NCT06474598 An Adaptive Design Study of MTX228

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 24 participants in total. It began in 2024-11-14 with a primary completion date of 2026-10.

Brief Summary

MTX228 has been identified as a medication that might allow the re-growth of insulin producing beta cells in people with Type 1 Diabetes. Promoting the re-growth of lost beta cells would be beneficial to people with Type 1 Diabetes because it would allow them to take less insulin by injection and would improve their overall blood sugar control while reducing the risk and rate of low blood sugars. This open-label dose selection study aims to determine the optimal dose ofMTX228 for use in a future phase IIb study. The purpose is to investigate the relative effectiveness of different doses of MTX228 and to select the most effective dose for further investigation in a phase 2b study.

Eligibility Criteria

Inclusion Criteria: * clinical diagnosis of T1DM with onset before the age of 35 requiring continuous treatment with insulin within 1 year of diagnosis and the presence of positive T1DM autoantibody titer if diagnosed after age 35 (past or present * HbA1c between 6.0 - 10.0 %. * Willing to wear study-provided CGM and share CGM data via cloud. * Diagnosis of T1DM ≥1year at time of screening. * Fasting or random (post-prandial) C-peptide level ≥ 100 pmol/l (or 0.3 ng/mL) during screening or pre-screening. Pre-screening C-peptide levels may be obtained by the study team (subject to patient's written consent) up to 56 days before planned enrolment to reduce the number of screen failures. * BMI ≤ 35 kg/m2 * eGFR \>45 ml/min/1.73m2 * Able and willing to comply with the study protocol for the duration of the study * Written informed consent must be obtained before any study-related assessment is performed. Exclusion Criteria: * Diagnosis or history indicative of monogenic, Type 2 or post-pancreatectomy diabetes * History of \>1 episode of severe (level 3) hypoglycemia in the prior 6 months * Significant cardiovascular history defined as: 1. History of myocardial infarction, coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accidents within six months prior to entry into the study 2. Congestive heart failure defined as New York Heart Association (NYHA) stage III and IV 3. Uncontrolled hypertension defined as SBP \> 160 mmHg and/or DBP \> 100 mmHg 4. Symptomatic postural hypotension 5. Use of systemic corticosteroids (except physiologic replacement doses for adrenal insufficiency) or other medications that would influence insulin sensitivity 6. Use of non-insulin antihyperglycemic agents within prior 30 days. 7. History of significant other major or unstable neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, or urological disorder including previous solid organ or cell transplant that would impact patient safety or data interpretation. 8. History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 5 years before screening (any history of treated cervical intraepithelial neoplasia is allowed) 9. Known recreational substance use or psychiatric illness that, in the opinion of the Investigator, may impact the safety of the subject or objectives with scheduled visits 10. A history of alcohol or drug abuse or drug addiction in the previous 12 months 11. A positive pregnancy blood test for women of childbearing age or breast-feeding women 12 Are unwilling to use an "effective" method of contraception during the course of the study. Sexually active male patients, who could have children, are required to use a condom or abstained from intercourse, and refrain from sperm donation for the purposes of conception. Females have to be surgically sterile (via hysterectomy or bilateral tubal ligation) or post-menopausal or using a medically acceptable barrier method of contraception (i.e. IUD, barrier methods with spermicide or abstinence).

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