CX11 TROMETAMOL MONOHYDRATE for Type 2 diabetes mellitus

Inclusion criteria

• {"criterion_text":"- 1.\tMale and female patients 18 to 75 years (both inclusive) of age"}
• {"criterion_text":"- 2.\tDiagnosis of T2DM ≥ 6 months before screening"}
• {"criterion_text":"- 3.\tHbA1c 7.0% - 10.5% (both inclusive)"}
• {"criterion_text":"- 4.\tBMI 23 - 50 kg/m2 (both inclusive)"}
• {"criterion_text":"- 5.\tHave a stable body weight for the 3 months prior to randomization"}
• {"criterion_text":"- 6.\tTreatment with stable dose of metformin with or without a stable dose of SGLT2 inhibitor for at least 3 months"}
• {"criterion_text":"- 7.\tParticipants and their partners must not intend to become pregnant or donate sperm or ova during the study and for 90 days following the last dose. Women of childbearing potential (WOCBP) are required to use highly effective contraception (see section 11.2) for at least 6 months prior to screening, throughout the study, and continuing for 90 days following the last dose. In addition, a negative pregnancy test must be obtained within 24 hours prior to the first dose."}

Exclusion criteria

• {"criterion_text":"- 1.\tPatients with type 1 diabetes or history of ketoacidosis"}
• {"criterion_text":"- 2.\tExposure to other GLP-1R agonists within 6 months prior to screening, or any previous exposure to CX11"}
• {"criterion_text":"- 3.\tUse of insulin for glycemic control within 12 months prior to screening."}
• {"criterion_text":"- 4.\tHave had more than 1 episode of severe hypoglycemia and aware of hypoglycemic symptoms within 6 months prior screening."}
• {"criterion_text":"- 5.\tHistory or evidence of any of the following diseases: Cardiovascular Events; Advanced Heart Failure; Significant ECG Abnormalities; Poorly Controlled Hypertension; Pancreatic and Gallbladder Disorders; Uncontrolled Thyroid Dysfunction; Family or Personal History of Specific Cancers; Recent or Active Malignancy; Serious Chronic Gastrointestinal Diseases; Active liver disease"}
• {"criterion_text":"- 6.\tANY of the following abnormalities in clinical laboratory tests at screening: (1) Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2 as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (2) Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2.5 × upper limit of normal (ULN) (3) Total bilirubin (TBIL) > 1.5 × ULN (except for cases of known Gilbert's syndrome) (4) Serum amylase or lipase > 1.5 × ULN (5) Fasting triglycerides (TG) > 5.7 mmol/L (6) Thyroid stimulating hormone (TSH) > 1.5 × ULN (7) Calcitonin ≥20 ng/L (8) Hemoglobin (Hb) < 110 g/L (male) or < 100 g/L (female)"}

Primary endpoints

• {"endpoint_text":"- Change in HbA1c from baseline","definition_or_measurement_approach":"Not specified in CTIS record; main objective references demonstrating superiority in change from baseline for HbA1c relative to placebo (timepoint referenced as Week 00 in main objective)."}

Secondary endpoints

• {"endpoint_text":"- 1. HbA1c < 7.0%","definition_or_measurement_approach":""}
• {"endpoint_text":"- 2. HbA1c ≤ 6.5%","definition_or_measurement_approach":""}
• {"endpoint_text":"- 3. Change of TIR on CGM from baseline","definition_or_measurement_approach":"Change from baseline as measured by continuous glucose monitoring (CGM); specific CGM metrics and timepoints not specified in CTIS record."}
• {"endpoint_text":"- 4. Change in FPG from baseline","definition_or_measurement_approach":"Fasting plasma glucose change from baseline; specific assay/timepoints not specified."}
• {"endpoint_text":"- 5. Change in body weight from baseline","definition_or_measurement_approach":""}
• {"endpoint_text":"- 6. Percent change in body weight from baseline","definition_or_measurement_approach":""}
• {"endpoint_text":"- 7. Body weight loss ≥ 5%","definition_or_measurement_approach":""}
• {"endpoint_text":"- 8. Body weight loss ≥ 10%","definition_or_measurement_approach":""}
• {"endpoint_text":"- 9. Change in SBP and DBP from baseline","definition_or_measurement_approach":"Change in systolic and diastolic blood pressure from baseline; measurement method/timepoints not specified."}
• {"endpoint_text":"- 10. Number of level 2 hypoglycemic episodes or severe hypoglycemic episodes","definition_or_measurement_approach":""}
• {"endpoint_text":"- 11. TEAE & AESI","definition_or_measurement_approach":"Treatment-emergent adverse events and adverse events of special interest; safety reporting per protocol (specific definitions not provided in CTIS record)."}
• {"endpoint_text":"- 12. Population PK parameters","definition_or_measurement_approach":"Population pharmacokinetic parameters to be characterised; sampling and analysis details not provided in CTIS record."}

Methods

• Posters at clinical sites (document titles include K2_CX11202_Poster_FutureMeds_POL_POL_Public and K2_CX11202_Poster_Master_POL_POL_Public) - target audience: patients with Type 2 Diabetes Mellitus in Poland.
• Leaflets and brochures (K2_CX11202_Leaflet_1200x630 and K2_CX11202_Recruitment_Brochure_Master_POL_POL_Public) - distributed to potential participants at clinics in Poland.
• Doctor information and doctor letters (K2_CX11202_Doctor_Information_FutureMeds_POL_POL_Public and K2_CX11202_Doctor_Letter_Master_POL_POL_Public) - targeted to healthcare professionals in Poland to facilitate patient referrals.
• Patient letters (K2_CX11202_Patient_Letter_Master_POL_POL_Public) - direct mail/contact to potential participants in Poland.
• Social media and website banners (K2_CX11202_Social_Media_Website_Banner_1080x1080_FutureMeds_POL_POL_Public, 1200x630, 1920x1080) - digital outreach targeted to potential patients in Poland.
• Ad packet / flyer materials (K2_CX11202_Corxel_ad_packet_POL_POL_Public, K2_CX11202__Flayer_Master_POL_POL_Public) - multi-channel promotional materials for Poland.
• Welcome guide and recruitment checklists (K2_CX11202_Welcome_Guide_Master_POL_POL_Public, K2_CX11202_FOV_SSQ_Checklist_T2DM_POL_POL_Public) - materials supporting site-level recruitment and onboarding in Poland.

Poland

Earliest CTIS Part Ii Submission Date

20-03-2026

Latest Decision Or Authorization Date

22-04-2026

Processing Time Days

33

Number Of Sites

15

Number Of Participants

121

Primary sponsor

Full Name

Corxel Pharmaceuticals Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

PPD Development LP

Responsibilities

sponsorDuties codes: 1,10,11,12,13,14,2,3,4,5,6,7,8,9

Name

4g Clinical LLC

Responsibilities

sponsorDuties codes: 3

Third parties

• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
• {"country":"China","full_name":"Shanghai Taikun Pharmaceutical Technology Co.,Ltd","duties_or_roles":"Packaging & labeling","organisation_type":"Industry"}
• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"Czechia","full_name":"VeraSafe Czech Republic s.r.o.","duties_or_roles":"EU Data Protection Representative","organisation_type":"Industry"}
• {"country":"Germany","full_name":"PCI Pharma Services Germany GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}