Montclair

Researchers are evaluating the safety, tolerability, and effectiveness of CYB003, a Deuterated Psilocin Analog, compared to a placebo when added to current antidepressant treatment in adults with moderate to severe Major Depressive Disorder (MDD). This Phase III trial focuses on participants aged 18 to 85 years who have had inadequate response to a stable antidepressant dose, aiming to better understand how CYB003 might improve depressive symptoms. Participants receive oral doses of CYB003 or matching placebo along with manualized psychological support provided by trained facilitators. The treatment period includes multiple dosing sessions with monitoring and assessments throughout. Placebo is used as a comparator to evaluate the combined safety and efficacy of CYB003 in this population. During the study, participants undergo evaluations using the Montgomery-Åsberg Depression Rating Scale (MADRS) at several time points, including screening, baseline, and multiple days up to the end of treatment at Day 42. Researchers monitor symptoms, side effects, and overall safety. Participants provide informed consent and are assessed regularly to track changes in depression severity and any adverse events over the course of the study.

Researchers are evaluating the safety and effectiveness of enicepatide, a dual GLP-1/GIP receptor agonist, for managing weight in adults with obesity or overweight who also have Type 2 diabetes mellitus (T2DM). This Phase III study compares multiple doses of enicepatide to a placebo to understand its impact on weight loss in this population. Participants receive either enicepatide or a placebo once weekly through an integrated drug-device combination. The study uses a randomized, double-blind, placebo-controlled design to assess the effects of the treatment. The placebo is volume-matched and administered using the same method as the active drug. During the study, participants will have their body weight changes measured up to week 72 to assess efficacy. Researchers will monitor weight changes as the primary outcome. Participants must be able to self-administer the injections or receive them from a trained individual, and their safety and adherence will be observed throughout the study period.

Researchers are studying the effects of zelquistinel, a drug being evaluated for treating major depressive disorder (MDD) in adults aged 18 to 64 years. This Phase 2 clinical trial aims to find out if zelquistinel can reduce depression symptoms compared to a placebo and to assess its safety. Participants diagnosed with MDD and meeting specific severity criteria will be enrolled to better understand the drug's impact on depression scores and potential side effects. Participants will be randomly assigned to receive either zelquistinel or a placebo tablet once a week for six weeks. The study is double-blind and placebo-controlled, meaning neither participants nor researchers know who receives the active drug. The trial includes up to 28 days of screening, a 42-day treatment period with weekly clinic visits, and a 4-week follow-up phase. During visits, depression severity is measured using the Hamilton Depression Rating Scale-17 (HDRS-17). Throughout the study, participants will attend weekly clinic visits for depression assessments and monitoring of adverse events. Researchers will track changes in depression scores from baseline to six weeks to evaluate effectiveness. Safety evaluations and follow-up assessments continue for four weeks after treatment. The total participation time may last up to 98 days, including screening, treatment, and follow-up.

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 safety and effectiveness of solbinsiran in reducing triglycerides and other fat-related measures in adults with severe hypertriglyceridemia. This phase 2 study compares solbinsiran to a placebo to better understand its potential benefits and risks in this condition. Participants will receive two subcutaneous injections of either solbinsiran or a placebo. The study is randomized and double-blind, meaning neither the participants nor the researchers know who receives the actual drug or placebo during the treatment period. Participants will be monitored for changes in their triglyceride levels from baseline through weeks 16 to 24. The study tracks safety and efficacy by measuring lipid changes and observing any side effects. The total duration of participation includes screening and treatment phases with regular assessments throughout the study.

Bipolar disorder is a serious, long-lasting mood disorder affecting adults and children in the United States. This study evaluates the safety and effectiveness of Icalcaprant, an investigational oral medication, in adults with bipolar I or II disorder who are experiencing depressive episodes. The trial is a Phase 2, double-blind, placebo-controlled study involving about 195 adult participants across approximately 35 U.S. sites. Participants are randomly assigned to one of three groups, including a placebo group, to receive oral capsules of either Icalcaprant or placebo once daily for 6 weeks. Following treatment, there is a 4-week safety follow-up period to monitor participants' health and any side effects. The study assesses changes in depression severity using the Montgomery-Åsberg Depression Rating Scale (MADRS) and tracks any adverse events during the approximately 10-week period. Throughout the trial, participants will visit clinics or hospitals regularly for medical assessments, blood tests, and questionnaires to monitor their condition, side effects, and overall health. Researchers will measure the change in depression symptoms from baseline to Week 6 and record any adverse events up to about 10 weeks. Participants' treatment adherence and safety are closely observed during the study and follow-up periods.

