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
1 other identifier
interventional
240
2 countries
46
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2026
Shorter than P25 for phase_2
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2026
CompletedFirst Posted
Study publicly available on registry
January 14, 2026
CompletedStudy Start
First participant enrolled
February 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 23, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 7, 2027
April 17, 2026
April 1, 2026
11 months
January 13, 2026
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Glycosylated hemoglobin, Type A1C (HbA1c) from baseline
At Week 24
Secondary Outcomes (16)
Proportion of participants achieving HbA1c < 7.0%
At Week 24
Proportion of participants achieving HbA1c ≤ 6.5%
At Week 24
Change from baseline in Time in Range (TIR) measured by Continuous Glucose Monitoring (CGM)
To Week 24
Change from baseline in fasting plasma glucose (FPG)
To Week 24
Change in body weight from baseline
To Week 24
- +11 more secondary outcomes
Study Arms (6)
Placebo group
PLACEBO COMPARATOR40 mg group
EXPERIMENTAL80 mg group
EXPERIMENTAL120 mg group
EXPERIMENTAL160 mg group
EXPERIMENTAL200 mg group
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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:
- +30 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (46)
Central Research Associates - Flourish - PPDS
Birmingham, Alabama, 35205-1605, United States
AES - DRS - Synexus Clinical Research US, Inc. - Birmingham
Birmingham, Alabama, 35211-1320, United States
AES - DRS - Optimal Research Alabama - Huntsville
Huntsville, Alabama, 35802-2569, United States
Ark Clinical Research - Long Beach
Long Beach, California, 90815-2521, United States
Flourish Research - Walnut Creek - PPDS
Walnut Creek, California, 94598-3343, United States
AES - DRS - Optimal Research Florida - Melbourne
Melbourne, Florida, 32934-8172, United States
Tampa General Hospital
Tampa, Florida, 33606-3571, United States
Conquest Research LLC - Winter Park
Winter Park, Florida, 32789-1857, United States
Privia Medical Group Georgia, LLC - Albany - Javara - PPDS
Albany, Georgia, 31707-0205, United States
Javara Inc. - Fayetteville
Fayetteville, Georgia, 30214, United States
Privia Medical Group Georgia, LLC - Savannah - Javara - PPDS
Savannah, Georgia, 31406-3928, United States
Privia Medical Group Georgia, LLC - Thomasville - Javara - PPDS
Thomasville, Georgia, 31792-6618, United States
AES - DRS - Synexus Clinical Research US, Inc. - Chicago
Chicago, Illinois, 60602-3960, United States
AES - DRS - Synexus Clinical Research US, Inc. - Evansville
Evansville, Indiana, 47714-7513, United States
Privia Medical Group, LLC - Kelly's Collaborative Care - Javara - PPDS
Silver Spring, Maryland, 20901-1586, United States
Elixia Health - Springfield - Elixia - PPDS
Springfield, Massachusetts, 01103, United States
Elixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDS
Pontiac, Michigan, 48341, United States
AES - DRS - Synexus Clinical Research US, Inc. - Edina - Minneapolis
Edina, Minnesota, 55435-4305, United States
Mankato Clinic - East Main Street - Javara - PPDS
Mankato, Minnesota, 56001, United States
Hassman Research Institute - Berlin - CenExel - PPDS
Berlin, New Jersey, 08009, United States
Albuquerque Clinical Trials Inc
Albuquerque, New Mexico, 87102-2619, United States
M3 Wake Research, Inc - M3 WR
Raleigh, North Carolina, 27612-8106, United States
Unity Clinical Research
Oklahoma City, Oklahoma, 73118-2872, United States
Monroe Biomedical Research Charleston
North Charleston, South Carolina, 29406, United States
M3 Wake Research - Dallas
Dallas, Texas, 75246, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-7202, United States
SMS Clinical Research, LLC - 400 W. Kearney St
Mesquite, Texas, 751497, United States
AES - DRS - Synexus Clinical Research US, Inc. - San Antonio
San Antonio, Texas, 78229-3272, United States
Flourish Research - San Antonio - PPDS
San Antonio, Texas, 78229-3539, United States
Privia Medical Group- North Texas - Stephenville - Javara - PPDS
Stephenville, Texas, 76401-1860, United States
Conquest Research - Arlington
Arlington, Virginia, 22205, United States
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
Poznan, Greater Poland Voivodeship, 60-702, Poland
Centrum Medyczne Pratia Bydgoszcz - PPDS
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85 001, Poland
Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne
Krakow, Lesser Poland Voivodeship, 31-261, Poland
FutureMeds - Krakow - PPDS
Krakow, Lesser Poland Voivodeship, 31-501, Poland
Gabinet Lekarski Robert Witek
Tarnów, Lesser Poland Voivodeship, 33-100, Poland
METABOLICA Sp. z o.o
Tarnów, Lesser Poland Voivodeship, 33-100, Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Wroclaw, Lower Silesian Voivodeship, 50-381, Poland
AES - DRS - Synexus Polska Sp. Z o.o. Oddzial w Lodzi
Lodz, Lódzkie, 90-127, Poland
FutureMeds - Lodz - PPDS
Lodz, Lódzkie, 91-363, Poland
FutureMeds - Warszawa Centrum - PPDS
Warsaw, Masovian Voivodeship, 00-215, Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, Masovian Voivodeship, 02-672, Poland
ETG Warszawa - PPDS
Warsaw, Masovian Voivodeship, 02-677, Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
Gdansk, Pomeranian Voivodeship, 80-382, Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdyni
Gdynia, Pomeranian Voivodeship, 81-537, Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Czestochowie
Częstochowa, Silesian Voivodeship, 42-202, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2026
First Posted
January 14, 2026
Study Start
February 6, 2026
Primary Completion (Estimated)
December 23, 2026
Study Completion (Estimated)
January 7, 2027
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share