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

NCT ID: NCT07340320
Registry status: Recruiting
Study type: Not specified in the registry data
Phase: Phase 2
Sponsor: Corxel Pharmaceuticals

Overview

ClinicalTrials.gov lists this study as Recruiting.

Enrollment: 240 participants (Estimated).

What is being studied

No interventions are listed in the registry data.

Who may be eligible

Ages: Not specified in the registry data
Sex: Not specified in the registry data
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

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 locations

48 study locations are listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: Poland, United States

Greater Poland Voivodeship, Poland: 1
Kuyavian-Pomeranian Voivodeship, Poland: 1
Lesser Poland Voivodeship, Poland: 3
Lódzkie, Poland: 2
Lower Silesian Voivodeship, Poland: 1
Masovian Voivodeship, Poland: 3
Pomeranian Voivodeship, Poland: 2
Silesian Voivodeship, Poland: 1
Alabama, United States: 3
California, United States: 3
Florida, United States: 3
Georgia, United States: 4
Illinois, United States: 1
Indiana, United States: 1
Maryland, United States: 1
Massachusetts, United States: 1
Michigan, United States: 1
Minnesota, United States: 2
Mississippi, United States: 1
New Jersey, United States: 1
New Mexico, United States: 1
New York, United States: 1
North Carolina, United States: 1
Oklahoma, United States: 1
South Carolina, United States: 1
Texas, United States: 6
Virginia, United States: 1

Sample of listed locations

AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu — Poznan, Greater Poland Voivodeship, 60-702, Poland — Site recruitment status not specified in the registry data
Centrum Medyczne Pratia Bydgoszcz - PPDS — Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85 001, Poland — Site recruitment status not specified in the registry data
FutureMeds - Krakow - PPDS — Krakow, Lesser Poland Voivodeship, 31-501, Poland — Site recruitment status not specified in the registry data
Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne — Krakow, Lesser Poland Voivodeship, 31-261, Poland — Site recruitment status not specified in the registry data
METABOLICA Sp. z o.o — Tarnów, Lesser Poland Voivodeship, 33-100, Poland — Site recruitment status not specified in the registry data
AES - DRS - Synexus Polska Sp. Z o.o. Oddzial w Lodzi — Lodz, Lódzkie, 90-127, Poland — Site recruitment status not specified in the registry data
FutureMeds - Lodz - PPDS — Lodz, Lódzkie, 91-363, Poland — Site recruitment status not specified in the registry data
AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu — Wroclaw, Lower Silesian Voivodeship, 50-381, Poland — Site recruitment status not specified in the registry data
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie — Warsaw, Masovian Voivodeship, 02-672, Poland — Site recruitment status not specified in the registry data
ETG Warszawa - PPDS — Warsaw, Masovian Voivodeship, 02-677, Poland — Site recruitment status not specified in the registry data
FutureMeds - Warszawa Centrum - PPDS — Warsaw, Masovian Voivodeship, 00-215, Poland — Site recruitment status not specified in the registry data
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku — Gdansk, Pomeranian Voivodeship, 80-382, Poland — Site recruitment status not specified in the registry data
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdyni — Gdynia, Pomeranian Voivodeship, 81-537, Poland — Site recruitment status not specified in the registry data
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Czestochowie — Częstochowa, Silesian Voivodeship, 42-202, Poland — Site recruitment status not specified in the registry data
AES - DRS - Synexus Clinical Research US, Inc. - Birmingham — Birmingham, Alabama, 35211-1320, United States — Site recruitment status not specified in the registry data
Central Research Associates - Flourish - PPDS — Birmingham, Alabama, 35205-1605, United States — Site recruitment status not specified in the registry data
AES - DRS - Optimal Research Alabama - Huntsville — Huntsville, Alabama, 35802-2569, United States — Site recruitment status not specified in the registry data
Core Healthcare Group — Cerritos, California, 90703, United States — Site recruitment status not specified in the registry data
Ark Clinical Research - Long Beach — Long Beach, California, 90815-2521, United States — Site recruitment status not specified in the registry data
Flourish Research - Walnut Creek - PPDS — Walnut Creek, California, 94598-3343, United States — Site recruitment status not specified in the registry data
AES - DRS - Optimal Research Florida - Melbourne — Melbourne, Florida, 32934-8172, United States — Site recruitment status not specified in the registry data
Tampa General Hospital — Tampa, Florida, 33606-3571, United States — Site recruitment status not specified in the registry data
Conquest Research LLC - Winter Park — Winter Park, Florida, 32789-1857, United States — Site recruitment status not specified in the registry data
Privia Medical Group Georgia, LLC - Albany - Javara - PPDS — Albany, Georgia, 31707-0205, United States — Site recruitment status not specified in the registry data
Javara Inc. - Fayetteville — Fayetteville, Georgia, 30214, United States — Site recruitment status not specified in the registry data

Study details

Start date: February 6, 2026
Primary completion date: April 16, 2027
First posted: January 14, 2026

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT07340320
Registry last updated: September 15, 2026
QualifiedStudies registry data refreshed: September 21, 2026

View NCT07340320 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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