Език: EN EN
← Назад към резултатите
Набира участници Фаза 2 NCT07340320

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

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Type II Diabetes Mellitus

Спонсор: Corxel Pharmaceuticals

Налично на: БГ
Обобщение
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.
Кой може да участва
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).
Интервенции
CX11
DRUG
Placebo
OTHER
Места на провеждане 46
Полша (15)
Centrum Medyczne Pratia Bydgoszcz - PPDS
Bydgoszcz , Kuyavian-Pomeranian Voivodeship
NOT_YET_RECRUITING
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Czestochowie
Częstochowa , Silesian Voivodeship
NOT_YET_RECRUITING
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
Gdansk , Pomeranian Voivodeship
NOT_YET_RECRUITING
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdyni
Gdynia , Pomeranian Voivodeship
NOT_YET_RECRUITING
Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne
Krakow , Lesser Poland Voivodeship
NOT_YET_RECRUITING
FutureMeds - Krakow - PPDS
Krakow , Lesser Poland Voivodeship
NOT_YET_RECRUITING
AES - DRS - Synexus Polska Sp. Z o.o. Oddzial w Lodzi
Lodz , Lódzkie
NOT_YET_RECRUITING
FutureMeds - Lodz - PPDS
Lodz , Lódzkie
NOT_YET_RECRUITING
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
Poznan , Greater Poland Voivodeship
NOT_YET_RECRUITING
Gabinet Lekarski Robert Witek
Tarnów , Lesser Poland Voivodeship
NOT_YET_RECRUITING
METABOLICA Sp. z o.o
Tarnów , Lesser Poland Voivodeship
NOT_YET_RECRUITING
FutureMeds - Warszawa Centrum - PPDS
Warsaw , Masovian Voivodeship
NOT_YET_RECRUITING
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw , Masovian Voivodeship
NOT_YET_RECRUITING
ETG Warszawa - PPDS
Warsaw , Masovian Voivodeship
NOT_YET_RECRUITING
AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Wroclaw , Lower Silesian Voivodeship
NOT_YET_RECRUITING
САЩ (31)
Privia Medical Group Georgia, LLC - Albany - Javara - PPDS
Albany , Georgia
Albuquerque Clinical Trials Inc
Albuquerque , New Mexico
Conquest Research - Arlington
Arlington , Virginia
Hassman Research Institute - Berlin - CenExel - PPDS
Berlin , New Jersey
Central Research Associates - Flourish - PPDS
Birmingham , Alabama
AES - DRS - Synexus Clinical Research US, Inc. - Birmingham
Birmingham , Alabama
AES - DRS - Synexus Clinical Research US, Inc. - Chicago
Chicago , Illinois
M3 Wake Research - Dallas
Dallas , Texas
University of Texas Southwestern Medical Center
Dallas , Texas
NOT_YET_RECRUITING
AES - DRS - Synexus Clinical Research US, Inc. - Edina - Minneapolis
Edina , Minnesota
AES - DRS - Synexus Clinical Research US, Inc. - Evansville
Evansville , Indiana
Javara Inc. - Fayetteville
Fayetteville , Georgia
NOT_YET_RECRUITING
AES - DRS - Optimal Research Alabama - Huntsville
Huntsville , Alabama
Ark Clinical Research - Long Beach
Long Beach , California
Mankato Clinic - East Main Street - Javara - PPDS
Mankato , Minnesota
AES - DRS - Optimal Research Florida - Melbourne
Melbourne , Florida
SMS Clinical Research, LLC - 400 W. Kearney St
Mesquite , Texas
Monroe Biomedical Research Charleston
North Charleston , South Carolina
Unity Clinical Research
Oklahoma City , Oklahoma
Elixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDS
Pontiac , Michigan
M3 Wake Research, Inc - M3 WR
Raleigh , North Carolina
AES - DRS - Synexus Clinical Research US, Inc. - San Antonio
San Antonio , Texas
Flourish Research - San Antonio - PPDS
San Antonio , Texas
Privia Medical Group Georgia, LLC - Savannah - Javara - PPDS
Savannah , Georgia
Privia Medical Group, LLC - Kelly's Collaborative Care - Javara - PPDS
Silver Spring , Maryland
Elixia Health - Springfield - Elixia - PPDS
Springfield , Massachusetts
Privia Medical Group- North Texas - Stephenville - Javara - PPDS
Stephenville , Texas
Tampa General Hospital
Tampa , Florida
Privia Medical Group Georgia, LLC - Thomasville - Javara - PPDS
Thomasville , Georgia
Flourish Research - Walnut Creek - PPDS
Walnut Creek , California
Conquest Research LLC - Winter Park
Winter Park , Florida
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
75 Years
Здрави доброволци
Не
Начална дата
06.02.2026
Крайна дата
07.01.2027
Регистрационен номер
NCT07340320
Източник
clinicaltrials.gov
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.