Open Randomized Study of Comparative Pharmacokinetics and Biosimilarity of GP40221 (GEROPHARM LLC, Russia) and Ozempic®.

What Was Tested

This registered phase 1 trial tested Semaglutide.

It had two arms (groups): GP40221 (experimental) and ozempic (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 120 actual participants took part.

It was open to men only aged from 18 years up to 45 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Signed informed consent to participate in the study. Males with a verified diagnosis "healthy" according to the data of standard clinical, laboratory and instrumental examination methods. Age 18-45 years old inclusive. Body mass index 18.5 - 29.9 kg/m2. Agree to use an adequate method of contraception (double barrier method) during the entire period of participation in the study and for 3 weeks after its completion.

The full record lists 7 inclusion and 28 exclusion criteria; among the exclusions: burdened allergic history, drug intolerance; hypersensitivity to heparin, semaglutide and any of the excipients of the study drug; any acute and chronic diseases, incl. but not limited to:.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Semaglutide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Semaglutide study: the participants and staff both knew the treatment.

It started in 2023-06-30 with completion listed for 2024-05-05.

It ran at 1 site in Russia.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: AUC 0-t (time frame: -60, -30, 0 minutes and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection). Cmax (time frame: -60, -30, 0 minutes and 2, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, 96, 144, 192, 240, 288 hours after injection).

It also tracked 4 secondary outcomes, for example tmax, t1/2, λz and AUC0-∞.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 120 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.