Actively Recruiting
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Finding Study of CX11 Tablets in Patients With Type 2 Diabetes Mellitus
Led by Corxel Pharmaceuticals · Updated on 2026-05-28
240
Participants Needed
45
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new medication called CX11 for adults with type 2 diabetes who have not achieved adequate blood sugar control despite taking a stable dose of metformin, with or without an SGLT2 inhibitor, for at least 90 days. This phase 2 study is randomized, double-blind, and placebo-controlled, aiming to determine the safety and effectiveness of different doses of CX11 in comparison to placebo. Participants will be randomly assigned to one of six groups, each receiving a different dose of CX11 (40 mg, 80 mg, 120 mg, 160 mg, or 200 mg) or a matching placebo. The medication is taken orally once daily for 24 weeks, followed by a 2-week safety follow-up period. The study is conducted across multiple medical centers and neither participants nor staff will know the group assignments during the trial. Throughout the study, participants will undergo regular assessments including blood tests to measure changes in HbA1c (a marker of blood sugar control), fasting plasma glucose, body weight, and blood pressure. Continuous glucose monitoring will track time spent in the target glucose range. Safety is monitored by recording adverse events and measuring plasma drug levels at specified intervals. The total participation period is approximately 26 weeks.
CONDITIONS
Brief Title
A Study of CX11 Tablets in Patients With Type 2 Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75
- Diagnosed with 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
- 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 6 months before and during the study and 90 days after last dose, have a negative pregnancy test within 24 hours before first dose, and not intend to donate sperm or ova
- Agree to avoid grapefruit and grapefruit products
You will not qualify if you...
- Planned change or start of medications affecting weight or glucose metabolism for more than 14 days
- Diagnosis of type 1 diabetes or history of diabetic ketoacidosis
- Use of GLP-1 receptor agonists in past 6 months or prior exposure to CX11
- Use of insulin for blood sugar control in past 12 months
- More than one severe hypoglycemia episode with symptoms awareness
- Cardiovascular or cerebrovascular events in past 6 months including heart attack, valve disease, unstable angina, stroke or transient ischemic attack, decompensated heart failure (NYHA III or IV), or significant ECG abnormalities
- Poorly controlled hypertension: systolic ≥180 mmHg or diastolic ≥100 mmHg
- Pancreatic or gallbladder diseases including pancreatitis or symptomatic gallbladder disease
- Poorly controlled thyroid function or significant thyroid disease, personal or family history of medullary thyroid carcinoma or MEN type 2A or 2B
- Cancer within past 5 years except certain low-risk types
- Severe gastrointestinal diseases or surgeries affecting drug absorption
- Active liver disease other than nonalcoholic fatty liver
- Uncontrolled diabetic eye disease
- Abnormal lab results including low kidney function, elevated liver enzymes, bilirubin, amylase, lipase, triglycerides, or abnormal thyroid and blood parameters
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - 24 weeks
Participants take CX11 tablets or placebo orally once daily to manage type 2 diabetes.
Regular visits at Weeks 2, 4, 6, 8, 12, 16, 22, and 24 for assessments and blood sampling
Trial Site Locations
Total: 45 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
Actively 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
Vienna, Virginia, United States, 22182
Actively Recruiting
32
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
Poznan, Greater Poland Voivodeship, Poland, 60-702
Actively Recruiting
33
Centrum Medyczne Pratia Bydgoszcz - PPDS
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85 001
Actively Recruiting
34
Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne
Krakow, Lesser Poland Voivodeship, Poland, 31-261
Actively Recruiting
35
FutureMeds - Krakow - PPDS
Krakow, Lesser Poland Voivodeship, Poland, 31-501
Actively Recruiting
36
METABOLICA Sp. z o.o
Tarnów, Lesser Poland Voivodeship, Poland, 33-100
Actively Recruiting
37
AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Wroclaw, Lower Silesian Voivodeship, Poland, 50-381
Actively Recruiting
38
AES - DRS - Synexus Polska Sp. Z o.o. Oddzial w Lodzi
Lodz, Lódzkie, Poland, 90-127
Actively Recruiting
39
FutureMeds - Lodz - PPDS
Lodz, Lódzkie, Poland, 91-363
Actively Recruiting
40
FutureMeds - Warszawa Centrum - PPDS
Warsaw, Masovian Voivodeship, Poland, 00-215
Actively Recruiting
41
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, Masovian Voivodeship, Poland, 02-672
Actively Recruiting
42
ETG Warszawa - PPDS
Warsaw, Masovian Voivodeship, Poland, 02-677
Actively Recruiting
43
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
Gdansk, Pomeranian Voivodeship, Poland, 80-382
Actively Recruiting
44
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdyni
Gdynia, Pomeranian Voivodeship, Poland, 81-537
Actively Recruiting
45
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Czestochowie
Częstochowa, Silesian Voivodeship, Poland, 42-202
Actively Recruiting
Research Team
S
Study Coordinator
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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