# A Study of DB-OTO, an Adeno-Associated Virus (AAV) Based Gene Therapy, in Children/Infants With Hearing Loss Due to Otoferlin Mutations

> **NCT05788536** · PHASE1,PHASE2 · RECRUITING · sponsor: **Regeneron Pharmaceuticals** · enrollment: 30 (estimated)

## Conditions studied

- Congenital Hearing Loss Secondary to Biallelic Mutations of the Otoferlin Gene (OTOF)

## Interventions

- **GENETIC:** DB-OTO
- **GENETIC:** DB-OTO

## Key facts

- **NCT ID:** NCT05788536
- **Lead sponsor:** Regeneron Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1,PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2023-06-27
- **Primary completion:** 2032-02-28
- **Final completion:** 2032-02-28
- **Target enrollment:** 30 (ESTIMATED)
- **Last updated:** 2026-05-05


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05788536

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05788536, "A Study of DB-OTO, an Adeno-Associated Virus (AAV) Based Gene Therapy, in Children/Infants With Hearing Loss Due to Otoferlin Mutations". Retrieved via AI Analytics 2026-06-24 from https://api.ai-analytics.org/clinical/NCT05788536. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*