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

May 26, 2026 updated by: Corxel Pharmaceuticals

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-702
        • Recruiting
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85 001
        • Recruiting
        • Centrum Medyczne Pratia Bydgoszcz - PPDS
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 31-261
        • Recruiting
        • Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne
      • Krakow, Lesser Poland Voivodeship, Poland, 31-501
        • Recruiting
        • FutureMeds - Krakow - PPDS
      • Tarnów, Lesser Poland Voivodeship, Poland, 33-100
        • Recruiting
        • METABOLICA Sp. z o.o
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 50-381
        • Recruiting
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
    • Lódzkie
      • Lodz, Lódzkie, Poland, 90-127
        • Recruiting
        • AES - DRS - Synexus Polska Sp. Z o.o. Oddzial w Lodzi
      • Lodz, Lódzkie, Poland, 91-363
        • Recruiting
        • FutureMeds - Lodz - PPDS
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-672
        • Recruiting
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie
      • Warsaw, Masovian Voivodeship, Poland, 02-677
        • Recruiting
        • ETG Warszawa - PPDS
      • Warsaw, Masovian Voivodeship, Poland, 00-215
        • Recruiting
        • FutureMeds - Warszawa Centrum - PPDS
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-382
        • Recruiting
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
      • Gdynia, Pomeranian Voivodeship, Poland, 81-537
        • Recruiting
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdyni
    • Silesian Voivodeship
      • Częstochowa, Silesian Voivodeship, Poland, 42-202
        • Recruiting
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Czestochowie
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205-1605
        • Recruiting
        • Central Research Associates - Flourish - PPDS
      • Birmingham, Alabama, United States, 35211-1320
        • Recruiting
        • AES - DRS - Synexus Clinical Research US, Inc. - Birmingham
      • Huntsville, Alabama, United States, 35802-2569
        • Recruiting
        • AES - DRS - Optimal Research Alabama - Huntsville
    • California
      • Long Beach, California, United States, 90815-2521
        • Recruiting
        • Ark Clinical Research - Long Beach
      • Walnut Creek, California, United States, 94598-3343
        • Recruiting
        • Flourish Research - Walnut Creek - PPDS
    • Florida
      • Melbourne, Florida, United States, 32934-8172
        • Recruiting
        • AES - DRS - Optimal Research Florida - Melbourne
      • Tampa, Florida, United States, 33606-3571
        • Recruiting
        • Tampa General Hospital
      • Winter Park, Florida, United States, 32789-1857
        • Recruiting
        • Conquest Research LLC - Winter Park
    • Georgia
      • Albany, Georgia, United States, 31707-0205
        • Recruiting
        • Privia Medical Group Georgia, LLC - Albany - Javara - PPDS
      • Fayetteville, Georgia, United States, 30214
        • Recruiting
        • Javara Inc. - Fayetteville
      • Savannah, Georgia, United States, 31406-3928
        • Recruiting
        • Privia Medical Group Georgia, LLC - Savannah - Javara - PPDS
      • Thomasville, Georgia, United States, 31792-6618
        • Recruiting
        • Privia Medical Group Georgia, LLC - Thomasville - Javara - PPDS
    • Illinois
      • Chicago, Illinois, United States, 60602-3960
        • Recruiting
        • AES - DRS - Synexus Clinical Research US, Inc. - Chicago
    • Indiana
      • Evansville, Indiana, United States, 47714-7513
        • Recruiting
        • AES - DRS - Synexus Clinical Research US, Inc. - Evansville
    • Maryland
      • Silver Spring, Maryland, United States, 20901-1586
        • Recruiting
        • Privia Medical Group, LLC - Kelly's Collaborative Care - Javara - PPDS
    • Massachusetts
      • Springfield, Massachusetts, United States, 01103
        • Recruiting
        • Elixia Health - Springfield - Elixia - PPDS
    • Michigan
      • Pontiac, Michigan, United States, 48341
        • Recruiting
        • Elixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDS
    • Minnesota
      • Edina, Minnesota, United States, 55435-4305
        • Recruiting
        • AES - DRS - Synexus Clinical Research US, Inc. - Edina - Minneapolis
      • Mankato, Minnesota, United States, 56001
        • Recruiting
        • Mankato Clinic - East Main Street - Javara - PPDS
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Recruiting
        • Hassman Research Institute - Berlin - CenExel - PPDS
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102-2619
        • Recruiting
        • Albuquerque Clinical Trials Inc
    • North Carolina
      • Raleigh, North Carolina, United States, 27612-8106
        • Recruiting
        • M3 Wake Research, Inc - M3 WR
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73118-2872
        • Recruiting
        • Unity Clinical Research
    • South Carolina
      • North Charleston, South Carolina, United States, 29406
        • Recruiting
        • Monroe Biomedical Research Charleston
    • Texas
      • Dallas, Texas, United States, 75390-7202
        • Not yet recruiting
        • University of Texas Southwestern Medical Center
      • Dallas, Texas, United States, 75246
        • Recruiting
        • M3 Wake Research - Dallas
      • Mesquite, Texas, United States, 751497
        • Recruiting
        • SMS Clinical Research, LLC - 400 W. Kearney St
      • San Antonio, Texas, United States, 78229-3272
        • Recruiting
        • AES - DRS - Synexus Clinical Research US, Inc. - San Antonio
      • San Antonio, Texas, United States, 78229-3539
        • Recruiting
        • Flourish Research - San Antonio - PPDS
      • Stephenville, Texas, United States, 76401-1860
        • Recruiting
        • Privia Medical Group- North Texas - Stephenville - Javara - PPDS
    • Virginia
      • Vienna, Virginia, United States, 22182
        • Recruiting
        • Conquest Research - Arlington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

