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Not yet recruitingNCT07850466Updated Sep 30, 2026

TRPTI Metabolic and GLP-1 Pharmacodynamic Study

A Phase 4 interventional study of TRPTI and Placebo in Overweight , Obesity, sponsored by RDC Clinical Pty Ltd. Not yet recruiting at 1 site in Australia. Open to participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by RDC Clinical Pty Ltd · Phase 4, Interventional, and Other

Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
30 Years and older
Sex
All
01

Study 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).

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).

02

Conditions studied

  • Overweight , Obesity

Keywords

  • metabolic markers
  • GLP-1
03

Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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)
04

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    TRPTI

    Participants will receive a single capsule of 150mg TRPTI

    Dietary Supplement: TRPTI

  • Placebo comparator
    Placebo

    Participants will receive a single capsule of placebo

    Other: Placebo

Interventions

  • Dietary supplementTRPTI

    Participants will receive a single capsule of 150mg TRPTI

    Also known as: Oleoylethanolamide

  • OtherPlacebo

    Participants will receive a single capsule of placebo

05

What researchers measure

Primary outcomes

  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

    Time frame: Baseline to 8hrs

Secondary outcomes

  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

    Time frame: Baseline to 8hrs

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

    Change from baseline at each individual time point for: GIP

    Time frame: 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)

    Time frame: Baseline to 8hrs

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

    Change from baseline at each individual time point for: glucose

    Time frame: Baseline to 8hrs

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

    Change from baseline at each individual time point for: insulin

    Time frame: Baseline to 8hrs

  6. AUC (total and blocks) for: GIP

    AUC (total and blocks) for: GIP

    Time frame: Baseline to 8hrs

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

    AUC (total and blocks) for: DPP-4

    Time frame: Baseline to 8hrs

  8. AUC (total and blocks) for: glucose

    AUC (total and blocks) for: glucose

    Time frame: Baseline to 8hrs

  9. AUC (total and blocks) for: insulin

    AUC (total and blocks) for: insulin

    Time frame: Baseline to 8hrs

  10. Tmax for GLP-1

    Tmax for GLP-1

    Time frame: Baseline to 8hrs

  11. Tmax for DPP-4

    Tmax for DPP-4

    Time frame: Baseline to 8hrs

  12. Tmax for glucose

    Tmax for glucose

    Time frame: Baseline to 8hrs

  13. Tmax for insulin

    Tmax for insulin

    Time frame: Baseline to 8hrs

  14. Cmax for GLP-1

    Cmax for GLP-1

    Time frame: Baseline to 8hrs

  15. Cmax for DPP-4

    Cmax for DPP-4

    Time frame: Baseline to 8hrs

  16. Cmax for glucose

    Cmax for glucose

    Time frame: Baseline to 8hrs

  17. Cmax for insulin

    Cmax for insulin

    Time frame: 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.

    Time frame: Baseline to 8 hours

  19. Safety via AE monitoring

    Safety via AE monitoring

    Time frame: Baseline to 8 hours

Other outcomes

  1. Exploratory: Change from baseline at each individual time point for glucagon

    Exploratory: Change from baseline at each individual time point for glucagon

    Time frame: Baseline to 8 hours

  2. Exploratory: Change from baseline at each individual time point for PYY (peptide YY)

    Exploratory: Change from baseline at each individual time point for PYY (peptide YY)

    Time frame: Baseline to 8 hours

  3. Exploratory: AUC (total and blocks) for glucagon

    AUC (total and blocks) for glucagon

    Time frame: Baseline to 8 hours

  4. Exploratory: AUC (total and blocks) for PYY

    AUC (total and blocks) for PYY

    Time frame: Baseline to 8 hours

  5. Exploratory: Tmax for glucagon

    Tmax for glucagon

    Time frame: Baseline to 8 hours

  6. Exploratory: Tmax for PYY

    Tmax for PYY

    Time frame: Baseline to 8 hours

  7. Exploratory: Cmax for glucagon

    Tmax for glucagon

    Time frame: Baseline to 8 hours

  8. Exploratory: Cmax for PYY

    Tmax for PYY

    Time frame: Baseline to 8 hours

  9. Exploratory: Visual analogue scale (VAS) for appetite

    VAS for appetite

    Time frame: Baseline to 8hrs

  10. Exploratory: Food consumption during time in clinic

    Food consumption during time in clinic

    Time frame: Baseline to 8 hours

  11. Exploratory: E/LFT

    Blood sample taken for E/LFT

    Time frame: Baseline to 8 hours

  12. Exploratory: Subgroup analysis by BMI stratum

    Subgroup analysis by BMI stratum (BMI 25.0-29.9 vs BMI 30.0-34.9).

    Time frame: Baseline

06

Study locations

1 site
  • RDC Clinical
    Fortitude Valley, Queensland 4006, Australia
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07850466
Lead sponsor
RDC Clinical Pty Ltd
Collaborators
Gencor Pacific Limited, Hong Kong
Responsible party
Sponsor
First posted
Sep 30, 2026
Start date
Oct 2026 (estimated)
Primary completion
Oct 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Sep 30, 2026

Study contacts

David Briskey
Contact
research@rdcglobal.com.au
+61(0)731024486
RV Venkatesh
study director · Gencor Pacific

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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