Bruce

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 effectiveness and safety of ribupatide KAI-9531 given as a once-weekly subcutaneous injection compared to semaglutide and placebo for people living with obesity who do not have diabetes. This Phase 3, randomized, partially-blinded study aims to show that ribupatide is superior in reducing body weight. Participants included have a body mass index BMI of 35 kgm or higher and a history of unsuccessful weight loss attempts through diet and exercise in the past 6 months. Participants will be randomly assigned to one of four groups two different doses of ribupatide once weekly, semaglutide once weekly, or a placebo injection once weekly. The study treatment is administered by subcutaneous injection, and the treatment period lasts for 76 weeks. The study compares the percentage change in body weight among these groups and also monitors several other health measures related to weight, metabolism, quality of life, and safety. During the study, participants will have regular visits for assessments including body weight, waist circumference, blood pressure, cholesterol levels, and questionnaires about eating behaviors and quality of life. Researchers will also monitor for any adverse events and test for antibodies against the study drugs throughout the 80-week period. The total participation duration may extend up to 80 weeks, including safety follow-up after the treatment period ends.

Researchers are studying the effects of ribupatide KAI-9531, given as a weekly subcutaneous injection, in adults living with obesity or overweight who also have type 2 diabetes. The main goal is to see if ribupatide is better than a placebo in reducing body weight and lowering hemoglobin A1c HbA1c, a key marker of blood sugar control. This is a Phase 3, randomized, double-blind, placebo-controlled trial evaluating safety and efficacy. Participants will be randomly assigned to receive one of four doses of ribupatide or a matching placebo once weekly. The study compares the effects of these different doses over time, focusing on changes in weight and HbA1c levels at week 76. The intervention involves subcutaneous injections administered once a week, with multiple doses tested to evaluate their impact relative to placebo. During the study, participants will be monitored regularly to measure changes in body weight, HbA1c, waist circumference, blood pressure, cholesterol levels, glucose, insulin, and quality of life related to weight. Safety assessments include tracking adverse events and immune responses to the drug. Blood samples will be collected to measure ribupatide concentrations. The study lasts up to 76 weeks, with ongoing monitoring for treatment effects and safety throughout this period.

Researchers are studying patients with stage II primary invasive cutaneous melanoma to compare the effects of two different surgical excision margins 1cm versus 2cm. The goal is to determine if narrower margins are as safe as wider margins in preventing melanoma recurrence and if they can improve patients quality of life. This trial also looks at the impact of these excision sizes on health services and society. Participants will be randomly assigned to receive either a 1cm or 2cm wide local excision margin around the primary melanoma lesion. Both groups will undergo sentinel lymph node biopsy and may have reconstruction surgery if needed. The surgery must be done within 120 days of diagnosis and within 28 days of randomization. During the study, participants will be followed for up to 60 months to measure disease-free survival as the primary outcome. Additional assessments include local recurrence, distant disease-free survival, melanoma-specific and overall survival, quality of life questionnaires, neuropathic pain evaluations, adverse event monitoring, and health economic analysis. Follow-up questionnaires and safety checks will occur at multiple time points up to 24 months after surgery, with longer-term monitoring continuing up to 120 months.

Researchers are evaluating the safety, immune response, and effectiveness of different doses of a Chlamydia messenger RNA mRNA vaccine in adults aged 18 to 29 years. The study includes three initial Sentinel Cohorts to carefully assess safety at low, medium, and high dose levels before expanding to a Main Cohort. The overall goal is to understand how well this vaccine candidate works and its safety profile in young adults. Participants will receive three injections of either a low, medium, or high dose of the Chlamydia mRNA vaccine or a placebo. The injections are given intramuscularly. The study is randomized and placebo-controlled, with multiple groups based on whether participants have prior exposure to Chlamydia trachomatis. The study is designed with stepwise safety assessments in the Sentinel Cohorts followed by evaluation in a larger Main Cohort. During the study, participants will be monitored for immediate reactions up to 30 minutes after vaccination and for side effects up to 12 months following the last injection. Immune responses will be measured through blood tests before and after each vaccine dose. Participants will be followed for about 18 months from the start, including safety monitoring, laboratory tests, and evaluation of immune responses to the vaccine and placebo injections.

Researchers are studying the safety and effectiveness of HB-1 compared to a placebo in adults aged 18 to 65 years who have Post-Traumatic Stress Disorder PTSD. This is a phase 2, multi-center, double-blind, placebo-controlled trial involving approximately 200 to 500 adults diagnosed with PTSD who do not have severe neuropsychiatric or medical conditions. The study takes place at multiple sites in Australia and the United States. Participants will receive either HB-1 or a placebo tablet once daily for 12 weeks. HB-1 doses start at 64192 mg of telmisartanverapamil extended release and may be increased to 86258 mg based on treatment response and tolerance assessed at weeks 4 and 8. Those showing a 50% or greater reduction in PTSD symptoms remain on the same dose, while others without severe side effects may have their dose increased. A safety follow-up visit occurs one week after the last dose to monitor any adverse effects. During the study, participants will undergo assessments at baseline, week 4, week 8, and week 12, including symptom rating scales such as CAPS-5 and other PTSD-related questionnaires. Safety evaluations include monitoring for adverse events, vital signs, ECGs, and laboratory tests. The studys main goal is to measure changes in clinician-rated PTSD symptoms, along with secondary measures of stress, symptoms, and disability. Participation lasts for approximately 13 weeks including treatment and safety follow-up.