Phase IIa – Obesity

Past Clinical Trials

Phase IIa – Obesity

At the end of 2001 the first Phase IIa study was completed (METAOD002). This was a double-blind placebo-controlled 4 ´ 4 Latin Square design study in which 24 healthy clinically obese males participated. LAT8881 was well tolerated over the dose range: there were no study drug-related withdrawals, serious AEs, clinically significant AEs, or changes of clinical significance in vital signs, safety laboratory tests, or ECGs during the study. No significant changes in glucose or insulin-like growth factor 1 (IGF-1) levels were observed following LAT8881 treatment compared with placebo.

A second double-blind placebo-controlled 4 x 4 Latin Square design Phase IIa study was conducted using single oral doses to evaluate safety, tolerability and pharmacodynamic endpoints in healthy, clinically obese males (METAOD003). LAT8881 was well tolerated over the oral dose range: there were no study drug-related withdrawals or serious AEs, clinically significant AEs, or changes of clinical significance in vital signs, safety laboratory tests or ECGs during the study. No significant differences in IGF-1 values were evident for any of the doses compared to placebo.

A third Phase IIa study was conducted to assess the safety of multiple daily oral dosing of LAT8881(METAOD004). LAT8881 was well tolerated over the oral dose range: there were no study drug-related withdrawals or serious AEs, clinically significant AEs, or changes of clinical significance in vital signs, safety laboratory tests or ECGs during the study.

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