HealthyPhase 2NCT06717867
Long-Term PEA Safety Study
A Phase 2 study testing Palmitoylethanolamide (PEA) in people with Healthy and Safety, run by RDC Clinical Pty Ltd at 1 site in Australia.
Trial summary
The goal of this clinical trial is to learn about the long term safety of PEA supplementation in healthy adults. This clinical trial will be in both males and females who are 18 years or older and are healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Palmitoylethanolamide (PEA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteAustralia
- Study dates
- 22 Jan 2025to Aug 2027
- Phase
- Phase 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (18 years and older)
- Generally healthy
- Able to provide informed consent
- BMI 18.5 - 35.0 kg/m2
- Agree to not participate in another clinical trial during enrolment period
Who cannot join
- Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
- Serious illness e.g., mood disorders (such as depression or bipolar disorder), anxiety, neurological disorders (such as MS), kidney disease, liver disease or heart conditions
- Unstable illness (e.g., diabetes and thyroid gland dysfunction)
- History of renal function impairment
- Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy [(excluding low dose aspirin (under 300 mg/day)]
- Regular consumption (>4 times a week) of PEA over the past 2 weeks
Show all 13Show fewer
- Substance Abuse (illicit and/or prescription) Drug (prescription or illegal substances) abuse
- Chronic past (within 12-months) and/or current alcohol use (>14 alcoholic drinks week)
- Pregnant or lactating women
- Allergic, sensitive, or intolerant to any of the ingredients in active or placebo formula
- Has a clinically significant abnormal finding on the medical assessment, medical history, or clinical laboratory results at screening.
- Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month.
- Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind Placebo-controlled Study in Healthy Adults to Assess Long Term Population Exposure to Palmitoylethanolamide (Levagen™) to Assess Clinical Safety.
The goal of this clinical trial is to learn about the long term safety of PEA supplementation in healthy adults. This clinical trial will be in both males and females who are 18 years or older and are healthy volunteers.
The main aim of the study is to assess the safety of long-term use of PEA by assessing the difference between the two groups for serious adverse events, non-serious adverse events, vital signs and biochemistry following 12 months of PEA supplementation.
Read more
Participants will:
- Have their suitability for the study checked against the full inclusion/exclusion criteria during the screening process.
- Eligible participants will then complete a baseline visit where assessments will be performed and the participant will be randomly assigned to receive the study product or a placebo. Participants will then consume their assigned study product every day for 12 months. Participants will not know what product they have been assigned during the study.
- Following the baseline visit, there will be 4 visits over 12 months. On months where participants do not have a visit there will be a check in phone call.
- During visits there will be safety assessments performed, blood sampling and questionnaires.
The trial will include two participation modes:
- In-clinic participation (Brisbane): Participants will attend all visits in-person at the RDC Clinical facility.
- Remote participation for participants outside of Brisbane: A subgroup of up to 120 participants will participate remotely with virtual visits and at-home assessments. Participants will attend their local pathology centre for blood sampling.
Read the detailed description
This is an interventional, phase II, randomised, double-blind, placebo-controlled, parallel dose safety study in healthy adults to assess long term population exposure to Palmitoylethanolamide (Levagen™).
- Being tested
- Palmitoylethanolamide (PEA), Placebo
- Keywords
- Palmitoylethanolamide, PEA, Levagen, PEA Safety study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palmitoylethanolamide (PEA)Dietary supplement
Also called Levagen™
Levagen™ capsule containing 300mg Palmitoylethanolamide (PEA). 600mg PEA per day.
PlaceboOther
Placebo capsules contain 300 mg microcrystalline cellulose (MCC), 600mg per day.
| Study group | Role | What they receive |
|---|---|---|
| PEA (Levagen) | Experimental | 600mg PEA each day. 1 oral capsule is taken twice per day after food, each capsule contains 300mg. Receives: Dietary Supplement: Palmitoylethanolamide (PEA) |
| Placebo | Placebo comparator | 600mg microcrystalline cellulose a day. 1 oral capsule is taken twice per day after food, each capsule contains 300mg. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to the end of the study period in participants with SAEs
Change from baseline to the end of the study period in:
Number of participants with Serious Adverse Events (SAE) after first administration of study drug through to the last dose of study drug plus 2 weeks [time frame: after first administration of study drug through to the last dose of study drug (12 months) plus 2 weeks (week 54)]
Measured: From Day O (Baseline) to 54 weeks
Secondary outcomes (16)
Change from baseline to month 12 in AEs
Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in all adverse events (AEs)
Measured: Baseline (Day 0) to month 12.
Change from baseline to month 12 in medical assessment
Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by Medical assessment (by a doctor).
