Farmers Branch

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 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 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.

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 phase 3 study focuses on participants with biopsy-confirmed advanced fibrosis stage F4 MASH and aims to assess important clinical outcomes related to liver disease progression. Participants will be randomly assigned to receive either pegozafermin or a matched placebo, both given by subcutaneous injection. The study includes a double-blind design where neither the participants nor the researchers know who receives the active drug or placebo. The treatment period extends up to 24 months with follow-up for clinical events up to 5 years, allowing long-term monitoring of disease progression and fibrosis regression. Throughout the study, participants will undergo regular assessments including liver fibrosis measurements, liver enzyme tests, and elastography scans. Researchers will monitor the proportion of participants achieving fibrosis regression and track time to clinical disease progression. Additional evaluations include changes in liver fibrosis scores and development of portal hypertension, with safety assessments continuing up to 60 months. The total participation may last several years to capture these important outcomes.

Researchers are studying the effects of oral KAI-7535 taken once daily in adults living with obesity or overweight who have at least one weight-related health condition. The study aims to compare the impact of KAI-7535 with a placebo on body weight changes, especially focusing on participants without diabetes mellitus, while also evaluating those with type 2 diabetes. Safety, tolerability, and other weight-related outcomes will also be assessed in both groups. Participants will be randomly assigned to receive either KAI-7535 or a matching placebo once daily. The study includes multiple dose schedules of KAI-7535 and involves a double-blind setup where neither participants nor researchers know which treatment is given. The trial is conducted at multiple centers and is designed to assess the treatment effects over a 44-week period. During the study, participants' body weight and body mass index (BMI) will be measured at the start and at week 44. Researchers will monitor changes in weight, safety, and tolerability throughout the trial. The main outcome is the percent change in body weight from baseline to week 44, with additional assessments of weight reduction percentages and BMI changes. Participants will be followed closely for the duration of the study, which lasts 44 weeks, to collect all relevant data.