Norcross

Researchers are evaluating changes in bone mineral density in premenopausal women with heavy menstrual bleeding caused by uterine fibroids or moderate-to-severe pain from endometriosis. This Phase 3B, open-label study looks at the effects of continuous treatment with a relugolix combination tablet for up to 48 months 4 years, followed by a 1-year period to monitor bone health after stopping treatment. Participants will take a daily oral relugolix combination tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg for 4 years. Bone mineral density will be measured every 6 months using dual-energy X-ray absorptiometry DXA. Some women who have completed a previous related study may join to complete 3 years of treatment. After treatment ends, bone density will be checked again at 6 months and 12 months during the follow-up year. Women in the study will have regular visits for bone density scans and health assessments, including physical and gynecological exams, lab tests, and vital signs. Researchers will track changes in bone density at the spine, hip, and femoral neck throughout treatment and follow-up. They will also monitor for any fractures or adverse events during the 4 years of treatment and the 1-year post-treatment period. Total participation can last up to 5 years including the follow-up.

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 a new care strategy for people at increased risk of atherosclerotic cardiovascular disease ASCVD but without symptoms. The study compares a Cleerly Coronary Artery Disease CAD Staging System-based care approach against the usual risk factor-based care to see if it better reduces cardiovascular events. This pragmatic, randomized trial addresses the need for improved methods to identify and personalize treatment for asymptomatic individuals at risk due to age, diabetes, prediabetes, or metabolic syndrome. Participants are randomly assigned to one of two groups. The risk factor-based care group receives usual care managed by their providers, while a cardiology team monitors and supports guideline-based treatment without revealing certain imaging results during the study. The Cleerly stage-based care group gets personalized management from a remote cardiologist-led team using the Cleerly CAD Staging System, which includes imaging to assess coronary atherosclerosis and guides pharmacotherapy and education. Treatment intensity may increase if plaque worsens after 24 months. During the study, participants will have assessments to monitor heart health and treatment adherence over an average of 3.5 years. Researchers will measure cardiovascular events and other related health outcomes to compare the two care strategies. The study involves ongoing medication monitoring, lab tests, and feedback to optimize prevention, with the goal of improving personalized care for cardiovascular risk management.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating RTN-001, a drug, to see if it can reduce high blood pressure in adults with uncontrolled hypertension who are already taking multiple blood pressure medications. This Phase 2b, randomized, double-blind study involves adults aged 18 to 70 years with blood pressure above specified thresholds despite treatment with at least two antihypertensive drugs. The study compares RTN-001 to a placebo to understand its effect on blood pressure and monitor safety. Participants will undergo a screening period up to 14 days to confirm eligibility, followed by a 14-day single-blind run-in period to test compliance and baseline blood pressure measurement. Then, around 280 patients will be randomly assigned to one of four groups to receive daily oral doses of RTN-001 at 15 mg, 30 mg, 45 mg, or placebo for 12 weeks. Blood pressure and laboratory tests will be performed at multiple visits, and ambulatory blood pressure monitoring will occur twice during treatment. After treatment ends, a follow-up phone call will assess any side effects or medication changes. During the study, participants will visit the clinic approximately every two weeks for blood pressure checks, blood sampling, and other assessments. They will keep a diary of symptoms and medications taken. Researchers will measure changes in systolic and diastolic blood pressure using office and ambulatory methods, evaluate drug levels and safety markers, and monitor adverse effects. The total participation includes screening, run-in, treatment, and a follow-up phone call about two weeks after treatment ends.

Major depressive disorder MDD is a mood disorder causing ongoing sadness and loss of interest, with emotional and physical symptoms such as irritability, difficulty focusing, tiredness, and changes in eating habits. Researchers are studying oral Icalcaprant, an investigational drug, to assess its effects on disease activity and side effects in adults currently experiencing a major depressive episode. Participants are randomly assigned to one of three groups two different doses of Icalcaprant or a placebo. They will take oral capsules once daily for 6 weeks, followed by a 30-day safety follow-up period. The study is conducted at about 35 sites across North America and involves approximately 195 adults. During the study, participants will attend regular visits at a hospital or clinic where medical assessments, blood tests, side effect checks, and questionnaires will be completed. Researchers will measure changes in depression severity using scales like the Montgomery-sberg Depression Rating Scale MADRS over about 6 weeks, and adverse events will be monitored for up to 10 weeks total.

