A Phase IIb study was conducted (capsule formulation) for 12 weeks (METAOD005). The patients were clinically obese males, and females of non-child bearing potential. LAT8881 was well tolerated over the dose range; there were no changes of clinical significance in vital signs, safety laboratory tests or ECGs during the study. This study demonstrated that daily oral administration of LAT8881 was safe and well tolerated.
The OPTIONS Study was a Phase IIb, randomised, double-blind, placebo-controlled, multicentre, parallel-group study to assess the efficacy, safety, and tolerability of 24 weeks of treatment with different doses of LAT8881 tablets for weight loss in obese adults (METAOD006). A total of 413 subjects contributed to the primary analysis. The results of the OPTIONS study did not meet its primary clinical endpoint and the project was terminated by Metabolic in February 2007.