The Medical Assessment is a medical review to elucidate symptoms of any occult medical conditions will be conducted for all participants and a medical assessment will then be performed. The assessment will include a review of vital signs and measurements, general appearance, brief cranial nerve assessment, cardiovascular, gastrointestinal and respiratory assessments. Other body systems will be examined (e.g. neurological, renal, musculoskeletal, ear, nose and throat or skin) as is deemed necessary by the trial doctor as guided by the medical review.
Measured: Baseline (day 0) and Month 12
Change from baseline to month 12 in Vital Signs (blood pressure)
Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by blood pressure (mmHg).
Measured: Baseline (Day 0) to month 12.
Change from baseline to month 12 in Vital Signs (heart rate)
Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by heart rate (bpm).
Measured: Baseline (Day 0) to month 12.
Change from baseline to month 12 in clinical laboratory determinations (Full Blood Count)
Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by Full Blood Count (FBC).
Measured: Baseline (Day 0) to month 12.
Change from baseline to month 12 in clinical laboratory determinations (fasting glucose)
Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by fasting glucose.
Measured: Baseline (Day 0) to month 12.
Change from baseline to month 12 in clinical laboratory determinations (insulin)
Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by insulin.
Measured: Baseline (Day 0) to month 12.
Change from baseline to month 12 in clinical laboratory determinations (lipids).
Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by lipids.
Measured: Baseline (Day 0) to month 12.
Change from baseline to month 12 in clinical laboratory determinations (electrolytes)
Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by electrolytes.
Measured: Baseline (Day 0) to month 12.
Change from baseline to month 12 in clinical laboratory determinations (kidney function tests)
Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by kidney function tests.
Measured: Baseline (Day 0) to month 12.
Change from baseline to month 12 in clinical laboratory determinations (Liver function tests)
Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by liver function tests.
Measured: Baseline (Day 0) to month 12.
Change from baseline to month 12 in sleep questionnaires.
Change from baseline (Day 0) to the end of the study period (month 12) in safety monitored by Leeds sleep evaluation questionnaire (LSEQ).
Each domain of the LSEQ is scored using a visual analogue scale (VAS) where participants mark their response on a line ranging from 0 to 100.
Higher scores indicate better sleep quality or easier sleep-related behaviors in the respective domain. Lower scores indicate poorer sleep quality or more difficulty in the respective domain.
Measured: Baseline (Day 0) to month 12.
Change from baseline to month 12 in anxiety questionnaires
Change from baseline (Day 0) to the end of the study period (month 12) in safety monitored by Anxiety questionnaires (Beck Anxiety Inventory Scale). Scores from 0 to 63, a score of 0-21 indicates low anxiety whereas a score of 36 and above indicates potentially concerning levels of anxiety.
Measured: Baseline (Day 0) to month 12.
Change from baseline to month 12 in Quality of life
Change from baseline (Day 0) to the end of the study period (month 12) in safety monitored by Quality of life (RAND 36-Item Short Form Survey Instrument, Rand SF-36).
Measured: Baseline (Day 0) to month 12.
Change from baseline to month 12 in Musculoskeletal health questionnaire
Change from baseline (Day 0) to the end of the study period (month 12) in safety monitored by Musculoskeletal health questionnaire (MSK-HQ). MSK-HQ is scored on a range of 0-56, with a better score indicating better MSK-HQ health status.
Measured: Baseline (Day 0) to month 12.
Change from baseline to month 12 in Gastrointestinal tolerance questionnaire
Change from baseline (Day 0) to the end of the study period (month 12) in safety monitored by Gastrointestinal tolerance questionnaire
Measured: Baseline (Day 0) to month 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start22 Jan 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RDC Clinical Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gencor Pacific Limited, Hong Kong
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717867
- Sponsor's protocol ID
- LEVESS
- Status last verified
- Dec 2025
- First submitted
- 21 Nov 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind Placebo-controlled Study in Healthy Adults to Assess Long Term Population Exposure to Palmitoylethanolamide (Levagen™) to Assess Clinical Safety.
- ClinicalTrials.gov ID
- NCT06717867
- Acronym / sponsor ID
- LEVESS
- Keywords
- Palmitoylethanolamide, PEA, Levagen, PEA Safety study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- RDC Clinical Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Gencor Pacific Limited, Hong Kong
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 5 Dec 2024 (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 learn about the long term safety of PEA supplementation in healthy adults. This clinical trial will be in both males and females who are 18 years or older and are healthy volunteers.
The main aim of the study is to assess the safety of long-term use of PEA by assessing the difference between the two groups for serious adverse events, non-serious adverse events, vital signs and biochemistry following 12 months of PEA supplementation.
Participants will:
- Have their suitability for the study checked against the full inclusion/exclusion criteria during the screening process.
- Eligible participants will then complete a baseline visit where assessments will be performed and the participant will be randomly assigned to receive the study product or a placebo. Participants will then consume their assigned study product every day for 12 months. Participants will not know what product they have been assigned during the study.
