NCT05312424 Annatto-derived GG for Statin-associated Myopathy
| NCT ID | NCT05312424 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Texas Tech University Health Sciences Center |
| Condition | Myopathy; Primary |
| Study Type | INTERVENTIONAL |
| Enrollment | 95 participants |
| Start Date | 2022-07-15 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 95 participants in total. It began in 2022-07-15 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To evaluate the effects of 3-months annatto-derived geranylgeraniol (GG) supplementation on statin-associated skeletal muscle health.
Eligibility Criteria
Inclusion Criteria: * Age ≥40 of either sex * Statin-treated patients with muscle pain alone or accompanied by other symptoms. * Patients currently receiving a statin who developed new-onset myalgias in within 90 day of initiation or a dosage increase Exclusion Criteria: * Malignancy or significant neurological or psychiatric disturbances, including alcohol or drug abuse. * Woman who is pregnant, breastfeeding, or of childbearing potential and not taking adequate contraceptive precautions. * Had CoQ10 supplement one month before starting the study. * Genetic musculoskeletal and neurologic disorder known to affect skeletal muscle metabolism * Had steroid medication one month before starting the study.
Contact & Investigator
Chwan-Li (Leslie) Shen, PhD
PRINCIPAL INVESTIGATOR
Texas Tech Health Science Center
Frequently Asked Questions
Who can join the NCT05312424 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Myopathy; Primary. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05312424 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05312424 currently recruiting?
Yes, NCT05312424 is actively recruiting participants. Contact the research team at leslie.shen@ttuhsc.edu for enrollment information.
Where is the NCT05312424 trial being conducted?
This trial is being conducted at Lubbock, United States.
Who is sponsoring the NCT05312424 clinical trial?
NCT05312424 is sponsored by Texas Tech University Health Sciences Center. The principal investigator is Chwan-Li (Leslie) Shen, PhD at Texas Tech Health Science Center. The trial plans to enroll 95 participants.