A Study of CX11 Tablets in Patients With Type 2 Diabetes Mellitus
Recruiting · NCT07340320 · Interventional (participants receive a specific treatment) · Lead sponsor: Corxel Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
CX11Placebo
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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).
Where it is running
48 locations listed across 19 US states.
- Central Research Associates - Flourish - PPDS - Birmingham, Alabama, United States
- AES - DRS - Synexus Clinical Research US, Inc. - Birmingham - Birmingham, Alabama, United States
- AES - DRS - Optimal Research Alabama - Huntsville - Huntsville, Alabama, United States
- Core Healthcare Group - Cerritos, California, United States
- Ark Clinical Research - Long Beach - Long Beach, California, United States
- Flourish Research - Walnut Creek - PPDS - Walnut Creek, California, United States
- AES - DRS - Optimal Research Florida - Melbourne - Melbourne, Florida, United States
- Tampa General Hospital - Tampa, Florida, United States
- Conquest Research LLC - Winter Park - Winter Park, Florida, United States
- Privia Medical Group Georgia, LLC - Albany - Javara - PPDS - Albany, Georgia, United States
- Javara Inc. - Fayetteville - Fayetteville, Georgia, United States
- Privia Medical Group Georgia, LLC - Savannah - Javara - PPDS - Savannah, Georgia, United States
- Privia Medical Group Georgia, LLC - Thomasville - Javara - PPDS - Thomasville, Georgia, United States
- AES - DRS - Synexus Clinical Research US, Inc. - Chicago - Chicago, Illinois, United States
- AES - DRS - Synexus Clinical Research US, Inc. - Evansville - Evansville, Indiana, United States
- Privia Medical Group, LLC - Kelly's Collaborative Care - Javara - PPDS - Silver Spring, Maryland, United States
- Elixia Health - Springfield - Elixia - PPDS - Springfield, Massachusetts, United States
- Elixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDS - Pontiac, Michigan, United States
- AES - DRS - Synexus Clinical Research US, Inc. - Edina - Minneapolis - Edina, Minnesota, United States
- Mankato Clinic - East Main Street - Javara - PPDS - Mankato, Minnesota, United States
- Sky Integrative Medical Center - Ridgeland, Mississippi, United States
- Hassman Research Institute - Berlin - CenExel - PPDS - Berlin, New Jersey, United States
- Albuquerque Clinical Trials Inc - Albuquerque, New Mexico, United States
- Brooklyn Clinical Research - Brooklyn, New York, United States
- M3 Wake Research, Inc - M3 WR - Raleigh, North Carolina, United States
- Unity Clinical Research - Oklahoma City, Oklahoma, United States
- Monroe Biomedical Research Charleston - North Charleston, South Carolina, United States
- M3 Wake Research - Dallas - Dallas, Texas, United States
- University of Texas Southwestern Medical Center - Dallas, Texas, United States
- SMS Clinical Research, LLC - 400 W. Kearney St - Mesquite, Texas, United States
- AES - DRS - Synexus Clinical Research US, Inc. - San Antonio - San Antonio, Texas, United States
- Flourish Research - San Antonio - PPDS - San Antonio, Texas, United States
- Privia Medical Group- North Texas - Stephenville - Javara - PPDS - Stephenville, Texas, United States
- Conquest Research - Arlington - Vienna, Virginia, United States
- AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu - Poznan, Greater Poland Voivodeship, Poland
- Centrum Medyczne Pratia Bydgoszcz - PPDS - Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
- Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne - Krakow, Lesser Poland Voivodeship, Poland
- FutureMeds - Krakow - PPDS - Krakow, Lesser Poland Voivodeship, Poland
- METABOLICA Sp. z o.o - Tarnów, Lesser Poland Voivodeship, Poland
- AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu - Wroclaw, Lower Silesian Voivodeship, Poland
- AES - DRS - Synexus Polska Sp. Z o.o. Oddzial w Lodzi - Lodz, Lódzkie, Poland
- FutureMeds - Lodz - PPDS - Lodz, Lódzkie, Poland
- FutureMeds - Warszawa Centrum - PPDS - Warsaw, Masovian Voivodeship, Poland
- AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie - Warsaw, Masovian Voivodeship, Poland
- ETG Warszawa - PPDS - Warsaw, Masovian Voivodeship, Poland
- AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku - Gdansk, Pomeranian Voivodeship, Poland
- AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdyni - Gdynia, Pomeranian Voivodeship, Poland
- AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Czestochowie - Częstochowa, Silesian Voivodeship, Poland