Santiago Del Estero

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

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 the efficacy and safety of brenipatide combined with standard of care compared to placebo plus standard of care in delaying the worsening of symptoms in adults with bipolar disorder. This Phase 2, randomized, double-blind study aims to understand if brenipatide can help delay relapse in bipolar disorder patients. The study is sponsored by Eli Lilly and Company and focuses on adults aged 18 to 75 years diagnosed with bipolar disorder I or II. Participants will be randomly assigned to receive one of two doses of brenipatide or a placebo, each administered by subcutaneous injection alongside their standard of care medication. The trial is divided into three periods a screening period lasting about one month, a treatment period lasting at least six months, and a follow-up period lasting approximately two months. The total duration of participation may vary and can be shortened if symptoms worsen or if the participant withdraws. During the study, participants will self-inject the study medication, maintain study diaries, and complete questionnaires assessing their condition. Researchers will monitor time to relapse, changes in functional impairment, mood symptoms using specific rating scales, quality of life, patient global impressions, body weight, and pharmacokinetics. Safety will be closely observed, including the presence of treatment-emergent anti-drug antibodies. Participants are expected to attend regular visits throughout the treatment and follow-up periods.

This research aims to evaluate the effectiveness and safety of adding KarXT to current treatment for mania in adults with Bipolar-I Disorder. Participants must be experiencing an acute manic episode, with or without mixed features, and currently taking lithium, valproate, or lamotrigine. The study is a Phase 3, randomized, double-blind, placebo-controlled trial assessing KarXT as an adjunctive therapy. Participants will be randomly assigned to receive either KarXT combined with lithium, valproate, or lamotrigine, or a placebo combined with these mood stabilizers. The study drug or placebo will be administered at specified doses on designated days. The trial focuses on treatment during an acute manic episode with monitoring over several weeks to assess changes in mania symptoms and other clinical outcomes. Participants will be monitored through scheduled visits where researchers will measure changes in mania severity using the Young Mania Rating Scale YMRS and other clinical scales. Safety assessments will include tracking adverse events and evaluating other symptom scales related to bipolar disorder. The total study duration includes treatment and follow-up periods lasting up to seven weeks, during which participants health and responses to the study drug are carefully observed.

Researchers are evaluating KarXT for the treatment of manic episodes in adults with Bipolar-I Disorder. This Phase 3, randomized, double-blind, placebo-controlled study involves participants experiencing an acute episode of mania or mania with mixed features. The study aims to compare the effectiveness and safety of KarXT against a placebo during a 3-week inpatient treatment period. Participants will receive flexible dosing of either KarXT or placebo during the 3-week double-blind inpatient phase. Before treatment, psychotropic medications must be washed out within 14 days. The study includes screening, the treatment period, and a safety follow-up, totaling no more than seven weeks. During the study, participants will have their symptoms assessed using tools such as the Young Mania Rating Scale and Clinical Global Impressions-Bipolar scale. Researchers will monitor changes in mania symptoms and overall clinical impression at week 3. Safety follow-up continues after treatment to ensure participant well-being throughout the study duration.

Researchers are evaluating the efficacy and safety of remibrutinib in patients with secondary progressive multiple sclerosis SPMS. This is a Phase III, randomized, double-blind, placebo-controlled, multi-center study involving approximately 1275 participants. The study aims to provide important data on remibrutinibs effect on disability progression in SPMS and includes both a Core Part and an Extension Part for further assessment. Participants are randomly assigned to receive either remibrutinib or a matching placebo as oral film-coated tablets during the Core Part. The Core Part includes double-blind treatment, followed by an Extension Part where all participants receive open-label remibrutinib tablets. Treatment is taken orally, and the study is event-driven, continuing until required endpoints are met. During the study, participants undergo regular assessments of disability progression using the Expanded Disability Status Scale EDSS, Timed 25-Foot Walk, 9-Hole Peg Test, and Symbol Digit Modalities Test, among others. Brain imaging and safety monitoring for adverse events are performed throughout up to approximately five years. Researchers track changes in brain lesions and atrophy, and follow participants for safety and treatment effects over time.

