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SAT-3247 OXALATE

Clinical trials are studying SAT-3247 OXALATE in people with Duchenne muscular dystrophy. These studies aim to check safety, tolerability, and whether the treatment may improve muscle force in ambulatory patients. The main trial is a Phase 2 study in patients who can still walk.

Table of Contents

Trial overview

The available study is an interventional trial of SAT-3247 OXALATE in people with Duchenne muscular dystrophy.[1] The trial title says it is a Phase 2a, randomized, double-blind, placebo-controlled dose comparison and exploratory efficacy study in ambulatory patients.[1] The brief summary says the main goals are to evaluate safety, tolerability, and early signs of benefit on muscle force.[1]

Who can join the study

The study is for ambulatory DMD patients, which means people with Duchenne muscular dystrophy who are still able to walk.[1] No other eligibility details are provided in the source data.[1]

Study design and treatment groups

This is a randomized study, so participants are assigned to study groups by chance.[1] It is also double-blind, which means neither the participants nor the study team knows who is receiving the active study treatment or placebo during the trial.[1] The study compares orally administered SAT-3247 OXALATE tablets with placebo tablets that are made to look the same as the active tablets.[1] The source lists two active tablet strengths, 10 mg and 50 mg, both given by mouth.[1]

What the study measures

The main efficacy endpoint is the change from baseline in muscle force measured by dynamometry at Week 12.[1] Baseline means the starting point before treatment begins, and dynamometry is a test that measures muscle strength.[1] The main safety endpoints include the number, severity, and relationship of adverse events to SAT-3247, plus changes in physical examination, laboratory tests, vital signs, ECG, and C-SSRS results.[1] Adverse events are unwanted health problems during a study, ECG checks the heart’s electrical activity, and C-SSRS is used to check for suicidal thoughts or behavior.[1]

Trial status and size

The trial status is Authorised.[1] The planned enrollment is 51 participants.[1] This is a small early-stage study, so it is mainly designed to learn more about safety and to look for a possible effect on muscle force rather than to give a final answer.[1]

Trial ID Phase Condition studied Status Enrollment
2025-522522-13-01 Phase 2 Duchenne muscular dystrophy Authorised 51

FAQ

  • What is being studied in the SAT-3247 OXALATE trial? The trial is studying whether SAT-3247 OXALATE may help improve muscle force in people with Duchenne muscular dystrophy. It is also checking safety and tolerability.
  • Who can take part in the trial? The study is for ambulatory patients with Duchenne muscular dystrophy. Ambulatory means the person can walk.
  • What phase is the trial? This is a Phase 2 trial. Phase 2 studies often look at early signs that a treatment may work, while also continuing to monitor safety.
  • What outcomes are measured? The main efficacy outcome is the change in muscle force measured by dynamometry at Week 12. Safety is also measured by side effects, physical exams, lab tests, vital signs, ECG, and C-SSRS.
  • Is the trial comparing SAT-3247 OXALATE with anything else? Yes. The study is randomized, double-blind, and placebo-controlled. That means some people get SAT-3247 OXALATE and others get placebo, and neither the participants nor the study team knows who gets which treatment during the trial.

Ongoing Clinical Trials on SAT-3247 OXALATE

  • Study of SAT-3247 Compared to Placebo for Patients with Duchenne Muscular Dystrophy Who Can Walk

    Recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Belgium Poland Spain

Glossary

  • Duchenne muscular dystrophy: A genetic disease that causes muscles to become weaker over time.
  • Ambulatory: Able to walk without help or with limited help.
  • Phase 2: A study stage that checks early signs of benefit and continues safety testing.
  • Randomized: Participants are assigned to study groups by chance.
  • Double-blind: Neither the participants nor the study team knows who gets the active treatment or placebo during the study.
  • Placebo: A look-alike treatment with no active study drug, used for comparison.
  • Dynamometry: A test that measures muscle force or strength.
  • Baseline: The starting point before treatment begins.
  • Adverse event: Any unwanted health problem that happens during a study.
  • ECG: A test that records the heart’s electrical activity.
  • C-SSRS: A questionnaire used to check for suicidal thoughts or behavior.

References

  1. https://clinicaltrials.gov/study/2025-522522-13-01