GHK and GHK-Cu Blood LevelsNCT07706361
Two-Part Study of the Effects of the X39 Patch on Circulating GHK and GHK-Cu Levels in Healthy Adults
A study testing X39 Patch in people with GHK and GHK-Cu Blood Levels, run by LifeWave, Inc. at 1 site in Canada.
Trial summary
The goal of this clinical trial is to investigate GHK and GHK-Cu blood levels pre- and post-intervention in healthy adults, and to investigate the efficacy of X39 patch on GHK and GHK-Cu blood levels in healthy adults compared to a placebo. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- GHK and GHK-Cu Blood Levels
- What is being tested?
- X39 Patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2027to Apr 2027
- Phase
- Interventional
- 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 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females 35 years and older
- Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or,
- Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Nexplanon)
- Double-barrier method
- Intrauterine devices
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- Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
- Vasectomy of partner at least 6 months prior to screening
- Abstinence and agrees to use contraception if planning on becoming sexually active during the study
- Agrees to refrain from vigorous physical activity, alcohol consumption, and taking NSAIDs 24 hours prior to study visits
- Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study
- Willingness to complete questionnaires, diaries and to complete all clinic visits
- Provided voluntary, written, informed consent to participate in the study
- Healthy as determined by medical history as assessed by the Qualified Investigator (QI)
Who cannot join
- Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- Allergy or sensitivity to the adhesive used for wearing the investigational patch
- Self-reported tattoos, skin conditions, or sensitive skin at or around the area of application
- Diagnosis with Wilson's disease
- Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy of the investigational product (Sections 7.3.1 and 7.3.2)
- Unstable metabolic disease or chronic diseases as assessed by the QI
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- Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
- Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 7.3)
- Type I or Type II diabetes
- Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case by-case basis
- History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
- Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
- Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
- Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
- Individuals with an autoimmune disease or are immune compromised as assessed by the QI
- Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
- Self-reported confirmation of blood/bleeding disorders as assessed by the QI
- Use of prescribed medical cannabinoid products
- Chronic use of cannabinoid products (>2 times/week). Occasional users will be required to washout and abstain for the duration of the study period
- Regular use of tobacco or nicotine products in the past six months, as assessed by the QI. Occasional users will be required to washout and abstain for the duration of the study period
- Alcohol intake average of >2 standard drinks per day as assessed by the QI
- Alcohol or drug abuse within the last 12 months
- Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
- Individuals who are unable to give informed consent
- Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Two-part Study Investigating the Effect of the X39 Patch on Circulating Blood Levels of GHK and GHK-Cu in a Healthy Adult Population
The goal of this clinical trial is to investigate GHK and GHK-Cu blood levels pre- and post-intervention in healthy adults, and to investigate the efficacy of X39 patch on GHK and GHK-Cu blood levels in healthy adults compared to a placebo. The main questions it aims to answer are:
- What is the change in GHK and GHK-Cu levels from baseline to Day 8?
- What is the difference in the change in GHK and GHK-Cu levels from baseline to Day 8 between the X39 patch and placebo? Researchers will compare X39 patches to placebo patches to evaluate their effects on circulating blood levels of GHK and GHK-Cu in healthy adults.
Participants will be asked to complete a questionnaire and use the X39 patch or placebo patch.
- Conditions
- GHK and GHK-Cu Blood Levels
- Being tested
- X39 Patch, Placebo Patch
- Keywords
- X39 patch, GHK, GHK-Cu
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X39 PatchDevice
Beginning on Day 1, participants will apply the patch daily until Day 7 or the day prior to their last study visit (Visit 3). Participants will apply the patch to the back of the neck (acupuncture point GV14) or directly below the belly button (acupuncture point CV6) on clean, dry skin first thing each morning and remove after approximately 12 hours later or before bed.
