NCT07037862 (ELEVATE-44) is a Phase 1, PHASE2 clinical trial of ENTR-601-44 in Duchenne Muscular Dystrophy (DMD), sponsored by Entrada Therapeutics, Inc..

Who is sponsoring NCT07037862?

NCT07037862 is sponsored by Entrada Therapeutics, Inc..

What drugs are being tested in NCT07037862?

Interventions in NCT07037862: ENTR-601-44, ENTR-601-44 - matching placebo.

What condition does NCT07037862 study?

NCT07037862 studies Duchenne Muscular Dystrophy (DMD).

Is NCT07037862 still recruiting?

NCT07037862 is currently recruiting now. Last updated 9 March 2026.

Last reviewed 2026-03-09 · How we verify

NCT07037862: ELEVATE-44

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study in Participants With Duchenne Muscular Dystrophy Amenable to Exon 44 Skipping to Evaluate the Safety and Efficacy of ENTR-601-44

Recruiting now Phase 1, PHASE2 Last updated 9 March 2026

What this trial tests

Phase 1, PHASE2 trial testing ENTR-601-44 in Duchenne Muscular Dystrophy (DMD) in 24 participants. Currently enrolling.

Timeline

30 June 2025

Primary endpoint
28 March 2029

28 March 2029

Quick facts

Lead sponsor	Entrada Therapeutics, Inc.
Phase	Phase 1, PHASE2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	24
Start date	30 June 2025
Primary completion	28 March 2029
Estimated completion	28 March 2029
Sites	14 locations across Belgium, Italy, United Kingdom, Spain

Drugs / interventions tested

ENTR-601-44 — full drug profile →
ENTR-601-44 - matching placebo — full drug profile →

Conditions studied

Duchenne Muscular Dystrophy (DMD) — all drugs for Duchenne Muscular Dystrophy (DMD) →

Sponsor

Entrada Therapeutics, Inc. — full company profile →

Who can join

Adults 4 to 20, male only, with Duchenne Muscular Dystrophy (DMD). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a study of the investigational medicine ENTR-601-44 in participants who have Duchenne muscular dystrophy (DMD), a rare genetic condition. The researchers want to: Test how safe ENTR-601-44 is, learn about any side effects, and look at the potential positive effects of ENTR-601-44, compared to placebo. Placebo looks like the investigational medicine but does not contain any active ingredient. In this summary ENTR-601-44 and placebo are both called study treatments. The study has 2 parts: * Part A * A Double-Blind Period, to evaluate if ENTR-601-44 is safe and to determine the best dose of ENTR-601-44 for Part B. * Following the Double-Blind period, participants will roll into an open-label treatment period during which the safety and efficacy of extended dosing will be evaluated. * Part B * To further evaluate the effect and safety of ENTR-601-44 at the dose determined in Part A. Participants will: * Receive study treatment in the form of multiple intravenous (IV) infusions (slow injection) into a vein over the course of several weeks in Part A and in Part B * Visit the clinic regularly for checkups and tests such as: blood and urine tests, physical examinations, questionnaires, and exercise tests. Participants will have a muscle biopsy at the beginning of their participation and after their last dose to allow researchers to compare whether there have been changes in the muscle as a result of the study drug. Participants are allowed to continue receiving their standard of care therapy for DMD during the study, as long as their health remains stable.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Duchenne Muscular Dystrophy (DMD)

Currently open trials in the same condition.

NCT07038824 — A Study in Participants With Duchenne Muscular Dystrophy Amenable to Exon 45 Skipping to Evaluate the Safety and Efficac · Phase 1, PHASE2 · recruiting
NCT07129954 — Fear of Falling in Muscular Dystrophy · NA · recruiting
NCT06755138 — Research on the Relationship Between Scoliosis, Pain, Quality of Life, and Trunk Muscle Compensation Patterns Among Pati · recruiting
NCT06773988 — Follow-up of NIV At Home in Patients with Duchenne Muscular Dystrophy · recruiting
NCT06900049 — Evaluation of the Safety, Tolerability, and Efficacy of LE051 in Patients With Duchenne Muscular Dystrophy · EARLY_PHASE1 · recruiting

Other Entrada Therapeutics, Inc. trials

Trials by the same sponsor.

NCT07038824 — A Study in Participants With Duchenne Muscular Dystrophy Amenable to Exon 45 Skipping to Evaluate the Safety and Efficac · Phase 1, PHASE2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT07037862 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Entrada Therapeutics, Inc.
Last refreshed: 9 March 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07037862.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing