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

Официальное название

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Finding Study of CX11 Tablets in Patients With Type 2 Diabetes Mellitus

Обзор

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.

Вмешательства

• Препарат CX11
  CX11 tablets administered orally once daily (QD)
• Другое Placebo
  Matching placebo tablets administered orally once daily (QD)

Первичные конечные точки

• Change in Glycosylated hemoglobin, Type A1C (HbA1c) from baseline [Срок оценки: At Week 24]

Вторичные конечные точки (12)

• Proportion of participants achieving HbA1c < 7.0% [Срок оценки: At Week 24]
• Proportion of participants achieving HbA1c ≤ 6.5% [Срок оценки: At Week 24]
• Change from baseline in Time in Range (TIR) measured by Continuous Glucose Monitoring (CGM) [Срок оценки: To Week 24]
• Change from baseline in fasting plasma glucose (FPG) [Срок оценки: To Week 24]
• Change in body weight from baseline [Срок оценки: To Week 24]
• Percent change in body weight from baseline [Срок оценки: To Week 24]
• Proportion of participants achieving body weight loss ≥ 5% [Срок оценки: At Week 24]
• Proportion of participants achieving body weight loss ≥ 10% [Срок оценки: At Week 24]
• Change in Systolic Blood Pressure (SBP) from baseline [Срок оценки: To Week 24]
• Change in Diastolic Blood Pressure (DBP) from baseline [Срок оценки: To Week 24]
• Number of Level 2 hypoglycemic episodes (glucose <54 mg/dL) [Срок оценки: To Week 24]
• Number of severe hypoglycemic episodes [Срок оценки: To Week 24]

Критерии участия

Критерии включения

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

Критерии исключения

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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 31 центр

• Central Research Associates - Flourish - PPDS — Birmingham
• AES - DRS - Synexus Clinical Research US, Inc. - Birmingham — Birmingham
• AES - DRS - Optimal Research Alabama - Huntsville — Huntsville
• Ark Clinical Research - Long Beach — Long Beach
• Flourish Research - Walnut Creek - PPDS — Walnut Creek
• AES - DRS - Optimal Research Florida - Melbourne — Melbourne
• Tampa General Hospital — Tampa
• Conquest Research LLC - Winter Park — Winter Park
• … и ещё 23 центра

Польша · 14 центров

• AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu — Poznan
• Centrum Medyczne Pratia Bydgoszcz - PPDS — Bydgoszcz
• Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne — Krakow
• FutureMeds - Krakow - PPDS — Krakow
• METABOLICA Sp. z o.o — Tarnów
• AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu — Wroclaw
• AES - DRS - Synexus Polska Sp. Z o.o. Oddzial w Lodzi — Lodz
• FutureMeds - Lodz - PPDS — Lodz
• … и ещё 6 центров

Идентификаторы

NCT: NCT07340320 · CX11202

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