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NCT07911995Not yet recruitingPhase 2

A Phase 2 Trial to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tegacorat in Male Participants 4 to <7 Years of Age With Duchenne Muscular Dystrophy

A Randomized, Open-label Phase 2 Trial Consisting of a 24-Week Core Phase Followed by a 72-Week Extension Phase to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tegacorat Oral Solution in Male Participants 4 to <7 Years of Age With Duchenne Muscular Dystrophy (DMD)

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

This Phase 2 clinical trial will evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of tegacorat oral solution in male participants 4 to less than 7 years of age with Duchenne muscular dystrophy (DMD). Participants will be randomized to one of three tegacorat treatment groups during a 24-week Core Phase. Participants who complete the Core Phase will continue into a 72-week Extension Phase. The study will assess muscle function, ambulatory performance, safety outcomes, pharmacokinetics, pharmacodynamic biomarkers, and health-related quality of life over a total treatment period of up to 96 weeks.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
36 (estimated)
First submitted
27 Oct 2026
Start date
9 Nov 2026
Primary completion date
4 Jan 2030
Lead sponsor
Grünenthal GmbH
NCT number
NCT07911995
EU CT number
2026-526326-40-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 36
  • From 9 Nov 2026 to the primary completion date, 4 Jan 2030
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Current or recent use of prohibited treatments or investigational products.
  • Prior exposure to delandistrogene moxeparvovec.
  • Participation in another clinical trial within the protocol-defined washout period.

Other illness

  • Moderate or severe renal impairment.
  • Moderate or severe hepatic impairment.
  • Chronic or latent infection that may increase study risk.
  • Acute illness that could affect safety.
  • Diabetes mellitus.
  • Severe behavioral, cognitive, or psychiatric disorders interfering with study participation.
  • Adrenal insufficiency.
  • Hypersensitivity to study intervention or its components.

Lab values

  • Clinically significant abnormal laboratory findings.

Other

  • Symptomatic cardiomyopathy.
  • Clinically significant ECG abnormalities.

Who the study is looking for

  • Male participant aged ≥4 years and \<7 years at randomization.
  • Clinically and genetically confirmed diagnosis of Duchenne muscular dystrophy.
  • Body weight between 13 kg and 35 kg at screening.
  • Able to walk independently without assistive devices.
  • Able to complete the TTSTAND assessment without assistance in less than 10 seconds.
  • Evidence of varicella immunity by serology or vaccination history.
  • Parent(s)/legal guardian(s) provide informed consent and participant assent as required.

Age in the registry: 4 years to 6 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.