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NCT07608432 · ClinicalTrials.gov registry record · Phase 3

Efficacy, Safety, and Tolerability of Zeleciment Rostudirsen (DYNE-251) Administered Intravenously Every 4 Weeks in Ambulatory Participants With Duchenne Muscular Dystrophy (FORZETTO)

A Phase 3 study, sponsored by Dyne Therapeutics.

Recruiting
Registry status
Phase 3
Development phase
90
Enrollment target

NCT07608432: Recruiting Phase 3 study, sponsored by Dyne Therapeutics.

NCT07608432 is a Phase 3 study that is actively recruiting participants, run by Dyne Therapeutics. The registered enrollment target is 90 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07608432, a Phase 3 study, is actively recruiting participants, sponsored by Dyne Therapeutics.

RECRUITING
Registry status
Phase 3
Development phase
90 participants
Enrollment target

Study Summary

The purpose of the study is to assess the efficacy, safety, and tolerability of zeleciment rostudirsen (DYNE-251) administered intravenously (IV) every 4 weeks to ambulatory Duchenne muscular dystrophy (DMD) participants, 4 to 18 years of age, with dystrophin mutations amenable to exon 51 skipping.

Interventions

  • DRUG Placebo
  • DRUG Zeleciment Rostudirsen (DYNE-251)

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2026-06
Est. Completion 2032-10
Phase Phase 3
Dyne Therapeutics

4 total trials

What NCT07608432 shows while recruiting

NCT07608432 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT07608432 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07608432 about?

NCT07608432 is a clinical study titled "Efficacy, Safety, and Tolerability of Zeleciment Rostudirsen (DYNE-251) Administered Intravenously Every 4 Weeks in Ambulatory Participants With Duchenne Muscular Dystrophy (FORZETTO)". The purpose of the study is to assess the efficacy, safety, and tolerability of zeleciment rostudirsen (DYNE-251) administered intravenously (IV) every 4 weeks to ambulatory Duchenne muscular dystrophy (DMD) participants, 4 to 18 years of age, with dystrophin mutations amenable to exon 51 skipping.

What is the current status of trial NCT07608432?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 90 participants. The study started on 2026-06. Estimated completion is 2032-10.

What interventions are being tested in trial NCT07608432?

The interventions under investigation include: Placebo (DRUG), Zeleciment Rostudirsen (DYNE-251) (DRUG).

Who is sponsoring clinical trial NCT07608432?

This trial is sponsored by Dyne Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07608432's enrollment target sits among peer trials

90 1724th of 2000 higher than 263 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07608432, the US trial registry maintained by the National Library of Medicine. NCT07608432 (small enrollment · none site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.