Researchers are conducting a Phase 2, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of the oral drug ML-007C-MA in adult inpatients aged 18 to 64 years who have schizophrenia and are experiencing a sudden worsening of psychosis. The study aims to compare ML-007C-MA to a placebo in treating symptoms of schizophrenia that are not well controlled, with effectiveness measured by changes in the Positive and Negative Syndrome Scale (PANSS) total score. Participants will be assigned to one of three groups: one receiving ML-007C-MA twice daily at a dose of 210/3 mg, another receiving ML-007C-MA once daily at 330/6 mg, and a third group receiving a matched placebo. The treatment period lasts 5 weeks, during which participants remain in an inpatient setting. The study is designed to maintain blinding and closely monitor participants' response to the treatments. Throughout the study, participants will undergo evaluations at the start and end of treatment, including assessments using the PANSS to measure schizophrenia symptoms. Researchers will monitor safety, tolerability, and any side effects while participants remain hospitalized and under observation for the full study duration. The main measure of success is the change in PANSS total score from baseline to the end of treatment after 5 weeks.

Researchers are evaluating the long-term safety and tolerability of KarXT in treating mania or mania with mixed features in adults with Bipolar-I disorder. This phase 3, open-label extension study aims to better understand how KarXT performs over an extended period in this population. The study includes participants who either completed previous double-blind placebo-controlled studies or are newly diagnosed with Bipolar-I disorder experiencing manic symptoms. Participants receive KarXT at specified doses on certain days, with some also taking therapeutic doses of Lithium, Valproate, or Lamotrigine as part of their treatment. The study does not mention a placebo group during this extension, focusing instead on monitoring the long-term effects of KarXT alone or in combination with these established therapies. During the study, participants are monitored for adverse events up to week 54 to assess safety. Evaluations include psychiatric assessments using scales such as the Young Mania Rating Scale and CGI-BP score at screening and baseline. Researchers will track treatment-emergent adverse events and overall tolerability throughout the study duration, which lasts up to 54 weeks for each participant.

Researchers are evaluating ALN-4324 in overweight to obese adults, including healthy volunteers and patients with type 2 diabetes mellitus (T2DM). This two-part Phase 1/2 study aims to assess the safety, tolerability, and pharmacokinetics of single ascending doses in healthy volunteers and the efficacy, safety, tolerability, and pharmacodynamics of multiple doses in patients with T2DM. The trial focuses on understanding how ALN-4324 works and its effects in these groups. ALN-4324 and placebo are both given as subcutaneous injections. In Part A, single doses of ALN-4324 are administered to overweight to obese healthy volunteers to evaluate safety and drug behavior over up to 9 months. Part B involves multiple doses given to overweight to obese patients with T2DM, with monitoring up to 12 months to study effects on diabetes and overall safety. During the study, participants will undergo regular assessments to monitor safety and tolerability, including tracking any adverse events. The study also measures pharmacokinetics and pharmacodynamics to understand the drug's action in the body. Participants' body mass index, diabetes control, and medication use will be closely observed. The trial includes a placebo group for comparison and lasts up to 12 months depending on the study part.

Researchers are evaluating the safety and effectiveness of adding KarXT (Xanomeline/Trospium Chloride) to standard treatment for mania in adults with Bipolar-I Disorder. This Phase 3, randomized, double-blind study focuses on individuals experiencing acute manic episodes, with or without mixed features, who are already taking lithium, valproate, or lamotrigine. The study aims to measure changes in mania symptoms using the Young Mania Rating Scale at Week 5. Participants will be randomly assigned to receive either KarXT or a placebo alongside their stable dose of lithium, valproate, or lamotrigine. The doses of these medications are specified and given on set days during the study. Only those with stable mood stabilizer doses for at least two weeks prior to screening, and valproate treatment for at least seven months, are eligible. The treatment period lasts for 5 weeks. During the study, participants will be closely monitored through psychiatric evaluations and clinical assessments. Researchers will assess mania severity, safety, and any side effects. The main outcome is the change from baseline in the Young Mania Rating Scale score at Week 5. Participants’ physical health, including liver function and risk of urinary or gastrointestinal issues, will also be monitored to ensure safety throughout the trial.