Hamilton

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 studying pulmonary arterial hypertension PAH, a condition where lung blood vessels become thick and narrow, causing high blood pressure in the lungs and making it hard for the heart to work. PAH can cause difficulty breathing and limit activity. While standard treatments help symptoms, they do not stop the disease from worsening. This research focuses on sotatercept, a targeted therapy aimed at specific proteins involved in PAH, to learn about its long-term safety and tolerability when added to usual PAH treatments. Participants in this long-term follow-up study, who previously took part in certain sotatercept trials, may continue receiving sotatercept by subcutaneous injection every three weeks. Those coming from blinded studies start at 0.3 mgkg with possible increases up to 0.7 mgkg, while those from unblinded studies continue their current dose with possible titration to 0.7 mgkg. The study monitors participants over an extended period to assess continued effects alongside their usual PAH therapy. During the study, participants will have regular assessments including monitoring for adverse events, blood tests for blood components and chemistry, body weight, blood pressure, and ECG readings. Researchers will also evaluate exercise capacity, heart function markers, and risk scores related to PAH. The study aims to follow participants for up to approximately 7 to 8 years to understand long-term safety, treatment tolerability, and health changes while using sotatercept with standard PAH care.

Researchers are studying ARO-INHBE, a drug administered by subcutaneous injection, in adults with obesity, with and without type 2 diabetes. This Phase 12a trial evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of ARO-INHBE. The study includes participants with obesity, defined by a body mass index between 30 and 50 kgm, and those with type 2 diabetes mellitus meeting specific criteria. The study phases explore different dosing regimens and combinations with tirzepatide. The trial has three parts Part 1 assesses single and multiple ascending doses of ARO-INHBE or placebo. Part 2 and Part 3 evaluate multiple doses of ARO-INHBE alone or combined with weekly tirzepatide injections at set dosages, or matching placebos, over periods ranging up to 365 days. Dosing schedules vary by study part and include injections on specific days such as Day 1, 29, 85, 169, 253, and weekly tirzepatide from Day 15 onwards. Participants will undergo regular assessments including monitoring for treatment-emergent adverse events up to Day 365. Pharmacokinetic measurements such as plasma concentration and clearance of ARO-INHBE are taken at various timepoints. Participants are expected to adhere to stable diet and exercise routines and comply with study visits and procedures throughout the study duration. Safety and drug activity are carefully evaluated during and after treatment periods.

Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously taken nerandomilast in another study. The aim is to assess how well patients tolerate long-term treatment with nerandomilast and to evaluate whether it improves lung function and delays worsening symptoms, hospital visits, or death. This open-label extension trial is sponsored by Boehringer Ingelheim and focuses on treatment over an extended period. Participants take nerandomilast tablets for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study involves a single treatment group receiving the drug, and no placebo or comparison groups. Regular visits with doctors help monitor health and collect data during this extended treatment phase. Throughout the study, participants undergo regular lung function tests and health assessments to track any adverse events and changes in lung capacity. The main outcome measured is the occurrence of any adverse events for up to about 99 weeks. Secondary outcomes include changes in forced vital capacity and time to worsening of disease symptoms or hospitalization. The study includes ongoing safety monitoring with a total participation time of up to nearly two years.

Researchers are evaluating the long-term safety and tolerability of dazodalibep in people with Sjgrens Syndrome. This phase 3 open-label study extends previous trials by continuing to monitor participants who completed 48 weeks of treatment with dazodalibep or placebo. The study is sponsored by Amgen and aims to better understand the safety profile of dazodalibep over an extended period. Participants who finished the initial 48-week trials HZNP-DAZ-301 or HZNP-DAZ-303 will receive an assigned dose of dazodalibep intravenously for an additional 132 weeks. This extension study involves a single treatment group receiving dazodalibep without placebo, focusing on ongoing treatment effects and participant safety. During the study, participants will be monitored for treatment-emergent adverse events for up to 152 weeks. Researchers will also measure the presence of anti-drug antibodies and plasma concentrations of dazodalibep for up to 132 weeks. Participants need to be available for all study visits and procedures, with safety assessments conducted regularly throughout the long-term extension period.

