Rialto

Researchers are evaluating the safety, tolerability, and how the body processes pharmacokinetics two drugs, AZD9550 and AZD6234, in adults with different levels of liver impairment compared to those with normal liver function. This Phase I, open-label study includes participants with severe or moderate hepatic impairment as classified by the Child-Pugh score, as well as matched healthy controls. The goal is to understand how liver problems affect these drugs when given as single subcutaneous doses. Participants will receive separate single doses of AZD9550 and AZD6234 administered subcutaneously in two periods, with a washout period between the doses to reduce interference between drugs. The study groups include those with severe hepatic impairment Child-Pugh Class C, moderate hepatic impairment Child-Pugh Class B, and healthy individuals matched for sex, age, and body mass index. Approximately 16 participants with hepatic impairment and up to 12 healthy controls will be enrolled. During the study, participants will be assessed for drug levels in the body over 56 days after dosing to measure pharmacokinetic parameters such as AUCinf, AUClast, and Cmax. Safety and immune response will also be monitored through laboratory tests, vital signs, electrocardiograms, and adverse event reporting. The study duration includes screening, dosing periods, and follow-up visits to capture these outcomes under medical supervision.

Researchers are evaluating the pharmacokinetics, safety, and tolerability of capivasertib in adults with moderate hepatic impairment compared to those with normal liver function. This phase I study aims to understand how the drug behaves in the body and its safety profile in these two groups. Participants will receive a single oral dose of capivasertib while staying at the investigative site from the day before dosing until four days after. The study includes two parallel groups one with moderate hepatic impairment and one with normal liver function. Before dosing, a screening period of up to three weeks includes liver function assessments, with an additional stability check for those with impaired hepatic function. During the study, participants will have blood samples taken to measure drug levels and monitor safety from Day 1 through Day 4, followed by a follow-up visit between Days 9 and 11. Researchers will assess drug concentration over time, maximum levels in the blood, and any adverse events to evaluate how the drug is processed and tolerated. Total participation lasts from screening through follow-up, approximately up to four weeks.

Researchers are studying an investigational drug called ALN-HSD in adults with Metabolic Dysfunction-Associated SteatoHepatitis MASH, a liver condition caused by fat buildup that damages liver cells and causes inflammation and scarring. This condition can worsen to cirrhosis and liver failure. The study aims to evaluate how ALN-HSD affects liver scarring related to MASH and to understand its impact on liver function and inflammation, as well as potential side effects and how the drug is processed in the body. Participants will be randomly assigned to receive either ALN-HSD or a placebo in a double-blind setup. The study involves a 52-week treatment period during which the effects of ALN-HSD on liver fibrosis and other liver-related biomarkers will be assessed. The trial includes genetic risk factor screening for enrollment and collects data on drug levels and metabolites. Treatment is administered according to the study protocol, with monitoring continuing through week 84 for adverse events. Throughout the study, participants will undergo liver biopsies and various laboratory tests to measure liver fibrosis, enzyme levels, and other biomarkers related to MASH. Researchers will track changes from baseline to week 52 in liver fibrosis and inflammation, along with monitoring adverse events until week 84. Participants are involved in regular assessments to evaluate the study drugs impact on their liver health over the course of the trial.

Researchers are evaluating the safety and effectiveness of 48 weeks of daily oral treatment with ALG-000184 compared to tenofovir disproxil fumarate TDF in adults with chronic hepatitis B virus HBV infection. This Phase 2 randomized, double-blind, active-controlled study includes both untreated HBeAg-positive and HBeAg-negative adults. The study aims to understand how well these treatments control HBV infection and their safety profiles. Participants will receive either ALG-000184 or TDF tablets once daily for 48 weeks. After this double-blind period, all participants may continue treatment with open-label ALG-000184 for an additional 48 weeks, making a total treatment duration of 96 weeks. The study is divided into two parts, focusing separately on HBeAg-positive and HBeAg-negative subjects, with some taking part in an exploratory liver biopsy sub-study. Throughout the study, participants will undergo regular assessments including measuring HBV DNA levels to see if the virus is suppressed below a set detection limit at 48 weeks. Safety and tolerability will be monitored up to 96 weeks. Other evaluations include liver enzyme levels, viral resistance, and drug pharmacokinetics. The study involves blood tests, liver assessments, and ongoing monitoring to track treatment effects and participant health over nearly two years.

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 who have liver fibrosis stage F2 or F3. This Phase 3 study aims to better understand how pegozafermin may impact liver fibrosis and steatohepatitis in this population. Participants will receive subcutaneous injections of either one of two pegozafermin regimens or a matched placebo. These treatments are given in parallel groups, and participants are randomly assigned to one of the study groups. The study compares the effects of pegozafermin on liver fibrosis and steatohepatitis over a treatment period that includes evaluations up to 52 weeks and monitoring for disease progression up to 5 years. During the study, participants will be monitored through biopsies and blood tests to assess liver fibrosis improvement, resolution of steatohepatitis, changes in liver enzyme levels, and enhanced liver fibrosis scores. Safety and disease progression are also tracked throughout the study period. The total participation duration includes treatment and long-term observation to evaluate outcomes and any potential changes in liver health.

