Type I Diabetes study: OPT101
Official title Pharmacokinetic and Early Efficacy of OPT101 in Patients With Type 1 Diabetes Mellitus
ClinicalTrials.gov ID: NCT06964087
What this study is testing
What is OPT101?
An investigational subcutaneous injectable medicine being studied for type I diabetes.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see how safe OPT101 is and to look at early signs of it working in type 1 diabetes patients.
- Who it's for
- Adults who have type 1 diabetes and are able to receive injections.
- What's involved
- Participants will get subcutaneous (under the skin) injections of OPT101 three times a week for two weeks, then either continue with OPT101 or receive a placebo for one year, with regular clinic visits and health checks.
- Time commitment
- The study lasts one year, with frequent visits for injections and monitoring.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50
You may be able to join if
- 1\. Able and willing and able to give informed consent for the trial (separate consent must be obtained for Parts B or C).
- 2\. Willing to wear a continuous glucose monitor for the duration of the trial (e.g., Freestyle Libre 3).
- 3\. Male or female aged ≥18 to 50 years on the day of signing informed consent. 4.
- 5\. For Parts B and C only, T-cell phenotype Th40 level greater than or equal to 35% of CD3+ leukocytes (performed at the OPT lab).
- 6\. Is medically stable based on physical examination, medical history, laboratory results, and vital signs performed at screening.
You likely can't join if
- Deep venous thrombosis, pulmonary embolism, myocardial infarction, stroke, transient ischemic attack, or arterial insufficiency causing digital...
- Patients with recent immobilization or recent surgery.
- Abnormal coagulation test at screening: prothrombin time (PT; \>14 sec), activated partial thromboplastin time (aPTT
- Abnormal liver function tests (except in the case of known Gilbert's syndrome): i. AST or ALT ≥3x ULN and total bilirubin ≥2x ULN ii.
See the full eligibility criteria
- 1\. Able and willing and able to give informed consent for the trial (separate consent must be obtained for Parts B or C).
- 2\. Willing to wear a continuous glucose monitor for the duration of the trial (e.g., Freestyle Libre 3).
- 3\. Male or female aged ≥18 to 50 years on the day of signing informed consent. 4. Diagnosis of T1DM within the last 20 years for Part A, within 1 to 10 years [N=15 at \>5 to 10, N=12 at 1 to 5 yrs] for Part B, within...
- 5\. For Parts B and C only, T-cell phenotype Th40 level greater than or equal to 35% of CD3+ leukocytes (performed at the OPT lab).
- 6\. Is medically stable based on physical examination, medical history, laboratory results, and vital signs performed at screening.
- 7\. Women of childbearing potential (WOCBP) must have a negative highly sensitive serum test (beta- human chorionic gonadotropin) at screening and a negative urine pregnancy test at the Visit 1 Day 1 prior to receiving...
- 8\. WOCBP must agree to use one of the following methods of birth control for the duration of the clinical trial: Systemic hormonal contraceptive (oral, injected, transdermal), intrauterine device, double barrier (e.g...
- Deep venous thrombosis, pulmonary embolism, myocardial infarction, stroke, transient ischemic attack, or arterial insufficiency causing digital gangrene.
- Patients with recent immobilization or recent surgery.
- Abnormal coagulation test at screening: prothrombin time (PT; \>14 sec), activated partial thromboplastin time (aPTT; \>32 sec) or fibrinogen level (\ 450 mg/dL).
- Abnormal liver function tests (except in the case of known Gilbert's syndrome): i. AST or ALT ≥3x ULN and total bilirubin ≥2x ULN ii. AST or ALT ≥5x ULN iii. Abnormal platelet counts (\ 450 x10 to the third/uL) iv.
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Walnut Creek, California, United States
- Aurora, Colorado, United States
- Chicago, Illinois, United States
- Renton, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Walnut Creek, California, United States; Aurora, Colorado, United States; Chicago, Illinois, United States; Renton, Washington, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.