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Researchers are evaluating new treatment options for people living with HIV-1 Human Immunodeficiency Virus Type 1 who have not been treated before. The current standard treatment, antiretroviral therapy ART, involves taking multiple medicines daily and may cause other health problems. This study aims to compare a new study ART combining two medicines, islatravir and ulonivirine, taken once a week, against the standard daily ART to see if it works as well and is safe and tolerable. Participants will receive one of several treatments for 96 weeks the study ART with islatravir and ulonivirine taken once weekly, the standard ART with bictegraviremtricitabinetenofovir alafenamide BICFTCTAF taken once daily, or combinations involving placebos matching these treatments. The study includes two phases Phase 2 which is open-label, and Phase 3 which is double-blind and randomized. During the study, participants will have regular assessments including measuring the amount of HIV-1 RNA in their blood and monitoring for adverse events and medication tolerance. Researchers will evaluate how well the treatments control the virus and affect immune cells over 24, 48, and 96 weeks. Safety monitoring will continue for about 102 weeks. The total study duration for participants is up to 96 weeks of treatment plus follow-up.

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 effectiveness and safety of Datopotamab Deruxtecan Dato-DXd with or without Durvalumab compared to investigators choice chemotherapy combined with Pembrolizumab in patients with PD-L1 positive locally recurrent inoperable or metastatic triple-negative breast cancer TNBC. This Phase III, randomized, open-label, international study aims to determine if Dato-DXd with Durvalumab can improve progression-free survival and overall survival while assessing quality of life impacts in this patient population. Participants are assigned to one of three groups Dato-DXd with Durvalumab, investigators choice chemotherapy paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin combined with Pembrolizumab, or Dato-DXd alone. All study drugs are given by intravenous infusion. The study includes stratification by geographic region, disease-free interval, and prior PD-1PD-L1 treatment. Treatment continues with monitoring up to about 33 months for progression-free survival and safety, with some outcomes followed up to 64 months. Throughout the study, participants undergo assessments including imaging to measure tumor response using RECIST criteria, laboratory tests, and questionnaires to evaluate symptoms and quality of life. Researchers monitor time to disease progression, overall survival, response duration, and safety outcomes. Follow-up includes evaluation of subsequent therapies and pharmacokinetics. The total participation duration can be up to several years to capture long-term outcomes.

Researchers are evaluating the effectiveness, safety, and tolerability of elecoglipron alone or combined with dapagliflozin compared with a placebo in adults with type 2 diabetes mellitus T2DM who are not adequately controlled by lifestyle management alone or who are on other background glucose-lowering medications. This Phase III study aims to understand how these treatments impact blood sugar control and related health factors. Participants will be randomly assigned to one of four groups elecoglipron at dose level 1 with dapagliflozin-matched placebo, elecoglipron at dose level 2 with dapagliflozin-matched placebo, a combination of elecoglipron at one of the studied doses with dapagliflozin, or matching placebos for both drugs. All treatments are taken orally once daily. The study uses a quadruple-blind design to compare these options over a treatment period lasting up to 40 weeks. During the study, participants will have their blood sugar levels measured by changes in Hemoglobin A1c HbA1c from baseline to week 40. Other assessments include body weight, blood pressure, and the time to start any additional rescue medication. Participants will attend regular visits for monitoring and safety evaluations throughout the study duration, which extends until the primary completion date in July 2028.

Researchers are evaluating the efficacy, safety, and tolerability of combining elecoglipron and dapagliflozin compared to each drug alone in adults with type 2 diabetes mellitus T2DM who have not achieved adequate control through lifestyle changes or other glucose-lowering medications. This Phase III study aims to better understand how these treatments work together in managing blood sugar levels in this population. Participants are randomly assigned to one of five groups two groups receive elecoglipron at different dose levels combined with dapagliflozin two groups receive elecoglipron at different dose levels combined with a placebo matching dapagliflozin and one group receives dapagliflozin alone with a placebo matching elecoglipron. All medications are taken orally once daily. The treatment period lasts 40 weeks, during which the effects of the drugs on blood sugar and other health measures will be monitored. Throughout the study, participants will have regular assessments of their blood sugar control, body weight, and blood pressure. Researchers will measure changes in Hemoglobin A1c HbA1c, fasting plasma glucose, and self-monitored blood glucose levels. Other outcomes include weight loss and the need for rescue medication. Safety and tolerability will be closely monitored. Participation in the trial lasts for 40 weeks, during which participants will attend scheduled visits for evaluation and medication monitoring.