Participants who meet all of the following criteria will be eligible to participate in this study:

  • 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.
  • Body weight stable for the past 3 months before joining.
  • Stable dose of metformin (≥1000 mg/day), with or without SGLT2i, for ≥3 months.
  • Women of childbearing potential (WOCBP): highly effective contraception ≥6 months prior to screening, throughout study, and 90 days post-last dose; negative pregnancy test within 24 hrs of first dose; no intent to donate sperm/ova
  • Agrees to avoid grapefruit/grapefruit products

Exclusion Criteria

Participants who meet any of the following criteria will be excluded from this study:

  • 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.
  • More than one episode of severe low blood sugar, with awareness of hypoglycemia symptoms.

  • Cardiovascular or cerebrovascular conditions within the past 6 months:

    • Heart attack, coronary angioplasty, or bypass surgery (diagnostic angiography allowed).
    • Valvular heart disease or prior heart valve repair surgery.
    • Unstable angina.
    • Transient ischemic attack (TIA) or stroke.
    • Decompensated heart failure (NYHA Class III or IV).
    • ECG abnormalities indicating significant safety risk, such as supraventricular tachycardia, torsades de pointes, second- or third-degree AV block, myocardial infarction, QTcF > 450 ms in males or > 470 ms in females, PR interval > 220 ms.
    • Poorly controlled hypertension at screening: systolic ≥ 180 mmHg or diastolic ≥ 100 mmHg.

  • Pancreatic or gallbladder conditions:

    • Acute or chronic pancreatitis.
    • Symptomatic gallbladder disease (previous cholecystectomy is allowed).
    • Pancreatic injury or risk factors that increase pancreatitis risk.

  • Thyroid conditions:

    • Poorly controlled abnormal thyroid function on a stable dose before screening.
    • Clinically significant abnormal thyroid test results at screening.
    • Personal or first-degree family history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) type 2A or 2B.

  • Cancer history:

    • Malignancy within the past 5 years, regardless of recurrence or metastasis. Exceptions: localized basal cell skin cancer, low-risk prostate cancer, cervical carcinoma in situ, or high-grade prostatic intraepithelial neoplasia.

