A Study of CX11 Tablets in Patients With Type 2 Diabetes Mellitus
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Finding Study of CX11 Tablets in Patients With Type 2 Diabetes Mellitus
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 75 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Mentioned in the study description
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Pills
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Mentioned in the study description
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether CX11 tablets are safe and help lower blood sugar in adults with type 2 diabetes. It is for people whose blood sugar is not well controlled after at least 90 days on a steady dose of metformin, with or without an SGLT2 inhibitor, another diabetes medicine. Participants receive CX11 or inactive pills for 24 weeks, followed by 2 weeks of safety checks.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 18 to 75 years old.
- You have had type 2 diabetes for at least 6 months.
- Your HbA1c, a measure of average blood sugar, is 7.0% to 10.5%.
- Your BMI, a measure of weight compared with height, is 23 to 50.
- Your weight has been stable for the past 3 months.
- You have taken a steady dose of metformin of at least 1,000 mg daily for at least 3 months, with or without a steady dose of an SGLT2 inhibitor.
- If you can become pregnant, you must use highly effective birth control for at least 6 months before screening, during the study, and for 90 days after the last dose. You must have a negative pregnancy test within 24 hours before the first dose and not plan to donate eggs or sperm.
- You agree to avoid grapefruit and grapefruit products.
Who can't join
- You expect to start or change medicines that affect weight or blood sugar and take them for more than 14 days in a row.
- You have type 1 diabetes, a history of diabetic ketoacidosis (dangerous acid buildup in the blood), or more than one severe low blood sugar episode with awareness of symptoms.
- You used a GLP-1 diabetes medicine in the past 6 months, insulin for blood sugar in the past 12 months, or CX11 at any time.
- You have certain heart or blood vessel problems within the past 6 months, such as a heart attack, stroke, heart valve disease, serious heart rhythm problems, or severe heart failure. Blood pressure of 180 or higher on top or 100 or higher on the bottom at screening also rules you out.
- You have pancreas inflammation or risk factors for it, gallbladder disease with symptoms, or certain thyroid problems. You or a parent, sibling, or child have had medullary thyroid cancer or MEN type 2A or 2B, conditions that can cause tumors.
- You had cancer in the past 5 years, except certain localized skin cancers, low-risk prostate cancer, early cervical cancer, or certain abnormal prostate cells.
- You have certain serious stomach or bowel problems, past digestive tract surgery other than appendix or polyp removal, or long-term use of medicines that affect how food moves through the gut.
- You have certain active liver diseases, unstable diabetes-related eye disease, or screening tests outside the study's limits for kidney, liver, pancreas, or thyroid function, blood fats, calcitonin, or hemoglobin (the protein that carries oxygen in blood).
Simplified for readability. The official criteria below are what the study team uses.
Official 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 sites (34)
AL
- Central Research Associates - Flourish - PPDS · Birmingham, AL 35205-1605More trials in Birmingham
- AES - DRS - Synexus Clinical Research US, Inc. - Birmingham · Birmingham, AL 35211-1320More trials in Birmingham
- AES - DRS - Optimal Research Alabama - Huntsville · Huntsville, AL 35802-2569More trials in Huntsville
CA
- Core Healthcare Group · Cerritos, CA 90703More trials in Cerritos
- Ark Clinical Research - Long Beach · Long Beach, CA 90815-2521More trials in Long Beach
- Flourish Research - Walnut Creek - PPDS · Walnut Creek, CA 94598-3343More trials in Walnut Creek
FL
- AES - DRS - Optimal Research Florida - Melbourne · Melbourne, FL 32934-8172More trials in Melbourne
- Tampa General Hospital · Tampa, FL 33606-3571More trials in Tampa
- Conquest Research LLC - Winter Park · Winter Park, FL 32789-1857More trials in Winter Park
GA
- Privia Medical Group Georgia, LLC - Albany - Javara - PPDS · Albany, GA 31707-0205More trials in Albany
- Javara Inc. - Fayetteville · Fayetteville, GA 30214More trials in Fayetteville
- Privia Medical Group Georgia, LLC - Savannah - Javara - PPDS · Savannah, GA 31406-3928More trials in Savannah
- Privia Medical Group Georgia, LLC - Thomasville - Javara - PPDS · Thomasville, GA 31792-6618More trials in Thomasville
IL
- AES - DRS - Synexus Clinical Research US, Inc. - Chicago · Chicago, IL 60602-3960More trials in Chicago
IN
- AES - DRS - Synexus Clinical Research US, Inc. - Evansville · Evansville, IN 47714-7513More trials in Evansville
MA
- Elixia Health - Springfield - Elixia - PPDS · Springfield, MA 01103More trials in Springfield
MD
- Privia Medical Group, LLC - Kelly's Collaborative Care - Javara - PPDS · Silver Spring, MD 20901-1586More trials in Silver Spring
MI
- Elixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDS · Pontiac, MI 48341More trials in Pontiac
MN
- AES - DRS - Synexus Clinical Research US, Inc. - Edina - Minneapolis · Edina, MN 55435-4305More trials in Edina
- Mankato Clinic - East Main Street - Javara - PPDS · Mankato, MN 56001More trials in Mankato
MS
- Sky Integrative Medical Center · Ridgeland, MS 39157More trials in Ridgeland
NC
- M3 Wake Research, Inc - M3 WR · Raleigh, NC 27612-8106More trials in Raleigh
NJ
- Hassman Research Institute - Berlin - CenExel - PPDS · Berlin, NJ 08009More trials in Berlin
NM
- Albuquerque Clinical Trials Inc · Albuquerque, NM 87102-2619More trials in Albuquerque
NY
- Brooklyn Clinical Research · Brooklyn, NY 11226More trials in Brooklyn
OK
- Unity Clinical Research · Oklahoma City, OK 73118-2872More trials in Oklahoma City
SC
- Monroe Biomedical Research Charleston · North Charleston, SC 29406More trials in North Charleston
TX
- M3 Wake Research - Dallas · Dallas, TX 75246More trials in Dallas
- University of Texas Southwestern Medical Center · Dallas, TX 75390-7202More trials in Dallas
- SMS Clinical Research, LLC - 400 W. Kearney St · Mesquite, TX 751497More trials in Mesquite
- AES - DRS - Synexus Clinical Research US, Inc. - San Antonio · San Antonio, TX 78229-3272More trials in San Antonio
- Flourish Research - San Antonio - PPDS · San Antonio, TX 78229-3539More trials in San Antonio
- Privia Medical Group- North Texas - Stephenville - Javara - PPDS · Stephenville, TX 76401-1860More trials in Stephenville
VA
- Conquest Research - Arlington · Vienna, VA 22182More trials in Vienna