Single Ascending Dose Study of SAR439459 in Adults With Osteogenesis Imperfecta (OI)
Terminated · Phase 1 · NCT05231668
Conditions: Osteogenesis Imperfecta
At a glance
- Research payments reported, 2025
- $177,461
- U.S. investigators named
- 6
- Sites paid
- 6
- Planned or actual enrollment
- 16
About the trial
- Sponsor
- Sanofi
- Tested
- SAR439459 (drug), Placebo (drug)
- Dates
- Started 2022-08-25; completion 2024-11-12
- Results posted
- Not yet
SAR439459 is a human anti-Transforming growth factor β (TGFβ) monoclonal antibody. This phase 1 clinical study investigates the safety, tolerability, and activity of a single dose of SAR439459 in adult participants with OI. Participants will receive a single IV dose of SAR439459 with safety, pharmacokinetic (PK), and pharmacodynamic (PD) assessments over 24 weeks. There will be up to 3 dose cohorts. In addition to safety, tolerability, and PK assessments, bone mineral density (BMD) will be evaluated by dual-energy Xray absorptimetry (DXA) scan and a series of blood biomarkers will be monitored to document pharmacodynamic effects of the single dose of SAR439459.
From ClinicalTrials.gov, last updated 2025-09-11. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Genzyme Corporation reported $177,461 in research payments for this study in 2025 (24 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
- Deborah Krakow, MD Medical Genetics · Santa Monica, CA
- Clemens Bergwitz, MD Endocrinology & Diabetes · New Haven, CT
- Mahim Jain, MD PHD Medical Genetics · Wilmington, DE
- Erik A. Imel, MD Pediatric Endocrinology · Indianapolis, IN
- Kathryn Dahir, MD Endocrinology & Diabetes · Nashville, TN
- Sandesh S. Nagamani, MD Internal Medicine · Houston, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Hugo W Moser Research Institute at Kennedy Krieger Inc $73,502
- Vanderbilt University Medical Center, TN $32,746
- Baylor College of Medicine $30,291
- Yale University Attn Treasury Services $15,244
- The Trustees of Indiana University $13,900
- Ronald Reagan UCLA Medical Center, CA $11,778
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.