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Prediabetes / Type 2 DiabetesNCT07195994

A Clinical Trial to Examine the Efficacy and Safety of an Investigational Product With and Without Use of Semaglutide on Glycemic Response in Adults With Prediabetes or Type 2 Diabetes

A study testing AMPK Charge+® and AMPK Charge+® with semaglutide in people with Prediabetes / Type 2 Diabetes, run by QuickSilver Scientific at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a randomized, single-blind, controlled, parallel clinical trial to examine the efficacy and safety of AMPK Charge+® with and without use of semaglutide on glycemic response in adults with prediabetes or Type 2 Diabetes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Prediabetes / Type 2 Diabetes
What is being tested?
AMPK Charge+® and AMPK Charge+® with semaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteCanada
Study dates
5 Feb 2026to Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males \& females between 18 years of age or older
  • Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening
  • Or,
  • Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
  • Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
  • Double-barrier method
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  • Intrauterine devices
  • Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
  • Vasectomy of partner at least 6 months prior to screening
  • Abstinence and agrees to use contraception if becomes sexually active during this study
  • Individuals eligible for, but not currently taking, semaglutide therapy as per standard-of-care including adults with:
  • Prediabetes (HbA1c 6.0-6.5%) who are treatment naïve
  • Type 2 Diabetes (HbA1c 6.5-7.5%) who are treatment naïve and metformin is inappropriate due to contraindication or intolerance
  • Self-reported stable body weight defined as not having gained or lost more than 5 kg of body weight in the three months prior to baseline
  • Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, sleep, use of nicotine, tobacco and cannabinoid products) as much as possible throughout the study
  • Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits
  • Provided voluntary, written, informed consent to participate in the study

Who cannot join

  • Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
  • Allergy, sensitivity, intolerance, or dietary restriction preventing use of study products
  • Personal or family history of MTC or in patients with MEN 2
  • Unstable metabolic disease or chronic diseases as assessed by the QI
  • Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
  • Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 7.3)
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  • Type I diabetes or diabetic ketoacidosis
  • Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
  • History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
  • Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
  • Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
  • Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
  • Individuals with an autoimmune disease or are immune compromised
  • Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
  • Self-reported confirmation of blood/bleeding disorders as assessed by the QI
  • Alcohol intake average of >2 standard drinks per day as assessed by the QI
  • Alcohol or drug abuse within the last 12 months
  • Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy and/or safety of the study products (See Section 7.3)
  • Clinically significant abnormal laboratory results at screening as assessed by the QI
  • Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
  • Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
  • Individuals who are unable to give informed consent
  • Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Marc Moulin, PhD contact

2267819094

mmoulin@kgkscience.com

Canada1 site, 1 recruiting
  • KGK Science Inc.

    London, Ontario, N6B3L1

    Marc Moulin, PhD, +12267819094;ext=300, mmoulin@kgkscience.com

    bhallam@kgkscience.com

    Recruiting

Other trials in Canada

About this study

Official title: A Randomized, Single-blind, Controlled, Parallel Clinical Trial to Examine the Efficacy and Safety of an Investigational Product With and Without Use of Semaglutide on Glycemic Response in Adults With Prediabetes or Type 2 Diabetes

This is a randomized, single-blind, controlled, parallel clinical trial to examine the efficacy and safety of AMPK Charge+® with and without use of semaglutide on glycemic response in adults with prediabetes or Type 2 Diabetes. The main question it aims to answer is:

What is the difference in change in fasting blood glucose and insulin, and hemoglobin A1c (HbA1c) from baseline at Day 84 between AMPK Charge+® and AMPK Charge+® with semaglutide?

Participants will consume AMPK Charge+® with or without semaglutide injections and will be evaluated for glycemic response parameters.

Being tested
AMPK Charge+®, AMPK Charge+® with semaglutide
Keywords
Prediabetes, AMPK Charge+®, Semaglutide, GLP-1 agonist
Medical subject headings
Prediabetic State, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AMPK Charge+®Dietary supplement

    Participants will be instructed to consume 1 teaspoon (5 mL) on an empty stomach before breakfast and 1 teaspoon on an empty stomach in the afternoon and to hold the product in the mouth for approximately 30-90 seconds before swallowing starting on Day 1.

