Study-specific information for healthcare providers
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The TRAVERSE study is designed to evaluate long-term testosterone replacement therapy with AndroGel 1.62% compared to placebo on major adverse cardiovascular events in symptomatic hypogonadal men ages 45-80 with a history of coronary artery disease, cerebrovascular disease, and peripheral vascular disease. Other safety and efficacy endpoints will also be evaluated. Qualified patients will be enrolled for up to 5 years. It is requested that serum testosterone, PSA, and Hct results remain blinded to the patient so treatment assignments cannot be “guessed”. Testosterone, PSA, and Hct will be obtained regularly in the study during the patient’s participation. Patients will still be encouraged to follow-up with their regular doctors visits while enrolled. For more information please visit clincialtrials.gov
The trial is a multi-center, randomized, double-blind, active (omalizumab) and placebo-controlled study to investigate the efficacy and safety of ligelizumab (QGE031) in the treatment of Chronic Spontaneous Urticaria (CSU) in adolescents and adults inadequately controlled with H1-antihistamines.
Ligelizumab is a humanized IgG-type monoclonal antibody that binds to IgE with higher affinity than omalizumab. Eligible patients are those aged ≥ 12 years and remain symptomatic despite the use of anti-histamines. However, patients with any prior exposure to omalizumab or ligelizumab are not eligible. For more information visit clinicaltrials.gov
Efficacy and safety of Tirzepatide (LY3298176) once weekly versus Insulin Glargine in patients with type 2 diabetes and increased risk for cardiovascular disease. Tirzepatide is a 39-amino acid synthetic peptide, dual GIP and GLP-1 receptor agonist. The primary endpoint of the trial will be the mean change in HbA1c levels from baseline to 52 weeks. Eligible patients will be randomized in a 1:1:1:3 ratio to receive 5mg LY3298176, 10mg LY3298176, 15mg LY3298176, or insulin glargine.
In order to qualify, patients must have a HbA1c between 7.5% – 10.5%, be at a stable weight, and have risk factors for cardiovascular disease. Cardiovascular events within the past 2 months are exculsionary. To read more about this trial, please visit clinicaltrials.gov
A safety and efficacy study of relamorelin in diabetic gastroparesis. Relamorelin is a novel small synthetic peptide pentapeptide that acts as a ghrelin receptor agonist. It binds to the GHS-1a receptor with ∼ 3-fold more potency than natural ghrelin and is 6-fold more potent than h-ghrelin in activating the GHS-1a receptor.
Eligible patients are those with Type 1 or 2 diabetes mellitus and experiencing symptoms of gastroparesis. Patients will be randomized 1:1 to blinded treatment with relamorelin 10µg or placebo. Their participation will last approximately 16 weeks with the possibility to continue in an additional 46-week relamorelin trial once completed. For more information, please visit clinicaltrials.gov
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