Influence of JY09 on Pharmacokinetics of Metformin , Rosuvastatin , and Digoxin and the QT Interval Study in Overweight Chinese Subjects

NCT06247748 · Completed

Last updated 2026-05-28

This clinical trial is testing how the drug JY09 affects the levels of metformin, rosuvastatin, and digoxin in the body, as well as its impact on the QT interval, in overweight adults with type 2 diabetes.

Status Completed The study has finished.

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

Type Interventional (clinical trial)

Design Non-randomized, open-label (no blinding) treatment study

Participants 28 people

Who can join Ages 18–45 · all sexes Healthy volunteers accepted.

Timeline Started 2023-10 · est. completion 2024-04

Where 1 site · China

What this study is testing ClinicalTrials.gov NCT06247748 ↗

Description as written by the study sponsor.

This trial is conducted in china. The aim of the trial is as follows: * To assess the effect of multiple subcutaneous injections of JY09 injection on the pharmacokinetic (PK) profile of multiple oral doses of metformin hydrochloride tablets, a single oral dose of Rosuvastatin calcium tablets, or digoxin tablets in overweight Chinese subjects; * To assess the effect of multiple subcutaneous injections of JY09 injection on QT interval in overweight Chinese subjects.

Treatments tested

Exendin-4 Fc fusion protein (JY09) injection also known as JY09 Drug

D22 received a single subcutaneous abdominal injection of 1.2 mg of JY09 injection after completion of PK blood sampling; D29, D36, D43, D50, D57, D64, D71, and D78 subjects returned to the study center to receive a subcutaneous abdominal injection of 2.4 mg of JY09 injection(total of 8 administrations).All doses were to be administered within 3 min.
Metformin Hydrochloride tablet also known as Metformin Drug

D1 to D4 continuous oral administration of 0.5 g metformin hydrochloride tablets twice daily (D4 was administered only in the morning, with a total of 7 administrations) for a washout period of 96 h;0.5 g metformin hydrochloride tablets orally twice a day continuously from D85 to D88 (D88 was given only in the morning, for a total of 7 doses).
Rosuvastatin calcium tablets also known as Rosuvastatin Drug

D8 received a single oral administration of 10 mg of Rosuvastatin calcium tablets in the morning, with a washout period of 168 h,and 10 mg Rosuvastatin calcium tablets orally at 72 h ± 0.5 h (D95) after JY09 administration.
Digoxin tablet also known as digoxin Drug

D15 received a single oral administration of 0.25 mg digoxin tablets in the morning, with a washout period of 168 h,oral 0.25 mg digoxin tablets 72 h±0.5 h after JY09 administration (D102)

Main thing measured	The Metformin Peak Concentration (Cmax )
Sponsor	Beijing Dongfang Biotech Co., Ltd.
Conditions studied	Diabetes Mellitus, Type 2, Overweight
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06247748 ↗