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Completed

NCT Number: NCT06398821

G3P-01 in Volunteers With Elevated Galectin-3

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).

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Key information

Conditions

Galectin 3 Healthy Aging

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

General Practitioners Research Institute

Groningen, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

G3P-01

Dietary Supplement

Nutritional supplement to promote healthy aging

Placebo

Dietary Supplement

Placebo

Primary outcomes

  1. To evaluate target engagement attributable to G3P-01 use in volunteers with elevated galectin-3 (≥ 16.0ng/mL)

    Time frame: 4 months

    Change from baseline of pathway markers consistent with galectin-3 inhibition (dose-response effect) measured by proteomics

  2. To evaluate tolerability of G3P-01

    Time frame: 4 months

    Changes in the Gastrointestinal Symptom Rating Scale (1 means no symptoms, 7 means symptoms)

  3. To evaluate tolerability of G3P-01

    Time frame: 4 months

    Number of participants with abnormal laboratory tests results

  4. To evaluate tolerability of G3P-01

    Time frame: 4 months

    Number of participants with abnormal physical examination findings

Sponsors and collaborators

Lead sponsor

General Practitioners Research Institute

Network

Collaborators

  • G3 Pharmaceuticals

Registry information

Official study title

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

Acronym: Galaxy

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 3, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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