IMCY-0098 for Type 1 Diabetes
(IMPACT Trial)

Recruiting in Palo Alto (17 mi)

+28 other locations

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Imcyse SA

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests IMCY-0098, a new drug for type 1 diabetes. It aims to stop the immune system from attacking insulin-producing cells. The study will determine the best dose and ensure it is safe for patients.

Eligibility Criteria

Adults aged 18-45 with recent Type 1 Diabetes diagnosis, on insulin therapy, and certain autoantibodies. They must have specific C-peptide levels, not be pregnant or breastfeeding, agree to contraception use if applicable, and meet other health criteria including HLA types.

Inclusion Criteria

I am being treated with insulin as per my local healthcare guidelines.

I am between 18 and 45 years old.

I was diagnosed with Type 1 Diabetes less than 9 weeks ago.

+8 more

Exclusion Criteria

I am currently experiencing a serious infection that requires IV antibiotics or hospitalization.

(US ONLY) History or current evidence of active drug, chemical or alcohol dependency

I have been diagnosed with LADA.

+16 more

Participant Groups

The IMPACT study is testing IMCY-0098 at two different doses versus a placebo in people with Type 1 Diabetes. The drug aims to protect insulin-producing cells by targeting the immune system's harmful cells.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: IMCY-0098, low doseExperimental Treatment1 Intervention

The dose A (Cohort 1) will consist of subcutaneous administrations of 450 µg of the peptide in two separate injections of 225 µg each (500 µL each).

Group II: IMCY-0098, high doseExperimental Treatment1 Intervention

The dose B (Cohort 2) will consist of subcutaneous administrations of 1350 µg of the peptide in two separate injections of 675 µg each (500 µL each).

Group III: PlaceboPlacebo Group1 Intervention

Participants randomized to placebo will receive subcutaneous administrations of identical volumes of placebo solution to maintain study blind.