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Type II Diabetes MellitusPhase 2NCT07340320

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

A Phase 2 study testing CX11 in people with Type II Diabetes Mellitus, run by Corxel Pharmaceuticals at 48 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type II Diabetes Mellitus
What is being tested?
CX11
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
240 participants
Where
48 sitesin 2 countries
Study dates
6 Feb 2026to 30 Apr 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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

Who cannot join

  • 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.
Show all 45Show fewer
  • 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).

Trial locations and contacts

48 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Study Coordinator contact

201-268-3723

information.center@corxelbio.com

48 sites in 2 countries

United States34 sites, 34 recruiting

  • Privia Medical Group Georgia, LLC - Albany - Javara - PPDS

    Albany, Georgia, 31707-0205

    Recruiting

  • Albuquerque Clinical Trials Inc

    Albuquerque, New Mexico, 87102-2619

    Recruiting

  • Hassman Research Institute - Berlin - CenExel - PPDS

    Berlin, New Jersey, 08009

    Recruiting

  • Central Research Associates - Flourish - PPDS

    Birmingham, Alabama, 35205-1605

    Recruiting

  • AES - DRS - Synexus Clinical Research US, Inc. - Birmingham

    Birmingham, Alabama, 35211-1320

    Recruiting

  • Brooklyn Clinical Research

    Brooklyn, New York, 11226

    Recruiting

  • Core Healthcare Group

    Cerritos, California, 90703

    Recruiting

  • AES - DRS - Synexus Clinical Research US, Inc. - Chicago

    Chicago, Illinois, 60602-3960

    Recruiting

  • M3 Wake Research - Dallas

    Dallas, Texas, 75246

    Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390-7202

    Not yet recruiting

  • AES - DRS - Synexus Clinical Research US, Inc. - Edina - Minneapolis

    Edina, Minnesota, 55435-4305

    Recruiting

  • AES - DRS - Synexus Clinical Research US, Inc. - Evansville

    Evansville, Indiana, 47714-7513

    Recruiting

  • Javara Inc. - Fayetteville

    Fayetteville, Georgia, 30214

    Recruiting

  • AES - DRS - Optimal Research Alabama - Huntsville

    Huntsville, Alabama, 35802-2569

    Recruiting

  • Ark Clinical Research - Long Beach

    Long Beach, California, 90815-2521

    Recruiting

  • Mankato Clinic - East Main Street - Javara - PPDS

    Mankato, Minnesota, 56001

    Recruiting

  • AES - DRS - Optimal Research Florida - Melbourne

    Melbourne, Florida, 32934-8172

    Recruiting

  • SMS Clinical Research, LLC - 400 W. Kearney St

    Mesquite, Texas, 751497

    Recruiting

  • Monroe Biomedical Research Charleston

    North Charleston, South Carolina, 29406

    Recruiting

  • Unity Clinical Research

    Oklahoma City, Oklahoma, 73118-2872

    Recruiting

  • Elixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDS

    Pontiac, Michigan, 48341

    Recruiting

  • M3 Wake Research, Inc - M3 WR

    Raleigh, North Carolina, 27612-8106

    Recruiting

  • Sky Integrative Medical Center

    Ridgeland, Mississippi, 39157

    Recruiting

  • AES - DRS - Synexus Clinical Research US, Inc. - San Antonio

    San Antonio, Texas, 78229-3272

    Recruiting

  • Flourish Research - San Antonio - PPDS

    San Antonio, Texas, 78229-3539

    Recruiting

  • Privia Medical Group Georgia, LLC - Savannah - Javara - PPDS

    Savannah, Georgia, 31406-3928

    Recruiting

  • Privia Medical Group, LLC - Kelly's Collaborative Care - Javara - PPDS

    Silver Spring, Maryland, 20901-1586

    Recruiting

  • Elixia Health - Springfield - Elixia - PPDS

    Springfield, Massachusetts, 01103

    Recruiting

  • Privia Medical Group- North Texas - Stephenville - Javara - PPDS

    Stephenville, Texas, 76401-1860

    Recruiting

  • Tampa General Hospital

    Tampa, Florida, 33606-3571

    Recruiting

  • Privia Medical Group Georgia, LLC - Thomasville - Javara - PPDS

    Thomasville, Georgia, 31792-6618

    Recruiting

  • Conquest Research - Arlington

    Vienna, Virginia, 22182

    Recruiting

  • Flourish Research - Walnut Creek - PPDS

    Walnut Creek, California, 94598-3343

    Recruiting

  • Conquest Research LLC - Winter Park

    Winter Park, Florida, 32789-1857

    Recruiting

Other trials in United States

Poland14 sites, 14 recruiting

  • Centrum Medyczne Pratia Bydgoszcz - PPDS

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85 001

    Recruiting

  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Czestochowie

    Częstochowa, Silesian Voivodeship, 42-202

    Recruiting

  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku

