Rialto

Researchers are evaluating the safety and tolerability of two drugs, AZD9550 and AZD6234, in people with severe or moderate liver impairment compared to those with normal liver function. This Phase I, open-label, parallel group study focuses on how these drugs behave in the body (pharmacokinetics) and their immune response effects in adults aged 18 to 85 years. Participants are grouped based on their liver function using the Child-Pugh scoring system: severe hepatic impairment (Class C), moderate hepatic impairment (Class B), and matched healthy controls with normal liver function. Participants will receive single subcutaneous doses of AZD9550 and AZD6234 in two separate periods, with a washout interval between to reduce the impact of the first drug before administering the second. The study plans to enroll 16 participants with hepatic impairment (8 with severe and 8 with moderate impairment) and up to 12 matched healthy controls. The dosing and safety of each drug will be assessed individually to understand their effects in different liver function groups. During the study, participants will undergo multiple assessments including pharmacokinetic measurements from Day 0 through Day 56 to analyze drug exposure and peak concentrations. Safety and tolerability will be closely monitored along with immunogenicity evaluations. Screening includes medical history, physical exams, laboratory tests, and ECGs to confirm eligibility. Participants will be followed throughout the study duration for any adverse events and other relevant health changes.

Researchers are studying the pharmacokinetics (how the drug moves through the body), safety, and tolerability of capivasertib in adults with moderate liver impairment compared to those with normal liver function. This Phase I trial focuses on understanding how moderate hepatic impairment affects the body's processing of capivasertib, a drug given as a single dose. The study includes participants classified as Child Pugh class B for liver impairment and healthy controls to provide comparison data. Participants will stay at the study site from the day before treatment (Day -1) until Day 4 after receiving a single oral dose of capivasertib on Day 1. Before treatment, a screening period from Day -21 to Day -2 occurs, during which those with moderate liver impairment undergo additional liver function stability assessments on Day -7. After the residential period, participants return for a follow-up visit between Days 9 and 11 to monitor their health. During the study, researchers will measure drug levels in the blood from Day 1 to Day 4, focusing on the area under the concentration-time curve and the maximum plasma drug concentration. Participants will undergo regular assessments including blood tests and monitoring for safety and tolerability. The study tracks how the drug behaves in the body and checks for any side effects or safety concerns during and after dosing.

Researchers are evaluating an investigational drug called ALN-HSD for adults with Metabolic dysfunction-Associated SteatoHepatitis (MASH), a type of liver disease where fat buildup causes liver cell damage, inflammation, and scarring. This condition can lead to serious complications like cirrhosis and liver failure. The study aims to assess how ALN-HSD affects liver scarring associated with MASH and to explore its impact on liver function, inflammation, side effects, and how the drug and its breakdown products appear in the blood. Participants will receive either ALN-HSD or a placebo according to the study protocol in this Phase 2, randomized, double-blind, placebo-controlled trial. The treatment is given based on the protocol's schedule, but specific dosing details are not provided. The study focuses on adults with specific genetic risk factors for MASH and with certain disease stages, ensuring a targeted precision medicine approach. During the study, participants will be monitored for changes in quantitative liver fibrosis from the start of the study to week 52. Researchers will evaluate liver scarring, liver function, inflammation, drug levels in the blood, and any side effects. The study includes genetic testing and specific liver assessments like FibroScan and FAST scores. Participants will be followed closely to understand the drug's effects and safety over the one-year period.

Researchers are evaluating the safety and effectiveness of a new oral medicine called ALG-000184 compared with tenofovir disproxil fumarate (TDF) in adults with chronic hepatitis B virus (HBV) infection. This Phase 2 study includes people who have never been treated or are currently not treated, and it focuses on both HBeAg-positive and HBeAg-negative participants. The study aims to understand how well these treatments control the virus over time. Participants will receive either ALG-000184 or TDF as a once-daily oral tablet for 48 weeks in a randomized, double-blind setting. After this period, all participants have the option to continue treatment with ALG-000184 alone for an additional 48 weeks in an open-label extension. The study includes two parts: one for HBeAg-positive subjects and one for HBeAg-negative subjects, each with the possibility of joining a liver biopsy sub-study. During the study, participants will be regularly monitored for viral levels, specifically measuring HBV DNA to see if it falls below a certain limit after 48 weeks. Researchers will also check safety and liver health through blood tests and imaging. The total study involvement can last up to 96 weeks, including the treatment extension. The study looks closely at how the virus responds to treatment and the overall health of participants throughout this time.

