Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07195994

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

Led by QuickSilver Scientific · Updated on 2026-03-16

90

Participants Needed

1

Research Sites

29 weeks

Total Duration

On this page

Sponsors

Q

QuickSilver Scientific

Lead Sponsor

K

KGK Science Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Females not able to have children due to sterilization or menopause for at least 1 year, or females of child-bearing potential with a negative pregnancy test and using approved birth control methods for the study duration
  • Adults eligible for semaglutide therapy but not currently taking it, including treatment-naïve prediabetes (HbA1c 6.0-6.5%) and Type 2 Diabetes (HbA1c 6.5-7.5%) with metformin contraindication or intolerance
  • Stable body weight with less than 5 kg change in the past 3 months
  • Willing to maintain current lifestyle habits including diet, physical activity, medications, supplements, sleep, and use of nicotine, tobacco, or cannabinoid products throughout the study
  • Willing to complete study questionnaires, diaries, and clinic visits
  • Provided written informed consent to participate
Not Eligible

You will not qualify if you...

  • Pregnant, breastfeeding, or planning pregnancy during the study
  • Allergy, sensitivity, intolerance, or dietary restrictions preventing use of study products
  • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
  • Unstable metabolic or chronic diseases
  • Current or past significant gastrointestinal diseases
  • Unstable hypertension (stable medication dose for at least 3 months may be considered)
  • Type 1 diabetes or diabetic ketoacidosis
  • Significant cardiovascular event in past 6 months (stable medication may be considered)
  • Kidney or liver diseases, except symptom-free history of kidney stones for 6 months
  • Thyroid condition requiring medication (stable dose for at least 3 months may be considered)
  • Major surgery in past 3 months or planned surgery during study (minor surgery considered case-by-case)
  • Cancer except fully excised basal cell carcinoma or cancer in remission for over 5 years
  • Autoimmune disease or immune compromised
  • HIV, Hepatitis B or C infection
  • Blood or bleeding disorders
  • Alcohol intake averaging more than 2 standard drinks per day
  • Alcohol or drug abuse within last 12 months
  • Use of medications, supplements, or foods affecting study product efficacy or safety
  • Abnormal lab results at screening
  • Blood donation within 30 days before, during, or planned within 30 days after study
  • Participation in another clinical trial within 30 days before baseline
  • Unable to give informed consent
  • Any other condition or lifestyle factor that may affect study participation or safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

KGK Science Inc.

London, Ontario, Canada, N6B3L1

Actively Recruiting

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Research Team

M

Marc Moulin, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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