R-5280 in Newly Diagnosed Patients with Type 1 Diabetes

Phase 1

Recruiting

• Conditions: Type 1 Diabetes; Type 1 Diabetes (Juvenile Onset); Diabetes Mellitus, Type 1
• Interventions: Other: Placebo; Drug: R-5280

• Registration Number: NCT06057454
• Lead Sponsor: Rise Therapeutics LLC

Brief Summary

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2023-09-15
• Study First Submitted QC: 2023-09-21
• Study First Posted: 2023-09-28
• Study Start: 2023-12-05
• Status Verified: 2024-10
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-07
• Primary Completion: 2025-05
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 39

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Comparator	Placebo	Food starch, taken twice a day, orally with food for 12 weeks (84 days)
Active Comparator	R-5280	R-5280, Taken Twice a day, orally with food for 12 weeks (84 days)

Primary Outcome Measures

Name	Time	Method
Measurement of adverse events from the date of the first dose through 12 weeks of R-5280 tolerance	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.

Secondary Outcome Measures

Name	Time	Method
Measurement of clinical activity and to determine the gut microbiome profile in youth with recently diagnosed Type 1 Diabetes	12 Weeks	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.

Trial Locations

Locations (4)

UTSW Medical Center; 🇺🇸 Dallas, Texas, United States

Edward Jenner Research Group LLC; 🇺🇸 Plantation, Florida, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Spectrum Clinical Research; 🇺🇸 Kansas City, Missouri, United States