Services Provided by Lambda: Study design Clinical conduct Protocol development PK Sampling Safety lab evaluations Bioanalysis Pharmacokinetic and Biostatistical analysis CSR preparation and Report Compilation Study Execution Overview Sample Size: 60 healthy adult subjects (Male and Female) 60 healthy adult subjects (Male and Female) Study Duration & Visits ~5 weeks study duration, with multiple outpatient visits for PK sampling ~5 weeks study duration, with multiple outpatient visits for PK sampling Key Safety Measures Implemented (in addition to routine safety parameters) In addition to standard laboratory assessments at screening, specific safety parameters serum lipase and amylase were also evaluated
Holst JJ, Deacon CF, Vilsbll T, Krarup T, Madsbad S
Taylor K et al
From 1991 onwards the group, and a growing list of collaborators, accumulated a preclinical literature base in rodent injury models that now exceeds 200 peer-reviewed papers
Oral GLP-1 drugs, with their convenient administration, are expected to become an important option for treating metabolic diseases
This suggests that similar precautions may be appropriate for Ozempic