Galectin 3Phase 2GalaxyNCT06398821
G3P-01 in Volunteers With Elevated Galectin-3
A Phase 2 study testing G3P-01 in people with Galectin 3 and Healthy Aging, run by General Practitioners Research Institute at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Galectin 3, Healthy Aging
- What is being tested?
- G3P-01
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Oct 2023to 30 May 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- G3P-01, Placebo
- Keywords
- Galectin 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G3P-01Dietary supplement
Nutritional supplement to promote healthy aging
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo for 30 days Receives: Dietary Supplement: Placebo |
| G3P-01 100mg | Active comparator | G3P-01 100mg daily for 30 days Receives: Dietary Supplement: G3P-01 |
| G3P-01 250mg | Active comparator | G3P-01 250mg daily for 30 days Receives: Dietary Supplement: G3P-01 |
| G3P-01 1000mg | Active comparator | G3P-01 1000mg daily for 30 days Receives: Dietary Supplement: G3P-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 months
To evaluate tolerability of G3P-01
Changes in the Gastrointestinal Symptom Rating Scale (1 means no symptoms, 7 means symptoms)
Measured: 4 months
To evaluate tolerability of G3P-01
Number of participants with abnormal laboratory tests results
Measured: 4 months
To evaluate tolerability of G3P-01
Number of participants with abnormal physical examination findings
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start18 Oct 2023
- Primary completion16 Apr 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Galectin 3Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Practitioners Research Institute
- Sponsor type
- Research network
- Collaborators
- G3 Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- J WH Kocks, MD, PhD, Principal investigator, General Practitioners Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398821
- Sponsor's protocol ID
- GPRI-23001-G3P
- Acronym
- Galaxy
- Status last verified
- Apr 2024
- First submitted
- 23 Aug 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06398821
- Acronym / sponsor ID
- Galaxy / GPRI-23001-G3P
- Conditions
- Galectin 3, Healthy Aging
- Keywords
- Galectin 3
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- General Practitioners Research InstituteResearch network
- Collaborators
- G3 Pharmaceuticals
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 16 Apr 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo for 30 days |
| G3P-01 100mg | Active comparator | Dietary Supplement: G3P-01G3P-01 100mg daily for 30 days |
| G3P-01 250mg | Active comparator | Dietary Supplement: G3P-01G3P-01 250mg daily for 30 days |
| G3P-01 1000mg | Active comparator | Dietary Supplement: G3P-01G3P-01 1000mg daily for 30 days |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G3P-01Nutritional supplement to promote healthy aging | Dietary supplement | G3P-01 1000mg, G3P-01 100mg, G3P-01 250mg |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
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
To evaluate tolerability of G3P-01
Time frame: 4 months
Changes in the Gastrointestinal Symptom Rating Scale (1 means no symptoms, 7 means symptoms)
To evaluate tolerability of G3P-01
Time frame: 4 months
Number of participants with abnormal laboratory tests results
To evaluate tolerability of G3P-01
Time frame: 4 months
Number of participants with abnormal physical examination findings
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J WH Kocks, MD, PhD principal investigator
General Practitioners Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing G3P-01 in people with Galectin 3 and Healthy Aging, run by General Practitioners Research Institute at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate target engagement attributable to G3P-01 use in volunteers with elevated galectin-3 (≥ 16.0ng/mL) (time frame: 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.