TRPTI Metabolic and GLP-1 Pharmacodynamic Study

NCT07850466 | Not Yet Recruiting Phase 4

• 1 other identifier: TRP150
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Overweight , Obesity

Keywords

metabolic markers; GLP-1

Outcome Measures

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

  Baseline to 8hrs

Secondary Outcomes (19)

• GLP-1 area under the curve (AUC)

  Baseline to 8hrs

• Change from baseline at each individual time point for: GIP

  Baseline to 8hrs

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

  Baseline to 8hrs

• Change from baseline at each individual time point for: glucose

  Baseline to 8hrs

• Change from baseline at each individual time point for: insulin

  Baseline to 8hrs

Other Outcomes (12)

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

  Baseline to 8 hours

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

  Baseline to 8 hours

• Exploratory: AUC (total and blocks) for glucagon

  Baseline to 8 hours

Study Arms (2)

TRPTI

EXPERIMENTAL

Participants will receive a single capsule of 150mg TRPTI

Dietary Supplement: TRPTI

Placebo

PLACEBO COMPARATOR

Participants will receive a single capsule of placebo

Other: Placebo

Interventions

TRPTI DIETARY_SUPPLEMENT

Participants will receive a single capsule of 150mg TRPTI

Also known as: Oleoylethanolamide

TRPTI

Placebo OTHER

Participants will receive a single capsule of placebo

Placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Regular use within the past 4 weeks of supplements containing OEA and LipiSperse (TRPTITM)

Sponsors & Collaborators

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

Study Sites (1)

RDC Clinical

Fortitude Valley, Queensland, 4006, Australia

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

oleoylethanolamide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• RV Venkatesh

  Gencor Pacific

  STUDY DIRECTOR

Central Study Contacts

David Briskey

CONTACT

+61(0)731024486; research@rdcglobal.com.au

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 30, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09

Locations

AU (1)