Wyomissing

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 whether retatrutide and tirzepatide can prevent major adverse liver outcomes in adults with metabolic dysfunction-associated steatotic liver disease MASLD who are at high risk based on non-invasive tests. This Phase 3 randomized controlled trial aims to assess these treatments compared to placebo in about 4,500 adults over approximately 224 weeks. The study is sponsored by Eli Lilly and Company and focuses on liver disease progression and related health measures. Participants will be randomly assigned to receive retatrutide, tirzepatide, or placebo, all administered by subcutaneous injection. The trial includes two placebo groups corresponding to each experimental drug. After completing the main study, eligible participants may join a 2-year extension where all will receive either retatrutide or tirzepatide regardless of their initial assignment. During the study, participants may attend around 25 to 30 clinic visits for health monitoring, study procedures, and assessments of liver function and disease status. Researchers will measure the time to major adverse liver outcomes, changes in liver fibrosis scores, liver stiffness, liver fat content, liver enzyme levels, body weight, and cardiovascular events. Monitoring will continue from baseline through study completion, with detailed evaluations at multiple timepoints including week 104.

Researchers are conducting a master protocol study to evaluate multiple pain treatments for people experiencing chronic pain conditions such as osteoarthritis of the knee, diabetic neuropathic pain, and chronic low back pain. This study aims to compare different pain interventions by using a flexible design where specific intervention appendices ISAs can begin independently as new treatments become available. The study is sponsored by Eli Lilly and Company and is designed as a phase 2 randomized, placebo-controlled trial. Participants may receive one of several study drugs administered either intravenously or orally, including LY3016859 given through IV and LY3556050, LY3526318, and LY3857210 given orally. Each treatment group is compared to a matching placebo group. The study uses a parallel design where participants are assigned randomly to one of the intervention groups or placebo. The protocol includes disease-state addenda to define target populations and assessment scales for each pain condition. During the trial, participants undergo screening to confirm eligibility based on pain levels, history, and health status. They are monitored for outcomes such as the number of participants allocated to each intervention up to week 8. Researchers assess pain and other health measures while participants maintain consistent use of any ongoing non-drug pain therapies and discontinue other chronic pain medications except for rescue use. The study includes safety monitoring and will continue through April 2027, with results posted for each intervention.

Researchers are evaluating the efficacy and safety of HBS-301 in adults aged 18 years and older who have idiopathic hypersomnia IH, a condition marked by excessive daytime sleepiness EDS. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to better understand how HBS-301 affects symptoms of IH including sleep inertia, fatigue, and cognitive complaints. Participants will be assigned to receive either HBS-301 tablets or matching placebo tablets once daily in the morning upon waking during an 8-week double-blind treatment period. Following this, there is an optional one-year open-label extension where all participants may receive HBS-301. The study begins with a screeningbaseline period lasting up to 28 days and concludes with 30 days of safety follow-up after treatment. During the trial, participants will undergo various assessments including the Epworth Sleepiness Scale to measure daytime sleepiness, the Idiopathic Hypersomnia Severity Scale, Sleep Inertia Questionnaire, and other patient-reported outcome measures. Researchers will monitor changes in fatigue, cognitive function, quality of life, work productivity, and side effects throughout the study and extension period. Total participation may last up to about 16 months including safety follow-up.

Researchers are conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of HBS-301 in adults aged 18 years and older with narcolepsy. The study focuses on treating excessive daytime sleepiness EDS, cataplexy, sleepinesswakefulness, and fatigue in participants diagnosed with narcolepsy. Approximately 258 participants will be included in this trial. Participants will be randomly assigned to receive either HBS-301 tablets or matching placebo tablets once daily in the morning upon waking. The study includes a ScreeningBaseline period lasting up to 28 days, followed by an 8-week Double-blind Treatment period. After this, participants may choose to enter a 1-year Open-label Extension period where they will receive HBS-301. Finally, a 30-day safety follow-up will monitor participants after treatment ends. Throughout the study, participants will undergo various assessments including evaluations of daytime sleepiness using the Epworth Sleepiness Scale, cataplexy frequency, wakefulness through the Maintenance of Wakefulness Test, fatigue levels, cognitive complaints, quality of life, and work productivity. Safety will be monitored by tracking adverse events and pharmacokinetic measurements. The total study participation may last up to approximately 16 months including all phases.

