Frexalimab in Preservation of Endogenous Insulin Secretion Compared to Placebo in Adults, Adolescents and Children on Top of Insulin Therapy (FABULINUS)

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NCT06111586 · readout in 251 d

Sponsored by Sanofi (industry) · SNY — their whole pipeline →.

Phase

Phase 2

Status

Active, not recruiting

Study type

Interventional

Design

Randomized · Triple · Treatment

Enrollment

197actual

Sites

Countries

Austria, Belgium, Canada +13

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2023-12-11

actual

When the study began enrolling

Primary completion

2027-04-28

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2030-10-29

estimated

The whole study's end, after follow-up

First posted

2023-11-01

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-06-29

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Type 1 Diabetes Mellitus

Interventions

Drug: Frexalimab
Drug: Placebo
Drug: Insulin

Primary outcomes

what the primary-completion date above is the date OF

Change in mean 2h mixed meal tolerance test (MMTT) stimulated C-peptide concentration, calculated from AUC from baseline to W52 for Part B (12-21 y.o.)

measured Baseline to Week 52

Change in mean 2h mixed meal tolerance test (MMTT) stimulated C-peptide concentration, calculated from AUC from baseline to W26 for Part C (6-11 y.o.)

measured Baseline to Week 26

Publications

PMID 42203212 — linked by the registry

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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