Bastrop

Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

Researchers are evaluating efruxifermin (EFX) in adults aged 18 to 80 who have compensated cirrhosis caused by nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH). This Phase 3, randomized, double-blind, placebo-controlled study aims to assess the safety and effectiveness of EFX in improving liver health and delaying disease progression in this population. The study focuses on subjects with advanced liver fibrosis (stage 4) but without liver decompensation. Participants are randomly assigned to receive either efruxifermin or a placebo, both administered by subcutaneous injection. The study includes two cohorts: Cohort 1 requires biopsy confirmation of liver fibrosis and specific metabolic features, while Cohort 2 allows biopsy or non-invasive diagnosis. Treatment and observation continue over an extended period to evaluate changes in liver fibrosis and clinical events. During the study, researchers will monitor the time until significant clinical events such as disease progression or liver decompensation occur, with a follow-up of up to five years. For Cohort 1, the proportion of participants showing improvement in fibrosis without worsening steatohepatitis will be assessed at 96 weeks. Participants will undergo regular evaluations including clinical assessments and laboratory tests to track liver function and safety throughout the study period.

Researchers are investigating the safety and effectiveness of efruxifermin in people with non-cirrhotic nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH) who have moderate to advanced liver fibrosis (stage 2 or 3). This Phase 3 study is randomized, double-blind, and placebo-controlled, enrolling a total of 1650 participants in two groups to evaluate treatment outcomes. Participants will receive either efruxifermin or a placebo by subcutaneous injection. The study involves two cohorts, with Cohort 1 including patients who have biopsy-confirmed NASH or MASH and specific liver fibrosis and activity scores. The treatment period and detailed dosing schedules are not provided but the study compares the effects of the active drug against placebo. During the study, participants will be monitored for improvement in liver disease status, including resolution of NASH/MASH and at least a one-stage improvement in liver fibrosis after 52 weeks for Cohort 1. Long-term outcomes such as event-free survival will be observed over 240 weeks. Safety and efficacy assessments will be conducted throughout the study period, including evaluations of liver histology and metabolic health.

Researchers are evaluating the safety, tolerability, and effects of a drug called HU6 for adults diagnosed with metabolic dysfunction-associated steatohepatitis (MASH). This Phase 2a study compares HU6 with a placebo to assess how the drug affects liver fat content and other symptoms of MASH, as well as to understand its pharmacokinetics, which is how the drug moves through the body. The trial has two parts: a blinded intervention period where participants receive either HU6 or a placebo without knowing which one, followed by an optional open-label extension where participants may continue receiving HU6. The study includes a screening phase, treatment period, end of treatment or early termination visit, safety follow-up, and two long-term follow-up visits. Participants will be monitored through various assessments including MRI scans to measure liver fat, blood tests to evaluate drug levels and safety, and tracking of any side effects over 26 weeks. Researchers will measure the number and percentage of adverse events, changes in liver fat, and detailed pharmacokinetic parameters to understand HU6's behavior and safety profile during and after treatment.

This research aims to evaluate the effectiveness of a multi-level, evidence-based weight loss program called LA-CEAL CONNECT for adults living with obesity in low-income and underserved communities in Louisiana. The study seeks to determine if LA-CEAL CONNECT leads to greater weight loss at 6 months compared to enhanced usual care, and whether weight loss is sustained at 12 months. The trial also examines improvements in waist size, diet quality, physical activity, quality of life, and blood pressure, while assessing the feasibility of implementing the program in these communities. Participants in both study groups receive health literacy-tailored educational materials and resources for weight loss and attend clinic visits at baseline, 6 months, and 12 months for clinical and survey assessments. Those in the LA-CEAL CONNECT intervention group additionally receive virtual health coaching from trained community health workers over 6 months, use digital tools like cellular-connected scales and wrist fitness trackers for daily self-monitoring of weight and activity, and attend group meetings to enhance use of community health and wellness resources identified through community asset mapping. The program also includes provider training and an obesity management toolkit for primary care providers at participating clinics. Throughout the study, participants are monitored through clinical visits collecting physical measurements and surveys at three timepoints over one year. Coaches remotely track weight and physical activity data to provide personalized support. The primary outcome is the difference in percentage weight change between groups at 6 months. The study also evaluates other health and behavioral measures, program feasibility, and sustainability over 12 months.

Researchers are conducting a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the effectiveness and safety of pemvidutide in adults with alcohol-associated liver disease (ALD). This trial focuses on individuals who are overweight or obese with a history of significant alcohol misuse and certain levels of liver stiffness. Participants will receive either pemvidutide 2.4 mg or a placebo, both administered as subcutaneous injections once weekly. The study compares these two treatments over a 24-week period to assess changes in liver stiffness. During the study, participants will undergo assessments including liver stiffness measurements by vibration-controlled transient elastography (VCTE) at baseline and Week 24. Researchers will monitor safety and efficacy throughout, focusing on the relative change in liver stiffness as the primary outcome measure.