R-5280 in Newly Diagnosed Patients with Type 1 Diabetes

Rise Therapeutics

Status and phase: Enrolling; Phase 1

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

Treatments: Other: Placebo; Drug: R-5280

Study type: Interventional

Funder types: Industry

Identifiers

NCT06057454

RISE R-5280

Details and patient eligibility

About

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

Full 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

Enrollment: 39 estimated patients

Sex: All

Ages: 11 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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39 participants in 2 patient groups, including a placebo group

Active Comparator

Active Comparator group

Description:

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

Treatment:

Drug: R-5280

Placebo Comparator

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo