Alken

Researchers are evaluating the long-term safety, tolerability, and lasting effects of ALKS 2680 tablets in adults with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia. This study is an open-label extension designed to continue monitoring participants who completed earlier ALKS 2680 parent studies, focusing on treatment durability and adverse events over an extended period. Participants receive ALKS 2680 oral tablets in doses ranging from 4 mg to 18 mg once daily. The study includes groups with Narcolepsy Type 1, Narcolepsy Type 2, and Idiopathic Hypersomnia. Treatment effects and safety are observed for up to 100 weeks, with dosing adjusted as needed. The study follows a non-randomized, open-label design without blinding. During the study, participants undergo regular assessments including monitoring of treatment-emergent adverse events, measurement of sleep latency using the Maintenance of Wakefulness Test, and evaluation of daytime sleepiness via the Epworth Sleepiness Scale. The total participation duration extends up to approximately 100 weeks, with safety, tolerability, and treatment effects closely tracked throughout this period.

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 immune response and safety of GlaxoSmithKlines investigational chickenpox vaccine and a marketed measles, mumps, and rubella MMR vaccine when given to healthy children aged 12 to 15 months. The study compares these vaccines administered by muscle injection to Mercks chickenpox vaccine given just under the skin. It also assesses the immune response and safety when the GSK vaccines are given together with other routine childhood vaccines. Participants are randomly assigned to receive either the candidate varicella vaccine intramuscularly along with MMR, hepatitis A virus HAV vaccine, and a pneumococcal conjugate vaccine PCV, or the marketed varicella vaccine subcutaneously with the same additional vaccines. The PCV given may be PCV 13, Vaxneuvance, or PCV 20 depending on availability and national recommendations. All vaccines are given on Day 1. Throughout the study, children are monitored for immune responses by measuring antibody levels against varicella zoster virus and MMR antigens at Day 43. Safety is evaluated by tracking any local and systemic reactions in the days following vaccination, as well as any adverse events up to six months after the dose. The study aims to understand both the immune response and safety profile over this period in healthy young children receiving these vaccines.

Researchers are evaluating the safety and effectiveness of KarXT in adults aged 55 to 90 with mild to severe Alzheimers Disease who experience moderate to severe psychosis related to this condition. This Phase 3 trial aims to study KarXT compared to a placebo to better understand its impact on psychotic symptoms associated with Alzheimers. Participants will be randomly assigned to receive either KarXT or a placebo at specified doses on certain days. The study lasts up to 14 weeks, during which changes in psychosis symptoms, as measured by the Neuropsychiatric Inventory-Clinician Hallucinations and Delusions score, will be closely monitored. Additional assessments include cognitive tests and monitoring for side effects. During the trial, participants will undergo regular evaluations including symptom ratings, cognitive tests such as the Mini-Mental State Examination, laboratory tests, and safety monitoring. Researchers will track any adverse events and changes in mental and physical health. The study aims to provide detailed information about how KarXT affects psychosis and cognition in Alzheimers disease over the treatment period.

Researchers are evaluating the optimal doses of the drug E2086 compared to placebo in adults with narcolepsy, a condition characterized by excessive daytime sleepiness EDS. The study focuses on reducing EDS as measured by the Mean Sleep Latency MSL using the first four maintenance of wakefulness tests MWTs. This Phase 2 trial includes participants diagnosed with either narcolepsy type 1 NT1 or type 2 NT2 within the last 10 years. Participants will be randomly assigned to receive either E2086 or a matching placebo tablet taken orally once daily for four weeks at low, middle, and high doses. Each dosing period is separated by a washout period of at least seven days, with a total treatment duration of approximately 14 weeks. This design allows comparison of the effects of different doses of E2086 on narcolepsy symptoms. During the study, participants will undergo assessments to measure changes in sleep latency, cataplexy episodes, and sleepiness scales. Additional safety evaluations include monitoring for adverse events, laboratory tests, vital signs, ECG parameters, and suicidality assessments. Blood samples will be collected to analyze drug concentration levels. The study involves regular monitoring up to Day 113 and aims to assess both efficacy and safety over the course of treatment and follow-up.

Researchers are studying the safety and impact on daytime sleepiness of ALKS 2680 in adults with Idiopathic Hypersomnia, a condition characterized by excessive sleepiness. This Phase 2 trial aims to compare different doses of ALKS 2680 with a placebo to better understand its effects on this condition. Participants receive daily oral tablets of ALKS 2680 at doses of 10 mg, 14 mg, or 18 mg, or a placebo tablet. The study uses a randomized, double-blind, parallel-group design to evaluate different dose levels over a period of up to 8 weeks. The main focus is on measuring changes in sleepiness and symptom severity. During the study, participants will be monitored for changes in their Epworth Sleepiness Scale scores and Idiopathic Hypersomnia Severity Scale scores from the start to Week 8. Researchers will also track any treatment-emergent adverse events for up to 10 weeks. Participants are expected to follow lifestyle guidelines, use actigraphy and diaries, and adhere to therapy for obstructive sleep apnea if applicable throughout the study period.

Researchers are evaluating ibuzatrelvir, an oral medication, to determine its effectiveness and safety in adults and adolescents aged 12 years and older with COVID-19 who are not hospitalized but are at high risk for severe illness. The study is a phase 3, randomized, double-blind trial comparing ibuzatrelvir with a placebo. Participants must have confirmed SARS-CoV-2 infection with symptoms starting within 5 days and meet specific risk factor criteria based on age. Eligible participants will be randomly assigned to receive either ibuzatrelvir or a matching placebo twice daily by mouth for 5 days. The study allows co-administration of standard care treatments available locally. The total study duration is about 6 months, including follow-up. Participants will be monitored for emergency department visits related to COVID-19, hospitalizations, and mortality up to 28 days after starting treatment. Additional evaluations include symptom resolution, occurrence of long COVID symptoms, viral RNA levels, and safety measures such as adverse events through 24 weeks. The study involves regular assessments, including clinical visits and laboratory tests, to track outcomes and safety over time.

Researchers are evaluating the effect of muvalaplin in lowering cardiovascular risks among adults with elevated lipoproteina who either have atherosclerotic cardiovascular disease or are at risk of a first heart attack or stroke. This phase 3, randomized, double-blind study aims to investigate whether muvalaplin can reduce major adverse cardiovascular events compared to placebo in this high-risk population. Participants are randomly assigned to receive either muvalaplin or a placebo, both given orally. The study is designed with parallel groups and will last about 5.25 years, during which the occurrence of cardiovascular events and changes in lipoproteina levels will be closely monitored. Throughout the study, participants will undergo regular assessments including measurement of lipoproteina levels, monitoring of cardiovascular events such as heart attacks or strokes, and evaluation of healthcare resource use. The primary outcome is the time to first major adverse cardiac event, tracked from baseline until the study ends. Safety and pharmacokinetics of muvalaplin will also be evaluated during the trial period.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Researchers are evaluating the long-term safety and tolerability of NBI-1065845 as an additional treatment for adults with Major Depressive Disorder MDD. This Phase 3, open-label study focuses on participants who have a primary diagnosis of recurrent moderate or severe MDD or persistent depressive disorder and have had an inadequate response to oral antidepressant treatments in their current depressive episode. Participants will receive NBI-1065845 tablets taken orally once daily as an adjunctive therapy alongside their ongoing antidepressant treatments. The study is designed as a single-group, open-label trial without placebo or comparison groups. The treatment period and follow-up extend over 52 weeks, during which safety and tolerability will be closely monitored. Throughout the study, participants will be assessed for treatment-emergent adverse events TEAEs from baseline through Week 52. Participants must be willing and able to comply with all study procedures and restrictions, including regular visits and evaluations determined by the investigators. The overall study duration allows for comprehensive monitoring of safety outcomes and participant well-being.