This research aims to evaluate the effectiveness and safety of two different dose schedules of pegozafermin compared to a placebo in adults with metabolic dysfunction-associated steatohepatitis (MASH) who have liver fibrosis at stage F2 or F3. This phase 3 study focuses on improving liver fibrosis and steatohepatitis in this patient group, which involves chronic liver disease associated with metabolic dysfunction. Participants will receive either pegozafermin or a placebo through subcutaneous injections. The study compares two doses of pegozafermin to assess their impact on liver fibrosis and steatohepatitis. The treatment period lasts up to 52 weeks, with outcomes measured at this time point. During the study, participants will be monitored for improvements in liver fibrosis and resolution of steatohepatitis without worsening fibrosis by week 52. Researchers will also track the time until any disease progression occurs, up to 5 years. Throughout the trial, safety and efficacy will be carefully assessed through clinical evaluations and laboratory tests to ensure participant well-being.

Researchers are evaluating the pharmacokinetics and safety of a single dose of efimosfermin alfa in adults with different levels of liver impairment caused by steatotic liver disease. This study focuses on individuals with hepatic impairment assessed by the Child-Pugh score, including those with and without significant alcohol consumption. The trial aims to understand how the drug behaves in the body and its safety profile in this specific group of participants. Participants will receive a single subcutaneous dose of efimosfermin alfa. The study is open-label and involves adults aged 18 to 70 years with liver cirrhosis classified as Child-Pugh B or C. The trial includes stable chronic hepatic impairment cases without recent acute deterioration. The administration and observation period covers up to 90 days, during which drug concentration and safety will be assessed. Throughout the study, participants will undergo monitoring of serum drug levels, including the area under the concentration-time curve and the maximum observed serum concentration of efimosfermin alfa, up to 90 days post-dose. Safety evaluations and clinical assessments will be conducted to track adverse effects and liver function stability. The study seeks to gather comprehensive data on the drug's pharmacokinetics and safety in this patient population over the duration of the trial.

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 and safety of pegozafermin in adults aged 18 to 75 years who have compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis (MASH), previously known as nonalcoholic steatohepatitis (NASH). Participants in this phase 3 study must have biopsy-confirmed advanced liver fibrosis (stage F4) due to MASH and meet specific metabolic health criteria. The study aims to understand how well pegozafermin can help improve liver fibrosis and delay disease progression over time. Participants will receive either pegozafermin or a placebo through subcutaneous injections. The study will monitor participants over a long period, up to five years, to observe changes in liver fibrosis and any clinical events related to disease progression. The treatment is given to those with compensated cirrhosis, meaning their liver is damaged but still functioning, and the study carefully evaluates the safety and potential benefits of pegozafermin in this group. Throughout the study, participants will undergo regular assessments to track liver health, including fibrosis regression and timing of disease progression. Researchers will use clinical events and laboratory tests to measure outcomes from the start of the study through 24 months and up to five years. Safety and health will be monitored closely, ensuring any side effects or complications are identified promptly. This comprehensive follow-up helps provide detailed information on the long-term effects of the treatment and participants' liver condition.

This research aims to evaluate how hepatic impairment (HI) affects the pharmacokinetics (PK), safety, and tolerability of a single dose of mavorixafor compared to healthy volunteers with normal liver function. It is an open-label, non-randomized Phase 1 study involving participants with chronic stable liver disease and matched healthy volunteers. The study focuses on measuring mavorixafor levels in the blood over time and monitoring safety outcomes in both groups. Participants will receive a single dose of mavorixafor administered according to a set schedule. The study includes two groups: those with hepatic impairment and matched healthy volunteers. All participants will be monitored closely for drug concentration levels in plasma from before dosing up to 192 hours after dosing to assess maximum plasma concentration and overall exposure to the drug. During the study, participants will undergo medical history reviews, physical exams, vital sign checks, ECGs, and laboratory tests to ensure safety and eligibility. Blood samples will be collected to measure drug levels and evaluate liver function. Researchers will track safety and tolerability throughout the study period. The total participation duration aligns with the sampling timeline, covering up to 9 days post-dose for pharmacokinetic assessments.

This trial investigates whether maridebart cafraglutide is better than a placebo at reducing liver fat and body weight in adults who are overweight or obese and have elevated liver fat. Participants must be adults with a body mass index between 27 and 40 kg/m2, including those with type 2 diabetes under specific treatment conditions. The study is designed as a Phase 2b randomized, double-blind, placebo-controlled trial to assess the drug's effectiveness, safety, and tolerability. Participants will receive either maridebart cafraglutide or a placebo through subcutaneous injections, alongside a reduced-calorie diet and increased physical activity. The treatment period and dosing schedule are detailed within the study protocol, with injections administered regularly. The study includes careful monitoring and comparison between the drug and placebo groups to determine the effects on liver fat content and weight. During the trial, participants will undergo assessments including MRI scans to measure liver fat content and body weight evaluations at the start and at week 52. Other evaluations will monitor safety and tolerability throughout the study. The total participation period includes baseline assessments and a follow-up at 52 weeks, with detailed monitoring of liver fat and weight changes as the primary outcomes.