G3P-01 in Volunteers With Elevated Galectin-3 (Galaxy)

A Dose Ranging Target Engagement Study of a Food-Grade Pectic Food Supplement (G3P-01) in Volunteers With Elevated Levels of Galectin-3 - the Galaxy Study

G3P-01 is an investigational pectin extracted, enriched and purified from commercial squash puree intended for human consumption. Pectins are an important constituent of fruits and vegetables, and health benefits are attributed to its intake. Some of the health benefits of pectins are attributed to inhibition of galectin-3. This study investigates if 30-days of G3P-01 intake in individuals with elevated galectin-3 induces biomarker changes that can be attributed to target engagement. Participants will be randomized into four groups (placebo, 100mg, 250mg and 1000mg G3P-01).

Study Overview

• Status: Completed
• Conditions: Healthy Aging; Galectin 3
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: G3P-01

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands
    • General Practitioners Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Invited through cohort study.
• Plasma galectin-3 level of 16 ng/mL or higher
• Male and female subjects ≥45 and ≤75 years of age
• Females will be non-pregnant, non-lactating, and have no intent to become pregnant during the study period.
• Able to participate in the study in the opinion of the Investigator.
• Has the ability to understand the requirements of the study and is willing to comply with all study procedures.
• An Independent Ethics Committee or in Dutch Medisch- Ethische Toetsingscommissie (METC) -approved informed consent is signed and dated prior to any study-related activities.

Exclusion Criteria:

• Existing clinically significant concurrent medical condition which in the opinion of the Investigator may interfere with the study.
• Clinically significant abnormal laboratory test values, as determined by the Investigator, at Screening.
• Participation in a clinical trial of an investigational drug within 30 days prior to Screening, or is currently participating in another trial of an investigational drug, supplement or device.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo for 30 days	Dietary supplement: Placebo; Placebo
Active Comparator: G3P-01 100mg; G3P-01 100mg daily for 30 days	Dietary supplement: G3P-01; Nutritional supplement to promote healthy aging
Active Comparator: G3P-01 250mg; G3P-01 250mg daily for 30 days	Dietary supplement: G3P-01; Nutritional supplement to promote healthy aging
Active Comparator: G3P-01 1000mg; G3P-01 1000mg daily for 30 days	Dietary supplement: G3P-01; Nutritional supplement to promote healthy aging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate target engagement attributable to G3P-01 use in volunteers with elevated galectin-3 (≥ 16.0ng/mL)	Change from baseline of pathway markers consistent with galectin-3 inhibition (dose-response effect) measured by proteomics	4 months
To evaluate tolerability of G3P-01	Changes in the Gastrointestinal Symptom Rating Scale (1 means no symptoms, 7 means symptoms)	4 months
To evaluate tolerability of G3P-01	Number of participants with abnormal laboratory tests results	4 months
To evaluate tolerability of G3P-01	Number of participants with abnormal physical examination findings	4 months

Collaborators and Investigators

• Sponsor: General Practitioners Research Institute
• Collaborators: G3 Pharmaceuticals
• Investigators: Principal Investigator: J WH Kocks, MD, PhD, General Practitioners Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2023
• Primary Completion (Actual): April 16, 2024
• Study Completion (Actual): May 30, 2024

Study Registration Dates

• First Submitted: August 23, 2023
• First Submitted That Met QC Criteria: April 30, 2024
• First Posted (Actual): May 3, 2024

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Galectin 3
• Other Study ID Numbers: GPRI-23001-G3P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No