St. Augustine

Researchers are evaluating the efficacy and safety of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced Stage III, unresectable non-small cell lung cancer NSCLC whose disease has not progressed after definitive platinum-based concurrent chemoradiotherapy cCRT. This Phase III, randomized, double-blind, placebo-controlled, international study aims to provide new insights into treatment options for this patient population. Participants will receive either durvalumab and domvanalimab or durvalumab plus placebo as intravenous infusions every four weeks, beginning on Day 1 and continuing for up to 12 months. The study includes two groups one receiving the combination of durvalumab and domvanalimab, and the other receiving durvalumab with a placebo. Both treatments are given through infusion to assess their effects on disease progression and safety. During the trial, participants will undergo regular assessments including monitoring progression-free survival for up to 8 years after randomization. Other measures include overall survival, response rates, duration of response, and various time-to-event outcomes related to disease progression and symptom deterioration. Researchers will also evaluate drug concentrations and immune responses approximately 12 weeks after the last dose. Participants can expect scheduled visits for infusions and evaluations as part of this long-term study.

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 safety and effectiveness of the Vagus Nerve Stimulation VNS Therapy System as an additional treatment for people with treatment-resistant depression. This prospective, multi-center, randomized, controlled, and blinded trial compares active VNS therapy to a no stimulation control group in reducing depressive symptoms over 12 months. The study follows guidelines aligned with Medicare and Medicaid coverage decisions for VNS in this condition. Participants receive an implant of the VNS device and are randomized at least two weeks after implantation to either have the device activated or remain without stimulation for the first 12 months. After this initial period, those in the control group can begin stimulation. Following the 12-month randomized phase, all participants enter an open-label, longitudinal study lasting about five years, including new enrollees after the initial trial phase. During the study, participants are monitored through various depression rating scales, including the Montgomery sberg Depression Rating Scale MADRS, to assess response and remission rates up to 12 months. Safety is tracked by recording adverse events from implantation through the first year. Additional assessments include disability and health outcome scales, as well as suicidality tracking. The study aims to gather long-term data on treatment effects and participant well-being.

Researchers are evaluating the safety and effects of different doses of a new medicine called NNC0519-0130 in people living with chronic kidney disease, some of whom have type 2 diabetes and are overweight or obese. This Phase 2 study also compares NNC0519-0130 to semaglutide, an already prescribed medicine, and a placebo to see how they may improve kidney function. Participants will be randomly assigned to receive once-weekly subcutaneous injections of NNC0519-0130 with a fixed dose escalation until reaching a maintenance dose, semaglutide with a similar dosing schedule, or a placebo matching NNC0519-0130. The treatment period lasts up to 43 weeks with several dosing schemes and groups. During the study, participants will have their kidney function monitored through urine albumin-to-creatinine ratio changes at weeks 12, 24, and 36. Other assessments include estimated glomerular filtration rate, body weight changes, waist circumference, blood pressure, and glycated hemoglobin levels. Safety will be evaluated by tracking adverse events throughout the trial duration. Participants will be regularly assessed to understand the medicines effects and safety.

Researchers are evaluating treatments for newly diagnosed multiple myeloma in patients who cannot undergo autologous stem cell transplantation. This Phase 3 study compares two drug combinations belantamab mafodotin with lenalidomide and dexamethasone BRd versus daratumumab with lenalidomide and dexamethasone DRd. The goal is to see if BRd extends progression-free survival and improves minimal residual disease negative status compared to DRd. Participants receive either BRd or DRd treatment, continuing until disease progression, death, unacceptable side effects, withdrawal, or study end. Both treatment arms involve the administration of lenalidomide and dexamethasone alongside either belantamab mafodotin or daratumumab. Treatment duration may last up to approximately seven years. During the study, participants will undergo regular assessments including monitoring disease progression, response to treatment, and side effects. Measurements include progression-free survival, overall survival, and the number achieving minimal residual disease negative status. Quality of life questionnaires and blood tests will also be conducted. Safety monitoring includes eye exams and tracking adverse events throughout the study duration.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Researchers are evaluating eloralintide, a drug given once weekly, in adults who have persistent obesity or are overweight, including those with or without type 2 diabetes. The study focuses on people who are already on stable incretin therapy, aiming to compare the effects and safety of eloralintide to a placebo over about 80 weeks. This phase 3 trial is sponsored by Eli Lilly and Company. Participants will be randomly assigned to receive one of four different doses of eloralintide or a placebo, all administered by subcutaneous injection. The treatment period involves weekly dosing, continuing through the study duration. The study uses a double-blind design, meaning neither participants nor researchers know who receives the drug or placebo. The main goal is to measure changes in body weight from the start to week 64, along with other health indicators. Throughout the study, participants will undergo various assessments including measurements of waist circumference, blood pressure, fasting glucose, insulin levels, and inflammatory markers. They will also complete questionnaires about their quality of life and eating behaviors. Researchers will monitor medication use and drug levels in the body to understand how eloralintide behaves. The total participation time is about 80 weeks, with safety and efficacy evaluations at regular intervals.

