R-5280 in Newly Diagnosed Patients With Type 1 Diabetes

NCT06057454 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: RISE R-5280
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

Brief Summary

Evaluating the adverse events and tolerance of R-5280 in Mitigating Type 1 Diabetes in Newly Diagnosed Patients

Conditions

Type 1 Diabetes; Type 1 Diabetes (Juvenile Onset); Diabetes Mellitus, Type 1

Keywords

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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.

  12 Weeks

Secondary Outcomes (1)

• Measurement of clinical activity and to determine the gut microbiome profile in youth with recently diagnosed Type 1 Diabetes

  12 Weeks

Study Arms (2)

Active Comparator

ACTIVE COMPARATOR

R-5280, Taken Twice a day, orally with food for 12 weeks (84 days)

Drug: R-5280

Placebo Comparator

PLACEBO COMPARATOR

Food starch, taken twice a day, orally with food for 12 weeks (84 days)

Other: Placebo

Interventions

R-5280 DRUG

Modified Superior Starch

Active Comparator

Placebo OTHER

Food Grade Starch

Placebo Comparator

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rise Therapeutics LLC: lead

Study Sites (3)

Edward Jenner Research Group LLC

Plantation, Florida, 33317, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

UTSW Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind placebo controlled trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double Blinided, placebo controlled, Phase 1B study.

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: September 28, 2023
• Study Start: December 5, 2023
• Primary Completion: November 5, 2025
• Study Completion: November 5, 2025
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (3)