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  • VY7523-102: Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study in Participants with Early Alzheimer's Disease

    Phase

    1/2

    Span

    117 weeks

    Sponsor

    Voyager Therapeutics

    Winter Park, Florida

    Recruiting

  • Efficacy, Safety and Tolerability of AZD6234 in Participants Living With Overweight or Obesity With Type 2 Diabetes Who Are on a Stable Dose of GLP-1 Receptor Agonist

    This is a Phase II, randomised, parallel-group, double-blind, placebo-controlled, multi-centre study to assess the efficacy, safety, and tolerability of AZD6234 compared with placebo, given once weekly as a subcutaneous (SC) injection, in adults living with overweight or obesity and type 2 diabetes who are on a stable dose of GLP-1 RA. The study is being conducted across sites in the USA to evaluate the efficacy, safety, and tolerability of AZD6234 in adults with overweight or obesity and type 2 diabetes on stable GLP-1 RA therapy. A total of 64 Participants, aged 18-75 with a BMI ≥ 27 kg/m², will be randomized to receive weekly subcutaneous injections of either AZD6234 or a placebo, alongside their current GLP-1 RA medication. The study involves a screening period and a treatment and follow-up period.

    Phase

    2

    Span

    46 weeks

    Sponsor

    AstraZeneca

    Winter Park, Florida

    Recruiting

    Healthy Volunteers

  • A Phase 1b Study of the NLRP3 Inhibitor VENT-02 in Patients With Mild to Moderate Parkinson's Disease

    Phase

    1/2

    Span

    48 weeks

    Sponsor

    Ventus Therapeutics U.S., Inc.

    Winter Park, Florida

    Recruiting

  • Efficacy of Dupilumab Added to Medium Dose Inhaled Corticosteroid/Long-acting Beta-agonist (ICS/LABA) in Comparison to ICS Dose Escalation to High Dose ICS/LABA in Adolescent and Adult Patients With Uncontrolled Asthma

    This study is a Phase 3b in Canada Minors will not be enrolled in Denmark

    Phase

    4

    Span

    123 weeks

    Sponsor

    Regeneron Pharmaceuticals

    Winter Park, Florida

    Recruiting

  • Development of a Database to Investigate Digital and Blood-Based Biomarkers and Their Relationship to Tau and Amyloid PET Imaging in Older Participants Who Are Cognitively Normal (CN), Have Mild Cognitive Impairment (MCI), or Have Mild-to-Moderate AD Dementia

    Phase

    N/A

    Span

    201 weeks

    Sponsor

    GAP Innovations, PBC

    Winter Park, Florida

    Recruiting

    Healthy Volunteers

  • Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia

    Phase

    3

    Span

    145 weeks

    Sponsor

    Vanda Pharmaceuticals

    Winter Park, Florida

    Recruiting

  • A Study to Evaluate the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Active, Difficult to Treat Rheumatoid Arthritis

    The study consists of several periods. During the Screening Period (5 weeks) participants will undergo screening procedures to determine eligibility. In Period 1 (Open-Label Treatment), all eligible participants will receive open-label treatment with IMVT-1402 at a dose of 600 mg subcutaneous (SC) once weekly (QW) for 16 weeks. Participants who meet the ACR20 response criteria at Weeks 14 and 16 will be randomized in a 1:1:1 ratio to receive blinded treatment with either IMVT-1402 600 mg SC QW, IMVT-1402 300 mg SC QW, or placebo SC QW for 12 weeks in Period 2 (Randomized Withdrawal). Eligible participants who complete Period 2 at Week 28 will have the option to receive IMVT-1402 for an additional 48 weeks in Period 3 (Long -Term Extension). A follow-up visit will occur 4 weeks after the last dose of study treatment to monitor safety. The primary endpoint of the study is the proportion of participants achieving an ACR20 response at the end of Period 2. Secondary objectives include evaluating the safety and tolerability of IMVT-1402, as well as its effects on other efficacy measures. This study aims to provide valuable data on the use of IMVT-1402 in treating adults with active, difficult-to-treat, ACPR-positive RA.

    Phase

    2

    Span

    142 weeks

    Sponsor

    Immunovant Sciences GmbH

    Winter Park, Florida

    Recruiting

  • PMN310 in Patients With Early Alzheimer's Disease (PRECISE-AD)

    This study is a Phase 1b, randomized, double-blind, placebo controlled, multi-ascending dose study of repeat doses of PMN310 to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of multiple intravenous infusions of PMN310 in patients with early Alzheimer's disease. This study will evaluate 3 dose levels (350 mg, 700 mg, and 1400 mg are planned). Patients will be randomly assigned 3:1, PMN310: placebo. Each patient will receive PMN310 or placebo once every 28 days for a total of 12 infusions.

    Phase

    1

    Span

    107 weeks

    Sponsor

    ProMis Neurosciences, Inc

    Winter Park, Florida

    Recruiting

  • A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia

    Phase

    2

    Span

    54 weeks

    Sponsor

    Centessa Pharmaceuticals (UK) Limited

    Winter Park, Florida

    Recruiting

  • Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy

    Phase

    3

    Span

    139 weeks

    Sponsor

    Vertex Pharmaceuticals Incorporated

    Winter Park, Florida

    Recruiting

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