Brownsville

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 liver fibrosis at stages F2 or F3. This phase 3, randomized, double-blind, placebo-controlled study aims to better understand how this drug affects participants with this liver condition related to metabolic syndrome components. Participants will be randomly assigned to one of three groups: one receiving Efimosfermin Alfa at dose level 1, another receiving Efimosfermin Alfa at dose level 2, and a third group receiving a placebo. The study will monitor the effects of these treatments over a period of 52 weeks, assessing safety and tolerability as well as changes in liver fibrosis markers and other related health measures. During the trial, participants will undergo regular assessments including laboratory tests, imaging scans such as MRI and elastography to measure liver stiffness and fat content, and blood tests to monitor liver enzymes and metabolic markers. Researchers will track treatment-emergent adverse events and laboratory abnormalities. The study involves continuous monitoring up to week 52 to evaluate changes from baseline and to ensure participant safety throughout the trial.

Researchers are evaluating whether two drugs, retatrutide and tirzepatide, can prevent serious liver problems in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk based on non-invasive tests. This Phase 3 randomized clinical trial plans to enroll about 4,500 adults and will last approximately 224 weeks, including up to 25 to 30 clinic visits to monitor health and liver disease progression. The study is sponsored by Eli Lilly and Company. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. After completing the main study, eligible participants may join a 2-year extension where everyone receives either retatrutide or tirzepatide, regardless of their original group. This Master Protocol evaluates multiple pharmacologic agents under controlled conditions. Throughout the study, participants will undergo various assessments including liver function tests, imaging to measure liver stiffness and fat content, and body weight measurements. Researchers will track the time to major adverse liver outcomes and cardiovascular events. Safety and disease progression will be closely monitored, and the study includes evaluations at baseline, week 104, and up to study completion.

Researchers are evaluating the effect of AZD0780, an oral PCSK9 inhibitor, compared with a placebo in reducing the risk of major adverse cardiovascular events plus (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or at high risk for a first ASCVD event. This phase 3, randomized, placebo-controlled, and double-blind study aims to assess the time to first MACE-PLUS event over up to approximately 54 months from randomization until the primary analysis censoring date. Participants will be randomly assigned to receive either oral AZD0780 once daily or an oral placebo once daily. The study includes a parallel-group design with two arms: the experimental AZD0780 group and the placebo comparator group. After the primary analysis censoring date, a study closure visit will be scheduled as the final visit for each participant. During the study, participants will be monitored for the occurrence of cardiovascular events including myocardial infarction, stroke, urgent coronary revascularization, cardiovascular death, major adverse limb events, and all-cause mortality. Researchers will assess these events through regular follow-up visits up to approximately 54 months. The study includes detailed safety monitoring and outcome evaluations to understand the effects of AZD0780 compared to placebo in this population at risk for cardiovascular events.

Researchers are evaluating the safety and effectiveness of efimosfermin alfa in people with metabolic dysfunction-associated steatohepatitis (MASH) who have biopsy-confirmed liver fibrosis at stage F2 or F3. This Phase 3, randomized, double-blind, placebo-controlled study aims to compare efimosfermin alfa to placebo in improving liver-related outcomes and resolving steatohepatitis over a long-term period. Participants will be randomly assigned to one of three groups: two different dose levels of efimosfermin alfa or a placebo group. The study treatment will be administered under medical supervision, and the trial includes multiple assessments at baseline, Week 52, and Month 48. The study will measure liver fibrosis improvement, steatohepatitis resolution, and liver-related clinical outcomes, among other key health indicators. During the study, participants will undergo liver biopsies, blood tests, imaging scans, and questionnaires to monitor liver health and treatment effects. Researchers will track clinical outcomes for up to 48 months from the start of treatment. Safety will be closely monitored through adverse event reporting and laboratory tests. Participants are expected to attend regular visits for evaluations and follow-up throughout the study duration.

Researchers are evaluating an investigational drug called ALN-HSD for adults with Metabolic Dysfunction-Associated SteatoHepatitis (MASH), a liver condition where fat buildup causes inflammation and scarring. The study aims to see how ALN-HSD affects liver scarring in MASH and explores how the drug works, its side effects, and how the body processes it. This is a phase 2, randomized, double-blind, placebo-controlled clinical trial focusing on participants with genetic risk factors for MASH. Participants will be randomly assigned to receive either ALN-HSD or a placebo in equal groups. The study drug and placebo are given according to the study protocol. The trial includes a treatment period lasting up to 52 weeks, with follow-up monitoring extending to 84 weeks to assess safety and side effects. During the study, participants will undergo evaluations including liver biopsies to measure changes in liver fibrosis, blood tests for liver enzymes and fibrosis biomarkers, and genetic assessments. Researchers will closely monitor side effects and the drug's behavior in the body. The main outcome is the change in quantitative liver fibrosis from baseline to week 52, with additional measures assessing liver function and disease progression. Participants' involvement may last up to 84 weeks to cover treatment and safety follow-up.

