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NCT07340320PHASE2Recruiting

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

Corxel Pharmaceuticals

Start Date

2/6/2026

Completion Date

1/7/2027

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 Criteria

Age Range: 18 years to 75 years

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).

Interventions

DRUG

CX11

OTHER

Placebo

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Conditions

Type II Diabetes Mellitus

Locations

Central Research Associates - Flourish - PPDS

Birmingham, Alabama 35205-1605

United States

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

Birmingham, Alabama 35211-1320

United States

AES - DRS - Optimal Research Alabama - Huntsville

Huntsville, Alabama 35802-2569

United States

Ark Clinical Research - Long Beach

Long Beach, California 90815-2521

United States

Flourish Research - Walnut Creek - PPDS

Walnut Creek, California 94598-3343

United States

AES - DRS - Optimal Research Florida - Melbourne

Melbourne, Florida 32934-8172

United States

Tampa General Hospital

Tampa, Florida 33606-3571

United States

Conquest Research LLC - Winter Park

Winter Park, Florida 32789-1857

United States

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

Albany, Georgia 31707-0205

United States

Javara Inc. - Fayetteville

Fayetteville, Georgia 30214

United States

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

Savannah, Georgia 31406-3928

United States

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

Thomasville, Georgia 31792-6618

United States

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

Chicago, Illinois 60602-3960

United States

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

Evansville, Indiana 47714-7513

United States

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

Silver Spring, Maryland 20901-1586

United States

Elixia Health - Springfield - Elixia - PPDS

Springfield, Massachusetts 01103

United States

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

Pontiac, Michigan 48341

United States

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

Edina, Minnesota 55435-4305

United States

Mankato Clinic - East Main Street - Javara - PPDS

Mankato, Minnesota 56001

United States

Hassman Research Institute - Berlin - CenExel - PPDS

Berlin, New Jersey 08009

United States

Albuquerque Clinical Trials Inc

Albuquerque, New Mexico 87102-2619

United States

M3 Wake Research, Inc - M3 WR

Raleigh, North Carolina 27612-8106

United States

Unity Clinical Research

Oklahoma City, Oklahoma 73118-2872

United States

Monroe Biomedical Research Charleston

North Charleston, South Carolina 29406

United States

M3 Wake Research - Dallas

Dallas, Texas 75246

United States

University of Texas Southwestern Medical Center

Dallas, Texas 75390-7202

United States

SMS Clinical Research, LLC - 400 W. Kearney St

Mesquite, Texas 751497

United States

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

San Antonio, Texas 78229-3272

United States

Flourish Research - San Antonio - PPDS

San Antonio, Texas 78229-3539

United States

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

Stephenville, Texas 76401-1860

United States

Conquest Research - Arlington

Vienna, Virginia 22182

United States

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

Poznan, Greater Poland Voivodeship 60-702

Poland

Centrum Medyczne Pratia Bydgoszcz - PPDS

Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85 001

Poland

Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne

Krakow, Lesser Poland Voivodeship 31-261

Poland

FutureMeds - Krakow - PPDS

Krakow, Lesser Poland Voivodeship 31-501

Poland

METABOLICA Sp. z o.o

Tarnów, Lesser Poland Voivodeship 33-100

Poland

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

Wroclaw, Lower Silesian Voivodeship 50-381

Poland

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

Lodz, Lódzkie 90-127

Poland

FutureMeds - Lodz - PPDS

Lodz, Lódzkie 91-363

Poland

FutureMeds - Warszawa Centrum - PPDS

Warsaw, Masovian Voivodeship 00-215

Poland

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

Warsaw, Masovian Voivodeship 02-672

Poland

ETG Warszawa - PPDS

Warsaw, Masovian Voivodeship 02-677

Poland

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

Gdansk, Pomeranian Voivodeship 80-382

Poland

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

Gdynia, Pomeranian Voivodeship 81-537

Poland

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

Częstochowa, Silesian Voivodeship 42-202

Poland