A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Finding Study of CX11 Tablets in Patients with Type 2 Diabetes Mellitus

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Corxel Pharmaceuticals Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

6 May 2026 → ongoing

Decision date (initial)

2026-04-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Corxel Pharmaceuticals, Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety, Dose response, Efficacy, Others

To evaluate the effect of different dose levels of CX11 on HbA1C and to demonstrate at least one dose level of CX11 is superior in change from baseline for HbA1c relative to placebo at Week 00

Secondary objectives 1

1. To evaluate the effect of CX11 on glucose control, body weight, blood pressure; To evaluate the tolerability and safety of different doses of CX11; To characterize the PK of CX11

Conditions and MedDRA coding

Type 2 Diabetes Mellitus

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 1. Male and female patients 18 to 75 years (both inclusive) of age 2. Diagnosis of T2DM ≥ 6 months before screening 3. HbA1c 7.0% - 10.5% (both inclusive) 4. BMI 23 - 50 kg/m2 (both inclusive) 5. Have a stable body weight for the 3 months prior to randomization 6. Treatment with stable dose of metformin with or without a stable dose of SGLT2 inhibitor for at least 3 months 7. Participants 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 1

1. 1. Patients with type 1 diabetes or history of ketoacidosis 2. Exposure to other GLP-1R agonists within 6 months prior to screening, or any previous exposure to CX11 3. Use of insulin for glycemic control within 12 months prior to screening. 4. Have had more than 1 episode of severe hypoglycemia and aware of hypoglycemic symptoms within 6 months prior screening. 5. History 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 6. ANY 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)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in HbA1c from baseline

Secondary endpoints 2

1. 1. HbA1c < 7.0% 2. HbA1c ≤ 6.5% 3. Change of TIR on CGM from baseline 4. Change in FPG from baseline 5. Change in body weight from baseline 6. Percent change in body weight from baseline 7. Body weight loss ≥ 5% 8. Body weight loss ≥ 10% 8. Body weight loss ≥ 10%
2. 9. Change in SBP and DBP from baseline 10. Number of level 2 hypoglycemic episodes or severe hypoglycemic episodes 11. TEAE & AESI; 12. Population PK parameters

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Corxel Pharmaceuticals Inc.

Sponsor organisation

Corxel Pharmaceuticals Inc.

Address

1209 North Orange Street

City

Wilmington

Postcode

19801-1120

Country

United States

Scientific contact point

Organisation

Corxel Pharmaceuticals Inc.

Contact name

Bo Liang

Public contact point

Organisation

Corxel Pharmaceuticals Inc.

Contact name

Bo Liang

Third parties 6

Locations

1 EU/EEA country · 15 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 25 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications