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NOT YET RECRUITING
NCT07872436
PHASE2

A Study of VCT220 Tablets in Adults With Type 2 Diabetes and Inadequate Blood Glucose Control

Sponsor: Vincentage Pharma Co., Ltd

View on ClinicalTrials.gov

Summary

This study will evaluate whether VCT220 tablets improve blood glucose control in adults with type 2 diabetes whose blood glucose remains inadequately controlled with lifestyle intervention alone, metformin alone, or metformin combined with a sodium-glucose cotransporter 2 (SGLT2) inhibitor. The study will also assess safety, tolerability, and how VCT220 is processed by the body. Approximately 120 participants will be randomly assigned in equal proportions to VCT220 40 mg, 80 mg, 120 mg, or placebo, taken orally once daily for 16 weeks. Higher-dose groups will start at 40 mg and increase the dose in steps. Participation will last approximately 22 weeks, including screening, a placebo run-in period, treatment, and safety follow-up. The main assessment is the change in glycated hemoglobin (HbA1c) from baseline to Week 16.

Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of VCT220 Tablets in Adults With Type 2 Diabetes Mellitus Inadequately Controlled With Lifestyle Intervention, Metformin Monotherapy, or Metformin in Combination With an SGLT2 Inhibitor

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-11-01

Completion Date

2027-09-01

Last Updated

2026-10-13

Healthy Volunteers

No

Interventions

DRUG

VCT220 tablets

VCT220 tablets will be administered orally once daily for 16 weeks, preferably with the first meal of the day, according to the assigned treatment regimen and protocol-specified titration schedule. Matching placebo tablets will be added as needed to maintain blinding.

DRUG

Placebo

Matching placebo tablets containing no active ingredient will be administered orally once daily for 16 weeks, preferably with the first meal of the day. The number of tablets will match that used in the active treatment groups at each treatment stage to maintain blinding.

Locations (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China