G3P-01 in Volunteers With Elevated Galectin-3

Healthy Aging Clinical Trial

— Galaxy  

Official 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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06398821
• Other study ID #: GPRI-23001-G3P
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: October 18, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: April 2024
• Source: General Practitioners Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 48
• Est. completion date: May 30, 2024
• Est. primary completion date: April 16, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Aging

Intervention

Dietary Supplement:
• G3P-01
Nutritional supplement to promote healthy aging
• Placebo
Placebo

Locations

Country	Name	City	State
Netherlands	General Practitioners Research Institute	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
General Practitioners Research Institute	G3 Pharmaceuticals

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	To evaluate tolerability of G3P-01	Changes in the Gastrointestinal Symptom Rating Scale (1 means no symptoms, 7 means symptoms)	4 months
Primary	To evaluate tolerability of G3P-01	Number of participants with abnormal laboratory tests results	4 months
Primary	To evaluate tolerability of G3P-01	Number of participants with abnormal physical examination findings	4 months