Port Charlotte

Researchers are evaluating the safety and effectiveness of orforglipron for treating people who have both hypertension and are either overweight or obese. This study is part of a larger master protocol called GZPL and focuses specifically on these health conditions. The trial is designed as a Phase 3 study to provide important information about this potential treatment. Participants will receive either orforglipron or a placebo, both given orally once daily. The study compares these two groups to understand the impacts of orforglipron on blood pressure and weight-related health issues. The treatment period lasts up to 36 weeks, during which participants are monitored closely. During the study, participants will have their office systolic blood pressure measured to track changes from the start of the trial to week 36. Researchers will also monitor safety and other health measures throughout the trial. The study involves regular visits and assessments to ensure participant well-being and to gather thorough data on the treatment's effects.

This research aims to assess the effectiveness and safety of orforglipron for treating hypertension in adults with obesity or overweight. It is conducted as part of the GZPL master protocol and focuses on participants who have both high blood pressure and elevated body weight. The study is designed as a Phase 3 clinical trial to provide detailed evaluation of this new treatment approach. Participants will receive either orforglipron or a placebo, both given orally once daily. The study compares these two groups to understand the benefits and any side effects of orforglipron when used for managing hypertension in this specific population. The treatment period and detailed dosing schedule are based on the master protocol, which guides participant management and study procedures. During the study, participants will have their systolic blood pressure measured regularly to track changes from the start through week 36. Researchers will monitor safety and treatment effects closely, following all procedures outlined in the master protocol. The overall duration of participant involvement and additional assessments are determined by the master protocol guidelines for this comprehensive evaluation.

Researchers are monitoring the long-term safety of efgartigimod, a biological treatment, in patients with generalized myasthenia gravis (gMG). This study is a non-interventional, prospective, post-authorization safety study designed to observe patients who are either starting or already receiving efgartigimod, as well as those with gMG who have not been treated with it. The study aims to compare the occurrence of serious infections and other safety outcomes over a period of up to 10 years. Patients with gMG who are expected to begin efgartigimod treatment at enrollment or who are currently in their first treatment cycle will be included in the efgartigimod group. Those with gMG who are not starting efgartigimod and have never received it will be enrolled in a non-efgartigimod group. There are no assigned treatments or interventions from the researchers; the study simply observes patients as they receive routine care. Participants will be followed for up to 10 years to track safety outcomes, including serious infections. Data collection will involve routine clinical assessments and monitoring as per standard medical practice. The study observes the real-world use of efgartigimod and its safety profile in managing gMG, providing valuable long-term information without altering patients' treatment plans.

Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and possible effectiveness of IM-101 in adults with generalized myasthenia gravis (gMG) who have acetylcholine receptor (AChR) antibodies. The study also explores IM-101’s safety and efficacy in adults with AChR antibody-negative gMG and both types of ocular myasthenia gravis (oMG). This is a Phase 1b/2 trial that investigates different dosages and treatment regimens of IM-101. The trial has two parts. In Part A, participants receive IM-101 or placebo intravenously at a loading dose on Day 1 and Day 15, followed by a maintenance dose on Day 29. In Part B, participants receive IM-101 or placebo intravenously at a loading dose on Day 1 and Day 15, with additional maintenance doses on Days 29, 57, and 85. The study compares multiple ascending doses of IM-101 and placebo to assess safety and efficacy. Participants will be monitored for treatment-emergent adverse events, serious adverse events, and other safety concerns up to approximately 99 days in Part A and up to about 169 days in Part B. Researchers will measure changes in myasthenia gravis symptoms using standardized scores at baseline and Week 16. The study includes various assessments to track participants’ health and how they respond to treatment throughout the trial.

Researchers are evaluating the effect of baxdrostat combined with dapagliflozin compared to baxdrostat with placebo on reducing albuminuria in people with chronic kidney disease (CKD) and high blood pressure. This Phase IIb, randomized, multicenter, double-blind study includes adults aged 18 years and older, with or without type 2 diabetes and regardless of current SGLT2 inhibitor treatment. The study aims to assess both the impact on albuminuria and the safety of these treatments. Participants will be randomly assigned to receive either baxdrostat with dapagliflozin or baxdrostat with a matching placebo. The study includes an optional pre-screening period to assess kidney function and other health markers, and those on SGLT2 inhibitors will undergo a washout before starting treatment. Randomization will consider diabetes status to ensure balanced groups. During the study, participants will be monitored up to 12 weeks to measure changes in albuminuria, specifically urinary albumin-to-creatinine ratio (UACR). Safety and other health parameters will also be assessed through blood tests and blood pressure measurements. The study ends when the last participant completes their final visit and procedures, ensuring thorough data collection on treatment effects and safety.

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating insulin icodec, a once-weekly insulin injection, compared to insulin glargine, a once-daily injection, in adults with type 1 diabetes. The study aims to see how well weekly insulin icodec controls blood sugar levels compared to daily insulin glargine when both are combined with insulin aspart. This phase 3 study will last about 26 weeks, or roughly 8.5 months. Participants will receive either insulin icodec or insulin glargine, both given as subcutaneous injections. All participants will also use insulin aspart as a subcutaneous injection. The study compares these two insulin regimens to assess their effects on blood sugar control over the 26-week period. During the study, researchers will monitor changes in glycosylated hemoglobin (HbA1c) from the start of the study to week 26. Participants will follow the study protocol including self-measured plasma glucose profiles. Safety and efficacy will be evaluated throughout the treatment period to understand the impact of the insulin regimens on blood sugar control and participant health.

Researchers are examining the safety and effectiveness of AAV2-GDNF gene therapy delivered directly into the putamen for adults with moderate Parkinson's Disease. This Phase 2, randomized, double-blind study compares this gene therapy to a control surgical procedure without dural penetration. Participants have been diagnosed with Parkinson's Disease for 4 to 10 years and experience motor fluctuations, with responsiveness to levodopa therapy. The treatment involves a single bilateral, image-guided infusion of AAV2-GDNF into the putamen. The control group undergoes a sham surgery involving partial burr and twist holes without penetrating the dura. This design helps evaluate the impact of the gene therapy compared to the control procedure over the study duration. Participants are involved in the study for at least 18 months, during which safety and efficacy are closely monitored. The main outcome measured is the change from baseline to month 18 using the PD Motor Diary to track motor fluctuations. The study also includes thorough screening to ensure participants meet criteria and ongoing assessments to monitor treatment effects and safety throughout the study period.

Researchers are evaluating the safety and effectiveness of brenipatide compared to placebo for people with opioid use disorder. This study focuses on participants who are also using buprenorphine, with or without naloxone, as part of their treatment. The trial includes two parts, each with separate groups of participants, to better understand how brenipatide works alongside current therapies in early recovery from opioid use disorder. The study has two parts: Part A involves a double-blind treatment phase followed by an open-label extension, while Part B offers an open-label treatment only. Brenipatide and placebo are given as subcutaneous injections, and buprenorphine is administered either sublingually or buccally. Participants will be enrolled in only one part of the study, with treatment durations potentially lasting up to 144 weeks in Part A and 116 weeks in Part B, depending on enrollment timing and study progress. Participants will regularly attend study visits where they will be assessed through urine drug screens and self-reports to measure abstinence from opioid use. They will also maintain study diaries and complete questionnaires to track adherence and effects. The main outcomes measured include the percentage of weeks participants remain abstinent from opioids between weeks 13 and 24, verified by negative drug tests and no self-reported opioid use. Safety and long-term effectiveness will be monitored throughout the study duration.