North Little Rock

Researchers are evaluating the safety and effectiveness of tenapanor in adults with Chronic Idiopathic Constipation CIC. This study is a 26-week, multi-center, randomized, double-blind, placebo-controlled trial followed by a 4-week treatment-free safety follow-up period. It aims to compare three different doses of tenapanor with a placebo taken twice daily to assess their impact on constipation symptoms. The study includes a 2-week screening period to confirm eligibility, followed by a 26-week randomized treatment period where patients receive either 5 mg, 25 mg, or 50 mg of tenapanor twice daily, or a matching placebo. Patients record their constipation symptoms daily in an electronic diary. After the treatment period, there is a 4-week safety follow-up without treatment to monitor any adverse effects. Participants will have regular visits every 2 to 6 weeks for safety checks including medical assessments, vital signs, ECG, and lab tests. Their symptom diaries will be reviewed throughout the study. The main outcome measured is the durable complete spontaneous bowel movements response at 12 weeks. Secondary outcomes include changes in bowel movement frequency, stool consistency, and straining. The total study duration is approximately 32 weeks including all phases.

This research aims to evaluate the long-term safety and effectiveness of liquid abrocitinib oral suspension, with or without topical medications, in children aged 2 years and older who have moderate-to-severe atopic dermatitis. The study is a Phase 3, open-label trial enrolling approximately 500 participants globally, including those who have previously completed abrocitinib studies and those new to this treatment. The study duration extends up to 2 years or until the medicine becomes commercially available, whichever comes first. Participants will receive abrocitinib oral suspension throughout the study. The trial enrolls two groups an extension cohort of children aged 2 to under 12 years who have completed prior abrocitinib studies, and a de novo cohort of children aged 6 to under 12 years who have not been in previous abrocitinib trials. Both groups may use topical medications alongside the study drug as needed. During the study, participants will be regularly assessed for safety by monitoring adverse events, laboratory abnormalities, and other health measures. Researchers will evaluate skin condition improvements using various scales such as the Validated Investigators Global Assessment vIGA, Worst Itch Numerical Rating Scale WI-NRS, and Eczema Area and Severity Index EASI. Quality of life and other patient-reported outcomes will also be tracked. The study includes follow-up to track treatment effects and safety over the full 24 months.

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 evaluating efruxifermin EFX in a phase 3, randomized, double-blind, placebo-controlled study involving adults with compensated cirrhosis caused by NASH Nonalcoholic Steatohepatitis or MASH Metabolic Dysfunction-Associated Steatohepatitis. This study aims to assess the safety and effectiveness of EFX in preventing significant clinical events such as disease progression and liver decompensation over a period of up to 5 years. Participants are randomly assigned to receive either efruxifermin 50 mg or a placebo, both given by subcutaneous injection. The study includes two cohorts one with biopsy-proven compensated cirrhosis and specific metabolic scores, and another with biopsy-proven or non-invasive diagnosis of compensated cirrhosis. The study treatment and monitoring extend up to 5 years, with evaluations at 96 weeks and long-term follow-up to track liver fibrosis, markers of liver injury, insulin sensitivity, glycemic control, body weight, and safety outcomes. During the trial, participants undergo regular assessments including laboratory tests, ECGs, ultrasounds, and vital sign monitoring. Researchers will measure changes in liver fibrosis, steatohepatitis resolution, and metabolic markers throughout the study. Safety and tolerability are closely tracked by documenting adverse events and exposure duration. The study duration allows for long-term observation of treatment effects and disease progression, with participant involvement lasting up to 5 years.

Researchers are evaluating efruxifermin EFX in adults with non-cirrhotic nonalcoholic steatohepatitis NASH or metabolic dysfunction-associated steatohepatitis MASH who have liver fibrosis stage 2 or 3. This Phase 3, multi-center, randomized, double-blind, placebo-controlled study aims to assess the safety and efficacy of EFX compared with placebo. The trial includes about 1,650 participants divided into two cohorts based on liver biopsy characteristics and fibrosis stage. Participants will be randomly assigned to one of three groups EFX 28 mg, EFX 50 mg, or placebo, each given as a weekly subcutaneous injection. Cohort 1 will be evaluated over 52 weeks for histologic efficacy endpoints, while Cohort 2 will have assessments over 96 weeks. After these periods, participants may continue long-term treatment and clinical follow-up for up to approximately 240 weeks total. A follow-up visit will occur about 30 days after the last dose. During the study, participants will undergo liver biopsies, blood tests, and non-invasive assessments such as FibroScan and Enhanced Liver Fibrosis ELF score to monitor liver health and fibrosis. Researchers will track liver-related clinical outcomes, including liver events and survival, as well as safety and tolerability of the treatment. Participants who stop the study drug may still continue with scheduled assessments to support long-term safety and efficacy evaluations.

