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Tests treatment safety and results for Myotonic Dystrophy Type 1 (DM1)
Official title Efficacy, Safety, and Tolerability of Zeleciment Basivarsen (DYNE-101) in Participants With Myotonic Dystrophy Type 1
ClinicalTrials.gov ID: NCT07486934
What this study is testing
What is zeleciment basivarsen (DYNE-101)?
zeleciment basivarsen (DYNE-101) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for myotonic dystrophy type 1 (dm1).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older
You may be able to join if
- Diagnosis of DM1 confirmed by molecular genetics with trinucleotide repeat size greater than (\>) 100. Historical results from clinical testing are...
- 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).
You likely can't join if
- 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...
- Use of glucagon-like peptide 1 (GLP-1) agonist/incretin medications including semaglutide, dulaglutide, liraglutide, exenatide, or tirzepatide within...
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, 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
- Richmond, Virginia, United States
- Leuven, Belgium
- Copenhagen, Denmark
- Nantes, France
- Paris, France
- Toulouse, France
- Munich, Bavaria, Germany
- Berlin, State of Berlin, Germany
- Milan, Milano, Italy
- Roma, Roma, Italy
- Toyonaka-Shi, Osaka, Japan
- Ube-Shi, Yamaguchi, Japan
- San Sebastián de los Reyes, Madrid, Spain
- London, England, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, 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 and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.