West Jordan

Researchers are evaluating the safety and tolerability of Efimosfermin Alfa in adults aged 18 to 75 years who have known or suspected metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis at stage F2 or F3. This Phase 3, randomized, double-blind, placebo-controlled study focuses on participants with non-alcoholic fatty liver disease and metabolic syndrome components, aiming to better understand treatment effects in this population. Participants will receive either Efimosfermin Alfa injection or a placebo, with the study designed as a three-arm trial. The treatment will be administered according to the study protocol, though specific dosing details are not provided. The study will monitor participants over a period extending to at least 52 weeks, comparing the safety and tolerability of Efimosfermin Alfa against placebo. During the study, participants will be closely observed through clinical assessments including monitoring for treatment-emergent adverse events (TEAEs), laboratory tests to detect Grade 3 and Grade 4 abnormalities, and evaluation of any adverse events leading to discontinuation of treatment. These safety and tolerability measures will be recorded at Week 52, helping researchers assess the impact of Efimosfermin Alfa over time.

Researchers are evaluating intravitreal EYE103 in participants with neovascular age-related macular degeneration (NVAMD) or macular edema following branch retinal vein occlusion (BRVO). This Phase 2, randomized, dose-masked study includes four patient cohorts: treatment-naive NVAMD participants, incomplete responder (IR) NVAMD participants as monotherapy, IR NVAMD participants receiving EYE103 combined with aflibercept 2.0 mg, and treatment-naive BRVO participants. The study aims to assess safety and efficacy of different doses of EYE103 in these conditions. Participants in each cohort will be randomly assigned to receive either a low or high dose of EYE103 via intravitreal injection. All participants will receive three injections spaced four weeks apart. IR NVAMD participants in the combination therapy cohort will also receive an injection of aflibercept 2.0 mg on Day 1. The timing of enrollment into each cohort is determined by the Sponsor. Participants will undergo safety and efficacy assessments at each injection visit, with some cohorts returning two weeks after injections for further evaluations. Assessments include measuring best-corrected visual acuity using the ETDRS chart, slit-lamp biomicroscopy, fundoscopy, and spectral domain optical coherence tomography (SD-OCT) to measure central subfield thickness. The study concludes at Week 12, which is the end-of-study visit for all participants.

The trial investigates the use of volrustomig in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not shown disease progression after receiving definitive concurrent chemoradiotherapy (cCRT). The study aims to evaluate the efficacy and safety of volrustomig compared to observation in this patient population. Participants have tumors that express PD-L1 and the study is conducted as a Phase III, randomized, open-label, multi-center global trial. Participants are assigned to receive either volrustomig as sequential therapy following cCRT or to an observation group. The treatment period involves monitoring participants who have completed definitive cCRT but remain unresected and have no evidence of metastatic disease. The study focuses on participants with Stage III, IVA, or IVB LA-HNSCC according to AJCC criteria, who have not undergone tumor resection before cCRT and have not been treated with radiotherapy alone. During the study, participants are regularly evaluated for progression-free survival, with follow-up lasting up to approximately 8 years to assess long-term outcomes. Researchers will monitor safety and disease progression closely. The overall participation duration includes screening, treatment or observation, and extended follow-up to capture both efficacy and safety data over time.

This research aims to evaluate the safety and effectiveness of efimosfermin alfa in improving liver fibrosis and resolving steatohepatitis in adults with metabolic dysfunction-associated steatohepatitis (MASH) confirmed by biopsy showing stage F2 or F3 fibrosis. The study compares efimosfermin alfa to a placebo and focuses on individuals with confirmed liver damage and metabolic syndrome features. Participants will receive either efimosfermin alfa or placebo, administered as a drug treatment. The study is designed as a phase 3, randomized, double-blind, placebo-controlled trial with three groups. Treatment effects will be assessed over 52 weeks, with a primary focus on liver fibrosis and steatohepatitis changes. The study includes long-term monitoring of liver-related clinical outcomes up to 48 months after randomization. During the study, participants will undergo liver biopsies confirmed by central pathology review, and researchers will monitor liver function and fibrosis improvement. Outcome measures include the proportion of participants showing fibrosis improvement without worsening steatohepatitis, resolution of steatohepatitis with stable fibrosis, and time to liver-related clinical events. Safety and efficacy will be closely evaluated throughout the treatment and follow-up periods.

This research focuses on pediatric participants aged 6 to 17 years with obesity or overweight conditions. Its aim is to establish a framework to evaluate the safety and effectiveness of drug treatments for managing chronic weight issues in this population. The study is part of a Phase 3 Master Protocol that includes multiple interventions and will report results when all intervention-specific arms finish. Participants may receive either Orforglipron, a drug given orally, or a placebo, also taken by mouth. Different intervention-specific arms may begin independently as new treatments become available for testing. The study sets clear entry criteria for newly enrolled participants across these intervention arms. During the study, researchers will monitor participants from baseline up to 72 weeks, focusing on the number of participants allocated to each intervention arm. They will also track safety and treatment effectiveness. Participation involves regular assessments of weight, health status, and any side effects, ensuring a thorough evaluation of the chronic weight management interventions over time.

