Type 1 DiabetesPhase 1R-5280NCT06057454
R-5280 in Newly Diagnosed Patients With Type 1 Diabetes
A Phase 1 study testing R-5280 in people with Type 1 Diabetes and Type 1 Diabetes (Juvenile Onset), run by Rise Therapeutics LLC at 3 sites in United States.
Trial summary
Evaluating the adverse events and tolerance of R-5280 in Mitigating Type 1 Diabetes in Newly Diagnosed Patients Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Type 1 Diabetes, Type 1 Diabetes (Juvenile Onset), Diabetes Mellitus, Type 1
- What is being tested?
- R-5280
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 3 sitesUnited States
- Study dates
- 5 Dec 2023to 5 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
UTSW Medical Center
Dallas, Texas, 75390
Edward Jenner Research Group LLC
Plantation, Florida, 33317
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Evaluating the Safety and Tolerability of R-5280 in Mitigating Type 1 Diabetes in Newly Diagnosed Patients
Evaluating the adverse events and tolerance of R-5280 in Mitigating Type 1 Diabetes in Newly Diagnosed Patients
Read the detailed description
Double blinded, placebo controlled, Phase 1B study assessing the safety and efficacy of 12 weeks daily administrations of R-5280 in newly diagnosed Type 1 Diabetes adolescents
- Being tested
- R-5280, Placebo
- Keywords
- Type 1 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-5280Drug
Modified Superior Starch
PlaceboOther
Food Grade Starch
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator | Active comparator | R-5280, Taken Twice a day, orally with food for 12 weeks (84 days) Receives: Drug: R-5280 |
| Placebo Comparator | Placebo comparator | Food starch, taken twice a day, orally with food for 12 weeks (84 days) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of adverse events from the date of the first dose through 12 weeks of R-5280 tolerance
The number of participants with treatment-related adverse events as evaluated by CTCAE v5.0, will be reviewed to see the results from baseline in toxicology scores at 12 Weeks compared to placebo.
Measured: 12 Weeks
Secondary outcomes (1)
Measurement of clinical activity and to determine the gut microbiome profile in youth with recently diagnosed Type 1 Diabetes
To measure the levels of glucose (in milligrams) in the blood at the beginning and again at 12 weeks, and the measurement of C-Peptide (in nanograms) in the blood at the beginning and again at 12 weeks versus placebo, changes in the type of gut bacteria at the beginning and again at 12 weeks versus placebo.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start5 Dec 2023
- Primary completion5 Nov 2025
- Study completion5 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double Blinided, placebo controlled, Phase 1B study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rise Therapeutics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057454
- Sponsor's protocol ID
- RISE R-5280
- Acronym
- R-5280
- Status last verified
- Nov 2025
- First submitted
- 15 Sep 2023
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Safety and Tolerability of R-5280 in Mitigating Type 1 Diabetes in Newly Diagnosed Patients
- ClinicalTrials.gov ID
- NCT06057454
- Acronym / sponsor ID
- R-5280 / RISE R-5280
- Keywords
- Type 1 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Rise Therapeutics LLCIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 5 Nov 2025 (actual)
- Study completion
- 5 Nov 2025 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluating the adverse events and tolerance of R-5280 in Mitigating Type 1 Diabetes in Newly Diagnosed Patients
Detailed description
Double blinded, placebo controlled, Phase 1B study assessing the safety and efficacy of 12 weeks daily administrations of R-5280 in newly diagnosed Type 1 Diabetes adolescents
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double Blinided, placebo controlled, Phase 1B study.
| Arm | Type | Receives |
|---|---|---|
| Active Comparator | Active comparator | Drug: R-5280R-5280, Taken Twice a day, orally with food for 12 weeks (84 days) |
| Placebo Comparator | Placebo comparator | Other: PlaceboFood starch, taken twice a day, orally with food for 12 weeks (84 days) |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| R-5280Modified Superior Starch | Drug | Active Comparator |
| PlaceboFood Grade Starch | Other | Placebo Comparator |
Primary outcome
Measurement of adverse events from the date of the first dose through 12 weeks of R-5280 tolerance
Time frame: 12 Weeks
The number of participants with treatment-related adverse events as evaluated by CTCAE v5.0, will be reviewed to see the results from baseline in toxicology scores at 12 Weeks compared to placebo.
1 secondary outcome
Measurement of clinical activity and to determine the gut microbiome profile in youth with recently diagnosed Type 1 Diabetes
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing R-5280 in people with Type 1 Diabetes and Type 1 Diabetes (Juvenile Onset), run by Rise Therapeutics LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of adverse events from the date of the first dose through 12 weeks of R-5280 tolerance (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.