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Researchers are studying a new treatment for HIV-1 infection that combines two medicines, islatravir and ulonivirine, taken once weekly. The goal is to see if this new study treatment works as well as the standard antiretroviral therapy (ART), which usually involves taking up to three medicines once or twice daily. This research also aims to learn about the safety and tolerability of the study treatment compared to the standard ART. The study compares the once-weekly combination of islatravir and ulonivirine with the standard daily treatment of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). Participants will take either the study drugs or the standard drugs for 96 weeks. Some participants may receive matching placebos as part of the study design. The treatment is given orally as capsules or tablets according to the assigned group. Participants will be monitored throughout the study with regular assessments, including measuring the amount of HIV-1 virus in the blood to see if it is suppressed below 50 copies/mL at weeks 24 and 48. The study will also track any side effects or adverse events and whether participants stop the treatment due to these events. Overall, the study lasts about 96 weeks, with ongoing safety and effectiveness evaluations to understand how well the treatments work and how safe they are over time.

This clinical study is testing a new medication, VH4524184, to see if it can effectively treat HIV-1 in adults who have never received treatment for their infection. The study is comparing two different doses of VH4524184, each taken with the medications emtricitabine and tenofovir alafenamide (FTC/TAF), to a standard HIV treatment called dolutegravir and lamivudine (DTG/3TC). The purpose of the study is to provide data on the long-term antiviral activity of the VH4524184 and provide information regarding dosing formulation for further evaluations.

Researchers are evaluating efruxifermin (EFX) in adults aged 18 to 80 who have compensated cirrhosis caused by nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH). This Phase 3, randomized, double-blind, placebo-controlled study aims to assess the safety and effectiveness of EFX in improving liver health and delaying disease progression in this population. The study focuses on subjects with advanced liver fibrosis (stage 4) but without liver decompensation. Participants are randomly assigned to receive either efruxifermin or a placebo, both administered by subcutaneous injection. The study includes two cohorts: Cohort 1 requires biopsy confirmation of liver fibrosis and specific metabolic features, while Cohort 2 allows biopsy or non-invasive diagnosis. Treatment and observation continue over an extended period to evaluate changes in liver fibrosis and clinical events. During the study, researchers will monitor the time until significant clinical events such as disease progression or liver decompensation occur, with a follow-up of up to five years. For Cohort 1, the proportion of participants showing improvement in fibrosis without worsening steatohepatitis will be assessed at 96 weeks. Participants will undergo regular evaluations including clinical assessments and laboratory tests to track liver function and safety throughout the study period.

Researchers are investigating the safety and effectiveness of efruxifermin in people with non-cirrhotic nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH) who have moderate to advanced liver fibrosis (stage 2 or 3). This Phase 3 study is randomized, double-blind, and placebo-controlled, enrolling a total of 1650 participants in two groups to evaluate treatment outcomes. Participants will receive either efruxifermin or a placebo by subcutaneous injection. The study involves two cohorts, with Cohort 1 including patients who have biopsy-confirmed NASH or MASH and specific liver fibrosis and activity scores. The treatment period and detailed dosing schedules are not provided but the study compares the effects of the active drug against placebo. During the study, participants will be monitored for improvement in liver disease status, including resolution of NASH/MASH and at least a one-stage improvement in liver fibrosis after 52 weeks for Cohort 1. Long-term outcomes such as event-free survival will be observed over 240 weeks. Safety and efficacy assessments will be conducted throughout the study period, including evaluations of liver histology and metabolic health.

Researchers are studying the safety and effectiveness of brenipatide, given alongside standard treatment, compared to a placebo with standard treatment, to see if it can delay the return of symptoms in adults with major depressive disorder. This is a Phase 3, randomized, double-blind study involving adult participants aged 18 to 75 years. The trial is designed to assess how long it takes for depression symptoms to relapse after starting the adjunctive treatment. Participants will receive either brenipatide or placebo, both administered by subcutaneous injection, in addition to their stable standard of care medication. The study has three main periods: a screening period lasting about one month, followed by a treatment phase of at least 12 months where participants receive the assigned injections, and finally a follow-up period of roughly two months. The total time in the study can be shorter if symptoms worsen or if a participant withdraws. During the trial, participants will need to attend scheduled visits, self-inject the study drug, maintain study diaries, and complete questionnaires. Researchers will monitor participants closely to determine the time until relapse of major depressive disorder symptoms occurs. Safety and adherence to study procedures will be tracked throughout the trial, with the primary outcome measuring the number of days from randomization until relapse.

