Pembroke Pines

Researchers are evaluating the efficacy and safety of enicepatide, a dual GLP-1GIP receptor agonist, at multiple doses compared with placebo for weight management in adults with obesity or overweight and type 2 diabetes mellitus T2DM. This Phase III study aims to better understand how enicepatide affects body weight and other health measures in this population. Participants will be randomly assigned to receive either placebo or one of three dosing regimens of enicepatide, administered once weekly using an integrated drug-device combination product. The study lasts for 72 weeks, during which participants will self-administer the study drug or receive injections from a trained individual if needed. Throughout the study, participants will undergo various assessments including body weight, hemoglobin A1c, waist circumference, fasting glucose and insulin, cholesterol levels, blood pressure, and quality of life questionnaires. Safety will be monitored through adverse event reporting and specific rating scales. This comprehensive evaluation will help determine the effects of enicepatide on weight and diabetes management over the study 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 evaluating a combination therapy of ruxolitinib, steroids, and lenalidomide in adults with relapsed or refractory multiple myeloma MM who have progressive disease despite previous treatments. MM is a cancer of plasma cells in the bone marrow with complex causes and limited curative options. This phase 1, open-label, multicenter study aims to assess the safety and effectiveness of these drugs together in patients who have failed at least two prior therapies including immunomodulatory drugs and proteasome inhibitors. Participants receive varying doses of ruxolitinib orally twice daily, lenalidomide once daily, and methylprednisolone every other day. The study includes dose escalation periods and treatment adjustments based on disease progression. Some groups start with ruxolitinib and steroids, adding lenalidomide only if the disease worsens. Treatment continues until disease progression or unacceptable side effects occur. During the study, participants will have regular evaluations including blood tests and clinical assessments to monitor safety, side effects, and treatment response. Researchers will measure outcomes such as the maximum tolerated dose, adverse events, response rates, progression-free and overall survival over a follow-up period extending up to 54 months. Participants are expected to adhere to visit schedules and study requirements throughout the trial.

Researchers are investigating two different doses of inhaled Glycopyrronium GP delivered by metered-dose inhaler MDI as add-on treatments to Budesonide and Formoterol Fumarate BFF MDI in children aged 4 to less than 12 years with asthma. This Phase II, multi-center, randomized, double-blind, crossover study aims to assess how these doses affect lung function compared to a placebo MDI added to BFF MDI. The study is designed to better understand the potential benefits and safety of these treatments in this young population with asthma. Participants will undergo a 3-week run-in period followed by three 3-week treatment periods. During the treatment periods, each participant will receive three treatments in different sequences BFF MDI combined with GP MDI Dose A, BFF MDI combined with GP MDI Dose B, and BFF MDI combined with placebo MDI. GP MDI and BFF MDI are both administered twice daily by oral inhalation. The study concludes with a safety follow-up visit 12 to 16 days after the last dose. Throughout the study, lung function will be closely monitored, with the primary outcome being the change from baseline in forced expiratory volume in one second FEV1 at 1-hour post-dose at the end of each 3-week treatment period. Additional measures include morning pre-dose trough FEV1 changes. Participants will attend scheduled visits for assessments, including lung function tests and safety evaluations, ensuring detailed monitoring of treatment effects and participant well-being during the study period.

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 the safety and effectiveness of a new medicine called CagriSema in helping adults living with obesity, with or without type 2 diabetes, to lose weight. This phase 3 clinical study compares two different weekly doses of CagriSema against an existing medicine, semaglutide. The study aims to understand how well these treatments support weight loss over a long period. Participants in this study will be randomly assigned to receive one of three treatments CagriSema at dose level 1, CagriSema at dose level 2, or semaglutide. Each treatment is given by weekly injection under the skin for 72 weeks. The study lasts about 83 weeks, covering treatment and follow-up periods to observe effects and safety. During the study, participants will have regular assessments to monitor body weight, body mass index BMI, waist size, cholesterol levels, blood sugar control HbA1c, and quality of life. Researchers will track changes from the start of treatment to the end of 72 weeks, including weight loss milestones and health measurements. Safety will also be closely monitored through reports of any adverse events until the study ends.

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

Researchers are evaluating insulin icodec, a once-weekly insulin injection, compared to insulin glargine, a once-daily injection. This study focuses on adults with type 1 diabetes to see how well the weekly insulin controls blood sugar when combined with insulin aspart, which is taken 2 to 4 times daily. The trial aims to assess blood sugar control over about 8.5 months. Participants will be randomly assigned to receive either insulin icodec once a week with insulin aspart daily or insulin glargine once a day with insulin aspart daily. Both insulins are given as subcutaneous injections. The study is designed as a parallel comparison to evaluate the effects of these insulin regimens on blood sugar control. During the study, participants will have regular assessments including blood tests to measure HbA1c and glucose levels, monitoring of hypoglycemic episodes, and tracking of insulin doses and body weight. The primary outcome is the change in HbA1c from baseline to week 26. Secondary outcomes include time spent in target glucose ranges and frequency of low blood sugar events. The study will last about 8.5 months with ongoing monitoring to evaluate treatment effects and safety.

Researchers are evaluating the safety, tolerability, and biomarker effects of VS-041 in people with Heart Failure with Preserved Ejection Fraction HFpEF, a type of heart condition where the heart pumps normally but is stiff. This Phase 1 trial aims to understand how VS-041 affects specific heart-related biomarkers and to monitor any treatment-emergent adverse events. The study is sponsored by Vasa Therapeutics and focuses on adults aged 50 and older diagnosed with HFpEF. Participants will be randomly assigned to receive either a high dose or low dose of VS-041, or a matching placebo tablet, taken twice daily. The treatment period lasts 28 days, during which safety, tolerability, and biomarker changes in the blood, including NordicPRO-C6, endotrophin, and NT-proBNP levels, will be closely tracked. Pharmacokinetic profiles of the drug will also be assessed to understand how the body processes VS-041. During the study, participants will undergo screening to confirm eligibility, including heart function tests and biomarker measurements. Throughout the 28-day treatment, researchers will monitor participants for side effects and changes in biomarkers. The main outcomes measured are adverse events and changes in serum biomarkers from baseline to Day 28. Participants must be willing to follow study procedures, including medication adherence and attending scheduled visits, to help assess the drugs safety and biological effects.

Researchers are evaluating how well JNJ-79635322 works compared to teclistamab in treating participants with relapsed or refractory multiple myeloma who have had 1 to 3 prior lines of therapy, including an anti-CD38 antibody and lenalidomide. This phase 3 randomized study is designed to assess these treatments in participants with measurable disease and varying performance status levels. Participants will receive either a subcutaneous dose of JNJ-79635322 for a limited time or until intolerable toxicity occurs, or teclistamab as a subcutaneous injection until disease progression or intolerable toxicity. Each treatment is given under medical supervision, and the study compares the effects and safety of these two drugs delivered via injection. During the study, participants will undergo assessments including laboratory tests and evaluations of treatment response using measures such as complete response, progression-free survival, and overall response rate up to approximately 41 months. Quality of life, symptom changes, and safety are also monitored regularly. The study aims to understand the benefits and risks of these treatments over an extended period, with ongoing follow-up and data collection throughout the trial.