Seabrook

Researchers are evaluating the safety and tolerability of Efimosfermin Alfa in adults aged 18 to 75 years who have known or suspected metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis at stage F2 or F3. This Phase 3, randomized, double-blind, placebo-controlled study focuses on participants with non-alcoholic fatty liver disease and metabolic syndrome components, aiming to better understand treatment effects in this population. Participants will receive either Efimosfermin Alfa injection or a placebo, with the study designed as a three-arm trial. The treatment will be administered according to the study protocol, though specific dosing details are not provided. The study will monitor participants over a period extending to at least 52 weeks, comparing the safety and tolerability of Efimosfermin Alfa against placebo. During the study, participants will be closely observed through clinical assessments including monitoring for treatment-emergent adverse events (TEAEs), laboratory tests to detect Grade 3 and Grade 4 abnormalities, and evaluation of any adverse events leading to discontinuation of treatment. These safety and tolerability measures will be recorded at Week 52, helping researchers assess the impact of Efimosfermin Alfa over time.

This research aims to evaluate the safety and effectiveness of efimosfermin alfa in improving liver fibrosis and resolving steatohepatitis in adults with metabolic dysfunction-associated steatohepatitis (MASH) confirmed by biopsy showing stage F2 or F3 fibrosis. The study compares efimosfermin alfa to a placebo and focuses on individuals with confirmed liver damage and metabolic syndrome features. Participants will receive either efimosfermin alfa or placebo, administered as a drug treatment. The study is designed as a phase 3, randomized, double-blind, placebo-controlled trial with three groups. Treatment effects will be assessed over 52 weeks, with a primary focus on liver fibrosis and steatohepatitis changes. The study includes long-term monitoring of liver-related clinical outcomes up to 48 months after randomization. During the study, participants will undergo liver biopsies confirmed by central pathology review, and researchers will monitor liver function and fibrosis improvement. Outcome measures include the proportion of participants showing fibrosis improvement without worsening steatohepatitis, resolution of steatohepatitis with stable fibrosis, and time to liver-related clinical events. Safety and efficacy will be closely evaluated throughout the treatment and follow-up periods.

This research aims to evaluate the efficacy and safety of PRAX-628 in adults diagnosed with focal onset seizures or primary generalized tonic-clonic seizures. Participants must be currently taking between one and three anti-seizure medications. The trial focuses on adults aged 18 to 75 years and investigates the effect of PRAX-628 on seizure frequency over an eight-week period. Participants in the trial receive 30 mg of PRAX-628 once daily by mouth. This open-label study involves adults who continue their stable anti-seizure medication regimens while taking the study drug. The study does not include a placebo or comparator group and is conducted over a defined observation period. During the study, participants will be monitored for changes in seizure frequency. Researchers will assess safety and efficacy through clinical evaluations, including seizure counts reported by participants or caregivers. The study includes imaging evidence to rule out progressive causes of epilepsy prior to enrollment and collects data on adverse events and medication adherence. The total duration and specific follow-up assessments are designed to capture the impact of PRAX-628 on seizure control and participant safety.

PRAX-628-321 (POWER1) is a double-blind, randomized, multicenter, trial to evaluate the efficacy and safety of PRAX-628 in adults who can attest to concurrently taking at least 1, but no more than 3 acceptable anti-seizure medications.

Researchers are evaluating the effects of clofutriben, an 11-hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor, in patients with type 2 diabetes who have elevated cortisol levels. This Phase 2, multicenter, randomized, double-blind, placebo-controlled trial aims to understand how different doses of clofutriben may improve blood sugar control and to identify suitable doses for future studies. The trial includes two parts: an initial screening phase and a treatment phase. The screening phase lasts about 5 to 9 weeks and involves assessing eligibility, performing a dexamethasone suppression test, and further evaluations. Eligible participants are then randomly assigned to receive either placebo or one of four doses of clofutriben during the 24-week treatment phase. After completing treatment, participants receive a follow-up phone call four weeks later to check on their status. Participants will undergo various assessments during the study, including measuring morning serum cortisol and plasma dexamethasone levels after a dexamethasone dose, as well as changes in glycated hemoglobin A1c over 24 weeks. Researchers will monitor medication adherence, laboratory results, and safety throughout the study. The total participation duration includes the screening period and the 24-week treatment, followed by the post-treatment follow-up.