Seabrook

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 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.

This research aims to evaluate the efficacy and safety of PRAX-628 in adults with focal onset seizures or primary generalized tonic-clonic seizures who are currently taking between one and three anti-seizure medications. The study is an open label clinical trial designed to assess how well PRAX-628 controls seizure frequency and its tolerability in this population. Participants who qualify will receive 30 mg of PRAX-628 orally once daily for a period of 8 weeks. This single treatment group will allow researchers to observe the effects of PRAX-628 without a placebo or comparison group. The study focuses on adults aged 18 to 75 years and excludes those with certain medical histories or conditions that might interfere with the trial. During the 8-week treatment, participants will be monitored for seizure frequency and changes in clinical global impressions of severity as well as patient global impressions. Safety and tolerability will be carefully tracked throughout the study. The main outcome is the change in seizure frequency, with additional assessments of symptom severity and side effects. Participation involves regular visits and evaluations to ensure thorough monitoring of responses to PRAX-628.

Researchers are evaluating the drug clofutriben, an 11-hydroxysteroid dehydrogenase type 1 HSD-1 inhibitor, in adults with type 2 diabetes who have elevated cortisol levels. This Phase 2 trial aims to understand how different doses of clofutriben affect blood sugar control and to find suitable doses for further studies. The trial involves two parts an initial screening phase and a treatment phase, conducted in multiple centers with participants randomly assigned to groups. The first part, lasting about 5 to 9 weeks, includes screening tests such as the dexamethasone suppression test to identify eligible participants with elevated cortisol. In the second part, participants are randomly assigned to receive either placebo or one of four doses of clofutriben taken once daily by mouth for 24 weeks. After treatment, a follow-up phone call occurs 4 weeks later to check on participants. Participants will undergo various assessments including blood tests to measure cortisol levels and blood sugar control glycated hemoglobin A1c and fasting plasma glucose. The study monitors changes in these measures from baseline through the 24-week treatment period. The trial also tracks safety and treatment adherence. Total participation time includes screening, a 24-week treatment, and a follow-up period, extending to the trials completion date in mid-2028.