  • Gastrointestinal conditions or treatments that may affect drug absorption:

    • Abnormal gastric emptying (e.g., gastric outlet obstruction).
    • Severe chronic gastrointestinal disease, including active ulcer within 6 months.
    • Crohn's disease, ulcerative colitis, or other inflammatory bowel diseases.
    • Prior gastrointestinal surgery (except polypectomy and appendectomy).
    • Long-term use of drugs that directly affect gastrointestinal motility (e.g., mosapride, cisapride).

  • Liver disease:

    • Active liver disease other than nonalcoholic fatty liver.
    • Chronic active hepatitis B or C.
    • Primary biliary cirrhosis.

  • Eye disease:

    • Uncontrolled or potentially unstable diabetic retinopathy or maculopathy.

  • Abnormal lab results at screening:

    • eGFR < 60 mL/min/1.73 m² (CKD-EPI).
    • ALT or AST > 2.5 × upper limit of normal (ULN).
    • Total bilirubin > 1.5 × ULN (except known Gilbert's syndrome).
    • Serum amylase or lipase > 1.5 × ULN.
    • Fasting triglycerides > 5.7 mmol/L.
    • TSH > 1.5 × ULN or < 1.0 × LLN.
    • Calcitonin ≥ 20 ng/L.
    • Hemoglobin < 110 g/L (male) or < 100 g/L (female).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo group
Other: Placebo
Matching placebo tablets administered orally once daily (QD)
Experimental: 120 mg group
Drug: CX11
CX11 tablets administered orally once daily (QD)
Other Names:
  • VCT220
Experimental: 160 mg group
Drug: CX11
CX11 tablets administered orally once daily (QD)
Other Names:
  • VCT220
Experimental: 40 mg group
Drug: CX11
CX11 tablets administered orally once daily (QD)
Other Names:
  • VCT220
Experimental: 80 mg group
Drug: CX11
CX11 tablets administered orally once daily (QD)
Other Names:
  • VCT220
Experimental: 200 mg group
Drug: CX11
CX11 tablets administered orally once daily (QD)
Other Names:
  • VCT220

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in Glycosylated hemoglobin, Type A1C (HbA1c) from baseline
Time Frame: At Week 24
At Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Proportion of participants achieving HbA1c < 7.0%
Time Frame: At Week 24
At Week 24
Proportion of participants achieving HbA1c ≤ 6.5%
Time Frame: At Week 24
At Week 24
Change from baseline in Time in Range (TIR) measured by Continuous Glucose Monitoring (CGM)
Time Frame: To Week 24
To Week 24
Change from baseline in fasting plasma glucose (FPG)
Time Frame: To Week 24
To Week 24
Change in body weight from baseline
Time Frame: To Week 24
To Week 24
Percent change in body weight from baseline
Time Frame: To Week 24
To Week 24
Proportion of participants achieving body weight loss ≥ 5%
Time Frame: At Week 24
At Week 24
Proportion of participants achieving body weight loss ≥ 10%
Time Frame: At Week 24
At Week 24
Change in Systolic Blood Pressure (SBP) from baseline
Time Frame: To Week 24
To Week 24
Change in Diastolic Blood Pressure (DBP) from baseline
Time Frame: To Week 24
To Week 24
Number of Level 2 hypoglycemic episodes (glucose <54 mg/dL)
Time Frame: To Week 24
To Week 24
Number of severe hypoglycemic episodes
Time Frame: To Week 24
To Week 24
Number of treatment-emergent adverse events (TEAEs)
Time Frame: Study duration, approximately 26 weeks
Study duration, approximately 26 weeks
Number of AEs of special interest (AESIs)
Time Frame: Study duration, approximately 26 weeks
Study duration, approximately 26 weeks
Plasma drug concentrations at each specified sampling time point
Time Frame: At Weeks 2, 4, 6, 8, 12, 16, 22 and 24
At Weeks 2, 4, 6, 8, 12, 16, 22 and 24
Mean plasma drug concentration at each specified sampling time point
Time Frame: At Weeks 2, 4, 6, 8, 12, 16, 22 and 24
At Weeks 2, 4, 6, 8, 12, 16, 22 and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Corxel Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 6, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 23, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 7, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CX11202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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