Efficacy, Safety, and Tolerability of Zeleciment Basivarsen (DYNE-101) in Participants With Myotonic Dystrophy Type 1

ClinicalTrials.gov ID: NCT07486934

Public ClinicalTrials.gov record NCT07486934. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 6, 2026, 3:41 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Randomized, Double-Blind, 48-Week Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of DYNE-101 Administered to Participants With Myotonic Dystrophy Type 1

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of the study is to assess the efficacy, safety, and tolerability of zeleciment basivarsen (DYNE-101) for the treatment of myotonic dystrophy 1 (DM1).

Study identification

NCT ID: NCT07486934
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Dyne Therapeutics; Industry
Enrollment: 150 participants

Conditions and interventions

Conditions

Interventions

zeleciment basivarsen (DYNE-101) Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 16 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 13, 2026
Primary completion: Jun 30, 2028
Completion: Dec 31, 2028
Last update posted: Sep 2, 2026

2026 – 2029

United States locations

U.S. sites: 10
U.S. states: 8
U.S. cities: 10

Facility	City	State	ZIP	Site status
UCSD - Altman Clinical and Translational Research Institute	La Jolla	California	92037	Recruiting
UCLA Medical Center (Department of Neurology)	Los Angeles	California	90095	Recruiting
Stanford Neuroscience Health Center	Palo Alto	California	94304	Recruiting
Rare Disease Research, LLC	Atlanta	Georgia	30329	Recruiting
IU Health Neuroscience Center	Indianapolis	Indiana	46202	Recruiting
Roy Blunt NextGen Precision Health Institute	Columbia	Missouri	65211	Recruiting
Rare Disease Research, LLC	Hillsborough	North Carolina	27278	Recruiting
The University of Texas Health Science Center at San Antonio	San Antonio	Texas	78229	Recruiting
University of Utah Clinical Neurosciences Center	Salt Lake City	Utah	84132	Recruiting
Virginia Commonwealth University - Biotech One	Richmond	Virginia	23298	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 27 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07486934, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 2, 2026 · Synced Sep 6, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07486934 live on ClinicalTrials.gov.

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