  • AMPK Charge+® with semaglutideDietary supplement

    Participants will be instructed to use the provided measuring tool to take 1 teaspoon (5 mL) on an empty stomach before breakfast and 1 teaspoon on an empty stomach in the afternoon and to hold the product in the mouth for approximately 30-90 seconds before swallowing starting on Day 1. Participants will be instructed to administer subcutaneous semaglutide once per week beginning with a dose of 0.25 mg for four weeks at which point participants will be instructed to increase the dose to 0.5 mg per week for the remainder of the study period.

Study groups in NCT07195994
Study groupRoleWhat they receive
AMPK Charge+®ExperimentalAMPK Charge+® is a dietary supplement comprised of highly purified phospholipids, diindolylmethane, quercetin dihydrate, milk thistle seed extract, resveratrol, and berberine delivered using liposomal and nanoemulsion technology.
Receives: Dietary Supplement: AMPK Charge+®
AMPK Charge+® with semaglutideActive comparatorSubcutaneous semaglutide (Ozempic®), a glucagon-like peptide-1 (GLP-1) receptor agonist, is indicated for adults with T2D to improve glycemic control with the safety and efficacy extensively investigated leading to approvals by the United States (U.S.) Food and Drug Administration and Health Canada
Receives: Dietary Supplement: AMPK Charge+® with semaglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The difference in change in fasting blood glucose between AMPK Charge+® and AMPK Charge+® with semaglutide

    The difference in change in fasting blood glucose from baseline at Day 84 between AMPK Charge+® and AMPK Charge+® with semaglutide

    Measured: Day 0 to 84

  2. The difference in change in fasting insulin between AMPK Charge+® and AMPK Charge+® with semaglutide

    The difference in change in fasting insulin from baseline at Day 84 between AMPK Charge+® and AMPK Charge+® with semaglutide

    Measured: Day 0 to 84

  3. The difference in change in hemoglobin A1c (HbA1c) between AMPK Charge+® and AMPK Charge+® with semaglutide

    The difference in change in hemoglobin A1c (HbA1c) from baseline at Day 84 between AMPK Charge+® and AMPK Charge+® with semaglutide

    Measured: Day 0 to 84

Secondary outcomes (22)
  1. The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in fasting blood glucose

    The difference in change from baseline at Day 42 between AMPK Charge+® and AMPK Charge+® with semaglutide in fasting blood glucose

    Measured: Day 0 to 42

  2. The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in HbA1c

    The difference in change from baseline at Day 42 between AMPK Charge+® and AMPK Charge+® with semaglutide in fasting HbA1c

    Measured: Day 0 to 42

  3. The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in fasting insulin

    The difference in change from baseline at Day 42 between AMPK Charge+® and AMPK Charge+® with semaglutide in fasting insulin

    Measured: Day 0 to 42

  4. The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

    The difference in change from baseline at Day 42 between AMPK Charge+® and AMPK Charge+® with semaglutide in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

    Measured: Day 0 to 42

  5. The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

    The difference in change from baseline at Day 84 between AMPK Charge+® and AMPK Charge+® with semaglutide in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

    Measured: Day 0 to 84

  6. The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

    The difference in change from baseline at Day 42 between AMPK Charge+® and AMPK Charge+® with semaglutide in Total Cholesterol (TC),

    Measured: Day 0 to 42

  7. The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

    The difference in change from baseline at Day 84 between AMPK Charge+® and AMPK Charge+® with semaglutide in Total Cholesterol (TC),

    Measured: Day 0 to 84

  8. The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

    The difference in change from baseline at Day 42 between AMPK Charge+® and AMPK Charge+® with semaglutide in Low-Density Lipoprotein (LDL) cholesterol

    Measured: Day 0 to 42

  9. The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in High-Density Lipoprotein (HDL) cholesterol

    The difference in change from baseline at Day 84 between AMPK Charge+® and AMPK Charge+® with semaglutide in High-Density Lipoprotein (HDL) cholesterol

