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A randomised, placebo controlled Phase I study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of G3215 in adult subjects.
Full description
Objectives:
Primary Objective
To investigate the safety and tolerability of single doses of G3215 in overweight but otherwise healthy male subjects. To investigate the safety and tolerability of multiple doses of G3215 in overweight male subjects with mild stable Type 2 diabetes or prediabetes.
Secondary Objectives • To assess the pharmacokinetic (PK) profile of single and multiple ascending doses of G3215 in overweight but otherwise healthy male subjects or overweight / obese male subjects with mild stable Type 2 diabetes or prediabetes.
Exploratory Objective
• To investigate the effects of multiple doses of G3215 on food consumption, body weight, enteropancreatic hormone changes and glucose tolerance in overweight male subjects with mild Type 2 diabetes or prediabetes.
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Interventional model
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90 participants in 19 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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