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

ConditionType II Diabetes Mellitus
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCorxel Pharmaceuticals

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 to 75.

Diagnosis of type 2 diabetes for at least 6 months.

HbA1c between 7.0% and 10.5%.

Body mass index (BMI) between 23 and 50 kg/m².

Disqualifiers

Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or systemic corticosteroids).

Type 1 diabetes or a history of diabetic ketoacidosis.

Use of any GLP-1 receptor agonist within the past 6 months, or any prior exposure to CX11.

Use of insulin to control blood sugar within the past 12 months.

Trial design

Design model

Parallel

Treatments tested in this trial

  • CX11

    Drug

    CX11 tablets administered orally once daily (QD)

  • Placebo

    Other intervention

    Matching placebo tablets administered orally once daily (QD)

Treatment groups

240 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Placebo groupPlacebo comparator 1 intervention
Group B: 40 mg groupExperimental treatment 1 intervention
Group C: 80 mg groupExperimental treatment 1 intervention
Group D: 120 mg groupExperimental treatment 1 intervention
Group E: 160 mg groupExperimental treatment 1 intervention
Group F: 200 mg groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Glycosylated hemoglobin, Type A1C (HbA1c) from baseline

Time frame
At Week 24

Secondary outcomes

1

Proportion of participants achieving HbA1c < 7.0%

Time frame
At Week 24
2

Proportion of participants achieving HbA1c ≤ 6.5%

Time frame
At Week 24
3

Change from baseline in Time in Range (TIR) measured by Continuous Glucose Monitoring (CGM)

Time frame
To Week 24
4

Change from baseline in fasting plasma glucose (FPG)

Time frame
To Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Corxel Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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