Long-Term PEA Safety Study

NCT06717867 | Recruiting Phase 2

• 1 other identifier: LEVESS
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy; Safety

Keywords

Palmitoylethanolamide; PEA; Levagen; PEA Safety study

Outcome Measures

Primary Outcomes (1)

• 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 \[time frame: after first administration of study drug through to the last dose of study drug (12 months) plus 2 weeks (week 54)\]

  From Day O (Baseline) to 54 weeks

Secondary Outcomes (16)

• Change from baseline to month 12 in AEs

  Baseline (Day 0) to month 12.

• Change from baseline to month 12 in medical assessment

  Baseline (day 0) and Month 12

• Change from baseline to month 12 in Vital Signs (blood pressure)

  Baseline (Day 0) to month 12.

• Change from baseline to month 12 in Vital Signs (heart rate)

  Baseline (Day 0) to month 12.

• Change from baseline to month 12 in clinical laboratory determinations (Full Blood Count)

  Baseline (Day 0) to month 12.

Other Outcomes (4)

• Exploratory: Change from baseline to month 12 in Vital Signs (temperature)

  Baseline (Day 0) to month 12.

• Exploratory: Change from baseline to month 12 in Vital Signs (O2 saturation)

  Baseline (Day 0) to month 12.

• Exploratory: Change from baseline to month 12 in PEA

  Baseline (Day 0) to month 12.

Study Arms (2)

PEA (Levagen)

EXPERIMENTAL

600mg PEA each day. 1 oral capsule is taken twice per day after food, each capsule contains 300mg.

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.

Other: Placebo

Interventions

Placebo OTHER

Placebo capsules contain 300 mg microcrystalline cellulose (MCC), 600mg per day.

Placebo

Palmitoylethanolamide (PEA) DIETARY_SUPPLEMENT

Levagen™ capsule containing 300mg Palmitoylethanolamide (PEA). 600mg PEA per day.

Also known as: Levagen™

PEA (Levagen)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male and Female cisgender
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• RDC Clinical Pty Ltd: lead
• Gencor Pacific Limited, Hong Kong: collaborator

Study Sites (1)

RDC Clinical

Brisbane, Queensland, 4006, Australia

RECRUITING

MeSH Terms

Interventions

palmidrol

Central Study Contacts

RV Venkatesh

CONTACT

(852) 2987 6894; venkat@gencorpacific.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: December 5, 2024
• Study Start: January 22, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)