Psoriatic arthritis PsA is a chronic inflammatory condition that affects the joints and skin in people with psoriasis. This study aims to evaluate how well zasocitinib TAK-279 works in adults with active PsA who have not previously been treated with biologic disease-modifying antirheumatic drugs. The trial is a Phase 3, randomized, double-blind study comparing zasocitinib with an active comparator and placebo. Participants will be assigned to one of four groups zasocitinib Dose A once daily, zasocitinib Dose B once daily, an active comparator capsule twice daily, or placebo once daily for 16 weeks followed by switching to zasocitinib Dose A or B up to 52 weeks. Treatments are taken orally as tablets or capsules over a period of up to 60 weeks. During the study, participants will undergo regular assessments including joint counts, skin evaluations, and various disease activity measurements such as ACR20 and PASI-75 responses. Researchers will monitor changes from baseline in functional and quality of life scores, as well as safety and tolerability. Participants will be involved in visits throughout the treatment period to evaluate the effects and collect data on the disease and treatment responses.

Researchers are evaluating the safety and effectiveness of different doses of ELV001 in adults with active rheumatoid arthritis who have not responded adequately to methotrexate and tumor necrosis factor inhibitors. This Phase 2 randomized, double-blind, placebo-controlled study plans to enroll about 180 to 220 participants and lasts 32 weeks from screening to the end of the study. The study aims to understand how ELV001 affects disease activity scores and other health measures in this patient group. Participants are divided into four groups receiving either placebo or ELV001 at doses of 25 mg, 75 mg, or 125 mg. The study includes a 4-week screening period, followed by a 12-week placebo-controlled treatment phase. After week 12, all participants receive ELV001 at 75 mg or 125 mg doses during a treatment extension lasting until week 24. This is followed by a 4-week safety follow-up period to monitor participants. Throughout the study, participants will have regular assessments including disease activity scoring, joint counts, health questionnaires, blood tests, ECGs, and vital sign monitoring up to week 28. The main measurement is the change in disease activity score from baseline to week 12. Safety outcomes such as adverse events and laboratory results will be tracked up to 32 weeks. Participants will be closely monitored for response and side effects during the entire 32-week study duration.

This research aims to evaluate the effects of ALKS 2680 tablets on adults with Narcolepsy Type 1 NT1. The study focuses on measuring reductions in daytime sleepiness, cataplexy sudden loss of muscle tone, and overall disease symptoms. Participants diagnosed with NT1 according to official guidelines are included to assess the impact of the treatment compared to placebo. Participants will be randomly assigned to one of three groups two different doses of ALKS 2680 or a placebo. Each participant will take oral tablets daily for 12 weeks. The study is designed as a phase 3, randomized, double-blind, placebo-controlled trial to thoroughly evaluate the drugs efficacy and safety during this period. During the study, participants will undergo assessments including the Maintenance of Wakefulness Test to measure sleep latency, along with various scales and inventories to evaluate sleepiness, cataplexy rates, cognitive complaints, fatigue, and narcolepsy severity. Safety will be monitored through reports of adverse events over approximately 14 weeks. The total participation time spans the 12-week treatment period and follow-up for safety monitoring.

Researchers are evaluating the effects of ALKS 2680 tablets on adults with Narcolepsy Type 2 NT2. This Phase 3 study aims to measure changes in daytime sleepiness and overall disease symptoms by comparing ALKS 2680 with placebo tablets. The trial focuses on assessing how the treatment impacts participants ability to stay awake and their symptom severity over time. Participants will be randomly assigned to one of four groups three different doses of ALKS 2680 tablets or placebo tablets. All tablets are taken daily by mouth for 12 weeks. The study uses a triple-blind design to fairly compare the effects of ALKS 2680 against placebo. The treatment period lasts for 12 weeks, during which participants take their assigned tablets regularly. During the study, participants undergo various assessments including the Maintenance of Wakefulness Test to measure sleep latency, the Epworth Sleepiness Scale, and other cognitive and fatigue-related questionnaires. Researchers monitor changes from baseline to Week 12 to evaluate treatment effects. Safety is also tracked through reports of any adverse events. Overall, participants are involved for about 12 weeks of treatment and follow-up assessments.

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.