Placebo PatchDevice
Beginning on Day 1, participants will apply the patch daily until Day 7 or the day prior to their last study visit (Visit 3). Participants will apply the patch to the back of the neck (acupuncture point GV14) or directly below the belly button (acupuncture point CV6) on clean, dry skin first thing each morning and remove after approximately 12 hours later or before bed.
| Study group | Role | What they receive |
|---|---|---|
| X39 Patch | Experimental | Beginning on Day 1, participants will apply the patch daily until Day 7 or the day prior to their last study visit (Visit 3). Participants will apply the patch to the back of the neck (acupuncture point GV14) or directly below the belly button (acupuncture point CV6) on clean, dry skin first thing each morning and remove after approximately 12 hours later or before bed. Receives: Device: X39 Patch |
| Placebo patch | Placebo comparator | Beginning on Day 1, participants will apply the patch daily until Day 7 or the day prior to their last study visit (Visit 3). Participants will apply the patch to the back of the neck (acupuncture point GV14) or directly below the belly button (acupuncture point CV6) on clean, dry skin first thing each morning and remove after approximately 12 hours later or before bed. Receives: Device: Placebo Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in GHK levels from baseline to Day 8
Part 1. Change in GHK levels from baseline to Day 8
Measured: Baseline (Day 0) to Day 8
Change in GHK levels from baseline to Day 8 between the X39 patch and placebo
Part 2. Change in GHK levels from baseline to Day 8 between the X39 patch and placebo
Measured: Baseline (Day 0) to Day 8
Change in GHK-Cu levels from baseline to Day 8
Part 1. Change in GHK-Cu levels from baseline to Day 8
Measured: Baseline (Day 0) to Day 8
Change in GHK-Cu levels from baseline to Day 8 between the X39 patch and placebo
Part 2. Change in GHK-Cu levels from baseline to Day 8 between the X39 patch and placebo
Measured: Baseline (Day 0) to Day 8
Secondary outcomes (6)
Change in GHK levels from baseline to Day 2
Part 1. Change in GHK levels from baseline to Day 2
Measured: Baseline (Day 0) to Day 2
Quality of Life, RAND SF-36
Part 1. Change in quality of life from baseline to Days 2 and 8, as assessed by the RAND 36-item Short-Form Health Survey (RAND SF-36)
Measured: Baseline (Day 0) to Day 8
Change in GHK levels from baseline to Day 2 between the X39 patch and placebo
Part 2. Change in GHK levels from baseline to Day 2 between the X39 patch and placebo
Measured: Baseline (day 0) to Day 2
Change in Quality of Life from Baseline to Days 2 and 8 (RAND 36-Item Short Form Health Survey - RAND SF-36) Between X39 Patch and Placebo
Part 2. Change in quality of life from baseline to Days 2 and 8, as assessed by the RAND 36-Item Short Form Health Survey (RAND SF-36), between the X39 patch and placebo. This questionnaire measures nine scales including physical functioning, role limitations due to physical health, role limitations due to emotional health, pain, general health, energy/fatigue, social functioning, emotional well-being, and health transition. The scores range from 0 to 100 where higher scores indicate a better state of health.
Measured: Baseline (day 0) to Day 8
Change in GHK-Cu levels from baseline to Day 2
Part 1. Change in GHK-Cu levels from baseline to Day 2
Measured: Baseline (Day 0) to Day 2
Change in GHK-Cu levels from baseline to Day 2 between the X39 patch and placebo
Part 2. Change in GHK-Cu levels from baseline to Day 2 between the X39 patch and placebo
Measured: Baseline (day 0) to Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study startJan 2027 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GHK and GHK-Cu Blood LevelsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part 1: Single-arm, open-label \& Part 2: Randomized, double-blind, placebo controlled, parallel
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LifeWave, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- David Crowley, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706361
- Sponsor's protocol ID
- 26LWCRL04
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-part Study Investigating the Effect of the X39 Patch on Circulating Blood Levels of GHK and GHK-Cu in a Healthy Adult Population
- ClinicalTrials.gov ID
- NCT07706361
- Acronym / sponsor ID
- 26LWCRL04
- Conditions
- GHK and GHK-Cu Blood Levels
- Keywords
- X39 patch, GHK, GHK-Cu
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- LifeWave, Inc.Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- Jan 2027 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to investigate GHK and GHK-Cu blood levels pre- and post-intervention in healthy adults, and to investigate the efficacy of X39 patch on GHK and GHK-Cu blood levels in healthy adults compared to a placebo. The main questions it aims to answer are:
- What is the change in GHK and GHK-Cu levels from baseline to Day 8?
- What is the difference in the change in GHK and GHK-Cu levels from baseline to Day 8 between the X39 patch and placebo? Researchers will compare X39 patches to placebo patches to evaluate their effects on circulating blood levels of GHK and GHK-Cu in healthy adults.
