A Study of CX11 Tablets in Patients With Type 2 Diabetes Mellitus

Conditions

• Type II Diabetes Mellitus

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• CX11 — DRUG
  CX11 tablets administered orally once daily (QD)
• Placebo — OTHER
  Matching placebo tablets administered orally once daily (QD)

Study Details

This study is testing whether a new medication called CX11 works and is safe for participants with type 2 diabetes who have not reached good blood sugar control while taking a steady dose of metformin, with or without a steady dose of an SGLT2 inhibitor, for at least 90 days. The study is being done at multiple medical centers. Participants are assigned by chance (randomized) to different groups, and neither the participants nor the study staff know which group they're in (double-blind). The groups are compared side by side (parallel), and some participants will receive inactive pills (placebo) to help measure the true effect of the study drug. After screening, participants will be randomly placed into one of six groups, with equal chances of being in any group. Each group will receive a different dose of CX11 or a placebo. Treatment will last 24 weeks. After that, all participants will have a 2-week follow-up period to check on safety.

Key Dates

Start date

Feb 6, 2026

Status verified

May 2026

Primary completion

Dec 23, 2026

Completion

Jan 7, 2027

Study Design

Enrollment

240 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo group
• Experimental: 40 mg group
• Experimental: 80 mg group
• Experimental: 120 mg group
• Experimental: 160 mg group
• Experimental: 200 mg group

Primary Outcome Measure

Change in Glycosylated hemoglobin, Type A1C (HbA1c) from baseline [ Time Frame: At Week 24 ]

Central Contacts

• Study Coordinator
  201-268-3723
  [email protected]

Locations (31)

Find similar trials in Birmingham, AL

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