Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT07340320

A Study of CX11 Tablets in Patients With Type 2 Diabetes Mellitus

Led by Corxel Pharmaceuticals · Updated on 2026-04-17

240

Participants Needed

46

Research Sites

47 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

A Study of CX11 Tablets in Patients With Type 2 Diabetes Mellitus

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 between 23 and 50 kg/m²
  • Stable body weight for the past 3 months
  • Stable dose of metformin (≥1000 mg/day) with or without SGLT2 inhibitor for at least 3 months
  • Women of childbearing potential must use highly effective contraception for at least 6 months before screening, during the study, and for 90 days after last dose
  • Negative pregnancy test within 24 hours before first dose
  • Agreement to avoid grapefruit and grapefruit products
Not Eligible

You will not qualify if you...

  • Planned start or change of medications affecting weight or glucose metabolism for more than 14 days
  • Type 1 diabetes or history of diabetic ketoacidosis
  • Use of GLP-1 receptor agonists within past 6 months or any prior exposure to CX11
  • Use of insulin for blood sugar control within past 12 months
  • More than one episode of severe low blood sugar with awareness
  • Cardiovascular or cerebrovascular events within past 6 months including heart attack, bypass surgery, valve disease, unstable angina, stroke, or decompensated heart failure
  • Abnormal ECG indicating safety risk
  • Poorly controlled hypertension (systolic ≥180 mmHg or diastolic ≥100 mmHg)
  • Acute or chronic pancreatitis or symptomatic gallbladder disease
  • Abnormal or unstable thyroid function or relevant family history
  • Cancer within past 5 years except certain low-risk skin or prostate cancers
  • Gastrointestinal conditions affecting drug absorption or major GI surgery
  • Active liver disease other than nonalcoholic fatty liver
  • Uncontrolled diabetic eye diseases
  • Abnormal lab results at screening including kidney function, liver enzymes, bilirubin, amylase, lipase, triglycerides, thyroid tests, calcitonin, or low hemoglobin levels

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 46 locations

1

Central Research Associates - Flourish - PPDS

Birmingham, Alabama, United States, 35205-1605

Actively Recruiting

2

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

Birmingham, Alabama, United States, 35211-1320

Actively Recruiting

3

AES - DRS - Optimal Research Alabama - Huntsville

Huntsville, Alabama, United States, 35802-2569

Actively Recruiting

4

Ark Clinical Research - Long Beach

Long Beach, California, United States, 90815-2521

Actively Recruiting

5

Flourish Research - Walnut Creek - PPDS

Walnut Creek, California, United States, 94598-3343

Actively Recruiting

6

AES - DRS - Optimal Research Florida - Melbourne

Melbourne, Florida, United States, 32934-8172

Actively Recruiting

7

Tampa General Hospital

Tampa, Florida, United States, 33606-3571

Actively Recruiting

8

Conquest Research LLC - Winter Park

Winter Park, Florida, United States, 32789-1857

Actively Recruiting

9

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

Albany, Georgia, United States, 31707-0205

Actively Recruiting

10

Javara Inc. - Fayetteville

Fayetteville, Georgia, United States, 30214

Not Yet Recruiting

11

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

Savannah, Georgia, United States, 31406-3928

Actively Recruiting

12

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

Thomasville, Georgia, United States, 31792-6618

Actively Recruiting

13

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

Chicago, Illinois, United States, 60602-3960

Actively Recruiting

14

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

Evansville, Indiana, United States, 47714-7513

Actively Recruiting

15

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

Silver Spring, Maryland, United States, 20901-1586

Actively Recruiting

16

Elixia Health - Springfield - Elixia - PPDS

Springfield, Massachusetts, United States, 01103

Actively Recruiting

17

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

Pontiac, Michigan, United States, 48341

Actively Recruiting

18

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

Edina, Minnesota, United States, 55435-4305

Actively Recruiting

19

Mankato Clinic - East Main Street - Javara - PPDS

Mankato, Minnesota, United States, 56001

Actively Recruiting

20

Hassman Research Institute - Berlin - CenExel - PPDS

Berlin, New Jersey, United States, 08009

Actively Recruiting

21

Albuquerque Clinical Trials Inc

Albuquerque, New Mexico, United States, 87102-2619

Actively Recruiting

22

M3 Wake Research, Inc - M3 WR

Raleigh, North Carolina, United States, 27612-8106

Actively Recruiting

23

Unity Clinical Research

Oklahoma City, Oklahoma, United States, 73118-2872

Actively Recruiting

24

Monroe Biomedical Research Charleston

North Charleston, South Carolina, United States, 29406

Actively Recruiting

25

M3 Wake Research - Dallas

Dallas, Texas, United States, 75246

Actively Recruiting

26

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390-7202

Not Yet Recruiting

27

SMS Clinical Research, LLC - 400 W. Kearney St

Mesquite, Texas, United States, 751497

Actively Recruiting

28

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

San Antonio, Texas, United States, 78229-3272

Actively Recruiting

29

Flourish Research - San Antonio - PPDS

San Antonio, Texas, United States, 78229-3539

Actively Recruiting

30

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

Stephenville, Texas, United States, 76401-1860

Actively Recruiting

31

Conquest Research - Arlington

Arlington, Virginia, United States, 22205

Actively Recruiting

32

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

Poznan, Greater Poland Voivodeship, Poland, 60-702

Not Yet Recruiting

33

Centrum Medyczne Pratia Bydgoszcz - PPDS

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85 001

Not Yet Recruiting

34

Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne

Krakow, Lesser Poland Voivodeship, Poland, 31-261

Not Yet Recruiting

35

FutureMeds - Krakow - PPDS

Krakow, Lesser Poland Voivodeship, Poland, 31-501

Not Yet Recruiting

36

Gabinet Lekarski Robert Witek

Tarnów, Lesser Poland Voivodeship, Poland, 33-100

Not Yet Recruiting

37

METABOLICA Sp. z o.o

Tarnów, Lesser Poland Voivodeship, Poland, 33-100

Not Yet Recruiting

38

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

Wroclaw, Lower Silesian Voivodeship, Poland, 50-381

Not Yet Recruiting

39

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

Lodz, Lódzkie, Poland, 90-127

Not Yet Recruiting

40

FutureMeds - Lodz - PPDS

Lodz, Lódzkie, Poland, 91-363

Not Yet Recruiting

41

FutureMeds - Warszawa Centrum - PPDS

Warsaw, Masovian Voivodeship, Poland, 00-215

Not Yet Recruiting

42

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

Warsaw, Masovian Voivodeship, Poland, 02-672

Not Yet Recruiting

43

ETG Warszawa - PPDS

Warsaw, Masovian Voivodeship, Poland, 02-677

Not Yet Recruiting

44

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

Gdansk, Pomeranian Voivodeship, Poland, 80-382

Not Yet Recruiting

45

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

Gdynia, Pomeranian Voivodeship, Poland, 81-537

Not Yet Recruiting

46

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

Częstochowa, Silesian Voivodeship, Poland, 42-202

Not Yet Recruiting

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Research Team

S

Study Coordinator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

6

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