A second Phase IIb clinical trial has been approved by British regulators to evaluate ATL-962 for the treatment of obesity in up to 600 clinically obese diabetic patients.

The randomised, double-blind trial will compare three doses of ATL-962 with a placebo and with the obesity drug Xenical.

Patients will be treated for 12 weeks with the primary endpoint being weight loss. In addition, a number of other parameters associated with obesity, including markers for diabetes and cholesterol, will be measured.

The multi-center trial, to be conducted in the United Kingdom and five other European countries, will enroll diabetic patients with a Body Mass Index above 28 who are managing their diabetes with the drug metformin.

An additional objective of the study is to determine the safety and tolerability profile of ATL-962 in these patients, compared to placebo and Xenical. Trial results are expected to be reported around the end of 2005.

In preparation for this current trial, Alizyme plc carried out a Phase I drug interaction study with metformin and ATL-962 to determine that ATL-962 does not adversely affect the therapeutic use of metformin.

The results of this study also confirmed the acceptable safety and tolerability profile of ATL-962 observed to date in the Phase Ib and Phase IIb trials, a company spokesperson said.

ATL-962, an inhibitor of gastro-intestinal lipases, is designed to cause weight loss by blocking the digestion and thus the absorption, of fat from the diet.