    Measured: Day 0 to 84

  10. The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in , High-Density Lipoprotein (HDL) cholesterol

    The difference in change from baseline at Day 42 between AMPK Charge+® and AMPK Charge+® with semaglutide in , High-Density Lipoprotein (HDL) cholesterol

    Measured: Day 0 to 42

  11. The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in Triglycerides (TG),

    The difference in change from baseline at Day 84 between AMPK Charge+® and AMPK Charge+® with semaglutide in Triglycerides (TG),

    Measured: Day 0 to 84

  12. The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in Triglycerides (TG),

    The difference in change from baseline at Day 42 between AMPK Charge+® and AMPK Charge+® with semaglutide in ,Triglycerides (TG),

    Measured: Day 0 to 42

  13. The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in TC:HDL-C, TG:HDL-C, and LDL-C:HDL-C ratios

    The difference in change from baseline at Day 84 between AMPK Charge+® and AMPK Charge+® with semaglutide in TC:HDL-C, TG:HDL-C, and LDL-C:HDL-C ratios

    Measured: Day 0 to 84

  14. The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in TC:HDL-C, TG:HDL-C, and LDL-C:HDL-C ratios

    The difference in change from baseline at Day 42 between AMPK Charge+® and AMPK Charge+® with semaglutide in TC:HDL-C, TG:HDL-C, and LDL-C:HDL-C ratios

    Measured: Day 0 to 42

  15. The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in Apolipoprotein B100 (ApoB100)

    The difference in change from baseline at Day 84 between AMPK Charge+® and AMPK Charge+® with semaglutide in Apolipoprotein B100 (ApoB100)

    Measured: Day 0 to 84

  16. The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in Inflammatory markers as assessed by C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)

    The difference in change from baseline at Day 84 between AMPK Charge+® and AMPK Charge+® with semaglutide in Inflammatory markers as assessed by C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)

    Measured: Day 0 to 84

  17. The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in Inflammatory markers as assessed by C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)

    The difference in change from baseline at Day 42 between AMPK Charge+® and AMPK Charge+® with semaglutide in Inflammatory markers as assessed by C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)

    Measured: Day 0 to 42

  18. The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in e. Body weight

    The difference in change from baseline at Day 84 between AMPK Charge+® and AMPK Charge+® with semaglutide in e. Body weight

    Measured: Day 0 to 84

  19. The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in e. Body weight

    The difference in change from baseline at Day 42 between AMPK Charge+® and AMPK Charge+® with semaglutide in e. Body weight

    Measured: Day 0 to 42

  20. The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in f. Framingham 10-year cardiovascular risk score (FCVRS)

    The difference in change from baseline at Day 84 between AMPK Charge+® and AMPK Charge+® with semaglutide in f. Framingham 10-year cardiovascular risk score (FCVRS)

    Measured: Day 0 to 84

  21. The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in f. Framingham 10-year cardiovascular risk score (FCVRS)

    The difference in change from baseline at Day 42 between AMPK Charge+® and AMPK Charge+® with semaglutide in f. Framingham 10-year cardiovascular risk score (FCVRS)

    Measured: Day 0 to 42

  22. The difference in change from baseline at Day 84 between AMPK Charge+® and AMPK Charge+® with semaglutide in Postprandial glucose and insulin as assessed by an oral glucose tolerance test (OGTT)

    The difference in change from baseline at Day 84 between AMPK Charge+® and AMPK Charge+® with semaglutide in Postprandial glucose and insulin as assessed by an oral glucose tolerance test (OGTT)

    Measured: Day 0 to 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2025
  2. Study start5 Feb 2026
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07195994
Sponsor's protocol ID
24QSCFA02
Status last verified
Mar 2026
First submitted
18 Sep 2025
Last updated
16 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing AMPK Charge+® and AMPK Charge+® with semaglutide in people with Prediabetes / Type 2 Diabetes, run by QuickSilver Scientific at 1 site in Canada.

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 17 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 16 Mar 2026. 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marc Moulin, PhD (2267819094, mmoulin@kgkscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The difference in change in fasting blood glucose between AMPK Charge+® and AMPK Charge+® with semaglutide (time frame: Day 0 to 84). The study lists 3 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 16 Mar 2026.

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