Bastrop

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 efimosfermin alfa in adults with biopsy-confirmed metabolic dysfunction-associated steatohepatitis MASH and stage F2 or F3 liver fibrosis. The study aims to assess the safety and effectiveness of efimosfermin alfa compared to a placebo in resolving steatohepatitis and improving liver-related clinical outcomes. This Phase 3 trial is randomized, double-blind, and placebo-controlled, focusing on participants with specific liver conditions and metabolic syndrome components. Participants are assigned to one of three groups two groups receive different dose levels of efimosfermin alfa, while the third group receives a placebo. Treatments are given under controlled conditions, and the study follows a parallel design. The trial monitors participants at set intervals over a course of 52 weeks, with some outcomes tracked up to 48 months to evaluate long-term effects on liver fibrosis and steatohepatitis. During the study, participants undergo liver biopsies to confirm diagnosis and assess changes. Researchers evaluate improvements in fibrosis stage, steatohepatitis resolution, and various liver function measurements using imaging and blood tests. Safety is monitored by tracking adverse events and laboratory abnormalities. Quality of life and other health indicators are also assessed throughout the study, which lasts several years to capture both short- and long-term outcomes.

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 safety, tolerability, and effects of HU6 in adults aged 30 years or older diagnosed with metabolic dysfunction-associated steatohepatitis MASH. The study aims to assess how HU6 affects liver fat content and other symptoms related to MASH, along with understanding its pharmacokinetics and safety profile. This is a phase 2a, randomized, double-blind, placebo-controlled trial sponsored by Rivus Pharmaceuticals, Inc. Participants are randomly assigned to one of four groups receiving either HU6 at 450 mg once daily, HU6 at 300 mg twice daily, placebo once daily, or placebo twice daily. The trial has two parts a blinded intervention period followed by an optional open-label extension for those who complete the first phase. The blinded period includes screening, treatment, an end of treatment or early termination visit, a safety follow-up visit, and two long-term follow-up visits. During the study, participants will undergo assessments including MRI scans to measure liver fat, laboratory tests, and monitoring of drug levels in the blood. Researchers will track adverse events and measure the drugs pharmacokinetics over 26 weeks. The total study duration includes multiple visits for safety and long-term observation to better understand the effects and safety of HU6 in treating MASH.

This research aims to evaluate the effectiveness of a multi-level weight loss intervention called LA-CEAL CONNECT in adults living with obesity in Louisiana. The study will compare this intervention with enhanced usual care to determine if it leads to greater weight loss at 6 months and sustained weight loss at 12 months. It also aims to assess improvements in waist size, diet quality, physical activity, quality of life, and blood pressure, as well as the feasibility of implementing the program in community settings. Participants in the study will be randomly assigned to either the LA-CEAL CONNECT intervention or enhanced usual care. Those in the intervention group will receive culturally tailored educational materials, health coaching from community health workers over 6 months, tools for self-monitoring weight and physical activity using digital devices like a Fitbit and digital scale, and group meetings to connect with community health resources. Both groups will receive educational materials and their healthcare providers will get training and toolkits to support obesity management. During the study, participants will visit clinic sites at the start, 6 months, and 12 months to have clinical measurements and surveys collected. Researchers will monitor weight change as the main outcome at 6 months, along with changes in waist circumference, blood pressure, diet, physical activity, and quality of life. The study will last up to 12 months, with ongoing support and tracking of health behaviors through coaching and digital monitoring devices.

Researchers are investigating the safety and effectiveness of pemvidutide in adults with Alcohol-Associated Liver Disease ALD. This Phase 2 trial is randomized, double-blind, and placebo-controlled, aiming to understand how pemvidutide affects liver stiffness in people who have a history of alcohol misuse and liver damage. The study is sponsored by Altimmune, Inc. and includes participants aged 18 to 75 years with overweight or obesity and specific liver stiffness measurements. Participants will receive either 2.4 mg of pemvidutide or a placebo through a weekly subcutaneous injection. The treatment lasts for 24 weeks, with continued monitoring up to 48 weeks to assess changes over time. The study design includes separate groups receiving pemvidutide or placebo to compare outcomes such as liver stiffness and the Enhanced Liver Fibrosis ELF score. During the study, participants will have liver stiffness measured by vibration-controlled transient elastography VCTE at baseline, week 24, and week 48. They will also undergo blood tests to evaluate fibrosis changes. Researchers will track safety and monitor symptoms throughout the study. Total participation includes treatment and follow-up visits over nearly a year, with detailed assessments to understand how the treatment impacts liver health.