    Gdansk, Pomeranian Voivodeship, 80-382

    Recruiting

  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdyni

    Gdynia, Pomeranian Voivodeship, 81-537

    Recruiting

  • Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne

    Krakow, Lesser Poland Voivodeship, 31-261

    Recruiting

  • FutureMeds - Krakow - PPDS

    Krakow, Lesser Poland Voivodeship, 31-501

    Recruiting

  • AES - DRS - Synexus Polska Sp. Z o.o. Oddzial w Lodzi

    Lodz, Lódzkie, 90-127

    Recruiting

  • FutureMeds - Lodz - PPDS

    Lodz, Lódzkie, 91-363

    Recruiting

  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu

    Poznan, Greater Poland Voivodeship, 60-702

    Recruiting

  • METABOLICA Sp. z o.o

    Tarnów, Lesser Poland Voivodeship, 33-100

    Recruiting

  • FutureMeds - Warszawa Centrum - PPDS

    Warsaw, Masovian Voivodeship, 00-215

    Recruiting

  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie

    Warsaw, Masovian Voivodeship, 02-672

    Recruiting

  • ETG Warszawa - PPDS

    Warsaw, Masovian Voivodeship, 02-677

    Recruiting

  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

    Wroclaw, Lower Silesian Voivodeship, 50-381

    Recruiting

Other trials in Poland

About this study

Official title: 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.

Being tested
CX11, Placebo
Keywords
Type 2 Diabetes Mellitus, HbA1C, Percentage change in HbA1C, Change in Fasting Plasma Glucose, Change in body weight, Body weight loss, Hypoglycemics episodes, Hypoglycemia, Continuous Glucose Monitoring, Blood glucose, Health Survey Short Form-36, Diabetes treatment satisfaction questionnaire, Columbia-suicide severity rating scale
Medical subject headings
Diabetes Mellitus, Type 2, Hypoglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CX11Drug

    Also called VCT220

    CX11 tablets administered orally once daily (QD)

  • PlaceboOther

    Matching placebo tablets administered orally once daily (QD)

Study groups in NCT07340320
Study groupRoleWhat they receive
Placebo groupPlacebo comparatorNot described
Receives: Other: Placebo
40 mg groupExperimentalNot described
Receives: Drug: CX11
80 mg groupExperimentalNot described
Receives: Drug: CX11
120 mg groupExperimentalNot described
Receives: Drug: CX11
160 mg groupExperimentalNot described
Receives: Drug: CX11
200 mg groupExperimentalNot described
Receives: Drug: CX11

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: At Week 24

Secondary outcomes (16)

  1. Proportion of participants achieving HbA1c < 7.0%

    Measured: At Week 24

  2. Proportion of participants achieving HbA1c ≤ 6.5%

    Measured: At Week 24

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

    Measured: To Week 24

  4. Change from baseline in fasting plasma glucose (FPG)

    Measured: To Week 24

  5. Change in body weight from baseline

    Measured: To Week 24

  6. Percent change in body weight from baseline

    Measured: To Week 24

  7. Proportion of participants achieving body weight loss ≥ 5%

    Measured: At Week 24

  8. Proportion of participants achieving body weight loss ≥ 10%

    Measured: At Week 24

  9. Change in Systolic Blood Pressure (SBP) from baseline

    Measured: To Week 24

  10. Change in Diastolic Blood Pressure (DBP) from baseline

    Measured: To Week 24

  11. Number of Level 2 hypoglycemic episodes (glucose <54 mg/dL)

    Measured: To Week 24

  12. Number of severe hypoglycemic episodes

    Measured: To Week 24

  13. Number of treatment-emergent adverse events (TEAEs)

    Measured: Study duration, approximately 26 weeks

  14. Number of AEs of special interest (AESIs)

    Measured: Study duration, approximately 26 weeks

  15. Plasma drug concentrations at each specified sampling time point

    Measured: At Weeks 2, 4, 6, 8, 12, 16, 22 and 24

  16. Mean plasma drug concentration at each specified sampling time point

    Measured: At Weeks 2, 4, 6, 8, 12, 16, 22 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2026
  2. Study start6 Feb 2026
  3. Primary completion16 Apr 2027 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07340320
Sponsor's protocol ID
CX11202
Status last verified
Sep 2026
First submitted
13 Jan 2026
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CX11 in people with Type II Diabetes Mellitus, run by Corxel Pharmaceuticals at 48 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Coordinator (201-268-3723, information.center@corxelbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Glycosylated hemoglobin, Type A1C (HbA1c) from baseline (time frame: At Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07340320.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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