What this study is
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.
What's being tested
- CX11
Intervention · DRUG
CX11 tablets administered orally once daily (QD)
- Placebo
Intervention · OTHER
Matching placebo tablets administered orally once daily (QD)
Study details
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Finding Study of CX11 Tablets in Patients With Type 2 Diabetes Mellitus
- Sponsor
- Corxel Pharmaceuticals
- Conditions
- Type II Diabetes Mellitus
- Enrolling
- 240 people
- Starts
- 2026-02-06
- Est. completion
- 2027-04-30
- Design
- Double-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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).
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (48)
48 openCentral Research Associates - Flourish - PPDS
Birmingham, Alabama, United States
RecruitingAES - DRS - Synexus Clinical Research US, Inc. - Birmingham
Birmingham, Alabama, United States
RecruitingAES - DRS - Optimal Research Alabama - Huntsville
Huntsville, Alabama, United States
RecruitingCore Healthcare Group
Cerritos, California, United States
RecruitingArk Clinical Research - Long Beach
Long Beach, California, United States
RecruitingFlourish Research - Walnut Creek - PPDS
Walnut Creek, California, United States
RecruitingAES - DRS - Optimal Research Florida - Melbourne
Melbourne, Florida, United States
RecruitingTampa General Hospital
Tampa, Florida, United States
RecruitingConquest Research LLC - Winter Park
Winter Park, Florida, United States
RecruitingPrivia Medical Group Georgia, LLC - Albany - Javara - PPDS
Albany, Georgia, United States
RecruitingJavara Inc. - Fayetteville
Fayetteville, Georgia, United States
RecruitingPrivia Medical Group Georgia, LLC - Savannah - Javara - PPDS
Savannah, Georgia, United States
RecruitingPrivia Medical Group Georgia, LLC - Thomasville - Javara - PPDS
Thomasville, Georgia, United States
RecruitingAES - DRS - Synexus Clinical Research US, Inc. - Chicago
Chicago, Illinois, United States
RecruitingAES - DRS - Synexus Clinical Research US, Inc. - Evansville
Evansville, Indiana, United States
RecruitingPrivia Medical Group, LLC - Kelly's Collaborative Care - Javara - PPDS
Silver Spring, Maryland, United States
RecruitingElixia Health - Springfield - Elixia - PPDS
Springfield, Massachusetts, United States
RecruitingElixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDS
Pontiac, Michigan, United States
RecruitingAES - DRS - Synexus Clinical Research US, Inc. - Edina - Minneapolis
Edina, Minnesota, United States
RecruitingMankato Clinic - East Main Street - Javara - PPDS
Mankato, Minnesota, United States
RecruitingSky Integrative Medical Center
Ridgeland, Mississippi, United States
RecruitingHassman Research Institute - Berlin - CenExel - PPDS
Berlin, New Jersey, United States
RecruitingAlbuquerque Clinical Trials Inc
Albuquerque, New Mexico, United States
RecruitingBrooklyn Clinical Research
Brooklyn, New York, United States
RecruitingM3 Wake Research, Inc - M3 WR
Raleigh, North Carolina, United States
RecruitingUnity Clinical Research
Oklahoma City, Oklahoma, United States
RecruitingMonroe Biomedical Research Charleston
North Charleston, South Carolina, United States
RecruitingM3 Wake Research - Dallas
Dallas, Texas, United States
RecruitingUniversity of Texas Southwestern Medical Center
Dallas, Texas, United States
Not yet recruitingSMS Clinical Research, LLC - 400 W. Kearney St
Mesquite, Texas, United States
RecruitingAES - DRS - Synexus Clinical Research US, Inc. - San Antonio
San Antonio, Texas, United States
RecruitingFlourish Research - San Antonio - PPDS
San Antonio, Texas, United States
RecruitingPrivia Medical Group- North Texas - Stephenville - Javara - PPDS
Stephenville, Texas, United States
RecruitingConquest Research - Arlington
Vienna, Virginia, United States
Recruiting
14 sites outside the US
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
Poznan, Greater Poland Voivodeship, Poland
RecruitingCentrum Medyczne Pratia Bydgoszcz - PPDS
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
RecruitingMedyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne
Krakow, Lesser Poland Voivodeship, Poland
RecruitingFutureMeds - Krakow - PPDS
Krakow, Lesser Poland Voivodeship, Poland
RecruitingMETABOLICA Sp. z o.o
Tarnów, Lesser Poland Voivodeship, Poland
RecruitingAES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Wroclaw, Lower Silesian Voivodeship, Poland
RecruitingAES - DRS - Synexus Polska Sp. Z o.o. Oddzial w Lodzi
Lodz, Lódzkie, Poland
RecruitingFutureMeds - Lodz - PPDS
Lodz, Lódzkie, Poland
RecruitingFutureMeds - Warszawa Centrum - PPDS
Warsaw, Masovian Voivodeship, Poland
RecruitingAES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, Masovian Voivodeship, Poland
RecruitingETG Warszawa - PPDS
Warsaw, Masovian Voivodeship, Poland
RecruitingAES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
Gdansk, Pomeranian Voivodeship, Poland
RecruitingAES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdyni
Gdynia, Pomeranian Voivodeship, Poland
RecruitingAES - DRS - Synexus Polska Sp. z o.o. Oddzial w Czestochowie
Częstochowa, Silesian Voivodeship, Poland
Recruiting
Study team
Sponsor
Corxel Pharmaceuticals
Study ID CX11202
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.