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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 the effect of baxdrostat combined with dapagliflozin compared to baxdrostat with placebo on reducing albuminuria in people with chronic kidney disease (CKD) and high blood pressure. This Phase IIb, randomized, multicenter, double-blind study includes adults aged 18 years and older, with or without type 2 diabetes and regardless of current SGLT2 inhibitor treatment. The study aims to assess both the impact on albuminuria and the safety of these treatments. Participants will be randomly assigned to receive either baxdrostat with dapagliflozin or baxdrostat with a matching placebo. The study includes an optional pre-screening period to assess kidney function and other health markers, and those on SGLT2 inhibitors will undergo a washout before starting treatment. Randomization will consider diabetes status to ensure balanced groups. During the study, participants will be monitored up to 12 weeks to measure changes in albuminuria, specifically urinary albumin-to-creatinine ratio (UACR). Safety and other health parameters will also be assessed through blood tests and blood pressure measurements. The study ends when the last participant completes their final visit and procedures, ensuring thorough data collection on treatment effects and safety.

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

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 effects of ECC4703, a thyroid hormone receptor beta isoform agonist, and ECC0509, a semicarbazide sensitive amine oxidase inhibitor, alone and combined, on reducing liver fat in adults with presumed metabolic dysfunction-associated steatohepatitis (MASH). This Phase 2a trial aims to measure changes in liver fat using magnetic resonance imaging proton density fat fraction (MRI-PDFF) after 12 weeks of treatment. Participants are randomly assigned to receive low or high doses of ECC4703, ECC0509, their combination, or placebo in oral capsule form. The study compares the dose-dependent effects of these treatments on hepatic fat reduction. Placebo capsules match the active treatments to maintain blinding. The treatment period lasts for 12 weeks. During the study, participants undergo MRI scans to measure liver fat content at baseline and week 12. Researchers monitor liver enzymes, metabolic markers, and safety throughout the trial. Participants must comply with study procedures, including regular assessments and biomarker tests, to evaluate the efficacy and safety of the treatments over the 12-week period.

Researchers are evaluating the safety and effectiveness of baricitinib, a medication taken by mouth, for treating severe or very severe alopecia areata, a type of hair loss, in children aged 6 to less than 18 years. This Phase 3 study involves children and adolescents who have had alopecia areata for at least one year and are experiencing a current episode lasting at least six months with significant hair loss. The study aims to see how well baricitinib works compared to a placebo. The study is divided into four distinct periods: a 5-week screening period to determine eligibility, a 36-week double-blind treatment period where participants receive either baricitinib or placebo, an approximately 2-year long-term extension period for continued treatment, and a 4-week post-treatment follow-up period to monitor participants after stopping the medication. Both baricitinib and placebo are administered orally. Participants will undergo various assessments throughout the study, including measuring the severity of hair loss using the Severity of Alopecia Tool (SALT) score. The main outcome is the percentage of participants achieving a SALT score of 20 or less after 36 weeks of treatment. Safety and pharmacokinetics of baricitinib will also be monitored during the study. The total participation may last over two years, including treatment and follow-up phases.

Researchers are evaluating the safety and effects of a medicine called disitamab vedotin for adults with advanced breast cancer that is hard to treat and has spread in the body. This study focuses on participants whose tumors express HER2 and who have received previous treatments for their advanced breast cancer. The goal is to understand how well this medicine works and its safety in these patients through a Phase 1b/2 open-label study. All participants will receive disitamab vedotin intravenously (IV) once every two weeks at the study clinic. They will continue the treatment until they or their doctor decide to stop, which could be due to cancer progression, side effects, or personal choice. During treatment, study visits occur every two weeks. After stopping treatment, participants will have follow-up visits about every six weeks, and later follow-up phone calls approximately every twelve weeks. Participants will undergo evaluations including assessments of their cancer response by the study doctors, following recognized criteria. The study team will monitor the participants for up to about two years or until their disease progresses or they pass away. This includes safety monitoring and collecting information about the medicine’s effects to determine its safety and effectiveness.

Researchers are evaluating the safety, tolerability, early effectiveness, and how the body processes efimosfermin in adults aged 18 to 75 who have metabolic dysfunction-associated steatohepatitis (MASH) with compensated cirrhosis confirmed by liver biopsy showing stage F4 fibrosis. This phase 2 study compares efimosfermin to a placebo to better understand its effects in this condition. Participants will receive either efimosfermin or a placebo through injections under the skin. The study is randomized, double-blinded, and placebo-controlled, meaning neither the participants nor the researchers know who receives the active drug or placebo. Treatment and follow-up will continue for up to 100 weeks to monitor safety and response. Throughout the study, researchers will track any treatment-emergent adverse events from the first day up to 100 weeks. Participants will be monitored regularly to assess their health and liver condition, ensuring their safety during the trial. The study aims to gather important information about how effective and safe efimosfermin is for people with MASH and compensated cirrhosis.

Researchers are evaluating the effectiveness, safety, optimal dosing, and immune response development of TRK-950 combined with ramucirumab and paclitaxel compared to ramucirumab and paclitaxel alone in people with gastric or gastro-esophageal junction (GEJ) adenocarcinoma. This phase 2 study aims to improve progression-free survival and also looks at overall survival, response rates, and disease control in participants with these cancers. Participants receive TRK-950 at two dose levels (5 mg/kg or 10 mg/kg) given by IV infusion over 60 minutes on Days 1, 8, 15, and 21 of each 28-day cycle. Ramucirumab (8 mg/kg IV) is given on Days 1 and 15, and paclitaxel (80 mg/m² IV) is administered on Days 1, 8, and 15 of each 28-day cycle. The study compares the combination treatment to ramucirumab plus paclitaxel alone. During the study, participants undergo regular assessments including CT scans to measure disease progression, laboratory tests to monitor organ function and immune response, and evaluations of overall health and symptoms. The main outcome measured is progression-free survival up to about 24 months. Safety and treatment effects are closely monitored throughout participation, with informed consent and tissue testing required before enrollment.