- Following the baseline visit, there will be 4 visits over 12 months. On months where participants do not have a visit there will be a check in phone call.
- During visits there will be safety assessments performed, blood sampling and questionnaires.
The trial will include two participation modes:
- In-clinic participation (Brisbane): Participants will attend all visits in-person at the RDC Clinical facility.
- Remote participation for participants outside of Brisbane: A subgroup of up to 120 participants will participate remotely with virtual visits and at-home assessments. Participants will attend their local pathology centre for blood sampling.
Detailed description
This is an interventional, phase II, randomised, double-blind, placebo-controlled, parallel dose safety study in healthy adults to assess long term population exposure to Palmitoylethanolamide (Levagen™).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEA (Levagen) | Experimental | Dietary Supplement: Palmitoylethanolamide (PEA)600mg PEA each day. 1 oral capsule is taken twice per day after food, each capsule contains 300mg. |
| Placebo | Placebo comparator | Other: Placebo600mg microcrystalline cellulose a day. 1 oral capsule is taken twice per day after food, each capsule contains 300mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults (18 years and older)
- Generally healthy
- Able to provide informed consent
- BMI 18.5 - 35.0 kg/m2
- Agree to not participate in another clinical trial during enrolment period
Key exclusion criteria (13 listed)
- Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
- Serious illness e.g., mood disorders (such as depression or bipolar disorder), anxiety, neurological disorders (such as MS), kidney disease, liver disease or heart conditions
- Unstable illness (e.g., diabetes and thyroid gland dysfunction)
- History of renal function impairment
- Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy [(excluding low dose aspirin (under 300 mg/day)]
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 |
|---|---|---|
| Palmitoylethanolamide (PEA)Also: Levagen™Levagen™ capsule containing 300mg Palmitoylethanolamide (PEA). 600mg PEA per day. | Dietary supplement | PEA (Levagen) |
| PlaceboPlacebo capsules contain 300 mg microcrystalline cellulose (MCC), 600mg per day. | Other | Placebo |
Primary outcome
Change from baseline to the end of the study period in participants with SAEs
Time frame: From Day O (Baseline) to 54 weeks
Change from baseline to the end of the study period in: Number of participants with Serious Adverse Events (SAE) after first administration of study drug through to the last dose of study drug plus 2 weeks [time frame: after first administration of study drug through to the last dose of study drug (12 months) plus 2 weeks (week 54)]
16 secondary outcomes
Change from baseline to month 12 in AEs
Time frame: Baseline (Day 0) to month 12.
Change from baseline to month 12 in medical assessment
Time frame: Baseline (day 0) and Month 12
Change from baseline to month 12 in Vital Signs (blood pressure)
Time frame: Baseline (Day 0) to month 12.
Change from baseline to month 12 in Vital Signs (heart rate)
Time frame: Baseline (Day 0) to month 12.
Change from baseline to month 12 in clinical laboratory determinations (Full Blood Count)
Time frame: Baseline (Day 0) to month 12.
Change from baseline to month 12 in clinical laboratory determinations (fasting glucose)
Time frame: Baseline (Day 0) to month 12.
Change from baseline to month 12 in clinical laboratory determinations (insulin)
Time frame: Baseline (Day 0) to month 12.
Change from baseline to month 12 in clinical laboratory determinations (lipids).
Time frame: Baseline (Day 0) to month 12.
Change from baseline to month 12 in clinical laboratory determinations (electrolytes)
Time frame: Baseline (Day 0) to month 12.
Change from baseline to month 12 in clinical laboratory determinations (kidney function tests)
Time frame: Baseline (Day 0) to month 12.
Change from baseline to month 12 in clinical laboratory determinations (Liver function tests)
Time frame: Baseline (Day 0) to month 12.
Change from baseline to month 12 in sleep questionnaires.
Time frame: Baseline (Day 0) to month 12.
Change from baseline to month 12 in anxiety questionnaires
Time frame: Baseline (Day 0) to month 12.
Change from baseline to month 12 in Quality of life
Time frame: Baseline (Day 0) to month 12.
Change from baseline to month 12 in Musculoskeletal health questionnaire
Time frame: Baseline (Day 0) to month 12.
Change from baseline to month 12 in Gastrointestinal tolerance questionnaire
Time frame: Baseline (Day 0) to month 12.
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 9 Sep 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Palmitoylethanolamide (PEA) in people with Healthy and Safety, run by RDC Clinical Pty Ltd at 1 site in Australia.
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 5 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 9 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 Australia. 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 phase mean?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to the end of the study period in participants with SAEs (time frame: From Day O (Baseline) to 54 weeks). 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 9 Sep 2026.