Researchers are evaluating the efficacy and safety of two different dose regimens of pegozafermin compared to a placebo in adults with metabolic dysfunction-associated steatohepatitis MASH who have liver fibrosis stage F2 or F3. This Phase 3 study aims to better understand how pegozafermin may impact liver fibrosis and steatohepatitis in this population. Participants will receive subcutaneous injections of either one of two pegozafermin regimens or a matched placebo. These treatments are given in parallel groups, and participants are randomly assigned to one of the study groups. The study compares the effects of pegozafermin on liver fibrosis and steatohepatitis over a treatment period that includes evaluations up to 52 weeks and monitoring for disease progression up to 5 years. During the study, participants will be monitored through biopsies and blood tests to assess liver fibrosis improvement, resolution of steatohepatitis, changes in liver enzyme levels, and enhanced liver fibrosis scores. Safety and disease progression are also tracked throughout the study period. The total participation duration includes treatment and long-term observation to evaluate outcomes and any potential changes in liver health.

This research study is evaluating the medicine abrocitinib in children aged 6 to less than 12 years with moderate-to-severe eczema. The purpose is to find out if abrocitinib improves eczema symptoms and is safe for this age group. Participants will be randomly assigned to receive either abrocitinib or a placebo for 16 weeks. The study is conducted as a phase 3, randomized, double-blind trial and will last about 24 weeks in total. Participants will receive abrocitinib or placebo as a liquid oral suspension. During the study, an electronic diary resembling a cell phone will be used to collect questionnaire information, remind participants to take their medicine daily, and record research data. Participants will also wear a wrist device similar to a childrens wristwatch to monitor scratching caused by eczema. The study includes laboratory tests, physical exams, and vital sign checks before and throughout the study. Participants will visit the clinic for study visits and receive follow-up calls from study doctors or nurses to monitor their health. Questionnaires will assess eczema symptoms, and physical measures such as height, weight, temperature, blood pressure, and heart rate will be tracked. The main outcomes measured include improvements in eczema severity and itchiness at Week 12, with safety and health closely monitored during the entire 24-week study period.

Hidradenitis suppurativa HS is a painful inflammatory skin condition affecting areas like the underarms, groin, and genital regions. This trial evaluates the safety and effectiveness of upadacitinib, an oral drug approved for other inflammatory diseases, in adults and adolescents with moderate to severe HS who have not responded well or cannot tolerate anti-TNF therapies. The study is double-blinded and involves multiple treatment periods to assess disease activity and side effects. Participants will take oral tablets of either upadacitinib or a placebo once daily during the first two periods, each lasting 36 weeks. In Period 1, participants are randomly assigned to receive either upadacitinib or placebo. Period 2 assigns participants to one of six groups based on their response in Period 1, with treatment continuing for 20 weeks. In Period 3, eligible participants continue their assigned treatment for an additional 68 weeks, followed by a 30-day follow-up. Throughout the study, participants will attend regular outpatient visits where medical assessments will monitor treatment effects and side effects. Questionnaires and clinical evaluations will be completed to measure changes in disease activity and quality of life. The trial aims to track the percentage of participants achieving clinical response and the occurrence of adverse events over the entire study duration, which may be longer than standard care treatments.

Researchers are evaluating the efficacy and safety of pegozafermin in adults with compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis MASH, previously known as nonalcoholic steatohepatitis NASH. This study focuses on participants with biopsy-confirmed advanced liver fibrosis stage F4 due to MASH. The research aims to understand how pegozafermin affects liver health over time compared to a placebo. Participants will receive either pegozafermin or a matched placebo through subcutaneous injections. The study follows a randomized, parallel design with quadruple masking to ensure unbiased results. The treatment period extends up to 24 months, with additional long-term follow-up lasting up to five years to assess disease progression and liver fibrosis regression. During the study, participants will undergo various assessments including measurements of liver fibrosis, disease progression through clinical events, and liver function tests such as alanine aminotransferase ALT levels. Tools like Enhanced Liver Fibrosis ELF score and FibroScan Vibration-controlled Transient Elastography VCTE will be used to monitor liver condition up to 60 months. Safety and efficacy will be closely monitored throughout the study period, which may last up to seven years in total.

Researchers are evaluating the efficacy and safety of amlitelimab, given as a subcutaneous injection, for treating moderate-to-severe atopic dermatitis AD in participants aged 12 years and older. This Phase 3, randomized, double-blind, placebo-controlled study includes participants who have not responded adequately to prior biologic or oral Janus kinase inhibitor JAKi therapies while using background topical corticosteroids TCS. Participants are randomly assigned to one of three groups receiving subcutaneous injections of either one of two doses of amlitelimab or a placebo, all alongside background TCS therapy. The treatment period lasts up to 36 weeks, followed by either a 16-week safety follow-up for those not entering the long-term safety study or no further treatment period for those entering the extension study. The entire study duration ranges up to 56 weeks for participants not entering the long-term safety study and up to 40 weeks for those who do. Participants will attend up to 13 visits during the study, or 12 visits if they join the long-term safety study. Assessments include evaluating skin condition using standardized scales such as the Validated Investigator Global Assessment for AD and the Eczema Area and Severity Index. Researchers will monitor safety, side effects, skin symptoms, quality of life, and various patient-reported outcomes. Long-term safety and response to treatment will also be observed for those who continue into the extension study.