Researchers are evaluating the safety and effectiveness of a new medicine called CagriSema in helping adults living with obesity, with or without type 2 diabetes, to lose weight. This phase 3 clinical study compares two different weekly doses of CagriSema against an existing medicine, semaglutide. The study aims to understand how well these treatments support weight loss over a long period. Participants in this study will be randomly assigned to receive one of three treatments CagriSema at dose level 1, CagriSema at dose level 2, or semaglutide. Each treatment is given by weekly injection under the skin for 72 weeks. The study lasts about 83 weeks, covering treatment and follow-up periods to observe effects and safety. During the study, participants will have regular assessments to monitor body weight, body mass index BMI, waist size, cholesterol levels, blood sugar control HbA1c, and quality of life. Researchers will track changes from the start of treatment to the end of 72 weeks, including weight loss milestones and health measurements. Safety will also be closely monitored through reports of any adverse events until the study ends.

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.

This research aims to evaluate the antiviral effects of S-337395 compared with a placebo in adults who are not hospitalized but have respiratory syncytial virus RSV infection and are at high risk of progressing to severe disease. Participants must start treatment within 72 hours of showing RSV symptoms. The study is a Phase 2b trial and involves adults with specific risk factors such as older age and chronic lung or cardiovascular disease. Participants will be randomly assigned to receive either a high dose or low dose of S-337395, or a matching placebo. The treatment is given orally twice daily for up to 5 days. The study is double-blind, meaning neither participants nor researchers know which treatment is being administered during the trial. Throughout the study, participants will be monitored closely with assessments including nasal swabs to measure RSV RNA levels at several time points up to day 6. Researchers will also track symptoms using questionnaires and record any side effects up to 28 days. Blood samples will be collected to measure drug levels, and safety will be monitored throughout the study, which runs until December 2026.

Researchers are evaluating the efficacy, safety, and immune response of MTBVAC, a candidate vaccine against tuberculosis TB, in adolescents and adults aged 14 to 45 years living in regions where TB is common. This Phase 2b study is randomized, double-blind, and placebo-controlled, aiming to compare MTBVAC to a placebo in preventing TB disease, particularly in participants who have tested positive or negative for latent TB infection using IGRA tests. Most participants likely received BCG vaccination in infancy. Participants are assigned to receive a single intradermal dose of MTBVAC at 5x105 CFU or placebo on Study Day 1. Those who test IGRA-positive at baseline are randomized 11 to either MTBVAC or placebo, while IGRA-negative participants are randomized 31. Subgroups of participants will be closely monitored for safety and immune responses, with specific evaluations in selected safety and immunogenicity sub-cohorts. The study also includes follow-up screening for pulmonary TB disease and HIV testing yearly and during suspected TB episodes. During the study, participants will attend regular visits or have contacts to monitor for TB signs and symptoms, with sputum tests performed if TB is suspected. Safety assessments include monitoring adverse events and laboratory tests in sub-cohorts. The main outcome is the protective effect of MTBVAC against bacteriologically confirmed pulmonary TB over 36 months, along with safety and immune response evaluations. Participants diagnosed with TB will be referred for standard treatment, and those who seroconvert for HIV will receive appropriate care. The study runs until March 2028.

Researchers are evaluating ibuzatrelvir, an oral medication, to determine its effectiveness and safety in adults and adolescents aged 12 years and older with COVID-19 who are not hospitalized but are at high risk for severe illness. The study is a phase 3, randomized, double-blind trial comparing ibuzatrelvir with a placebo. Participants must have confirmed SARS-CoV-2 infection with symptoms starting within 5 days and meet specific risk factor criteria based on age. Eligible participants will be randomly assigned to receive either ibuzatrelvir or a matching placebo twice daily by mouth for 5 days. The study allows co-administration of standard care treatments available locally. The total study duration is about 6 months, including follow-up. Participants will be monitored for emergency department visits related to COVID-19, hospitalizations, and mortality up to 28 days after starting treatment. Additional evaluations include symptom resolution, occurrence of long COVID symptoms, viral RNA levels, and safety measures such as adverse events through 24 weeks. The study involves regular assessments, including clinical visits and laboratory tests, to track outcomes and safety over time.