Evaluating R-5280 for newly diagnosed Type 1 Diabetes patients
Official title: Evaluating the Safety and Tolerability of R-5280 in Mitigating Type 1 Diabetes in Newly Diagnosed Patients
Run by Rise Therapeutics LLC · NCT06057454 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
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 | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 11 Years to 17 Years |
| Sex | All |
| Enrollment | 39 (estimated) |
| Sponsor | Rise Therapeutics LLC Industry-sponsored |
| Locations | 3 sites (Plantation, Florida and 2 other locations) |
| Trial ID | NCT06057454 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is novel in its specific application, similar studies targeting Type 1 Diabetes have shown promise in the past.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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CNP-103 treatment for adolescents and young adults recently diagnosed with stage 3 type 1 diabetes
This trial will test whether multiple doses of CNP-103, compared with placebo, help people ages 12–35 who were diagnosed with stage 3 type 1 diabetes within the past 6 months.
-
Investigating the safety and effectiveness of porcine pancreatic cells in patients with Type 1 diabetes
This study is testing if using pig pancreas cells can help adults with tough-to-manage Type 1 diabetes feel better and avoid dangerous low blood sugar episodes.
-
Evaluating CELZ-201 for recent onset Type 1 Diabetes
This study is testing a new treatment called CELZ-201 to see if it can help people who have recently been diagnosed with Type 1 Diabetes feel better when used alongside their usual care.
-
Registry for individuals with type 1 diabetes
This study is collecting information from people with type 1 diabetes to help researchers understand the condition better and improve diabetes management.
-
Semaglutide on body composition in adults with type 1 diabetes and overweight/obesity
This study tests whether weekly semaglutide changes body composition in adults with type 1 diabetes who are overweight or obese, compared with a placebo over 24 weeks.
-
Next Generation Extended Wear Sensors in Type 1 and Type 2 Diabetes
This study tests a new extended wear sensor and algorithm in people with type 1 or type 2 diabetes to see how well it works across adults and children.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.