Participants will be asked to complete a questionnaire and use the X39 patch or placebo patch.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Part 1: Single-arm, open-label \& Part 2: Randomized, double-blind, placebo controlled, parallel
| Arm | Type | Receives |
|---|---|---|
| X39 Patch | Experimental | Device: X39 PatchBeginning on Day 1, participants will apply the patch daily until Day 7 or the day prior to their last study visit (Visit 3). Participants will apply the patch to the back of the neck (acupuncture point GV14) or directly below the belly button (acupuncture point CV6) on clean, dry skin first thing each morning and remove after approximately 12 hours later or before bed. |
| Placebo patch | Placebo comparator | Device: Placebo PatchBeginning on Day 1, participants will apply the patch daily until Day 7 or the day prior to their last study visit (Visit 3). Participants will apply the patch to the back of the neck (acupuncture point GV14) or directly below the belly button (acupuncture point CV6) on clean, dry skin first thing each morning and remove after approximately 12 hours later or before bed. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Males and females 35 years and older
- Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or,
- Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- Agrees to refrain from vigorous physical activity, alcohol consumption, and taking NSAIDs 24 hours prior to study visits
- Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study
Key exclusion criteria (25 listed)
- Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- Allergy or sensitivity to the adhesive used for wearing the investigational patch
- Self-reported tattoos, skin conditions, or sensitive skin at or around the area of application
- Diagnosis with Wilson's disease
- Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy of the investigational product (Sections 7.3.1 and 7.3.2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| X39 PatchBeginning on Day 1, participants will apply the patch daily until Day 7 or the day prior to their last study visit (Visit 3). Participants will apply the patch to the back of the neck (acupuncture point GV14) or directly below the belly button (acupuncture point CV6) on clean, dry skin first thing each morning and remove after approximately 12 hours later or before bed. | Device | X39 Patch |
| Placebo PatchBeginning on Day 1, participants will apply the patch daily until Day 7 or the day prior to their last study visit (Visit 3). Participants will apply the patch to the back of the neck (acupuncture point GV14) or directly below the belly button (acupuncture point CV6) on clean, dry skin first thing each morning and remove after approximately 12 hours later or before bed. | Device | Placebo patch |
Primary outcome
Change in GHK levels from baseline to Day 8
Time frame: Baseline (Day 0) to Day 8
Part 1. Change in GHK levels from baseline to Day 8
Change in GHK levels from baseline to Day 8 between the X39 patch and placebo
Time frame: Baseline (Day 0) to Day 8
Part 2. Change in GHK levels from baseline to Day 8 between the X39 patch and placebo
Change in GHK-Cu levels from baseline to Day 8
Time frame: Baseline (Day 0) to Day 8
Part 1. Change in GHK-Cu levels from baseline to Day 8
Change in GHK-Cu levels from baseline to Day 8 between the X39 patch and placebo
Time frame: Baseline (Day 0) to Day 8
Part 2. Change in GHK-Cu levels from baseline to Day 8 between the X39 patch and placebo
6 secondary outcomes
Change in GHK levels from baseline to Day 2
Time frame: Baseline (Day 0) to Day 2
Quality of Life, RAND SF-36
Time frame: Baseline (Day 0) to Day 8
Change in GHK levels from baseline to Day 2 between the X39 patch and placebo
Time frame: Baseline (day 0) to Day 2
Change in Quality of Life from Baseline to Days 2 and 8 (RAND 36-Item Short Form Health Survey - RAND SF-36) Between X39 Patch and Placebo
Time frame: Baseline (day 0) to Day 8
Change in GHK-Cu levels from baseline to Day 2
Time frame: Baseline (Day 0) to Day 2
Change in GHK-Cu levels from baseline to Day 2 between the X39 patch and placebo
Time frame: Baseline (day 0) to Day 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Crowley principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing X39 Patch in people with GHK and GHK-Cu Blood Levels, run by LifeWave, Inc. at 1 site in Canada.
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 14 inclusion and 25 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: opening soon, as of the sponsor's last update on 15 Jul 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 Canada. 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.
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 Erin Lewis, PhD (+248 1-226-242-4551, elewis@kgkscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in GHK levels from baseline to Day 8 (time frame: Baseline (Day 0) to Day 8). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2026.