Monroe

Researchers are evaluating molnupiravir, an oral medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 in people at high risk of disease progression. The study focuses on adults with confirmed COVID-19 infection who are at increased risk due to age, medical conditions, or other factors. This is a Phase 3 randomized, placebo-controlled, double-blind clinical trial led by Merck Sharp & Dohme LLC. Participants will be randomly assigned to receive either molnupiravir or a matching placebo. Those in the molnupiravir group will take 800 mg orally every 12 hours for 5 days, totaling 10 doses. The same dosing schedule applies to the placebo group. Some participants may also receive remdesivir as part of standard care if clinically appropriate. During the study, participants will be monitored for up to 29 days to assess outcomes such as hospitalization, death, or medically attended visits related to COVID-19. Safety will be evaluated by tracking adverse events and discontinuation due to side effects. Researchers will also measure symptom relief, viral RNA levels, and other health indicators. The study is expected to continue until January 2031.

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.

This research focuses on adults with obesity or overweight and aims to evaluate the safety and effectiveness of various investigational treatments for chronic weight management. It is a Phase 2 master protocol study that uses a framework to test multiple interventions, each detailed in separate appendices. The study establishes criteria for enrolling new participants and reports results when all intervention appendices have completed. Participants may receive different investigational drugs administered either by subcutaneous injection or orally, including LY3305677, LY3841136, tirzepatide, LY3549492, and others. Each intervention-specific appendix outlines the particular treatment details and analyses. Some participants receive placebos matching the administration method of the active treatments. Treatments and analyses are conducted in parallel groups, and interventions may start independently as they become available. Throughout the study, participants undergo screening to confirm eligibility and are randomly assigned to one of the intervention groups or placebo. Researchers monitor participant allocation up to week 6. The trial emphasizes double-blind procedures, and participant involvement includes receiving study treatments and attending scheduled visits. Safety and efficacy data are collected, and the study is planned to continue until early 2028, with primary outcome measures focusing on participant allocation to interventions.

Researchers are evaluating the safety and tolerability of an oral drug called ERX1000 in adults with obesity. The study includes men and women aged 18 to 60 years with a body mass index BMI between 30 and 50 kgm2. The trial is a randomized, double-blind, placebo-controlled Phase 2A study designed to compare ERX1000 with a placebo in people living with obesity. Participants will be assigned to receive either ERX1000 or a placebo. ERX1000 is given as a 2 mg tablet taken orally twice a week. The treatment period lasts for 24 weeks, during which participants take the assigned tablets regularly. The study monitors safety and tolerability while assessing changes in body weight and other metabolic markers. Throughout the trial, participants will have regular assessments to measure changes in body weight, body composition, and metabolic biomarkers. Safety is monitored by tracking adverse events and laboratory tests including liver function. The primary measurement focuses on body weight changes from the start of treatment to weeks 12 and 24. Participation lasts about 28 weeks in total, including follow-up after treatment ends.

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 disitamab vedotin alone or combined with pembrolizumab to treat urothelial cancer that expresses HER2. This study focuses on participants with locally advanced or metastatic urothelial cancer that cannot be removed by surgery. It aims to assess how well the drug works and to monitor the side effects experienced by participants. Participants receive disitamab vedotin intravenously every 2 weeks, either alone or with pembrolizumab given by intravenous infusion on Day 1 of each 6-week cycle. The study includes multiple cohorts receiving different combinations or monotherapy treatments. The treatment period and monitoring last approximately 2 years, with ongoing assessments of drug effects and safety. During the study, participants undergo regular evaluations including imaging scans to measure tumor response, laboratory tests, electrocardiograms to monitor heart function, and assessments of side effects. Researchers measure treatment response using established cancer evaluation criteria and track survival and disease control over about 3 years. Participants are closely monitored for adverse effects and blood levels of the drugs to understand how the treatments behave in the body.

