Monroe

Researchers are evaluating the safety, tolerability, and effectiveness of CYB003, a deuterated psilocin analog, compared to a matching placebo as an additional treatment for people with Major Depressive Disorder (MDD). The study focuses on adults aged 18 to 85 who have moderate to severe depression and have not responded adequately to a stable antidepressant medication. This phase III trial aims to add knowledge about treating MDD by assessing CYB003 alongside current antidepressants and psychological support. Participants are randomly assigned to one of two groups. One group receives 16 mg of CYB003 in two dosing sessions spaced about three weeks apart, while the other group receives a placebo on the same schedule. All participants continue their current antidepressant treatments and receive manualized psychological support throughout the study. Those who do not respond to placebo may join a later extension trial to receive CYB003. Throughout the trial, participants undergo several assessments, including the Montgomery-Åsberg Depression Rating Scale (MADRS) at multiple time points from screening to 42 days after treatment begins. Other evaluations include the Beck Depression Inventory, Clinical Global Impression Scale, Generalized Anxiety Disorder scale, and Quality of Life questionnaire. Participants are monitored for safety, treatment response, and tolerability, with the total study period lasting around six weeks after dosing begins.

Researchers are evaluating molnupiravir, a study medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 in adults who are at high risk. This trial focuses on people who may not be able to take certain other COVID-19 treatments due to availability or potential drug interactions. The study aims to compare molnupiravir with a placebo to understand if it reduces hospitalization, death, or medically attended visits related to COVID-19. Participants are randomly assigned to receive either 800 mg of molnupiravir or a matching placebo orally every 12 hours for 5 days, totaling 10 doses. Some participants may also receive remdesivir as part of standard care if it is clinically appropriate and available. The study is double-blind, meaning neither participants nor researchers know who receives the active drug or placebo. During the study, participants will be monitored for up to 29 days to track hospitalizations, deaths, and adverse events. Researchers will assess symptoms, viral levels, and any medical interventions related to COVID-19. Safety will be followed for approximately five months, including any side effects or reasons for stopping the study treatment. The total time commitment varies, with regular assessments and monitoring to understand the treatment's effects and safety.

Researchers are evaluating whether two drugs, retatrutide and tirzepatide, can prevent serious liver problems in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk based on non-invasive tests. This Phase 3 randomized clinical trial plans to enroll about 4,500 adults and will last approximately 224 weeks, including up to 25 to 30 clinic visits to monitor health and liver disease progression. The study is sponsored by Eli Lilly and Company. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. After completing the main study, eligible participants may join a 2-year extension where everyone receives either retatrutide or tirzepatide, regardless of their original group. This Master Protocol evaluates multiple pharmacologic agents under controlled conditions. Throughout the study, participants will undergo various assessments including liver function tests, imaging to measure liver stiffness and fat content, and body weight measurements. Researchers will track the time to major adverse liver outcomes and cardiovascular events. Safety and disease progression will be closely monitored, and the study includes evaluations at baseline, week 104, and up to study completion.

Researchers are conducting a Phase 2 clinical trial to evaluate the safety and effectiveness of several investigational treatments for chronic weight management in adults with obesity or overweight. This master protocol study includes multiple intervention-specific appendices (ISAs) that allow for independent assessment of each treatment as they become available. The study aims to establish entry criteria and report results after all ISAs are completed. Participants will be randomly assigned to receive one of several treatments or a placebo. These treatments include LY3305677, LY3841136, tirzepatide, LY3549492, LY3532226, macupatide, and eloralintide, administered either by subcutaneous injection or orally, depending on the specific ISA. Each ISA provides detailed analysis of its respective intervention. During the study, participants will be monitored from baseline through week 6 to assess how many are allocated to each ISA. The trial uses a double-blind design to ensure unbiased results. Participants will be assessed regularly throughout their involvement, which lasts until the completion of all ISAs. Safety and efficacy data will be collected and analyzed throughout the trial.

Researchers are evaluating AMG 691, a drug given by subcutaneous injection, in a Phase 1 clinical trial to assess its safety and tolerability in healthy adults and adults with mild-to-moderate asthma. The study compares single and multiple doses of AMG 691 to placebo. It involves healthy participants and participants with asthma to better understand how the drug behaves in the body and its effects. The trial is randomized and double-blind, with healthy participants assigned in a 3:1 ratio to receive AMG 691 or placebo and asthma participants assigned in a 2:1 ratio. The study has different parts including single ascending dose, multiple ascending dose, and multiple dose periods. Each participant receives subcutaneous injections of either AMG 691 or placebo according to their group assignment. Participants will undergo medical evaluations, including lung function tests and blood tests, to monitor safety and drug effects over approximately 11 months. Researchers will track treatment-emergent adverse events and measure drug concentration in the blood. The study includes follow-up visits to assess safety and tolerability over time, ensuring comprehensive monitoring of participants throughout the trial.

