Inverness

Researchers are evaluating the safety and tolerability of Efimosfermin Alfa in adults with known or suspected metabolic dysfunction-associated steatohepatitis MASH with fibrosis at stages F2 or F3. This phase 3 clinical trial aims to understand how participants respond to this treatment compared to a placebo, focusing on managing this liver condition characterized by metabolic syndrome components and liver fibrosis. Participants will be randomly assigned to one of three groups two groups receiving different dose levels of Efimosfermin Alfa and one group receiving a placebo. The study involves administering the drug or placebo injections over a period of up to 52 weeks. Researchers will monitor participants throughout this time to assess the drugs effects and tolerability. During the study, participants will undergo regular assessments including laboratory tests for liver enzymes and fibrosis markers, imaging tests such as magnetic resonance elastography and MRI-derived fat fraction measurements, and evaluations of metabolic factors like blood sugar and cholesterol. Safety will be closely monitored by tracking adverse events and laboratory abnormalities. The total participation time is about one year, during which participants will have scheduled visits for treatment and evaluation.

Researchers are evaluating whether retatrutide and tirzepatide can prevent major adverse liver outcomes in adults with metabolic dysfunction-associated steatotic liver disease MASLD who are at high risk based on non-invasive tests. This Phase 3 randomized controlled trial aims to assess these treatments compared to placebo in about 4,500 adults over approximately 224 weeks. The study is sponsored by Eli Lilly and Company and focuses on liver disease progression and related health measures. Participants will be randomly assigned to receive retatrutide, tirzepatide, or placebo, all administered by subcutaneous injection. The trial includes two placebo groups corresponding to each experimental drug. After completing the main study, eligible participants may join a 2-year extension where all will receive either retatrutide or tirzepatide regardless of their initial assignment. During the study, participants may attend around 25 to 30 clinic visits for health monitoring, study procedures, and assessments of liver function and disease status. Researchers will measure the time to major adverse liver outcomes, changes in liver fibrosis scores, liver stiffness, liver fat content, liver enzyme levels, body weight, and cardiovascular events. Monitoring will continue from baseline through study completion, with detailed evaluations at multiple timepoints including week 104.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating efimosfermin alfa in adults with biopsy-confirmed metabolic dysfunction-associated steatohepatitis MASH and stage F2 or F3 liver fibrosis. The study aims to assess the safety and effectiveness of efimosfermin alfa compared to a placebo in resolving steatohepatitis and improving liver-related clinical outcomes. This Phase 3 trial is randomized, double-blind, and placebo-controlled, focusing on participants with specific liver conditions and metabolic syndrome components. Participants are assigned to one of three groups two groups receive different dose levels of efimosfermin alfa, while the third group receives a placebo. Treatments are given under controlled conditions, and the study follows a parallel design. The trial monitors participants at set intervals over a course of 52 weeks, with some outcomes tracked up to 48 months to evaluate long-term effects on liver fibrosis and steatohepatitis. During the study, participants undergo liver biopsies to confirm diagnosis and assess changes. Researchers evaluate improvements in fibrosis stage, steatohepatitis resolution, and various liver function measurements using imaging and blood tests. Safety is monitored by tracking adverse events and laboratory abnormalities. Quality of life and other health indicators are also assessed throughout the study, which lasts several years to capture both short- and long-term outcomes.

Researchers are evaluating oral icotrokinra as a treatment for adults and adolescents with moderately to severely active ulcerative colitis, a chronic inflammatory disease of the large intestine causing ulcers in the colon lining. The study aims to assess how well icotrokinra works, along with its safety and tolerability in this population. This is a Phase 3, randomized, double-blind, placebo-controlled trial with a parallel group design including both adults and adolescents. Adult participants will be randomly assigned to receive either icotrokinra or placebo daily by mouth during a 12-week induction phase. At Week 12, those showing clinical response will enter a maintenance phase where they will continue icotrokinra or placebo daily for 40 weeks. Adults who do not respond will also enter the maintenance phase and receive icotrokinra. Adolescents will receive open-label icotrokinra during induction and then continue on icotrokinra during maintenance regardless of response. After completing the 40-week maintenance phase, eligible participants may join a long-term extension study. Participants will be monitored regularly through clinical assessments at specified time points including Week 12 for induction and Week 40 for maintenance. Outcomes measured include rates of clinical remission, symptom improvement, endoscopic and histologic healing, and quality of life scores. Safety will be evaluated by tracking adverse and serious adverse events throughout the study. The total study duration may extend up to approximately 6 years, ending in 2032, allowing long-term evaluation of icotrokinra in ulcerative colitis management.