Researchers are evaluating the pharmacokinetic and safety profiles of a single dose of efimosfermin alfa in adults with different levels of liver impairment caused by steatotic liver disease. The study focuses on participants who have hepatic impairment classified by the Child-Pugh score, with or without significant alcohol consumption. This is a phase 1, open-label study assessing efimosfermin alfa in adults aged 18 to 70 with metabolic dysfunction-associated steatohepatitis MASH. All participants will receive a single subcutaneous dose of efimosfermin alfa. The study includes three groups based on the degree of hepatic impairment and alcohol use moderate impairment with low alcohol consumption, moderate impairment with higher alcohol consumption, and severe impairment regardless of alcohol use. The study uses a sequential design to evaluate these groups. Participants will be monitored up to 90 days after dosing. Researchers will measure drug concentration in blood over time and monitor for adverse events, changes in lab results, vital signs, and ECG readings. The main outcomes include drug exposure levels and safety assessments to understand how hepatic impairment affects efimosfermin alfa pharmacokinetics. Participants will have regular assessments during this period to track these outcomes.

Researchers are evaluating the safety, tolerability, preliminary effectiveness, and how the body processes efimosfermin in adults with metabolic dysfunction-associated steatohepatitis MASH and compensated cirrhosis showing stage F4 fibrosis. This study focuses on people diagnosed by liver biopsy with advanced but stable liver disease caused by metabolic problems. It aims to understand the impact of efimosfermin on this condition. Participants will be randomly assigned to one of three groups two groups will receive different doses of efimosfermin, and one group will receive a placebo. All treatments are given as subcutaneous injections once every four weeks. The study will last up to 100 weeks for safety and includes monitoring drug levels in the blood up to 21 weeks. The comparison of two doses of efimosfermin versus placebo allows researchers to assess tolerability and drug behavior. During the trial, participants will be regularly assessed for any treatment-related side effects and have blood samples taken to measure drug concentrations. Researchers will monitor adverse events from the first day through 100 weeks. The study includes multiple visits for injections and evaluations. Participants will be observed closely to gather information on safety and the drugs effects over time, with the total duration extending up to nearly two years.

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 study focuses on participants with biopsy-confirmed advanced liver fibrosis stage F4 due to MASH. The research aims to understand how pegozafermin affects liver health over time compared to a placebo. Participants will receive either pegozafermin or a matched placebo through subcutaneous injections. The study follows a randomized, parallel design with quadruple masking to ensure unbiased results. The treatment period extends up to 24 months, with additional long-term follow-up lasting up to five years to assess disease progression and liver fibrosis regression. During the study, participants will undergo various assessments including measurements of liver fibrosis, disease progression through clinical events, and liver function tests such as alanine aminotransferase ALT levels. Tools like Enhanced Liver Fibrosis ELF score and FibroScan Vibration-controlled Transient Elastography VCTE will be used to monitor liver condition up to 60 months. Safety and efficacy will be closely monitored throughout the study period, which may last up to seven years in total.

Researchers are evaluating how the medicine BI 1291583 is absorbed into the blood in adults aged 18 to 80 years, including those with and without liver problems. This medicine is being developed to treat bronchiectasis, a long-term lung disease. Because many people with bronchiectasis also have liver issues, the study aims to understand whether liver function affects how BI 1291583 is processed in the body. Participants receive a single oral dose of BI 1291583. They are divided into four groups based on liver function healthy individuals and those with mild, moderate, or severe liver impairment. Each participant without liver problems is matched with others in the liver impairment groups based on age, sex, smoking habits, and body weight to allow accurate comparisons. The study lasts about three months, including a three-day stay at the study site and up to nine additional visits. During these visits, doctors collect health information and regularly take blood samples to measure how much BI 1291583 is in the blood over time. Participants health is closely monitored for any side effects throughout the study.

Researchers are evaluating maridebart cafraglutide in adults living with overweight or obesity and elevated liver fat to determine if it is better than a placebo in reducing liver fat content and body weight. This Phase 2b randomized, double-blind, placebo-controlled trial aims to assess the drugs efficacy, safety, and tolerability when combined with a reduced-calorie diet and increased physical activity. Participants include adults aged 18 to 99 with specific body mass index and liver fat requirements. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo as subcutaneous injections every 4 weeks for 52 weeks. Both groups will follow a reduced-calorie diet and increase physical activity during the study. The trial includes two groups one receiving the experimental drug and the other receiving placebo, allowing comparison of their effects on liver fat and body weight. During the study, participants will undergo various assessments including MRI scans to measure liver fat content and body composition, blood tests for liver enzymes and glucose control markers, and weight measurements at baseline, 24 weeks, and 52 weeks. Researchers will monitor treatment-emergent adverse events and serious adverse events throughout the study, which lasts approximately 69 weeks from screening to completion. This monitoring ensures participant safety and collects data on the drugs effects over time.