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Clinical Trials in the USA / NCT07340320
Recruiting Phase 2

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

NCT07340320 · tracked via the Priya Life Science USA tracker
Sponsor
Corxel Pharmaceuticals
Phase
Phase 2
Started
2026-02-06
Last updated
2026-09-15

Condition(s) studied

Type II Diabetes Mellitus

Investigational drug(s) / intervention(s)

CX11Placebo

CX11: CX11 tablets administered orally once daily (QD)

Placebo: Matching placebo tablets administered orally once daily (QD)

Study 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.

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

Sex
ALL
Min age
18 Years
Max age
75 Years
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).

Primary outcome measure(s)

Trial sites (48)

FacilityCityRegionStatus
Central Research Associates - Flourish - PPDS Birmingham Alabama Recruiting
AES - DRS - Synexus Clinical Research US, Inc. - Birmingham Birmingham Alabama Recruiting
AES - DRS - Optimal Research Alabama - Huntsville Huntsville Alabama Recruiting
Core Healthcare Group Cerritos California Recruiting
Ark Clinical Research - Long Beach Long Beach California Recruiting
Flourish Research - Walnut Creek - PPDS Walnut Creek California Recruiting
AES - DRS - Optimal Research Florida - Melbourne Melbourne Florida Recruiting
Tampa General Hospital Tampa Florida Recruiting
Conquest Research LLC - Winter Park Winter Park Florida Recruiting
Privia Medical Group Georgia, LLC - Albany - Javara - PPDS Albany Georgia Recruiting
Javara Inc. - Fayetteville Fayetteville Georgia Recruiting
Privia Medical Group Georgia, LLC - Savannah - Javara - PPDS Savannah Georgia Recruiting
Privia Medical Group Georgia, LLC - Thomasville - Javara - PPDS Thomasville Georgia Recruiting
AES - DRS - Synexus Clinical Research US, Inc. - Chicago Chicago Illinois Recruiting
AES - DRS - Synexus Clinical Research US, Inc. - Evansville Evansville Indiana Recruiting
Privia Medical Group, LLC - Kelly's Collaborative Care - Javara - PPDS Silver Spring Maryland Recruiting
Elixia Health - Springfield - Elixia - PPDS Springfield Massachusetts Recruiting
Elixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDS Pontiac Michigan Recruiting
AES - DRS - Synexus Clinical Research US, Inc. - Edina - Minneapolis Edina Minnesota Recruiting
Mankato Clinic - East Main Street - Javara - PPDS Mankato Minnesota Recruiting
Sky Integrative Medical Center Ridgeland Mississippi Recruiting
Hassman Research Institute - Berlin - CenExel - PPDS Berlin New Jersey Recruiting
Albuquerque Clinical Trials Inc Albuquerque New Mexico Recruiting
Brooklyn Clinical Research Brooklyn New York Recruiting
M3 Wake Research, Inc - M3 WR Raleigh North Carolina Recruiting
Unity Clinical Research Oklahoma City Oklahoma Recruiting
Monroe Biomedical Research Charleston North Charleston South Carolina Recruiting
M3 Wake Research - Dallas Dallas Texas Recruiting
University of Texas Southwestern Medical Center Dallas Texas Not Yet Recruiting
SMS Clinical Research, LLC - 400 W. Kearney St Mesquite Texas Recruiting
AES - DRS - Synexus Clinical Research US, Inc. - San Antonio San Antonio Texas Recruiting
Flourish Research - San Antonio - PPDS San Antonio Texas Recruiting
Privia Medical Group- North Texas - Stephenville - Javara - PPDS Stephenville Texas Recruiting
Conquest Research - Arlington Vienna Virginia Recruiting
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu Poznan Greater Poland Voivodeship Recruiting
Centrum Medyczne Pratia Bydgoszcz - PPDS Bydgoszcz Kuyavian-Pomeranian Voivodeship Recruiting
Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne Krakow Lesser Poland Voivodeship Recruiting
FutureMeds - Krakow - PPDS Krakow Lesser Poland Voivodeship Recruiting
METABOLICA Sp. z o.o Tarnów Lesser Poland Voivodeship Recruiting
AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu Wroclaw Lower Silesian Voivodeship Recruiting

+ 8 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07340320 on ClinicalTrials.gov ↗ ← All trials in the USA