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Myopathy; PrimaryPhase 1/2GG-statinNCT05312424

Annatto-derived GG for Statin-associated Myopathy

A Phase 1/2 study testing Low GG and High GG in people with Myopathy; Primary, run by Texas Tech University Health Sciences Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

To evaluate the effects of 3-months annatto-derived geranylgeraniol (GG) supplementation on statin-associated skeletal muscle health. Read more about this study

Who is it for?
Ages 40 years and olderHealthy volunteers can take part
Conditions the study is for
Myopathy; Primary
What is being tested?
Low GG and High GG
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
95 participants
Where
1 siteUnited States
Study dates
15 Jul 2022to 31 Dec 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chwan-Li (Leslie) Shen, PhD contact

8067432815

leslie.shen@ttuhsc.edu

United States1 site, 1 recruiting

  • Texas Tech University Health Sciences Center

    Lubbock, Texas, 79430

    Chwan-Li (Leslie) Shen, PhD, 806-743-2815, Leslie.Shen@ttuhsc.edu

    Chwan-Li (Leslie) Shen, PhD

    Recruiting

Other trials in United States

About this study

Official title: Effect of Annatto-derived Geranylgeraniol (GG) on Statin-associated Myopathy

To evaluate the effects of 3-months annatto-derived geranylgeraniol (GG) supplementation on statin-associated skeletal muscle health.

Read the detailed description

Statins are widely prescribed cholesterol-lowering oral drugs. The majority of reported adverse effects due to statin include muscle pain, weakness, cramp, and tiredness. CoQ10 supplementation has been widely used to reduce statin-related muscle complaints. Several human studies have been reported with inconsistent effects of CoQ10 on statin-related symptoms. This study is to investigate the role of 3-month annatto-derived geranylgeraniol (GG) in statin-related muscle outcomes in humans. Qualified subjects will be matched by age, gender, and body weight, and then randomly assigned to a no GG group, a low GG dose group, or a high GG dose group. The outcome measures will be assessed at baseline and after 3 months. Muscle-associated measurements will be recorded using subject questionnaires (also follow-up after 3 and 6 months), muscle performance results, and blood samples. We will monitor the safety of subjects after 3 months. Food intake, physical activity, and medication changes will be recorded at baseline and after 3 months. All data will be analyzed statistically.

Being tested
Placebo, Low GG, High GG
Medical subject headings
Muscular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDietary supplement

    300 mg olive oil

  • Low GGDietary supplement

    150 mg GG

  • High GGDietary supplement

    300 mg GG

Study groups in NCT05312424
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo group: subject will take one pill (150 mg olive oil) after breakfast and another pill (150 mg olive oil) after dinner
Receives: Dietary Supplement: Placebo
Low GGActive comparatorLOW GG group: subject will take one pill (150 mg olive oil) after breakfast and another pill (150 mg GG) after dinner
Receives: Dietary Supplement: Low GG
High GGActive comparatorHIGH GG group: subject will take one pill (150 mg GG) after breakfast and another pill (150 mg GG) after dinner
Receives: Dietary Supplement: High GG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SAMS-CI

    Statin-Associated Muscle Symptom Clinical Index (SAMS-CI) is to assess muscle pain, muscle weakness, tiredness, and cramps.

    Measured: change in SAMS-CI at 3 months

  2. BPI

    Brief Pain Inventory (BPI) is to assess pain and interference of pain with everyday life.

    Measured: change in BPI at 3 months

Secondary outcomes (11)

  1. Lower body isometric strength

    Lower body (i.e., predominantly of the quadriceps and hip extensors) isometric strength is measured using a dynamometer

    Measured: change in lower body isometric strength at 3 months

  2. Functional lower body strength

    Functional lower body strength is measured using a loaded 50m walk.

    Measured: change in functional lower body strength at 3 months

  3. Wall-sit test

    Wall-sit test (wall-slide test) is to assess static leg strength and endurance, particularly of the quadriceps and hip extensors

    Measured: change in wall-sit test at 3 months

  4. Heel raise test

    Heel raise test is commonly used to test calf muscle endurance, function, and performance. Single-leg or both-leg raise will be tested while staining on a step bench

    Measured: change in heel raise test at 3 months

  5. blood biomarkers: serum creatinine kinase activity

    Creatine kinase is to assess muscle damage.

    Measured: change in serum creatinine kinase activity at 3 months

  6. blood biomarkers: myostatin

    Myostatin is to assess muscle damage

    Measured: changes in serum myostatin at 3 months

  7. blood biomarkers: atrogin 1

    atrogin 1 is to assess muscle damage

    Measured: changes in serum atrogin 1 at 3 months

  8. blood biomarkers: hsCRP

    hsCRP is to assess inflammation

    Measured: changes in serum hsCRP at 3 months

  9. blood biomarker: IL-6

    IL-6 is to assess inflammation

    Measured: changes in serum IL-6 at 3 months

  10. blood lipid profiles

    lipid profiles include total triglycerides, total cholesterol, HDL, and calculated LDL

    Measured: changes in blood lipid profiles at 3 months

  11. plasma menaquinone-4 (MK4) + menaquinone-4 (MK7)

    MK4 and MK4 are vitamin K2 homologues and are measured by HPLC

    Measured: changes in plasma MK4+MK7 at 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2022
  2. Study start15 Jul 2022
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
95 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05312424
Sponsor's protocol ID
L22-130
Acronym
GG-statin
Status last verified
Sep 2026
First submitted
9 Mar 2022
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Low GG and High GG in people with Myopathy; Primary, run by Texas Tech University Health Sciences Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chwan-Li (Leslie) Shen, PhD (8067432815, leslie.shen@ttuhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SAMS-CI (time frame: change in SAMS-CI at 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05312424.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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