G3P-01 in Volunteers With Elevated Galectin-3

NCT06398821 | Completed Phase 2

• 1 other identifier: GPRI-23001-G3P
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Galectin 3; Healthy Aging

Keywords

Galectin 3

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo for 30 days

Dietary Supplement: Placebo

G3P-01 100mg

ACTIVE COMPARATOR

G3P-01 100mg daily for 30 days

Dietary Supplement: G3P-01

G3P-01 250mg

ACTIVE COMPARATOR

G3P-01 250mg daily for 30 days

Dietary Supplement: G3P-01

G3P-01 1000mg

ACTIVE COMPARATOR

G3P-01 1000mg daily for 30 days

Dietary Supplement: G3P-01

Interventions

G3P-01 DIETARY_SUPPLEMENT

Nutritional supplement to promote healthy aging

G3P-01 1000mg; G3P-01 100mg; G3P-01 250mg

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Practitioners Research Institute: lead
• G3 Pharmaceuticals: collaborator

Study Sites (1)

General Practitioners Research Institute

Groningen, Netherlands

Location

Study Officials

• J WH Kocks, MD, PhD

  General Practitioners Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: May 3, 2024
• Study Start: October 18, 2023
• Primary Completion: April 16, 2024
• Study Completion: May 30, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)