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A Study of Tirzepatide (LY3298176) Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Participants With Type 2 Diabetes
The reason for this study is to compare the effect of the study drug tirzepatide to semaglutide on blood sugar levels in participants with type 2 diabetes. The study will last approximately 47 weeks and may include about 12 visits.
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Strategies for the Management of Atrial Fibrillation in patiEnts Receiving Dialysis
The prevention of atrial fibrillation related thromboembolism in the dialysis population is unclear. While the practice of anticoagulation appears favorable in patients with mild-to-moderate chronic kidney disease, no patients with severe chronic kidney disease (estimated glomerular filtration rate \<25 ml/min), and specifically those receiving dialysis, have been included in randomized trials.Moreover, the effect of anticoagulation in the dialysis population may fundamentally differ from those studied in clinical trials. Accordingly, characterization of the optimal management strategy to reduce the risk of stroke and systemic embolism in patients with atrial fibrillation receiving dialysis is a priority. The overall goal of this pilot trial is to evaluate the feasibility of conducting a randomized controlled trial comparing anticoagulation strategies in patients with atrial fibrillation receiving dialysis (either hemodialysis or peritoneal dialysis).
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Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis
The main purpose of the study was to assess the efficacy and safety of nemolizumab after a 16-week treatment period in adult and adolescent subjects with moderate-to-severe atopic dermatitis (AD) not adequately controlled with topical treatments.
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Observational Study of Patients With Moderate to Severe Chronic Plaque Psoriasis
This study will assess the use of risankizumab in adult patients with moderate to severe chronic plaque psoriasis and compare risankizumab to other commonly used biologics.
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Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Therapeutic Intervention Enhancing Care Linkage in People Who Inject Drugs
This study will evaluate the proportion of patients achieving confirmed SVR12 (undetectable HCV RNA at time point 12 weeks plus post treatment commencement) in patients hospitalised for IRID (injecting related infectious diseases) and commencing inpatient DAA treatment within public hospital services.
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A Study to Compare Nivolumab Drug Product Process D to Nivolumab Drug Product Process C in Participants With Stage IIIa/b/c/d or Stage IV Melanoma After Complete Resection
The purpose of this study is to compare the drug levels, immunogenicity and safety of Nivolumab Process D to Nivolumab Process C after complete resection of stage IIIa/b/c/d or stage IV melanoma.
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Study of Lenalidomide, Venetoclax and Obinutuzumab in Patients With Treatment-Naïve Follicular Lymphoma
The trial will investigate the combination of venetoclax, obinutuzumab and lenalidomide in patients with treatment-naïve follicular lymphoma. Patients will receive induction treatment for 0.5 years with venetoclax, obinutuzumab and lenalidomide followed by maintenance treatment for upto 2 years. Maintenance treatment will be determined by the response at the end of induction. Following completion of treatment patients will be followed up for 3 years after the last patient completes induction treatment.
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A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy late preterm and term infants who are 35 weeks or greater gestational age and entering their first RSV season.
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A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)
The main objective of this study was to evaluate the safety and efficacy of elsubrutinib, upadacitinib (UPA), and ABBV-599 (elsubrutinib/upadacitinib) High Dose and Low Dose combinations vs placebo for the treatment of signs and symptoms of Systemic Lupus Erythematosus (SLE) in participants with moderately to severely active SLE and to define doses for further development.
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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EYP001a in Healthy Volunteers and Nonalcoholic Steatohepatitis Patients
This is a single centre, open label, randomized, 3 treatment arms, with and without food dosing, Phase 1b pharmacology study to assess the safety, tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Farnesoid X Receptor (FXR) agonist/modulator EYP001a in healthy volunteers and Nonalcoholic Steatohepatitis (NASH) patients.