Evaluating R-5280 for newly diagnosed Type 1 Diabetes patients
Evaluating the Safety and Tolerability of R-5280 in Mitigating Type 1 Diabetes in Newly Diagnosed Patients
PHASE1 · Rise Therapeutics LLC · NCT06057454
This study is testing a new medication called R-5280 to see if it can help teenagers aged 11-17 who have recently been diagnosed with Type 1 Diabetes feel better over 12 weeks.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 39 (estimated) |
| Ages | 11 Years to 17 Years |
| Sex | All |
| Sponsor | Rise Therapeutics LLC (industry) |
| Locations | 3 sites (Plantation, Florida and 2 other locations) |
| Trial ID | NCT06057454 on ClinicalTrials.gov |
What this trial studies
This Phase 1B clinical trial is a double-blinded, placebo-controlled study that aims to assess the safety and efficacy of R-5280 in adolescents aged 11-17 who have been newly diagnosed with Type 1 Diabetes within the last two years. Participants will receive daily administrations of R-5280 or a placebo for a duration of 12 weeks. The study will monitor adverse events and tolerance to the treatment, providing insights into its potential benefits for managing Type 1 Diabetes.
Who should consider this trial
Good fit: Ideal candidates are children aged 11-17 who have been diagnosed with Type 1 Diabetes within the last two years and meet specific health criteria.
Not a fit: Patients with monogenic forms of diabetes, type 2 diabetes, or those with certain health conditions or allergies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve management and outcomes for newly diagnosed Type 1 Diabetes patients.
How similar studies have performed: While this approach is novel in its specific application, similar studies targeting Type 1 Diabetes have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newly Diagnosed children (age 11-17 years old) * BMI \<85% * Diagnosed by ADA criteria with T1D within 2 years * Accepted to adhere to a healthy diabetic diet as recommended by the ADA Exclusion Criteria: * Monogenic forms of diabetes or type 2 diabetes * History of ongoing infection or antibiotic treatment within the past four (4) weeks * History of immunocompromised, recurrent infections, steroid intake (inhaled or oral forms) or other immunosuppressant use in the past six (6) months * History of chronic gastrointestinal disease, possible or confirmed celiac disease * Pregnancy or possible pregnancy * Allergy to corn (prebiotic), milk allergy, soy (present in the MMTT meal) or their products * Participation in other intervention research trials within the past three (3) months * Anticipated major change in diabetes management during the study (e.g., change from injections to insulin pump therapy or new continuous monitor usage, all known to significantly alter glycemia) * Children consuming a high-fiber or vegetarian diet (consuming three (3) or more servings of high fiber foods on four (4) or more days per week) or any fiber supplements will be excluded (to be assessed at screening) * Any COVID vaccines within 30 days prior to Day 1
Where this trial is running
Plantation, Florida and 2 other locations
- Edward Jenner Research Group LLC — Plantation, Florida, United States (RECRUITING)
- Mayo Clinic — Rochester, Minnesota, United States (RECRUITING)
- UTSW Medical Center — Dallas, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: Janet Stephens, PhD
- Email: jstephens@risetherapeutics.com
- Phone: 6504178556
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 1 Diabetes, Diabetes Mellitus, Type 1