Researchers are evaluating efruxifermin (EFX) in a randomized, double-blind, placebo-controlled Phase 3 study involving adults aged 18 to 80 with compensated cirrhosis caused by Nonalcoholic Steatohepatitis (NASH) or Metabolic Dysfunction-Associated Steatohepatitis (MASH). The study aims to assess the safety and efficacy of EFX in preventing disease progression and liver complications over a long-term period. Participants receive either efruxifermin or a placebo by subcutaneous injection. The study includes multiple groups, with one cohort requiring biopsy-proven compensated cirrhosis and specific metabolic features, and another allowing biopsy or non-invasive diagnosis. The treatment and follow-up last up to five years, with detailed monitoring at 96 weeks and beyond. During the trial, participants will undergo regular assessments of liver fibrosis, markers of liver injury, lipoproteins, insulin sensitivity, glycemic control, and body weight. Researchers will also monitor adverse events, laboratory tests, ECGs, ultrasounds, and vital signs throughout the study. The primary outcome measures include time to significant clinical events and improvements in fibrosis and steatohepatitis, with extensive safety and efficacy evaluations conducted over five years.

Researchers are evaluating the safety and effectiveness of efruxifermin (EFX) 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 will involve about 1,650 participants divided into two groups based on fibrosis stage and will use a randomized, double-blind, placebo-controlled design. Participants will be assigned to receive either 28 mg or 50 mg of efruxifermin or a placebo, all given by weekly subcutaneous injection. The study includes a screening period of up to 12 weeks, a 52-week primary treatment phase, and long-term follow-up that may last up to approximately 240 weeks. Liver biopsies and other assessments will be done at specific times, including weeks 52, 96, and 240, to evaluate liver changes and treatment effects. Throughout the study, participants will undergo various assessments such as liver biopsies, blood tests, FibroScan scans, and questionnaires to monitor liver health, fibrosis progression, and overall safety. Researchers will track outcomes like resolution of NASH/MASH, fibrosis improvement, liver-related events, and survival over the long term. After the last dose, participants will have a follow-up visit about 30 days later to check their condition.

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) and liver fibrosis at stages F2 or F3. This Phase 3 study aims to better understand how pegozafermin may help treat liver fibrosis in this population. Participants will receive either pegozafermin or a matched placebo through subcutaneous injections according to one of two dosing regimens. The treatments are administered in a randomized, quadruple-masked design to ensure unbiased results. The study evaluates effects after 52 weeks of treatment and monitors participants for up to 5 years to assess disease progression. During the study, participants will undergo liver biopsies to confirm fibrosis stage and will have blood tests to measure liver enzymes and fibrosis markers. Researchers will track improvements in fibrosis, resolution of steatohepatitis, changes in liver enzyme levels, and liver fibrosis scores. Participants' health and safety will be monitored throughout the study period, which includes follow-up assessments extending up to 5 years.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate (BGF MDI 320/14.4/9.6 bcg) on heart and lung outcomes in people with chronic obstructive pulmonary disease (COPD) who have a higher risk of heart and lung problems. This Phase III study compares this triple therapy to a dual therapy inhaler containing glycopyrronium and formoterol fumarate (GFF MDI 14.4/9.6 bcg). The trial is randomized, double-blind, and conducted at multiple centers to assess which treatment better affects cardiopulmonary outcomes.

Researchers are evaluating the effects of two drugs, ECC4703 and ECC0509, alone and in combination, on reducing liver fat in adults with presumed Metabolic Dysfunction-associated Steatohepatitis (MASH). This Phase 2a, randomized, double-blind, placebo-controlled study aims to understand how different doses impact liver fat as measured by MRI proton density fat fraction (MRI-PDFF) at 12 weeks. Participants will be randomly assigned to one of six groups: placebo, low or high dose ECC4703, low or high dose ECC0509, or a combination of high doses of both drugs. All treatments are given as oral capsules. The main treatment period lasts 12 weeks, during which the impact on liver fat and other related health markers will be assessed. During the study, participants will undergo various assessments including MRI scans to measure liver fat, blood tests to monitor liver enzymes and metabolic markers, and other biomarker evaluations at baseline and Week 12. Safety and drug levels will be monitored throughout. The study involves close follow-up to track changes in liver fat content and related health outcomes over the 12-week treatment period.