Zealand Pharma has reported positive results from Part 1 of multiple ascending dose (MAD) trial of ZP8396, a long-acting amylin analog designed for the management of obesity and overweight.
The placebo-controlled, double-blind, single-centre, randomised study is designed to assess the tolerability, safety and clinical effects of ZP8396 0.6mg and 1.2mg doses in healthy lean and overweight participants.
Two cohorts of 20 participants with a median BMI of 25 (kg/m2) were randomised into 7:3 ratio to receive subcutaneous ZP8396 once-weekly for six weeks or placebo.
Participants who received 0.6mg and 1.2mg ZP8396 for six weeks showed mean body weight reductions of 5.3% and 5.1%, respectively.
Meanwhile, participants who received placebo showed body weight reduction of 0.4%.
Within two days after administration of the first dose, subjects showed mild adverse events related to the gastrointestinal system.
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Zealand Pharma chief medical officer David Kendall said: “We are very encouraged by the reductions in body weight seen after six weeks of treatment at lower doses of ZP8396.
“We have initiated the second part of this multiple ascending dose clinical trial assessing both a longer duration of treatment and higher doses of ZP8396.
“We are excited about the different opportunities with amylin, both as an alternative, non-incretin treatment for overweight and obesity and as a potential combination with incretin-based therapy, such as GLP-1.”
Part 2 of the MAD trial intends to enrol 48 subjects and use a dose up-titration scheme to administer subcutaneous doses of ZP8396 once-weekly for 16 weeks or placebo.
Results from Part 1 are anticipated later this year while topline results from Part 2 are expected next year.