged 18 to 55 years. The study aims to compare the amounts of these medicines in the body over time when given separately and when combined into a single tablet. This research is a Phase 1 trial focused on basic science to understand how these drugs behave when taken together or alone. Participants will receive either a single dose of enlicitide with rosuvastatin tablets taken together or a single dose of a combined tablet called MK-0616A or its formulation B. The study includes two parts where these treatments are given in a randomized crossover design, meaning participants receive different treatments in sequence to compare drug absorption. During the study, participants will be monitored for drug levels in their blood at specific times up to 168 hours after dosing. Researchers will measure how much of each drug is present over time and the highest concentration reached. Safety will also be evaluated by tracking any side effects or adverse events during the approximately nine weeks of observation. Participants will have scheduled visits for dosing and blood sampling throughout the study period.

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 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 the relative bioavailability and bioequivalence of two capsule formulations of varegacestat in healthy adult participants aged 18 to 55 years. This open-label, randomized crossover Phase 1 study aims to compare how the body absorbs and processes the test capsule formulation versus the reference capsule under fasting conditions. Participants will receive varegacestat orally in two different forms a reference formulation and a test formulation. They will be randomly assigned to receive either the reference formulation followed by the test formulation or vice versa. The study includes a crossover design, allowing each participant to serve as their own control while assessing drug absorption and peak concentration. During the approximately three-week study period, participants will undergo various assessments including measurements of drug concentration over time AUC0-t, AUC0-inf and peak drug level Cmax. Safety and tolerability will also be monitored through reports of adverse events, laboratory tests, vital signs, and ECGs. The total participation duration is around three to four weeks, with careful monitoring to ensure participant well-being throughout the study.

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 the drug orforglipron in people who have obesity or are overweight and also suffer from osteoarthritis OA of the knee with pain. This study aims to assess how well and safely orforglipron works for this group of participants. The trial is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study sponsored by Eli Lilly and Company. Participation in the study will last about 74 weeks. Participants will be randomly assigned to receive orforglipron or a placebo orally. The study includes two independent groups under a master protocol, each comparing orforglipron to placebo. Treatment is given once daily, and the study design is parallel-arm, meaning participants remain in their assigned group throughout the trial. During the study, participants will undergo various assessments including pain evaluation using the Western Ontario and McMaster Universities Osteoarthritis Index WOMAC pain subscale, physical function tests, body weight measurement, health surveys, walking tests, and blood tests for inflammation markers and cholesterol. Safety and drug levels will also be monitored. These evaluations occur from the beginning of the study through week 72, with participant involvement spanning about 74 weeks total.

Researchers are evaluating the safety and effectiveness of brenipatide at different dose levels compared with placebo in adults with uncontrolled moderate to severe asthma. This Phase 2 study aims to better understand how brenipatide may affect asthma symptoms and exacerbations over one year of treatment. Participants in this study are adults aged 18 to 75 years with a history of asthma and recent severe exacerbations. Participants will be randomly assigned to receive either one of two doses of brenipatide or a placebo, all administered by subcutaneous injection. The treatment period lasts 52 weeks, during which participants receive their assigned injections and are monitored regularly. The study includes a screening period before treatment and a follow-up period after treatment to assess ongoing safety and effects. During the study, participants will attend visits to complete questionnaires, lung function tests such as forced expiratory volume in one second FEV1, and assessments of asthma control and medication use. Researchers will monitor asthma exacerbation rates, rescue medication use, and the presence of anti-drug antibodies. The total study duration including screening, treatment, and follow-up is approximately 65 weeks.

Researchers are studying the drug INCA033989 to understand how it behaves in the body, its safety, and how well healthy adults tolerate it when given by injection under the skin or into a vein. This Phase 1 trial involves healthy adult participants aged 18 to 55 years with no significant medical history. The study aims to compare the drugs levels in the body when given by different methods and monitor any side effects that may arise. Participants will receive a single dose of INCA033989 either as a subcutaneous injection or an intravenous infusion. Some groups may receive INCA033989 combined with a bioavailability enhancer to assess its effects. The trial includes several cohorts, each receiving the treatment according to a defined protocol. The drug administration will take place once, and the study will follow participants for up to 12 weeks to evaluate pharmacokinetics and safety. During the study, participants will undergo evaluations including clinical exams, laboratory tests, vital signs, and ECGs to monitor their health and response to the drug. Researchers will measure key pharmacokinetic parameters such as peak concentration and overall drug exposure after dosing. Safety will be assessed by recording any treatment-emergent adverse events. Participants must comply with study procedures and restrictions, including avoiding pregnancy and certain medications. The total participation time can last up to 12 weeks.

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.