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

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: Recruiting
• Conditions: Type II Diabetes Mellitus
• Intervention / Treatment: Other: Placebo; Drug: CX11

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Study Coordinator; Phone Number: 201-268-3723; Email: information.center@corxelbio.com

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Change in Glycosylated hemoglobin, Type A1C (HbA1c) from baseline	At Week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants achieving HbA1c < 7.0%	At Week 24
Proportion of participants achieving HbA1c ≤ 6.5%	At Week 24
Change from baseline in Time in Range (TIR) measured by Continuous Glucose Monitoring (CGM)	To Week 24
Change from baseline in fasting plasma glucose (FPG)	To Week 24
Change in body weight from baseline	To Week 24
Percent change in body weight from baseline	To Week 24
Proportion of participants achieving body weight loss ≥ 5%	At Week 24
Proportion of participants achieving body weight loss ≥ 10%	At Week 24
Change in Systolic Blood Pressure (SBP) from baseline	To Week 24
Change in Diastolic Blood Pressure (DBP) from baseline	To Week 24
Number of Level 2 hypoglycemic episodes (glucose <54 mg/dL)	To Week 24
Number of severe hypoglycemic episodes	To Week 24
Number of treatment-emergent adverse events (TEAEs)	Study duration, approximately 26 weeks
Number of AEs of special interest (AESIs)	Study duration, approximately 26 weeks
Plasma drug concentrations at each specified sampling time point	At Weeks 2, 4, 6, 8, 12, 16, 22 and 24
Mean plasma drug concentration at each specified sampling time point	At Weeks 2, 4, 6, 8, 12, 16, 22 and 24

Collaborators and Investigators

• Sponsor: Corxel Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2026
• Primary Completion (Estimated): December 23, 2026
• Study Completion (Estimated): January 7, 2027

Study Registration Dates

• First Submitted: January 13, 2026
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Hypoglycemia; Continuous Glucose Monitoring; Type 2 Diabetes Mellitus; Blood glucose; HbA1C; Percentage change in HbA1C; Change in Fasting Plasma Glucose; Change in body weight; Body weight loss; Hypoglycemics episodes; Health Survey Short Form-36; Diabetes treatment satisfaction questionnaire; Columbia-suicide severity rating scale
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Hypoglycemia; Diabetes Mellitus, Type 2
• Other Study ID 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