Researchers are studying the safety and effects of combined doses of ensifentrine and glycopyrrolate in adults with chronic obstructive pulmonary disease (COPD). This Phase IIb trial compares two doses of the combination to each drug alone and to a placebo, aiming to evaluate their ability to improve lung function in adults aged 40 to 80 years with COPD symptoms and a history of smoking. Participants will be randomly assigned to one of six groups: two groups will receive fixed combinations of ensifentrine 3 mg with either 21.25 mcg or 42.5 mcg glycopyrrolate; two groups will receive glycopyrrolate alone at one of the two doses; one group will receive ensifentrine alone; and one group will receive a placebo. All treatments are inhaled twice daily using a standard jet nebulizer over a 28-day period. The study lasts about seven weeks, including 1 to 2 weeks for screening, 4 weeks of treatment, and a 1-week follow-up. Participants will undergo lung function tests measuring forced expiratory volume in one second (FEV1) at various time points and complete questionnaires about symptoms and quality of life. Researchers will monitor safety, lung function changes, symptom improvements, and adverse events throughout the study.

Researchers are evaluating the effect of AZD0780, an oral PCSK9 inhibitor, compared with a placebo in reducing the risk of major adverse cardiovascular events plus (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or at high risk for a first ASCVD event. This phase 3, randomized, placebo-controlled, and double-blind study aims to assess the time to first MACE-PLUS event over up to approximately 54 months from randomization until the primary analysis censoring date. Participants will be randomly assigned to receive either oral AZD0780 once daily or an oral placebo once daily. The study includes a parallel-group design with two arms: the experimental AZD0780 group and the placebo comparator group. After the primary analysis censoring date, a study closure visit will be scheduled as the final visit for each participant. During the study, participants will be monitored for the occurrence of cardiovascular events including myocardial infarction, stroke, urgent coronary revascularization, cardiovascular death, major adverse limb events, and all-cause mortality. Researchers will assess these events through regular follow-up visits up to approximately 54 months. The study includes detailed safety monitoring and outcome evaluations to understand the effects of AZD0780 compared to placebo in this population at risk for cardiovascular events.

Researchers are evaluating disitamab vedotin, alone or combined with pembrolizumab, to treat HER2-expressing urothelial cancer that has either spread locally and cannot be removed or has metastasized throughout the body. This phase 2 clinical trial aims to assess how well these treatments work and how safe they are for participants with this type of advanced cancer. The study includes several groups receiving either disitamab vedotin alone given intravenously every two weeks or in combination with pembrolizumab administered intravenously on the first day of each six-week cycle. Different cohorts represent variations in prior treatment history and tumor HER2 expression levels. The trial also includes specific cohorts in Japan and evaluates both monotherapy and combination therapy approaches, with treatment continuing for about two years. Participants will undergo regular assessments including tumor measurements by imaging using standardized criteria, monitoring for side effects, laboratory tests, heart function evaluations, and analysis of drug levels in the body. Safety and response to treatment will be tracked during the treatment period lasting up to two years, with an overall study duration of about three years to observe outcomes such as survival and disease control.

Researchers are studying the effects of eloralintide in adults who are obese or overweight but do not have type 2 diabetes. The study aims to evaluate how well and how safely eloralintide works in this group. This phase 3 trial is sponsored by Eli Lilly and Company and includes adults with specific weight-related health conditions or a history of unsuccessful weight loss efforts. Participants in this randomized, double-blind study will receive weekly subcutaneous injections of eloralintide at one of four doses or a placebo. The main phase lasts about 75 weeks, during which participants are monitored closely. Those with prediabetes at the start may continue in an extension phase for an additional two years to further assess long-term effects. Throughout the study, participants will undergo various assessments including body weight, body fat mass, waist circumference, blood pressure, blood markers like triglycerides and HbA1c, and quality of life questionnaires. Researchers will track changes from baseline at week 64 and monitor the onset of type 2 diabetes up to week 191. Safety and medication use will also be observed, ensuring comprehensive evaluation over the course of participation.

Researchers are evaluating the drug RTN-001 in adults with uncontrolled hypertension to see if it can lower high blood pressure and to assess its safety. This Phase 2b, randomized, double-blind study includes patients aged 18 to 70 years who have uncontrolled hypertension despite taking two or more antihypertensive medications. The study also stratifies patients by medication use, sex, and race to better understand the treatment effects across groups. The trial has three periods: Screening, Run-in, and Treatment. After initial screening, patients enter a 14-day Run-in Period to assess compliance and baseline blood pressure using 24-hour ambulatory monitoring. Eligible patients are then randomly assigned to one of four groups to receive daily oral RTN-001 at doses of 15, 30, or 45 mg, or a matching placebo for 12 weeks. Study visits occur approximately every two weeks, including blood pressure measurements and blood sampling for safety and drug level assessments. Two weeks after treatment ends, a follow-up call checks for adverse events and medication changes. Participants will visit the clinic about every two weeks for checkups and tests, including peripheral and central blood pressure measurements and blood draws. They will keep diaries of symptoms and medications throughout the study. Researchers will measure changes in systolic blood pressure at 4 weeks as the main outcome, along with several secondary blood pressure measures during and after treatment. Safety reviews may occur during the trial, and overall participation lasts from screening through the follow-up call approximately 14 weeks after treatment starts.