Researchers are evaluating the safety and immune response of a chikungunya virus virus-like particle (CHIKV VLP) vaccine in children aged 1 to under 12 years. This phase 3, global, randomized, double-blind, placebo-controlled study aims to compare the vaccine with a placebo to understand its effects in this young population. The study focuses on measuring the vaccine's ability to produce antibodies and monitoring safety events over an extended follow-up period. Participants will receive either the CHIKV VLP vaccine, which contains virus-like particles adsorbed on aluminum hydroxide adjuvant, or a placebo consisting of formulation buffer. The vaccination occurs on Day 1, followed by monitoring for adverse events up to Day 29 and immune response assessment on Day 22. The study is planned to continue safety monitoring through Day 732 for those who complete the trial. During the study, children will undergo medical history reviews, physical examinations, and regular safety assessments including recording of any adverse events. Researchers will collect blood samples to measure antibody responses on Day 22 and monitor for any serious or medically significant events throughout the trial. Participants are expected to attend all scheduled visits and comply with study procedures over the course of the study period.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are studying the effects of two experimental drugs, pozelimab and cemdisiran, in adults aged 50 to 85 who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD), a condition that affects central vision. The study aims to compare how quickly GA progresses in patients treated with cemdisiran alone, a combination of pozelimab and cemdisiran, or a placebo. Additional goals include monitoring possible side effects, measuring drug levels in the blood, and checking for antibodies that might reduce drug effectiveness or cause side effects. Participants receive subcutaneous injections of either pozelimab combined with cemdisiran, cemdisiran alone, or a placebo. The study is randomized, double-masked, and placebo-controlled, conducted at multiple centers. Treatment schedules and dosing are managed as described in the protocol, with vaccinations for meningococcal and pneumococcal infections required prior to participation. Throughout the study, participants undergo regular clinic visits where eye imaging using Fundus Autofluorescence (FAF) tracks the progression of GA lesion area over 52 weeks. Researchers also monitor safety, side effects, and immune responses, ensuring adherence to study procedures. The main outcome measured is the growth rate of the GA lesion area over one year, helping to evaluate the potential benefits and risks of the study drugs.

Researchers are evaluating the effectiveness and safety of pegozafermin in adults aged 18 to 75 years who have compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis (MASH), previously known as nonalcoholic steatohepatitis (NASH). Participants in this phase 3 study must have biopsy-confirmed advanced liver fibrosis (stage F4) due to MASH and meet specific metabolic health criteria. The study aims to understand how well pegozafermin can help improve liver fibrosis and delay disease progression over time. Participants will receive either pegozafermin or a placebo through subcutaneous injections. The study will monitor participants over a long period, up to five years, to observe changes in liver fibrosis and any clinical events related to disease progression. The treatment is given to those with compensated cirrhosis, meaning their liver is damaged but still functioning, and the study carefully evaluates the safety and potential benefits of pegozafermin in this group. Throughout the study, participants will undergo regular assessments to track liver health, including fibrosis regression and timing of disease progression. Researchers will use clinical events and laboratory tests to measure outcomes from the start of the study through 24 months and up to five years. Safety and health will be monitored closely, ensuring any side effects or complications are identified promptly. This comprehensive follow-up helps provide detailed information on the long-term effects of the treatment and participants' liver condition.

Researchers are evaluating the use of baloxavir marboxil in children under 12 years old with influenza. This study has two parts: Part A focuses on checking for resistance-related changes in the virus before and after treatment, while Part B looks at how influenza might spread from young children treated with baloxavir marboxil to their household contacts. Enrollment for Part B has stopped as per the latest protocol. Baloxavir marboxil is given as an oral suspension, with the dose based on the child's body weight: 80 mg for those 80 kg or more, 40 mg for 20 to less than 80 kg, and 2 mg per kg for those under 20 kg. Part A involves monitoring these children for resistance changes at baseline and during treatment on specific days. Part B included participants from Part A who lived with household contacts, assessing transmission, but no new participants are being enrolled in this part. Participants will be involved in screening to confirm influenza and absence of COVID-19, with symptom onset within 48 hours before starting treatment. Researchers will measure resistance-associated viral changes at baseline and during treatment days 4, 6, and 10. Household contacts in Part B were also assessed for influenza transmission risk and monitored through scheduled visits, but Part B enrollment is closed. The total study duration varies depending on participation in Parts A and B.