This research aims to evaluate whether participants who previously took donanemab receive clinical benefits from annual doses of the drug. The study focuses on individuals with Alzheimer Disease, Dementia, and Amyloid Plaque accumulation. Sponsored by Eli Lilly and Company, it is a phase 3 trial designed to assess the treatments effects over a long period. Participants are randomly assigned to receive either donanemab or a placebo through intravenous IV administration. The study follows a parallel design with double masking to compare the outcomes between the two groups. The treatment period lasts up to 2.5 years, during which participants will have six visits, including drug administration and monitoring. Throughout the study, participants will undergo evaluations such as the Clinical Dementia Rating - Sum of Boxes CDR-SB, Cognitive Function Index CFI, brain amyloid plaque imaging with Florbetapir F 18 PET scans, and plasma tests for phosphorylated tau protein. Pharmacokinetics of donanemab will be measured at baseline, week 52, and week 104. The study involves close monitoring of safety and clinical changes over the entire duration.

Researchers are studying the effectiveness and safety of eloralintide in adults who are obese or overweight but do not have type 2 diabetes. This Phase 3 trial aims to understand how eloralintide affects body weight and related health measures over a long period. The study includes a main phase and an extension phase for those with prediabetes to evaluate ongoing effects. Participants are randomly assigned to receive one of four doses of eloralintide or a placebo, all given by subcutaneous injection once weekly. The main phase lasts about 75 weeks, and participants with prediabetes may continue in an extension phase for an additional two years. This structure allows researchers to assess both short-term and longer-term outcomes. During the study, participants will have regular visits to measure body weight, body fat, waist size, blood pressure, blood markers like triglycerides and insulin, and quality of life questionnaires. Safety and treatment effects are monitored throughout. The main outcome is the percent change in body weight from the start to week 64, with follow-up continuing up to week 191 for some. Overall participation can last up to several years depending on the participants health status.

Researchers are evaluating RTN-001, a drug, to see if it can reduce high blood pressure in adults with uncontrolled hypertension who are already taking multiple blood pressure medications. This Phase 2b, randomized, double-blind study involves adults aged 18 to 70 years with blood pressure above specified thresholds despite treatment with at least two antihypertensive drugs. The study compares RTN-001 to a placebo to understand its effect on blood pressure and monitor safety. Participants will undergo a screening period up to 14 days to confirm eligibility, followed by a 14-day single-blind run-in period to test compliance and baseline blood pressure measurement. Then, around 280 patients will be randomly assigned to one of four groups to receive daily oral doses of RTN-001 at 15 mg, 30 mg, 45 mg, or placebo for 12 weeks. Blood pressure and laboratory tests will be performed at multiple visits, and ambulatory blood pressure monitoring will occur twice during treatment. After treatment ends, a follow-up phone call will assess any side effects or medication changes. During the study, participants will visit the clinic approximately every two weeks for blood pressure checks, blood sampling, and other assessments. They will keep a diary of symptoms and medications taken. Researchers will measure changes in systolic and diastolic blood pressure using office and ambulatory methods, evaluate drug levels and safety markers, and monitor adverse effects. The total participation includes screening, run-in, treatment, and a follow-up phone call about two weeks after treatment ends.

Researchers are studying the safety and effects of two drugs, PF-08653945 and PF-08653944, given alone or together for weight loss in adults with overweight or obesity. This Phase 2b trial compares these drugs to a placebo to better understand their impact on body weight over time. The study is designed to evaluate different doses and combinations of these drugs to find the most effective approach. Participants receive subcutaneous injections of either PF-08653945 alone, PF-08653945 combined with PF-08653944, PF-08653944 alone, or a placebo. The study uses a randomized, double-blind design with multiple cohorts receiving different drug combinations or placebo. Treatments are administered as injections under the skin over a planned period of 48 weeks, with follow-up extending to 70 weeks to monitor safety and outcomes. During the study, participants will have their body weight measured at baseline and regularly through Week 48 and Week 60 to track changes. Researchers will assess the percentage of weight loss and monitor any treatment-emergent or serious adverse events up to Week 70. Participants will attend scheduled visits for injections and evaluations throughout the trial, which lasts for over a year in total.