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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 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.

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.

Alopecia areata AA is a condition where the immune system attacks hair follicles, causing hair loss mainly on the head and face but possibly on other body parts. This research evaluates the safety, effectiveness, and tolerance of upadacitinib, an approved drug, in adolescents and adults with severe AA. The study is a Phase 3 randomized, placebo-controlled, double-blind trial enrolling about 1500 participants worldwide. Participants are randomly assigned to one of three groups receiving different treatments two doses of upadacitinib or placebo. In initial periods, some may switch from placebo to upadacitinib based on their Severity of Alopecia Tool SALT score. Those completing early parts may enter an extension phase receiving upadacitinib for up to 108 weeks. Treatment involves taking oral tablets once daily for up to 160 weeks, with possible re-randomization at Weeks 24 and 52. Throughout the study, participants attend regular clinic visits for medical assessments, blood tests, side effect monitoring, and questionnaires to track treatment effects. Researchers measure hair loss improvement using SALT scores and record adverse events over approximately 164 weeks. Participants are followed for up to 30 days after their last dose for safety monitoring.

Researchers are studying the effects of camlipixant in adults with two types of irritable bowel syndrome IBS-D diarrhea-predominant and IBS-M mixed type. This Phase 2b trial aims to assess how well camlipixant works and how safe it is when compared to a placebo. The study includes two parts, where after the first part, some participants may be randomly assigned to receive a higher dose of camlipixant or stop taking the drug. Participants receive camlipixant at different dose levels or a placebo during the first part of the study. In the second part, all participants are randomized again to either continue with camlipixant or placebo. The treatment lasts up to 26 weeks, with doses adjusted in the second phase. The study uses a triple-blind design where neither participants nor researchers know who receives which treatment during the trial. During the study, participants will regularly report their abdominal pain intensity and stool form using specific scoring systems. Researchers will monitor safety by tracking adverse events and changes in vital signs and laboratory tests. The main outcome measures focus on changes in abdominal pain intensity over weeks 7 to 12. Participants will be assessed throughout the 26-week period to evaluate the treatments effects and safety.

Researchers are evaluating lunsekimig, a subcutaneous injection, compared with placebo in adults aged 40 to 80 years with inadequately controlled Chronic Obstructive Pulmonary Disease COPD characterized by an eosinophilic phenotype. This Phase 2bPhase 3 parallel study aims to assess the efficacy, safety, and tolerability of lunsekimig in reducing COPD exacerbations and improving lung function and symptoms. Participants are randomly assigned to one of three groups lunsekimig dose regimen A, lunsekimig dose regimen B, or a matching placebo. They will receive subcutaneous injections during a 48-week treatment period. The study also includes a screening period of up to 4 weeks before treatment and an approximately 8-week follow-up period after treatment, totaling up to 60 weeks of participation. During the study, participants will undergo regular assessments including lung function tests such as post- and pre-bronchodilator Forced Expiratory Volume in 1 second FEV1, questionnaires measuring respiratory health and symptoms, and monitoring of COPD exacerbations. Safety will be evaluated through reported adverse events and laboratory tests. Researchers will also monitor blood levels of lunsekimig and the presence of antidrug antibodies. Participants will be followed closely throughout the study duration to assess treatment impact and safety.

Researchers are studying atopic dermatitis AD, a skin condition marked by worsening periods called flares. This observational study aims to evaluate an investigational device called Nevisense Go, which measures electrical properties of the skin related to its barrier function, to see if it can detect early changes that may predict AD flares before visible signs or symptoms appear. Participants aged 12 to 89 years with a history of AD flares are included. Participants will use the Nevisense Go device at home for about 90 days to take skin measurements five days a week. Along with these device measurements, they will complete electronic symptom diaries and attend up to five in-person study visits. The study collects data from both affected and unaffected skin areas, but device measurements will not affect clinical care or treatment decisions during the trial. During the study, researchers will assess the relationship between skin measurements and subsequent AD flares, develop and validate an algorithm to predict flare onset, and evaluate adherence and feasibility of device use. Participants will also complete patient- and clinician-reported measures of AD severity, itch, flare frequency, and flare resolution. The total participation lasts about 90 days, with ongoing data collection and evaluations to better understand flare prediction.

This research evaluates the long-term safety and effects of plozasiran in adults with hypertriglyceridemia HTG and severe hypertriglyceridemia SHTG. Participants must have completed prior related studies and meet specific health criteria, including controlled blood sugar levels HbA1c 10%. The study is designed as an open-label Phase 3 trial to extend understanding of this treatment in these populations. Participants will receive plozasiran injections under the skin approximately every three months for two years. They will continue following a low-fat diet according to local care standards. Some participants may join based on meeting additional criteria from previous studies, ensuring they fit the trials health requirements. During the study, participants will undergo regular assessments including monitoring for treatment-related side effects and changes in blood triglyceride and cholesterol levels. Researchers will track various blood markers and cardiovascular events over 24 months. Safety and response to treatment will be closely observed throughout the trial period.

This trial evaluates icovamenib in adults with Type 2 Diabetes who have not met blood sugar goals despite using standard antihyperglycemic medications. It is a Phase 2, randomized, double-blind, placebo-controlled study that aims to assess whether icovamenib can better reduce HbA1c compared to current therapies. Participants are adults aged 18 to 75 years with stable antihyperglycemic treatment and HbA1c above the target set by the American Diabetes Association. Participants are randomly assigned to receive either icovamenib 100 mg once daily or a matching placebo for 12 weeks, in addition to their prescribed antihyperglycemic medications such as metformin, SGLT2 inhibitors, alogliptin, or sitagliptin. After this 12-week treatment period, they continue their usual antihyperglycemic medications without study drug for the remaining duration of the trial, totaling approximately 56 weeks. During the study, participants undergo assessments of blood sugar control, including HbA1c levels, fasting plasma glucose, and safety evaluations throughout the 52-week trial period. Researchers will monitor tolerability, changes in glycemic control, and adverse effects. Participants provide informed consent and comply with study procedures, including regular visits and laboratory tests, to help determine the effects and safety of icovamenib compared to placebo.

Researchers are evaluating two experimental drugs, REGN7508 and REGN9933, in adults with atrial fibrillation, a condition where the heart beats too fast and unevenly. The study aims to compare how well these drugs prevent blood clots and their bleeding effects against apixaban, a commonly used medicine for preventing blood clots in atrial fibrillation. The research also explores side effects, drug levels in the blood, and whether the body develops antibodies that might affect the drugs action or cause side effects. Participants will be randomly assigned to receive REGN7508, REGN9933, or apixaban according to the study protocol. The treatments are given as monoclonal antibodies targeting FXI for the experimental drugs, while apixaban is an active comparator. The study is conducted with a parallel design in multiple centers, focusing on safety and prevention over a 12-week period primarily. During the study, participants will have regular monitoring to assess bleeding events, side effects, blood levels of the study drugs, and antibody responses over approximately 25 weeks. Researchers will measure various bleeding outcomes, stroke or embolism incidence, and changes in blood clotting times. Safety and treatment effects will be tracked closely throughout the trial period, which continues until study completion in 2027.