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

NCT07486934

RecruitingPhase 3

Sponsor: Dyne Therapeutics

Conditions: Myotonic Dystrophy Type 1 (DM1), DM1, Myotonic Dystrophy, Steinert Disease, Steinert

Interventions: zeleciment basivarsen (DYNE-101), Placebo

Countries: United States, Belgium, Denmark, France, Germany, Italy, Japan, Netherlands

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).

Eligibility overview

Sex: ALL

Age: 16 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Diagnosis of DM1 confirmed by molecular genetics with trinucleotide repeat size greater than (\>) 100. Historical results from clinical testing are acceptable.
* Able to walk 10 meters and complete 5 times sit to stand independently (inserts or supports that don't go above the ankle are allowed).
* Body mass index (BMI) less than (\<) 35 kilograms per meter square (kg/m\^2).

Exclusion Criteria:

* A known diagnosis of congenital DM1.
* History of major surgical procedure (based on Investigator judgment) within 12 weeks prior to the start of screening, with the exception of implanted pacemaker or defibrillator.
* Use of glucagon-like peptide 1 (GLP-1) agonist/incretin medications including semaglutide, dulaglutide, liraglutide, exenatide, or tirzepatide within a period of 5 half-lives of the medication prior to performing screening assessments.

Note: Other inclusion and exclusion criteria may apply.
Locations (34)
  • La Jolla, California, United States
  • Los Angeles, California, United States
  • Atlanta, Georgia, United States
  • Indianapolis, Indiana, United States
  • Columbia, Missouri, United States
  • Hillsborough, North Carolina, United States
  • San Antonio, Texas, United States
  • Salt Lake City, Utah, United States
  • Richmond, Virginia, United States
  • Edegem, Belgium
  • Leuven, Belgium
  • Copenhagen, Denmark
  • Garches, France
  • Marseille, France
  • Nantes, France
  • Paris, France
  • Toulouse, France
  • Munich, Bavaria, Germany
  • Bonn, North Rhine-Westphalia, Germany
  • Berlin, State of Berlin, Germany
  • Gussago, Brescia, Italy
  • Milan, Milano, Italy
  • Roma, Roma, Italy
  • Roma, Roma, Italy
  • Kashiwazaki, Niigata, Japan
  • Suita-shi, Osaka, Japan
  • Toyonaka-Shi, Osaka, Japan
  • Kodaira, Tokyo, Japan
  • Ube-Shi, Yamaguchi, Japan
  • Maastricht, Netherlands
  • + 4 more on CT.gov