The first-in-human trial is designed to evaluate the pharmacokinetics, pharmacodynamics, and safety of a single dose of ZP8396, which is in development as an alternative non-incretin peptide therapy.
Seven cohorts of 56 patients were administered subcutaneously with ZP8396 0.04 mg, 0.08 mg, 0.16 mg, 0.35 mg, 0.70 mg, 1.40 mg, and 2.40 mg against placebo. They were further followed for six weeks.
Healthy lean and overweight participants who received a single dose of ZP8396 0.7 mg, 1.4 mg or 2.4 mg for one week showed mean body weight reductions of 2.6%, 3.6% and 4.2%, respectively.
Body weight reductions were found to be well-sustained without any further administration of ZP8396 doses and consistent during the additional five weeks of observation.
An increase of 0.6% in mean body weight was observed in placebo-treated group in the first week and continued during the follow-up period.
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ZP8396 was well tolerated with no traces of anti-drug antibodies.
Zealand Pharma chief medical officer David Kendall said: “We are very encouraged that treatment with a single dose of ZP8396 led to meaningful dose-dependent and consistent reductions in body weight that were sustained over six weeks in this Phase I study and look forward to results from further clinical trials of longer duration and at higher doses.”
Zealand is also evaluating ZP8396 in an ongoing multiple ascending dose study including part 1 of six weeks and part 2 of 16 weeks.
Results from Part 1 are anticipated during the second half of this year and Part 2 next year.