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

NCT06497049 · Completed

Last updated 2026-05-28

This clinical trial compares how two diabetes medications, GP40221 and Ozempic®, are absorbed and processed in the body among healthy adult participants.

Status Completed The study has finished.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 120 people

Who can join Ages 18–45 · male only Healthy volunteers accepted.

Timeline Started 2023-06 · est. completion 2024-05

Where 1 site · Russia

What this study is testing ClinicalTrials.gov NCT06497049 ↗

Description as written by the study sponsor.

Study of comparative pharmacokinetics and biosimilarity of drugs containing semaglutide - GP40221 and Ozempic® in healthy volunteers.

Treatments tested

GP40221 also known as semaglutide Drug

Solution for Subcutaneous Administration 1.34 mg/ml
ozempic also known as semaglutide Drug

Solution for Subcutaneous Administration 1.34 mg/ml

Main thing measured	AUC 0-t
Sponsor	Geropharm
Conditions studied	Pharmacokinetics, Safety Issues, Bioequivalence
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06497049 ↗