A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Finding Study of CX11 Tablets in Patients with Type 2 Diabetes Mellitus.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524514-28-00

Enrollment

121

Registered

2026-04-22

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Brief summary

Change in HbA1c from baseline

Detailed description

1. HbA1c < 7.0% 2. HbA1c ≤ 6.5% 3. Change of TIR on CGM from baseline 4. Change in FPG from baseline 5. Change in body weight from baseline 6. Percent change in body weight from baseline 7. Body weight loss ≥ 5% 8. Body weight loss ≥ 10% 8. Body weight loss ≥ 10%, 9. Change in SBP and DBP from baseline 10. Number of level 2 hypoglycemic episodes or severe hypoglycemic episodes 11. TEAE & AESI; 12. Population PK parameters

Interventions

DRUGCX11

DRUGPlacebo to cx11 40 mg

DRUGPlacebo to cx11 80 mg

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change in HbA1c from baseline	—

Secondary

Measure	Time frame
1. HbA1c < 7.0% 2. HbA1c ≤ 6.5% 3. Change of TIR on CGM from baseline 4. Change in FPG from baseline 5. Change in body weight from baseline 6. Percent change in body weight from baseline 7. Body weight loss ≥ 5% 8. Body weight loss ≥ 10% 8. Body weight loss ≥ 10%, 9. Change in SBP and DBP from baseline 10. Number of level 2 hypoglycemic episodes or severe hypoglycemic episodes 11. TEAE & AESI; 12. Population PK parameters	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Apr 23, 2026