Montebello

Researchers are evaluating LBP-EC01, a recombinant bacteriophage cocktail, in a Phase 2 study for treating acute uncomplicated urinary tract infections (UTIs) caused by drug-resistant E. coli. The study includes an initial open-label pharmacokinetic phase with 30 patients to find the best dosing regimen, followed by a blinded randomized phase with 288 patients comparing LBP-EC01 plus antibiotic to placebo plus antibiotic. All participants must have active acute uncomplicated UTI at the start and a history of prior UTI caused by antimicrobial-resistant E. coli. The study has two parts: Part 1 involves three different dosing regimens of LBP-EC01 combined with oral trimethoprim/sulfamethoxazole (TMP/SMX) given over three days. These regimens include intraurethral doses on Days 1 and 2 plus intravenous doses of varying amounts and infusion methods on Days 1 through 3. Part 2 is a double-blind randomized trial using the selected dosing regimen from Part 1, comparing LBP-EC01 plus antibiotic to placebo plus antibiotic, both given orally twice daily for three days. Participants will be closely monitored through urine and blood testing to measure LBP-EC01 levels and assess symptom resolution and microbiologic response by Day 10. Study visits include sample collection, adherence to medication, and safety assessments. Female participants of childbearing potential must use effective contraception during the study and for two weeks after treatment. The study also includes a six-month follow-up period to monitor outcomes and any recurrence of infection.

Researchers are studying how well and safely orforglipron works in adult women who have stress urinary incontinence (SUI) and are overweight or have obesity. SUI is a condition where urine leaks during movements like coughing or exercising. This trial is part of a master protocol including two independent studies, and it is a Phase 3 clinical trial. Participants will be randomly assigned to receive either orforglipron tablets or a placebo, both taken orally once daily. The treatment period and study participation will last approximately 58 weeks, including screening and safety follow-up. The study compares the effects of orforglipron against placebo in this specific group of female patients. During the study, researchers will track changes in the frequency of incontinence episodes from the start to week 52. Participants will undergo screening, treatment, and safety monitoring throughout the trial. The study aims to assess the effectiveness and safety of orforglipron in reducing urinary leakage events over time.

Researchers are evaluating the effectiveness, safety, and behavior of a new treatment called sefaxersen (RO7434656), an Antisense Oligonucleotide (ASO) therapy, for people with primary IgA nephropathy (IgAN). The study focuses on participants who have a high risk of their kidney disease worsening despite receiving the best available supportive care. This is a Phase III, randomized, double-blind, placebo-controlled trial conducted at multiple centers. Participants will receive either sefaxersen or a matching placebo through subcutaneous injections according to a specified schedule. The study compares these two groups to see how the treatment affects kidney function over time. The intervention is designed to inhibit Complement Factor B, which is involved in the disease process. The study includes vaccination requirements and contraceptive use for women of childbearing potential to ensure safety. During the study, participants will be monitored for changes in their urine protein-to-creatinine ratio (UPCR) at baseline and at week 37, which is the primary measure of kidney function improvement. Other assessments include kidney biopsy results, kidney function tests estimating glomerular filtration rate (eGFR), and ongoing safety evaluations. The trial tracks participants' health closely to assess the treatment's effect and any side effects throughout the study period.

Researchers are investigating the effectiveness of Saruparib (AZD5305) combined with a physician's choice of new hormonal agents (NHA) compared to a placebo plus NHA in men with metastatic castration-sensitive prostate cancer (mCSPC). This phase III study aims to demonstrate whether Saruparib plus NHA can improve radiographic progression-free survival (rPFS) in two groups of participants: those with homologous recombination repair mutations (HRRm) and those without (non-HRRm). About 1800 adult male participants with mCSPC will be divided into two cohorts based on their HRRm status. Each cohort will be randomized equally to receive either Saruparib orally with their chosen NHA or a placebo orally with the chosen NHA. The new hormonal agents may include abiraterone acetate, darolutamide, or enzalutamide. Participants will continue their assigned treatment and undergo regular tumor evaluation scans until their disease progresses or treatment is stopped for other reasons. Throughout the study, participants will have tumor tissue and blood samples collected to confirm HRRm status and monitor disease. They will be followed for survival until the study ends. An independent data monitoring committee will review safety and tolerability of Saruparib plus NHA. The main outcome measured is radiographic progression-free survival, tracked for up to approximately 50 months, to evaluate how well the treatments control cancer progression.