A Phase 2 interventional study of Tegacorat in Duchenne Muscular Dystrophy (DMD), sponsored by Grünenthal GmbH. Not yet recruiting. Open to male participants aged 4 Years to 6 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Grünenthal GmbH · Phase 2, Interventional, and Treatment
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.
DMD is a severe, progressive neuromuscular disorder caused by mutations in the dystrophin gene, resulting in muscle degeneration and loss of function. Current standard-of-care glucocorticoid therapy may slow disease progression but is associated with significant long-term adverse effects. Tegacorat is a selective glucocorticoid receptor agonist and modulator (SEGRAM) that has demonstrated anti-inflammatory activity with reduced glucocorticoid receptor-mediated transactivation in clinical and nonclinical studies.
481 studies on the registry are indexed under Muscular Dystrophy, Duchenne; 108 are open to participants now.
This study's planned enrollment of 36 is above the median of 26 across 332 interventional studies indexed under Muscular Dystrophy, Duchenne.
Browse Muscular Dystrophy, Duchenne studies →Grünenthal GmbH is the lead sponsor of 69 studies on the registry; 3 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 8 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
EXCLUSION CRITERIA:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tegacorat Treatment Group 1
Drug: Tegacorat
Tegacorat Treatment Group 2
Drug: Tegacorat
Tegacorat Treatment Group 3
Drug: Tegacorat
Oral solution
Core Phase: Change From Baseline in Time-to-Stand-from-Supine (TTSTAND) Velocity
Change from baseline to Week 24 in TTSTAND velocity.
Time frame: Baseline to Week 24
Extension Phase: Incidence of Adverse Events
Safety and Tolerability.
Time frame: First dose through Week 96
Core Phase: Change From Baseline in Stride Velocity 95th Centile (SV95C)
Change from baseline to Week 24 in SV95C measured using wearable sensor technology.
Time frame: Baseline to Week 24
Core Phase: Change From Baseline in 10-Meter Walk/Run (10MWR) velocity
Change From Baseline in Functional Test Performance.
Time frame: Baseline to Week 24
Core Phase: Change From Baseline in Time-to-Climb-4-Stairs (TTCLIMB) velocity
Change From Baseline in Functional Test Performance.
Time frame: Baseline to Week 24
Core Phase: Incidence of Adverse Events
Safety and Tolerability.
Time frame: First dose through Week 24
Extension Phase: Time to Treatment Discontinuation Due to Adverse Events
Time to permanent discontinuation of study treatment due to an adverse event.
Time frame: Up to Week 96
Extension Phase: Change From Baseline in Weight and BMI Z-Scores
Change from baseline in weight and body mass index (BMI) Z-scores.
Time frame: Baseline to Week 96
Extension Phase: Change From Baseline in Cushingoid Features
Change from baseline in Cushingoid features.
Time frame: Baseline to Week 96
Extension Phase: Change From Baseline in Glucose Metabolism
Change from baseline in fasting glucose and fasting serum insulin.
Time frame: Baseline to Week 96
Extension Phase: Change From Baseline in PARS-III Score
Change from baseline in Personal Adjustment and Role Skills Scale (PARS-III) score.
Time frame: Baseline to Week 96
Extension Phase: Change From Baseline in Bone Mineral Density
Change from baseline in bone mineral density assessed by dual-energy X-ray absorptiometry (DXA).
Time frame: Baseline to Week 96
Extension Phase: Vertebral Fracture Assessment
Assessment of vertebral fractures by lateral thoracolumbar spine X-ray.
Time frame: Baseline to Week 96
Extension Phase: Change From Baseline in Height Z-Score
Change from baseline in height Z-score.
Time frame: Baseline to Week 96
Extension Phase: Change From Baseline in Bone Age
Change from baseline in bone age assessed by left hand X-ray.
Time frame: Baseline to Week 96
Extension Phase: Change From Baseline in TTSTAND Velocity
Change From Baseline in Functional Test Performance.
Time frame: Baseline to Week 96
Extension Phase: Change From Baseline in 10MWR Velocity
Change From Baseline in Functional Test Performance.
Time frame: Baseline to Week 96
Extension Phase: Change From Baseline in TTCLIMB Velocity
Change From Baseline in Functional Test Performance.
Time frame: Baseline to Week 96
Extension Phase: Change From Baseline in SV95C
Change from baseline in SV95C measured using wearable sensor technology.
Time frame: Baseline to Week 96
No study locations are listed for this record.
Plan to share: Yes — Information available on the Grünenthal Group Web Site (https://www.grunenthal.com/science/clinical-trial-transparency/data-sharing) and according to the European Federation of Pharmaceutical Industries and Associations (EFPIA) Data Sharing Principles
Supporting information: Study protocol, Informed consent form, Clinical study report
Data sharing details ↗ · www.grunenthal.com
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Tegacorat
Muscular Dystrophy, Duchenne →