Lampasas

Researchers are evaluating the effect of muvalaplin on reducing cardiovascular risk in adults with elevated lipoprotein(a) levels who either have atherosclerotic cardiovascular disease or are at risk for a heart attack or stroke. This Phase 3, randomized, double-blind, placebo-controlled study focuses on adults with high Lp(a) levels and prior or potential cardiovascular events. The study aims to assess the time to the first major adverse cardiovascular event over about 5.25 years. Participants will be randomly assigned to receive either muvalaplin or a placebo, both administered orally. The study includes individuals with Lp(a) levels of at least 175 nanomoles per liter who have had a prior cardiovascular event within 10 years or are at risk for a first event due to conditions such as coronary artery disease, carotid stenosis, peripheral artery disease, high coronary artery calcium score, reduced kidney function with diabetes, or other high-risk factors. The treatment period lasts through the study duration, with close monitoring. During the study, participants will be regularly evaluated to track the occurrence of major adverse cardiovascular events, including heart attacks and strokes. Safety assessments will monitor blood pressure, kidney function, and heart failure status among other health indicators. The primary outcome measures the time to the first major cardiovascular event from baseline up to the end of the study, which spans approximately 5.25 years.

Researchers are evaluating depemokimab as a treatment for adults aged 40 to 80 years with moderate to severe chronic obstructive pulmonary disease (COPD) who have type 2 inflammation and frequent exacerbations. This Phase 3 study aims to assess the safety and effectiveness of depemokimab when added to optimized inhaler therapy compared to placebo in participants whose COPD is uncontrolled despite current treatment. Participants must have an elevated blood eosinophil count and a history of COPD symptoms and exacerbations. Participants will receive depemokimab, a sterile liquid drug, or a placebo consisting of a sterile 0.9% sodium chloride solution. The treatments are administered as an add-on to their usual inhaler therapies, which include inhaled corticosteroids, long-acting muscarinic antagonists, and long-acting beta2-adrenergic agonists. The study is randomized, double-blind, placebo-controlled, and takes place across multiple centers. Treatment duration and detailed dosing schedules are not specified but participants are monitored up to 104 weeks. Throughout the study, participants will be monitored for the annual rate of moderate to severe COPD exacerbations. Researchers will also assess safety and other clinical outcomes related to lung function and COPD symptoms. Participants will have regular visits for evaluation of their disease status, treatment adherence, and any side effects. The total duration of participation includes baseline screening and follow-up visits over the study period to ensure comprehensive data collection for efficacy and safety analysis.

Researchers are evaluating the effectiveness, safety, and tolerability of subcutaneous lunsekimig compared to a placebo in adults aged 40 to 80 years with inadequately controlled chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype. This Phase 2b/Phase 3, parallel, 3-arm study focuses on participants who have a history of COPD with an eosinophilic profile and have not achieved control with current treatments. Eligible participants will receive either lunsekimig or a matching placebo through subcutaneous injections over a randomized treatment period of approximately 48 weeks. The study involves three periods: an initial screening period lasting up to 4 weeks, followed by the 48-week treatment period, and finally an 8-week follow-up period. The total study duration may last up to 60 weeks. During the study, participants will be regularly assessed for the annualized rate of moderate-to-severe COPD exacerbations from baseline up to 48 weeks. Researchers will monitor safety, tolerability, and treatment effects through various evaluations throughout the treatment and follow-up periods. Participant involvement includes completing assessments and receiving scheduled injections as part of the study protocol.

Menstrual migraine is a type of moderate to severe headache occurring around the time of menstruation, often accompanied by symptoms like nausea, vomiting, and sensitivity to light and sound. This trial evaluates the safety and effectiveness of ubrogepant, a drug being studied as a short-term preventive treatment for menstrual migraine. Adult women who experience migraine attacks in at least two out of three menstrual cycles are invited to participate in this Phase 3 study. Participants will be randomly assigned to receive either oral ubrogepant tablets or a placebo once daily for 7 consecutive days, starting 3 days before the expected start of their period, across three menstrual cycles during a 16-week double-blind treatment phase. Those who qualify may continue taking ubrogepant daily for 7 days per cycle during a 52-week open-label extension. The study involves about 496 women at around 100 sites across the United States and Puerto Rico. Throughout the study, participants will record daily information in electronic diaries and attend regular clinic visits. Researchers will monitor treatment effects through medical assessments, blood tests, questionnaires, and side effect checks. The main outcomes measured include changes in the number of migraine days during perimenstrual periods over 16 weeks and the number of participants experiencing adverse events up to approximately 68 weeks.

Migraine is a common neurological disorder causing moderate to severe headaches, often with nausea, vomiting, and sensitivity to light and sound. It is especially disabling in children and adolescents. This trial evaluates the safety and effectiveness of ubrogepant, a drug approved for adults, for the acute treatment of migraine in children and adolescents aged 6 to 17 years. The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial. Participants aged 6 to 11 years in a pharmacokinetic (PK) cohort will receive one of two doses of ubrogepant to determine the best dose for the main study. In the main study, children and adolescents will be randomized to receive either a low or high dose of ubrogepant or a placebo, with a one in three chance of receiving placebo. The study treatment is given as oral tablets during qualifying migraine attacks, with an option for a second dose or rescue medication at least 2 hours after the initial dose if the headache remains moderate or severe. Approximately 1059 participants will be enrolled across about 120 sites in the United States. Participants will attend regular hospital or clinic visits throughout the study, which lasts up to 6 months. Researchers will monitor the effects of the treatment through medical assessments, blood tests, side effect checks, and questionnaires. The primary outcome is the percentage of participants aged 6 to 17 years who experience freedom from pain 2 hours after the initial dose. The study includes safety monitoring and evaluates tolerability and pharmacokinetics of ubrogepant in this age group.

Researchers are evaluating the effects of clofutriben, an 11-hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor, in patients with type 2 diabetes who have elevated cortisol levels. This Phase 2, multicenter, randomized, double-blind, placebo-controlled trial aims to understand how different doses of clofutriben may improve blood sugar control and to identify suitable doses for future studies. The trial includes two parts: an initial screening phase and a treatment phase. The screening phase lasts about 5 to 9 weeks and involves assessing eligibility, performing a dexamethasone suppression test, and further evaluations. Eligible participants are then randomly assigned to receive either placebo or one of four doses of clofutriben during the 24-week treatment phase. After completing treatment, participants receive a follow-up phone call four weeks later to check on their status. Participants will undergo various assessments during the study, including measuring morning serum cortisol and plasma dexamethasone levels after a dexamethasone dose, as well as changes in glycated hemoglobin A1c over 24 weeks. Researchers will monitor medication adherence, laboratory results, and safety throughout the study. The total participation duration includes the screening period and the 24-week treatment, followed by the post-treatment follow-up.