Researchers are evaluating the safety, tolerability, and pharmacokinetics of the drug HJB647 in people with chronic stable heart failure who have reduced or mildly reduced ejection fraction HFrEFHFmrEF. This Phase 1 trial is designed as a multi-center, randomized, participant- and investigator-blinded, placebo-controlled crossover study to better understand how two different doses of HJB647 affect these participants. The study includes participants with stable heart failure under standard care with sacubitrilvalsartan therapy. Participants are randomly assigned to one of three treatment sequences, each lasting 3 days, which include two different doses of HJB647 and a placebo, all given as capsules by mouth. During the dosing period, participants stay in a controlled setting for close monitoring. Following the dosing, there is an in-clinic follow-up visit on Day 7 and a safety phone call on Day 33 to monitor any adverse events or vital sign changes. Throughout the study, participants undergo monitoring to track adverse events and changes in vital signs up to 33 days. Pharmacokinetic measurements such as maximum drug concentration, time to reach maximum concentration, and area under the concentration-time curve are collected up to 7 days. The study lasts approximately one month, including dosing, follow-up visits, and safety assessments to evaluate the drugs behavior and tolerability in this patient group.

Researchers are evaluating efruxifermin EFX in a phase 3, randomized, double-blind, placebo-controlled study involving adults with compensated cirrhosis caused by NASH Nonalcoholic Steatohepatitis or MASH Metabolic Dysfunction-Associated Steatohepatitis. This study aims to assess the safety and effectiveness of EFX in preventing significant clinical events such as disease progression and liver decompensation over a period of up to 5 years. Participants are randomly assigned to receive either efruxifermin 50 mg or a placebo, both given by subcutaneous injection. The study includes two cohorts one with biopsy-proven compensated cirrhosis and specific metabolic scores, and another with biopsy-proven or non-invasive diagnosis of compensated cirrhosis. The study treatment and monitoring extend up to 5 years, with evaluations at 96 weeks and long-term follow-up to track liver fibrosis, markers of liver injury, insulin sensitivity, glycemic control, body weight, and safety outcomes. During the trial, participants undergo regular assessments including laboratory tests, ECGs, ultrasounds, and vital sign monitoring. Researchers will measure changes in liver fibrosis, steatohepatitis resolution, and metabolic markers throughout the study. Safety and tolerability are closely tracked by documenting adverse events and exposure duration. The study duration allows for long-term observation of treatment effects and disease progression, with participant involvement lasting up to 5 years.

Researchers are evaluating efruxifermin EFX in adults with non-cirrhotic nonalcoholic steatohepatitis NASH or metabolic dysfunction-associated steatohepatitis MASH who have liver fibrosis stage 2 or 3. This Phase 3, multi-center, randomized, double-blind, placebo-controlled study aims to assess the safety and efficacy of EFX compared with placebo. The trial includes about 1,650 participants divided into two cohorts based on liver biopsy characteristics and fibrosis stage. Participants will be randomly assigned to one of three groups EFX 28 mg, EFX 50 mg, or placebo, each given as a weekly subcutaneous injection. Cohort 1 will be evaluated over 52 weeks for histologic efficacy endpoints, while Cohort 2 will have assessments over 96 weeks. After these periods, participants may continue long-term treatment and clinical follow-up for up to approximately 240 weeks total. A follow-up visit will occur about 30 days after the last dose. During the study, participants will undergo liver biopsies, blood tests, and non-invasive assessments such as FibroScan and Enhanced Liver Fibrosis ELF score to monitor liver health and fibrosis. Researchers will track liver-related clinical outcomes, including liver events and survival, as well as safety and tolerability of the treatment. Participants who stop the study drug may still continue with scheduled assessments to support long-term safety and efficacy evaluations.

Researchers are evaluating the efficacy and safety of eloralintide compared with placebo for reducing body weight in adults with overweight or obesity who also have type 2 diabetes. This phase 3 study is designed to assess the treatments effects over a course of about 75 weeks, aiming to provide insights into managing weight in this population. Participants are randomly assigned to receive one of several doses of eloralintide or a placebo, all administered by weekly subcutaneous injections. The study involves a double-blind design, meaning neither participants nor researchers know which treatment is given. The treatment period lasts 64 weeks, during which body weight and other health measures are closely monitored. Participants will undergo regular assessments including measurements of body weight, fat mass, waist circumference, blood sugar control HbA1c, blood pressure, and other health indicators. Questionnaires about quality of life and eating behavior are also used. Safety and medication use changes are tracked throughout. Participation includes screening, treatment, and follow-up visits over the total duration of about 75 weeks.

Researchers are evaluating icotrokinra for its effectiveness and safety in people with moderately to severely active Crohns disease, a condition causing severe inflammation in the intestines. This clinical trial is a Phase 2b3 study aiming to understand how well icotrokinra works compared to placebo to improve symptoms and intestinal healing. Participants will be randomly assigned to receive one of several treatments two different doses of icotrokinra or a matching placebo, taken orally every day during an induction period of up to 12 weeks. Based on their response at Week 12, participants may continue with maintenance dosing or placebo up to Week 40. Those completing the maintenance phase may join a long-term extension study for further evaluation. During the trial, participants will be monitored with clinical assessments, endoscopy, and patient-reported outcomes to measure response, remission, and safety. The main outcomes include clinical response and remission at Weeks 12 and 40, along with endoscopic healing. Safety will be tracked through adverse event reporting up to four weeks after the last dose. The study is expected to continue until 2032, with multiple visits for treatment and evaluations throughout.