Researchers are studying the long-term safety and tolerability of KarXT and KarX-EC in adolescents with schizophrenia and children and adolescents with autism-related irritability. This Phase 3, open-label study evaluates these treatments to better understand their effects over extended periods in these young populations. The trial is led by Karuna Therapeutics, Inc., a Bristol Myers Squibb company. Participants receive KarXT as the study drug, with dosing specified on certain days. The study includes two groups adolescents aged 13 to 17 years with schizophrenia receiving KarXT alone, and children and adolescents aged 5 to 17 years with irritability associated with autism spectrum disorder receiving KarXT combined with KarX-EC. The treatment period extends up to 54 weeks, during which safety and tolerability are closely monitored. During the study, participants are regularly evaluated for treatment-emergent adverse events, serious adverse events, and adverse events of special interest. Additional assessments include monitoring for procholinergic and anticholinergic symptoms, suicidal ideation and behavior, and movement disorders using validated rating scales. The total participation duration spans up to 54 weeks, encompassing treatment and observation to track long-term effects and safety outcomes.

This research evaluates the long-term safety and effectiveness of pembrolizumab in participants with advanced tumors or hematologic malignancies who have previously taken part in Merck pembrolizumab-based studies. This phase 3 extension study includes participants currently on treatment or in follow-up from parent trials. The study has three phases based on participants prior treatment status First Course Phase, Survival Follow-up Phase, and Second Course Phase, allowing continuation or observation depending on prior participation. Participants receive pembrolizumab alone or combined with other treatments such as standard of care therapies, lenvatinib, olaparib, MK-4280, MK-4280A, or pembrolizumab with berahyaluronidase alfa. Dosing schedules vary by phase and regimen, including intravenous infusions of pembrolizumab every 3 or 6 weeks, oral lenvatinib capsules daily, oral olaparib tablets twice daily, and other biologics administered intravenously or subcutaneously. The study allows up to 35 doses in the First Course Phase and fewer doses in the Second Course Phase, with treatment durations adjusted for crossover eligibility and combination therapies. Participants are monitored through regular treatment visits involving drug administration and follow-up assessments. Researchers evaluate overall survival up to approximately 10 years, along with progression-free survival, event-free survival, and adverse events including serious and clinically significant side effects. The study includes ongoing safety monitoring up to around 40 months post-treatment. Participants remain under observation for long-term outcomes and potential treatment effects for many years after enrollment.

Researchers are evaluating an organ dysfunction score adapted specifically for pregnant and early postpartum patients up to 3 days after birth admitted to intensive care units ICU. This observational study aims to determine if this adjusted score, called SOFA-OBS, better predicts ICU mortality compared to the general SOFA score. The study also assesses whether a non-invasive pulse oximeter can effectively evaluate respiratory function instead of the standard arterial blood gas test, which is more painful and invasive. The study involves following pregnant and postpartum patients admitted to the ICU for at least 24 hours. Researchers will collect routine clinical data and laboratory results already used in ICU care, without requiring extra interventions. The SOFA-OBS score adjusts kidney function and blood pressure measurements to reflect the physiological changes during pregnancy and postpartum. It also replaces arterial blood gas oxygen measurements with pulse oximetry when blood gas analysis is unavailable. Data will be recorded daily during the ICU stay. Participants will be monitored for organ dysfunction and mortality outcomes during their ICU stay or up to 28 days after enrollment. Researchers will evaluate and compare the predictive ability of the SOFA-OBS and general SOFA scores for ICU mortality and sepsis-related death. Data quality will be carefully checked, and privacy will be protected by anonymizing patient information. The study is approved by ethical boards and requires informed consent from participants, with a planned enrollment of 130 patients.

Researchers are evaluating the effect of seltorexant as an add-on treatment to antidepressants in adults and elderly people with major depressive disorder who also have insomnia symptoms and have not responded well to their current antidepressant therapy with SSRIs or SNRIs. This Phase 3 study aims to understand how well seltorexant works, its safety, and its ability to maintain improvement compared with a placebo. Participants in part 1 of the study will receive either seltorexant or a matching placebo once daily for 6 weeks, alongside their usual SSRI or SNRI antidepressant. Those who complete part 1 and meet criteria for part 2, plus new participants entering directly into part 2, will receive seltorexant during an open-label induction and stabilization phase. Participants who respond well will then enter a double-blind maintenance phase, receiving either seltorexant or placebo daily, continuing their baseline antidepressant throughout. During the study, participants will be monitored through rating scales measuring depression severity, sleep disturbance, and patient health questionnaires at baseline and specified days up to two years and ten months. Researchers will assess changes in depression symptoms and time to relapse, along with safety and tolerability. Participants will be followed through treatment phases and post-treatment periods to evaluate the maintenance of effects and overall safety.