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New diabetes drug CX11 shows promise in major trial

NCT ID NCT07340320

Disease control Sponsor: Corxel Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 4 times

Summary

This study tests a new medication, CX11, for people with type 2 diabetes who need better blood sugar control despite taking metformin. About 240 adults will receive different doses of CX11 or a placebo for 24 weeks to see if it safely lowers blood sugar. The goal is to find the best dose for managing diabetes long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

hypoglycemia type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type II diabetes mellitus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    48 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AES - DRS - Optimal Research Alabama - Huntsville

    RECRUITING

    Huntsville, Alabama, 35802-2569, United States

  • AES - DRS - Optimal Research Florida - Melbourne

    RECRUITING

    Melbourne, Florida, 32934-8172, United States

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

    RECRUITING

    Birmingham, Alabama, 35211-1320, United States

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

    RECRUITING

    Chicago, Illinois, 60602-3960, United States

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

    RECRUITING

    Edina, Minnesota, 55435-4305, United States

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

    RECRUITING

    Evansville, Indiana, 47714-7513, United States

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

    RECRUITING

    San Antonio, Texas, 78229-3272, United States

  • AES - DRS - Synexus Polska Sp. Z o.o. Oddzial w Lodzi

    RECRUITING

    Lodz, Lódzkie, 90-127, Poland

  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Czestochowie

    RECRUITING

    Częstochowa, Silesian Voivodeship, 42-202, Poland

  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku

    RECRUITING

    Gdansk, Pomeranian Voivodeship, 80-382, Poland

  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdyni

    RECRUITING

    Gdynia, Pomeranian Voivodeship, 81-537, Poland

  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu

    RECRUITING

    Poznan, Greater Poland Voivodeship, 60-702, Poland

  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie

    RECRUITING

    Warsaw, Masovian Voivodeship, 02-672, Poland

  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

    RECRUITING

    Wroclaw, Lower Silesian Voivodeship, 50-381, Poland

  • Albuquerque Clinical Trials Inc

    RECRUITING

    Albuquerque, New Mexico, 87102-2619, United States

  • Ark Clinical Research - Long Beach

    RECRUITING

    Long Beach, California, 90815-2521, United States

  • Brooklyn Clinical Research

    RECRUITING

    Brooklyn, New York, 11226, United States

  • Central Research Associates - Flourish - PPDS

    RECRUITING

    Birmingham, Alabama, 35205-1605, United States

  • Centrum Medyczne Pratia Bydgoszcz - PPDS

    RECRUITING

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85 001, Poland

  • Conquest Research - Arlington

    RECRUITING

    Vienna, Virginia, 22182, United States

  • Conquest Research LLC - Winter Park

    RECRUITING

    Winter Park, Florida, 32789-1857, United States

  • Core Healthcare Group

    RECRUITING

    Cerritos, California, 90703, United States

  • ETG Warszawa - PPDS

    RECRUITING

    Warsaw, Masovian Voivodeship, 02-677, Poland

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

    RECRUITING

    Pontiac, Michigan, 48341, United States

  • Elixia Health - Springfield - Elixia - PPDS

    RECRUITING

    Springfield, Massachusetts, 01103, United States

  • Flourish Research - San Antonio - PPDS

    RECRUITING

    San Antonio, Texas, 78229-3539, United States

  • Flourish Research - Walnut Creek - PPDS

    RECRUITING

    Walnut Creek, California, 94598-3343, United States

  • FutureMeds - Krakow - PPDS

    RECRUITING

    Krakow, Lesser Poland Voivodeship, 31-501, Poland

  • FutureMeds - Lodz - PPDS

    RECRUITING

    Lodz, Lódzkie, 91-363, Poland

  • FutureMeds - Warszawa Centrum - PPDS

    RECRUITING

    Warsaw, Masovian Voivodeship, 00-215, Poland

  • Hassman Research Institute - Berlin - CenExel - PPDS

    RECRUITING

    Berlin, New Jersey, 08009, United States

  • Javara Inc. - Fayetteville

    RECRUITING

    Fayetteville, Georgia, 30214, United States

  • M3 Wake Research - Dallas

    RECRUITING

    Dallas, Texas, 75246, United States

  • M3 Wake Research, Inc - M3 WR

    RECRUITING

    Raleigh, North Carolina, 27612-8106, United States

  • METABOLICA Sp. z o.o

    RECRUITING

    Tarnów, Lesser Poland Voivodeship, 33-100, Poland

  • Mankato Clinic - East Main Street - Javara - PPDS

    RECRUITING

    Mankato, Minnesota, 56001, United States

  • Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne

    RECRUITING

    Krakow, Lesser Poland Voivodeship, 31-261, Poland

  • Monroe Biomedical Research Charleston

    RECRUITING

    North Charleston, South Carolina, 29406, United States

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

    RECRUITING

    Albany, Georgia, 31707-0205, United States

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

    RECRUITING

    Savannah, Georgia, 31406-3928, United States

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

    RECRUITING

    Thomasville, Georgia, 31792-6618, United States

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

    RECRUITING

    Silver Spring, Maryland, 20901-1586, United States

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

    RECRUITING

    Stephenville, Texas, 76401-1860, United States

  • SMS Clinical Research, LLC - 400 W. Kearney St

    RECRUITING

    Mesquite, Texas, 751497, United States

  • Sky Integrative Medical Center

    RECRUITING

    Ridgeland, Mississippi, 39157, United States

  • Tampa General Hospital

    RECRUITING

    Tampa, Florida, 33606-3571, United States

  • Unity Clinical Research

    RECRUITING

    Oklahoma City, Oklahoma, 73118-2872, United States

  • University of Texas Southwestern Medical Center

    NOT_YET_RECRUITING

    Dallas, Texas, 75390-7202, United States

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Other studies related to the condition(s) this trial covers.