Researchers are evaluating the safety and tolerability of single and multiple intravenous doses of GIGA-2339 in adults with chronic Hepatitis B Virus HBV infection. This Phase 1 randomized, double-blind, placebo-controlled study aims to understand how the drug behaves in the body and monitor any treatment-related side effects in participants who have been living with HBV for at least six months. Participants will receive either a single intravenous infusion of GIGA-2339 or a placebo in increasing doses on the first day. Following this, participants will receive multiple intravenous infusions of the drug or placebo once every four weeks at the dose determined during the single-dose phase. The study includes two parts Part 1 for single ascending doses and Part 2 for multiple ascending doses, both designed to assess safety, tolerability, and how the drug is processed in the body over time. During the study, participants will undergo regular evaluations including blood tests to measure drug concentration and monitor liver function, safety assessments for any adverse events, and other laboratory tests over periods up to 105 days for single doses and up to 245 days for multiple doses. Researchers will track treatment-emergent adverse events, serious adverse events, and detailed pharmacokinetic data to understand the drugs behavior. Participation may last several months, with visits scheduled according to dosing and monitoring needs.

Researchers are studying the effects of a drug called TNX-102 SL on adults with moderate to severe major depressive disorder MDD. This clinical trial aims to find out if TNX-102 SL improves depression symptoms compared to a placebo and to assess its safety. The study focuses on changes in depression symptoms measured by a rating scale over six weeks. Participants will take either 5.6 mg of TNX-102 SL two 2.8 mg tablets or placebo tablets every night at bedtime for six weeks. The study is randomized and double-blind, meaning neither participants nor researchers know who receives the drug or placebo. Checkups and tests will take place at the clinic every two weeks during the treatment period. During the trial, participants will have depression symptom assessments and other evaluations to monitor safety and treatment effects. The main measurement is the change in depression rating scores from the start to week six. Participants will be closely followed throughout the six-week treatment, with regular visits every two weeks for monitoring and questionnaires.

Researchers are evaluating the safety and immune response of a new multivalent pneumococcal vaccine called PG4 compared to the currently used 20-valent pneumococcal conjugate vaccine 20vPnC in healthy infants. The study aims to understand how well the new vaccine helps fight germs causing pneumonia, meningitis, and ear infections. This phase 3 trial involves infants aged 2 to 6 months and seeks to determine if the new vaccine is as safe as the existing one while assessing its immune response when given alongside other childhood vaccines. Participants are divided into three groups based on age and location. Group 1 includes about 3000 infants aged 2 months who receive either PG4 or 20vPnC by injection into the left thigh muscle at ages 2, 4, 6, and 12 to 15 months. Groups 2 and 3, with about 230 infants outside the United States aged 2 to 6 months, receive vaccinations on a slightly different schedule, with Group 3 exploring both intramuscular and subcutaneous administration of PG4. Participants have a randomized chance of receiving one of the study vaccines. During the study, infants will attend six clinic visits and one phone call where parents report any side effects. Blood samples will be collected three times to assess the immune response by measuring proteins that fight the germs. Researchers will track local and systemic reactions, adverse events, and serious adverse events throughout the study period, which lasts about 1 to 1.5 years depending on the group. The study monitors safety closely to compare the new vaccines effects with the current standard vaccine.

Researchers are evaluating the effectiveness and safety of the drug SEP-363856 in adults experiencing acute psychotic episodes related to schizophrenia. This Phase 3 clinical trial uses a randomized, double-blind, placebo-controlled design to compare SEP-363856 against placebo in a parallel-group multicenter setting. The study focuses on participants aged 18 to 65 who are experiencing a recent worsening of schizophrenia symptoms. Participants are assigned to one of three groups receiving either a placebo, 75 mgday of SEP-363856, or 100 mgday of SEP-363856 tablets. The study treatment is given daily, and the trial lasts for six weeks. During this time, efficacy and safety data are collected to assess the impact of SEP-363856 on schizophrenia symptoms. Throughout the study, participants undergo regular assessments including the Positive and Negative Syndrome Scale PANSS and the Clinical Global Impression-Severity CGI-S scale to measure symptom changes from baseline to week 6. Safety is monitored as part of the trial. Participants are followed until the end of the six-week treatment period, with all study visits and procedures conducted during this timeframe.