Researchers are evaluating the effectiveness and safety of brenipatide compared to a placebo in adults with Alcohol Use Disorder (AUD) and hazardous alcohol use. This Phase 3, multicenter, randomized, double-blind study aims to understand if brenipatide can help participants reduce or stop drinking. The study lasts approximately 56 weeks and focuses on changes in drinking patterns using the Timeline Followback Method (TLFB). Participants will receive either brenipatide (LY3537031) or a placebo, both administered by subcutaneous injection. Participants who cannot self-inject will have assistance from a trained support person. They are expected to store and use the blinded study drug as directed, maintain electronic and paper diaries, and complete questionnaires throughout the study. During the study, participants will have scheduled visits to monitor their progress, including assessments of drinking behavior and safety evaluations. Researchers will measure changes in alcohol use patterns up to 56 weeks. Participants must be motivated to reduce or stop drinking and be available for all study visits and procedures. Safety and adherence will be closely monitored throughout the trial.

Researchers are evaluating the safety and effectiveness of brenipatide compared to a placebo for adults with moderate-to-severe Alcohol Use Disorder (AUD). This phase 3 study aims to better understand if brenipatide can help reduce drinking in this population. Participants will be followed for about 56 weeks to gather comprehensive information. Participants will receive either brenipatide (LY3537031) or a placebo, both given by subcutaneous injection. The study involves a randomized, double-blind design, meaning neither the participants nor the researchers know who receives which treatment during the trial. This method helps provide reliable results about the effects and safety of brenipatide. During the study, participants will attend scheduled visits, self-inject the study drug, and complete electronic and paper diaries as well as questionnaires. Researchers will monitor changes in drinking patterns using the Timeline Followback Method for up to 56 weeks. Safety monitoring and regular assessments will be performed throughout the study to track participants' health and adherence.

Researchers are evaluating whether RSLV-132 can improve symptoms in adult females with Primary Sjögren Syndrome (pSS), a condition characterized by fatigue, dryness, and pain. This Phase 2, multicenter, randomized, double-blind study aims to assess the safety and effectiveness of RSLV-132 compared to a placebo. Key questions include whether RSLV-132 reduces tiredness caused by pSS, its blood levels over time, immune responses, and overall safety. Participants will receive either RSLV-132, an intravenous drug made of a human ribonuclease fused to an immunoglobulin, or a placebo containing saline. They will get 13 doses over 22 weeks. Clinic visits will occur weekly for the first 2 weeks, then every 2 weeks until the end of treatment, with a final checkup 4 weeks later on Day 211. During the study, participants will record their symptoms daily on an electronic device. Researchers will monitor symptoms and conduct tests and questionnaires at each visit to assess the main outcomes, focusing on the cardinal symptoms of Sjögren's measured daily from a week before the first dose until 169 days after. The study includes safety monitoring and symptom tracking throughout the 22-week treatment and follow-up period.

Researchers are conducting a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the safety and effectiveness of KarXT in men and women aged 55 to 90 years who have mild to severe Alzheimer's Disease with moderate to severe psychosis related to the condition. The main goal is to compare KarXT against a placebo by measuring changes in hallucinations and delusions using the Neuropsychiatric Inventory-Clinician (NPI-C) score. Participants will receive different doses of KarXT ranging from 20/2 mg to 66.7/6.67 mg daily or placebo capsules. The study is designed to compare the effects of KarXT with placebo in a parallel group format, maintaining the double-blind setup to ensure unbiased results. During the study, participants will be assessed at the start and end of treatment (up to 14 weeks) to evaluate changes in psychotic symptoms. They will undergo clinical scales such as the NPI-C and the Clinical Global Impression-Severity (CGI-S) scale. The study also requires imaging scans like MRI or CT to rule out other brain diseases. A study partner who has regular contact with the participant will be involved to support adherence and observation. Safety and efficacy will be monitored throughout the treatment period.

Researchers are evaluating the efficacy and safety of ML-007C-MA in treating hallucinations and delusions associated with Alzheimer's Disease Psychosis (ADP) in men and women aged 55 to 90 years. This Phase 2 study is randomized, double-blind, and placebo-controlled, aiming to compare ML-007C-MA with placebo by measuring changes in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C H+D) score over seven weeks. Participants receive ML-007C-MA at doses of either 105/1.5 mg twice daily or 210/3 mg twice daily, or placebo tablets, during the treatment period. The study is designed to assess the impact of these treatments on psychotic symptoms associated with Alzheimer's disease, specifically hallucinations and delusions. Throughout the study, participants are monitored for changes in the NPI-C H+D score from baseline to the end of treatment at seven weeks. Researchers also evaluate safety and monitor participants' overall condition. The total involvement includes assessments related to cognition, symptom severity, and adherence, ensuring comprehensive evaluation of the treatment's effects and safety profile.