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

NCT07195994 | Recruiting

• 1 other identifier: 24QSCFA02
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Prediabetes / Type 2 Diabetes

Keywords

Prediabetes; AMPK Charge+®; Semaglutide; GLP-1 agonist

Outcome Measures

Primary Outcomes (3)

• 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

  Day 0 to 84

• 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

  Day 0 to 84

• 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

  Day 0 to 84

Secondary Outcomes (22)

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

  Day 0 to 42

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

  Day 0 to 42

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

  Day 0 to 42

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

  Day 0 to 42

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

  Day 0 to 84

Study Arms (2)

AMPK Charge+®

EXPERIMENTAL

AMPK 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.

Dietary Supplement: AMPK Charge+®

AMPK Charge+® with semaglutide

ACTIVE COMPARATOR

Subcutaneous 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

Dietary Supplement: AMPK Charge+® with semaglutide

Interventions

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+®

AMPK Charge+® with semaglutide DIETARY_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.

AMPK Charge+® with semaglutide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• QuickSilver Scientific: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N6B3L1, Canada

RECRUITING

MeSH Terms

Conditions

Prediabetic State; Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Moulin, PhD

CONTACT

2267819094; mmoulin@kgkscience.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is a single-blind clinical trial wherein the Statistician and Research Scientist will be blinded to the allocation of study arms.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: September 29, 2025
• Study Start: February 5, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

CA (1)