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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 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-03-16

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

AMPK Charge+®

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.

DIETARY_SUPPLEMENT

AMPK Charge+® with semaglutide

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.

Sponsors & Collaborators

  • KGK Science Inc.

    collaborator INDUSTRY

  • QuickSilver Scientific

    lead INDUSTRY

Principal Investigators

  • David Crowley, MD · KGK Science Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-05
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07195994 on ClinicalTrials.gov