BridgeMD
Tests treatment safety and results for Type I Diabetes
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?
OPT101 is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment 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
- This study will examine the safety of three times weekly SC injections of OPT101 at each of three dose levels over two weeks as well as one year of treatment with SC OPT101 or placebo to match at a single dose level.
- 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. Diagnosis of T1DM within the last 20 years for Part A, within 1 to...
- 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
- 1\. Current malignancy or history of malignancy other than basal cell carcinoma or squamous cell carcinoma in situ. 2\. Has an immune deficiency...
- Deep venous thrombosis, pulmonary embolism, myocardial infarction, stroke, transient ischemic attack, or arterial insufficiency causing digital...
- Patients with recent immobilization or recent surgery.
- Patients with a history of abnormal prothrombotic laboratories such as congenital or inherited deficiency of antithrombin III, protein C, protein S...
- Abnormal coagulation test at screening: prothrombin time (PT; \>14 sec), activated partial thromboplastin time (aPTT; \>32 sec) or fibrinogen level...
- 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...
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...
- 1\. Current malignancy or history of malignancy other than basal cell carcinoma or squamous cell carcinoma in situ. 2\. Has an immune deficiency syndrome (for example, severe combined immunodeficiency syndrome, T-cell...
- Deep venous thrombosis, pulmonary embolism, myocardial infarction, stroke, transient ischemic attack, or arterial insufficiency causing digital gangrene.
- Patients with recent immobilization or recent surgery.
- Patients with a history of abnormal prothrombotic laboratories such as congenital or inherited deficiency of antithrombin III, protein C, protein S, or confirmed diagnosis of antiphospholipid syndrome. 6\. Has an active...
- 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's taking place
- 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 - 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?
Study sites include 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 site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.