This research aims to evaluate elafibranor, a study drug, compared to a placebo in adults with Primary Biliary Cholangitis PBC and cirrhosis, a liver disease causing bile duct damage and scarring. The trial focuses on whether elafibranor can better prevent worsening of the disease, including progression leading to liver transplant or death, and also assesses long-term safety and symptom impact such as itching and tiredness. Participants will be randomly assigned to take either an 80 mg tablet of elafibranor or a matching placebo tablet once daily, orally, with or without food. This double-blind treatment period can last up to 3.5 years for each participant, with tablets taken at approximately the same time each morning. The study is designed to compare these two groups over the long term. During the study, participants will undergo regular assessments including physical exams, vital signs, electrocardiograms, laboratory tests, and symptom questionnaires at intervals up to 3.5 years. Researchers will measure liver function tests, symptom scales, liver stiffness, and clinical outcomes related to disease progression. Safety is monitored through adverse event tracking and laboratory parameters, with follow-up extending to four weeks after the last dose. Overall participation may last up to 3.5 years.

Researchers are studying ZL-1503 in a phase 11b clinical trial to assess its safety, tolerability, and how the body processes the drug. The study includes both healthy adults and adults with moderate to severe atopic dermatitis AD, a skin condition characterized by inflammation and itching. This randomized, double-blind, placebo-controlled trial aims to better understand the effects of ZL-1503 in these groups. The trial has two parts Part A involves single increasing doses of ZL-1503 given to healthy volunteers, while Part B involves multiple increasing doses given to adults with moderate to severe AD. Participants will receive either ZL-1503 or a placebo. The study monitors participants closely during dosing to evaluate how the drug is tolerated and how it behaves in the body. Participants will undergo various assessments throughout the study, including monitoring for adverse events, vital signs, laboratory tests, and electrocardiograms ECGs for up to 48 weeks after the last dose. These evaluations help researchers track safety and any potential side effects. The total participation period can last up to 48 weeks following dosing to ensure thorough observation.

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.

Heart attacks occur when a blood clot blocks the hearts blood vessels, stopping blood flow to the heart muscle. This trial focuses on patients with ST-elevation myocardial infarction STEMI and looks at how microcirculatory damage can be measured using the Index of Microcirculatory Resistance IMR. The study aims to find out if treating patients with impaired microcirculatory perfusion using low-dose intracoronary thrombolytic therapy can reduce heart muscle damage and improve clinical outcomes. Participants who have had a heart attack and undergone angioplasty will have their IMR measured. Those with an IMR above 32 will be randomly assigned to receive either low-dose tenecteplase a clot-dissolving drug or a placebo sterile water administered directly into the coronary artery. Patients with lower IMR will be followed in a registry. The treatment is given as an intracoronary infusion over 3 minutes. Cardiac enzymes, MRI scans, and other heart function tests will be done at various time points. During the study, participants will have heart enzyme tests at hospital admission and discharge. Those in the randomised group will receive cardiac MRI scans at discharge and six months later. Follow-up visits will occur at 30 days, then 6, 12, and 24 months after discharge to monitor heart function, rehospitalisation, and mortality. The main outcomes measured include cardiovascular death, heart failure rehospitalisation, heart attack size, and bleeding events, with safety and efficacy monitored closely throughout the study period.

Researchers are evaluating nemtabrutinib compared with investigators choice of ibrutinib or acalabrutinib in adults with untreated chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL. The study aims to assess whether nemtabrutinib is not worse than these comparators in terms of objective response rate and whether it can provide longer progression-free survival. This is a Phase 3 randomized clinical trial sponsored by Merck Sharp & Dohme LLC. Participants will receive either nemtabrutinib, ibrutinib, or acalabrutinib orally at specified doses until their disease progresses, unacceptable side effects occur, or other discontinuation criteria are met. The trial uses a parallel-group design where participants are randomly assigned to one of the treatment groups, and no masking is involved. Both treatment arms continue until progression or intolerance. During the study, participants will be monitored regularly up to about 33 months for response rate and up to about 104 months for progression-free survival and overall survival. Assessments include clinical evaluations, safety monitoring for adverse events, and duration of response measurements. The study tracks treatment tolerability, discontinuations due to adverse events, and overall outcomes to better understand the therapies effects in this patient population.