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

Purpose

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.

Condition

  • Type II Diabetes Mellitus

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo group
  • Other: Placebo
    Matching placebo tablets administered orally once daily (QD)
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
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
200 mg group
  • Drug: CX11
    CX11 tablets administered orally once daily (QD)
    Other names:
    • VCT220

Recruiting Locations

Central Research Associates - Flourish - PPDS
Birmingham, Alabama 35205-1605

AES - DRS - Synexus Clinical Research US, Inc. - Birmingham
Birmingham, Alabama 35211-1320

AES - DRS - Optimal Research Alabama - Huntsville
Huntsville, Alabama 35802-2569

Ark Clinical Research - Long Beach
Long Beach, California 90815-2521

Flourish Research - Walnut Creek - PPDS
Walnut Creek, California 94598-3343

AES - DRS - Optimal Research Florida - Melbourne
Melbourne, Florida 32934-8172

Tampa General Hospital
Tampa, Florida 33606-3571

Conquest Research LLC - Winter Park
Winter Park, Florida 32789-1857

Privia Medical Group Georgia, LLC - Albany - Javara - PPDS
Albany, Georgia 31707-0205

Privia Medical Group Georgia, LLC - Savannah - Javara - PPDS
Savannah, Georgia 31406-3928

Privia Medical Group Georgia, LLC - Thomasville - Javara - PPDS
Thomasville, Georgia 31792-6618

AES - DRS - Synexus Clinical Research US, Inc. - Chicago
Chicago, Illinois 60602-3960

AES - DRS - Synexus Clinical Research US, Inc. - Evansville
Evansville, Indiana 47714-7513

Privia Medical Group, LLC - Kelly's Collaborative Care - Javara - PPDS
Silver Spring, Maryland 20901-1586

Elixia Health - Springfield - Elixia - PPDS
Springfield, Massachusetts 01103

Elixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDS
Pontiac, Michigan 48341

AES - DRS - Synexus Clinical Research US, Inc. - Edina - Minneapolis
Edina, Minnesota 55435-4305

Mankato Clinic - East Main Street - Javara - PPDS
Mankato, Minnesota 56001

Hassman Research Institute - Berlin - CenExel - PPDS
Berlin, New Jersey 08009

Albuquerque Clinical Trials Inc
Albuquerque, New Mexico 87102-2619

M3 Wake Research, Inc - M3 WR
Raleigh, North Carolina 27612-8106

Unity Clinical Research
Oklahoma City, Oklahoma 73118-2872

Monroe Biomedical Research Charleston
North Charleston, South Carolina 29406

M3 Wake Research - Dallas
Dallas, Texas 75246

SMS Clinical Research, LLC - 400 W. Kearney St
Mesquite, Texas 751497

AES - DRS - Synexus Clinical Research US, Inc. - San Antonio
San Antonio, Texas 78229-3272

Flourish Research - San Antonio - PPDS
San Antonio, Texas 78229-3539

Privia Medical Group- North Texas - Stephenville - Javara - PPDS
Stephenville, Texas 76401-1860

Conquest Research - Arlington
Arlington, Virginia 22205

More Details

Status
Recruiting
Sponsor
Corxel Pharmaceuticals

Study Contact

Study Coordinator
201-268-3723
information.center@corxelbio.com