Researchers are evaluating the effectiveness and safety of pirtobrutinib LOXO-305 compared to ibrutinib in participants with chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL. The study includes participants who may or may not have received prior treatment for their cancer. Part 1 of the trial lasts up to six years, while Part 2 focuses on treatment-nafve participants with a specific genetic deletion 17p deletion and lasts up to two years. Participants will receive pirtobrutinib or ibrutinib orally, depending on their assigned study group. Part 1 compares pirtobrutinib to ibrutinib in a randomized, open-label design. Part 2 evaluates pirtobrutinib alone in participants with the 17p deletion who have not yet been treated. Treatment continues until disease progression, unacceptable side effects, or other study-defined reasons. During the study, participants undergo regular assessments including clinical evaluations and monitoring of their response to treatment using established criteria. Researchers measure overall response rates, progression-free survival, event-free survival, duration of response, overall survival, time to next treatment, symptom worsening, and treatment tolerability. Participation involves ongoing monitoring for up to six years in Part 1 and two years in Part 2 to evaluate long-term outcomes and safety.

This research aims to evaluate the safety and effectiveness of Icalcaprant in adults diagnosed with bipolar I or II disorder, specifically focusing on depressive episodes. Bipolar disorder is a chronic mood condition affecting a significant portion of the adult and pediatric populations in the United States. The study targets approximately 195 adult participants across about 35 sites in the U.S., aiming to understand how Icalcaprant impacts disease activity and adverse events. Participants are randomly assigned to one of three groups two groups receive different doses of oral Icalcaprant once daily for 6 weeks, and one group receives a matching placebo daily for the same period. After the treatment phase, all participants enter a 4-week safety follow-up period. The study uses a parallel design with quadruple masking to compare the effects of the investigational drug versus placebo. During the study, participants will attend regular visits at hospitals or clinics where they undergo medical assessments, blood tests, and complete questionnaires to monitor side effects and treatment effects. Researchers will measure changes from baseline to week 6 in depression severity using the Montgomery-sberg Depression Rating Scale and the Clinician Global Impression of Severity for bipolar disorder. Safety will be monitored up to approximately 10 weeks, ensuring participant well-being throughout the trial.

Researchers are evaluating the safety and effectiveness of Armour Thyroid compared to synthetic T4 in adults with primary hypothyroidism who have been stable on synthetic T4 treatment. The study will also assess how well patients tolerate switching from synthetic T4 to Armour Thyroid. This trial is a Phase 23, randomized, double-blind study sponsored by AbbVie to compare these two thyroid hormone replacement therapies. Participants will be randomly assigned to receive either Armour Thyroid or to alternate between Armour Thyroid and synthetic T4 for up to 81 weeks. The treatments are oral capsules or tablets taken daily, with doses carefully converted from their stable synthetic T4 dose. The study includes a dose-conversion period where dosage adjustments may be made to maintain appropriate thyroid hormone levels. During the study, participants will have regular blood tests to measure thyroid-stimulating hormone TSH levels, including at week 55 to see who achieves a target TSH response. Researchers will also monitor for any adverse events throughout the study, which lasts up to about 90 weeks. Dose adjustments and safety data will be tracked closely to understand treatment effects and tolerability over time.