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Could a modified starch help tame type 1 diabetes?

NCT ID NCT06057454

Disease control Sponsor: Rise Therapeutics LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tested the safety of a new drug called R-5280, a modified starch, in 9 children aged 11-17 who were recently diagnosed with type 1 diabetes. The study compared R-5280 to a placebo (food-grade starch) and monitored side effects and blood sugar levels over 12 weeks. The goal was to see if the drug is safe and tolerable, not yet to prove it works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
R-5280 (a modified starch)
What this could lead to
If it works, this could point toward a way to help manage type 1 diabetes by affecting gut health.
What could go wrong
This was a very small, early-phase safety study with only 9 participants, so it cannot prove effectiveness. The results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

9 people

The number who actually took part.

Started

Dec 2023

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

11 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus type 1 diabetes mellitus 1

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus, type 1 Type 1 diabetes Type 1 diabetes (juvenile onset)

Contacts and locations

Locations

  • Edward Jenner Research Group LLC

    Plantation, Florida, 33317, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • UTSW Medical Center

    Dallas, Texas, 75390, United States

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