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Overweight , ObesityPhase 4NCT07850466

TRPTI Metabolic and GLP-1 Pharmacodynamic Study

A Phase 4 study testing TRPTI in people with Overweight , Obesity, run by RDC Clinical Pty Ltd at 1 site in Australia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to assess whether TRPTI™ supplementation affects GLP-1 and related metabolic markers in generally healthy adults who are overweight or obese (BMI 25.0-34.9 kg/m², aged 30 years and older). Read more about this study

Who is it for?
Ages 30 years and olderHealthy volunteers can take part
Conditions the study is for
Overweight , Obesity
What is being tested?
TRPTI
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteAustralia
Study dates
Oct 2026to Oct 2027
Phase
Phase 4
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 30 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adults aged 30 years and older
  • Generally healthy
  • BMI 25.0-34.9 kg/m²
  • Able to provide informed consent
  • Agree to not participate in another clinical trial while enrolled in this trial
  • Agree not to change current diet and/or exercise frequency or intensity during entire study period
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  • Females using a prescribed form of birth control (e.g., oral contraceptive)
  • Participant's ability to participate fully and comply with demands of the study including attendance at all scheduled blood collection time points
  • Able to attend the clinic on all required days

Who cannot join

  • Have a serious illness e.g., neurological disorders such as MS, kidney disease, liver disease or heart conditions
  • History of any glucose or insulin regulation problem, including diabetes
  • Have an unstable illness e.g., thyroid gland dysfunction, uncontrolled mood disorders (e.g., depression, anxiety, bipolar)
  • Diagnosed with any known metabolic or endocrine dysfunctions e.g., diabetes, NAFLD, hyperinsulinaemia, hypoglycaemia
  • Use of any medication or supplements that may affect any metabolic pathway associated with satiety (e.g., GLP-1, GIP, glucagon), glucose or insulin
  • Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
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  • Significant change in diet in the past 1 month (e.g., removal of a food group or calorie restriction)
  • Active smokers, nicotine use or drug (prescription or illegal substances) abuse
  • Chronic past and/or current alcohol use (>21 alcoholic drinks/week)
  • Pregnant or lactating women
  • Allergic to any of the ingredients in active or placebo formula
  • Participants who are or who have participated in any other clinical trial during the past 1 month (excludes RDC clinical trials which are to be assessed on a case-by-case basis)
  • Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
  • Regular use within the past 4 weeks of supplements containing OEA and LipiSperse (TRPTITM)

Trial locations and contacts

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

David Briskey contact

+61(0)731024486

research@rdcglobal.com.au

Australia1 site

  • RDC Clinical

    Fortitude Valley, Queensland, 4006

    David Briskey, +61 (0) 731024486, research@rdcglobal.com.au

    David Briskey

Other trials in Australia

About this study

Official title: Short-term Effect of TRPTI Supplementation on GLP-1 and Related Metabolic Markers in Overweight or Obese Adults - a Double-blind, Randomised, Placebo-controlled, Two-arm Cross-over Study

The goal of this clinical trial is to assess whether TRPTI™ supplementation affects GLP-1 and related metabolic markers in generally healthy adults who are overweight or obese (BMI 25.0-34.9 kg/m², aged 30 years and older).

Researchers will compare TRPTI™ 150 mg to a matching placebo capsule to see if TRPTI™ produces a meaningful difference in GLP-1 response and associated metabolic and appetite-related markers over 8 hours.

Participants will attend two 9-hour clinic visits (crossover design, with a minimum 6-day washout between visits).

Being tested
TRPTI, Placebo
Keywords
metabolic markers, GLP-1
Medical subject headings
Overweight, Obesity

What participants receive

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

  • TRPTIDietary supplement

    Also called Oleoylethanolamide

    Participants will receive a single capsule of 150mg TRPTI

  • PlaceboOther

    Participants will receive a single capsule of placebo

Study groups in NCT07850466
Study groupRoleWhat they receive
TRPTIExperimentalParticipants will receive a single capsule of 150mg TRPTI
Receives: Dietary Supplement: TRPTI
PlaceboPlacebo comparatorParticipants will receive a single capsule of placebo
Receives: Other: Placebo

What is being measured

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

  1. Change from baseline in plasma GLP-1 concentration

    Change from baseline in plasma GLP-1 concentration at each individual post-dose time point (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3, 4, 5, 6, 7, and 8-hours post-dose). Comparing TRPTI 150 mg to placebo

    Measured: Baseline to 8hrs

Secondary outcomes (19)

  1. GLP-1 area under the curve (AUC)

    GLP-1 area under the curve (AUC) 0: total (0-8 h) and pre-defined blocks (0-15 min, 15 min-2 h, 2-4 h, 4-6 h, 6-8 h). Comparing TRPTI 150 mg to placebo

    Measured: Baseline to 8hrs

  2. Change from baseline at each individual time point for: GIP

    Change from baseline at each individual time point for: GIP

    Measured: Baseline to 8hrs

  3. Change from baseline at each individual time point for: DPP-4 (dipeptidyl peptidase-4)

    Change from baseline at each individual time point for: DPP-4 (dipeptidyl peptidase-4)

    Measured: Baseline to 8hrs

  4. Change from baseline at each individual time point for: glucose

    Change from baseline at each individual time point for: glucose

    Measured: Baseline to 8hrs

  5. Change from baseline at each individual time point for: insulin

    Change from baseline at each individual time point for: insulin

    Measured: Baseline to 8hrs

  6. AUC (total and blocks) for: GIP

    AUC (total and blocks) for: GIP

    Measured: Baseline to 8hrs

  7. AUC (total and blocks) for: DPP-4

    AUC (total and blocks) for: DPP-4

    Measured: Baseline to 8hrs

  8. AUC (total and blocks) for: glucose

    AUC (total and blocks) for: glucose

    Measured: Baseline to 8hrs

  9. AUC (total and blocks) for: insulin

    AUC (total and blocks) for: insulin

    Measured: Baseline to 8hrs

  10. Tmax for GLP-1

    Tmax for GLP-1

    Measured: Baseline to 8hrs

  11. Tmax for DPP-4

    Tmax for DPP-4

    Measured: Baseline to 8hrs

  12. Tmax for glucose

    Tmax for glucose

    Measured: Baseline to 8hrs

  13. Tmax for insulin

    Tmax for insulin

    Measured: Baseline to 8hrs

  14. Cmax for GLP-1

    Cmax for GLP-1

    Measured: Baseline to 8hrs

  15. Cmax for DPP-4

    Cmax for DPP-4

    Measured: Baseline to 8hrs

  16. Cmax for glucose

    Cmax for glucose

    Measured: Baseline to 8hrs

  17. Cmax for insulin

    Cmax for insulin

    Measured: Baseline to 8hrs

  18. Tolerability including GIT tolerance

    Tolerability including gastrointestinal (GIT) tolerance will be measured via a Gastronintestinal tolerance questionnaire and GIT adverse events.

    Measured: Baseline to 8 hours

  19. Safety via AE monitoring

    Safety via AE monitoring

    Measured: Baseline to 8 hours

Timeline

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

  1. First posted30 Sep 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionOct 2027 (estimated)
  4. Study completionOct 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 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07850466
Sponsor's protocol ID
TRP150
Status last verified
Sep 2026
First submitted
14 Sep 2026
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing TRPTI in people with Overweight , Obesity, 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 9 inclusion and 14 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 30 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 David Briskey (+61(0)731024486, research@rdcglobal.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in plasma GLP-1 concentration (time frame: Baseline to 8hrs). 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 NCT07850466.

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 30 Sep 2026.

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