Recruiting
Phase 2

CX11

Sponsor:

Corxel Pharmaceuticals

Code:

NCT07340320

Conditions

Type II Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

CX11

Placebo

Study Details

Brief summary:

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.

Conditions

Type II Diabetes Mellitus

Study ID

NCT07340320

Start date

Feb 6, 2026

Status verified date

Aug, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 16, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo group

experimental: 40 mg group

experimental: 80 mg group

experimental: 120 mg group

experimental: 160 mg group

experimental: 200 mg group

Interventions

CX11

CX11 tablets administered orally once daily (QD)

Placebo

Matching placebo tablets administered orally once daily (QD)

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Study Coordinator

201-268-3723information.center@corxelbio.com

Locations

Central Research Associates - Flourish - PPDS

Recruiting

Birmingham, Alabama, United States, 35205-1605

AES - DRS - Synexus Clinical Research US, Inc. - Birmingham

Recruiting

Birmingham, Alabama, United States, 35211-1320

AES - DRS - Optimal Research Alabama - Huntsville

Recruiting

Huntsville, Alabama, United States, 35802-2569

Ark Clinical Research - Long Beach

Recruiting

Long Beach, California, United States, 90815-2521

Flourish Research - Walnut Creek - PPDS

Recruiting

Walnut Creek, California, United States, 94598-3343

AES - DRS - Optimal Research Florida - Melbourne

Recruiting

Melbourne, Florida, United States, 32934-8172

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606-3571

Conquest Research LLC - Winter Park

Recruiting

Winter Park, Florida, United States, 32789-1857

Privia Medical Group Georgia, LLC - Albany - Javara - PPDS

Recruiting

Albany, Georgia, United States, 31707-0205

Javara Inc. - Fayetteville

Recruiting

Fayetteville, Georgia, United States, 30214

Privia Medical Group Georgia, LLC - Savannah - Javara - PPDS

Recruiting

Savannah, Georgia, United States, 31406-3928

Privia Medical Group Georgia, LLC - Thomasville - Javara - PPDS

Recruiting

Thomasville, Georgia, United States, 31792-6618

AES - DRS - Synexus Clinical Research US, Inc. - Chicago

Recruiting

Chicago, Illinois, United States, 60602-3960

AES - DRS - Synexus Clinical Research US, Inc. - Evansville

Recruiting

Evansville, Indiana, United States, 47714-7513

Privia Medical Group, LLC - Kelly's Collaborative Care - Javara - PPDS

Recruiting

Silver Spring, Maryland, United States, 20901-1586

Elixia Health - Springfield - Elixia - PPDS

Recruiting

Springfield, Massachusetts, United States, 01103

Elixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDS

Recruiting

Pontiac, Michigan, United States, 48341

AES - DRS - Synexus Clinical Research US, Inc. - Edina - Minneapolis

Recruiting

Edina, Minnesota, United States, 55435-4305

Mankato Clinic - East Main Street - Javara - PPDS

Recruiting

Mankato, Minnesota, United States, 56001

Hassman Research Institute - Berlin - CenExel - PPDS

Recruiting

Berlin, New Jersey, United States, 08009

Albuquerque Clinical Trials Inc

Recruiting

Albuquerque, New Mexico, United States, 87102-2619

M3 Wake Research, Inc - M3 WR

Recruiting

Raleigh, North Carolina, United States, 27612-8106

Unity Clinical Research

Recruiting

Oklahoma City, Oklahoma, United States, 73118-2872

Monroe Biomedical Research Charleston

Recruiting

North Charleston, South Carolina, United States, 29406

M3 Wake Research - Dallas

Recruiting

Dallas, Texas, United States, 75246

SMS Clinical Research, LLC - 400 W. Kearney St

Recruiting

Mesquite, Texas, United States, 751497

AES - DRS - Synexus Clinical Research US, Inc. - San Antonio

Recruiting

San Antonio, Texas, United States, 78229-3272

Flourish Research - San Antonio - PPDS

Recruiting

San Antonio, Texas, United States, 78229-3539

Privia Medical Group- North Texas - Stephenville - Javara - PPDS

Recruiting

Stephenville, Texas, United States, 76401-1860

Conquest Research - Arlington

Recruiting

Vienna, Virginia, United States, 22182

More Information

Sponsor

Corxel Pharmaceuticals

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • Type 2 Diabetes Mellitus
  • HbA1C
  • Percentage change in HbA1C
  • Change in Fasting Plasma Glucose
  • Change in body weight
  • Body weight loss
  • Hypoglycemics episodes
  • Hypoglycemia
  • Continuous Glucose Monitoring
  • Blood glucose
  • Health Survey Short Form-36
  • Diabetes treatment satisfaction questionnaire
  • Columbia-suicide severity rating scale

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Corxel Pharmaceuticals on 2026-08-20.