Frexalimab in Preservation of Endogenous Insulin Secretion Compared to Placebo in Adults and Adolescents on Top of Insulin Therapy (FABULINUS)
Active, not recruiting · Phase 2 · NCT06111586
Conditions: Type 1 Diabetes Mellitus
At a glance
- Research payments reported, 2025
- $606,485
- U.S. investigators named
- 14
- Sites paid
- 14
- Planned or actual enrollment
- 197
About the trial
- Sponsor
- Sanofi
- Tested
- Frexalimab (drug), Placebo (drug), Insulin (drug)
- Dates
- Started 2023-12-11; completion 2030-10-29
- Results posted
- Not yet
This is a randomized, parallel group, double-blind Phase 2 study with a blinded extension evaluating the safety and efficacy of 3 dose levels of frexalimab in comparison with placebo in participants with newly diagnosed T1D on insulin treatment. Study details include: Screening period: at least 3 weeks and up to 5 weeks. Enrollment date of the participant must take into consideration this constraint) Double-blind treatment period 104 weeks: Main treatment period: 52 weeks Blinded extension: 52 weeks Optional OLE period: 104 weeks Safety follow-up: 26 weeks The treatment duration will be up to 104 weeks , the total study duration will be up to 135 weeks for Part A and Part B. If participan…
From ClinicalTrials.gov, last updated 2026-11-02. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Genzyme Corporation reported $606,485 in research payments for this study in 2025 (55 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Stephen E. Gitelman, M.D. Pediatric Endocrinology · San Francisco, CA
- Peter Gottlieb, MD Endocrinology & Diabetes · Aurora, CO
- David Baidal, M.D. Endocrinology & Diabetes · Miami, FL
- Michael J. Haller, MD Pediatric Endocrinology · Gainesville, FL
- Richard E. Pratley, MD Endocrinology & Diabetes · Orlando, FL
- Joshua M. Smith, M.D. Pediatric Endocrinology · Idaho Falls, ID
- Liana K. Billings, MD, MMSC Endocrinology & Diabetes · Skokie, IL
- Jason L. Gaglia, M.D. Endocrinology & Diabetes · Boston, MA
- Nina Jain, M.D. Pediatric Endocrinology · Sanford, NC
- Teresa Quattrin, MD Specialist · Buffalo, NY
- Deborah A. Elder, MD Pediatric Endocrinology · Cincinnati, OH
- Steven M. Willi, M.D. Pediatric Endocrinology · Philadelphia, PA
- Perrin C. White, MD Pediatric Endocrinology · Dallas, TX
- Sandra M. Lord Internal Medicine · Kent, WA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- University of Florida Contracts Grants $108,135
- Children's Hospital of Philadelphia, PA $83,413
- UCSF Langley Porter Psychiatric Hospital and Clinics, CA $69,573
- Benaroya Research Institute at Virg Mason $68,640
- The University of North Carolina at Chapel Hill $58,875
- Cincinnati Children's Hospital Medical Center, OH $44,391
- The Research Foundation for The Station University of New York $34,508
- Adventhealth Orlando, FL $33,802
- The University of Texas Southwester Medical Center $33,397
- Regents of the University of Colorado $31,119
- Northshore University Healthsystem - Evanston Hospital, IL $15,128
- Joslin Diabetes Center $14,100
- Rocky Mountain Clinical Research, Llc $8,105
- Office of Research Administration $3,300
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.