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Trial · NCT07911995

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

NCT07911995, Phase 2, Not yet recruiting, Grünenthal GmbH

3 sourcestrials-2026-11-12-0.4.0

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ConductScience Library. 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. Trials, record NCT07911995. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07911995

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
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
NCT number
NCT07911995
Status
Not yet recruiting
Phases
Phase 2
Enrollment
36 participants, estimated
Lead sponsor
Grünenthal GmbH
Conditions
Duchenne Muscular Dystrophy (DMD)
Interventions
Tegacorat
First posted
2026-11-03
Last updated
2026-11-03

Source ClinicalTrials.gov

Registered outcomes19

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryCore Phase: Change From Baseline in Time-to-Stand-from-Supine (TTSTAND) VelocityBaseline to Week 24Change from baseline to Week 24 in TTSTAND velocity.
PrimaryExtension Phase: Incidence of Adverse EventsFirst dose through Week 96Safety and Tolerability.
SecondaryCore Phase: Change From Baseline in Stride Velocity 95th Centile (SV95C)Baseline to Week 24Change from baseline to Week 24 in SV95C measured using wearable sensor technology.
SecondaryCore Phase: Change From Baseline in 10-Meter Walk/Run (10MWR) velocityBaseline to Week 24Change From Baseline in Functional Test Performance.
SecondaryCore Phase: Change From Baseline in Time-to-Climb-4-Stairs (TTCLIMB) velocityBaseline to Week 24Change From Baseline in Functional Test Performance.
SecondaryCore Phase: Incidence of Adverse EventsFirst dose through Week 24Safety and Tolerability.
SecondaryExtension Phase: Time to Treatment Discontinuation Due to Adverse EventsUp to Week 96Time to permanent discontinuation of study treatment due to an adverse event.
SecondaryExtension Phase: Change From Baseline in Weight and BMI Z-ScoresBaseline to Week 96Change from baseline in weight and body mass index (BMI) Z-scores.
SecondaryExtension Phase: Change From Baseline in Cushingoid FeaturesBaseline to Week 96Change from baseline in Cushingoid features.
SecondaryExtension Phase: Change From Baseline in Glucose MetabolismBaseline to Week 96Change from baseline in fasting glucose and fasting serum insulin.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release
trials-2026-11-12-0.4.0
Release manifest SHA-256
0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture
2026-11-12
Results copy, AACT
2026-03-23
NIH clinical studies file
2026-11-13

Source ClinicalTrials.gov

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07911995

GET https://conductscience.org/api/trials/v1/NCT07911995/registered